xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05998941</url>
    </required_header>
    <id_info>
      <org_study_id>TQB2868-II-01</org_study_id>
      <nct_id>NCT05998941</nct_id>
    </id_info>
    <brief_title>A Trial of TQB2868 Plus Platinum-based Chemotherapy With or Without Bevacizumab in the First-line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer</brief_title>
    <official_title>TQB2868 Plus Platinum-based Chemotherapy With or Without Bevacizumab in the First-line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer: a Single-arm, Open-label Phase Ⅱ Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study used a single-arm, open phase II multicenter trial design. All eligible subjects&#xD;
        received TQB2868 plus platinum-based chemotherapy with or without bevacizumab. A total of 39&#xD;
        subjects will be enrolled.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">February 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Investigator-assessed objective response rate (ORR)</measure>
      <time_frame>Baseline to CR or PR ,about 12 months</time_frame>
      <description>The proportion of subjects who achieve a prespecified reduction in tumor volume and maintain the minimum time requirement, including complete response (CR) and partial response (PR).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression free survival (PFS)</measure>
      <time_frame>Baseline up to PD or death, about 24 months</time_frame>
      <description>The time between the first dose of medication and disease progression (PD) or death before PD; If there was no PD or death before PD, the date of the last imaging assessment was used as the cutoff date.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>Baseline up to PD or death, about 24 months</time_frame>
      <description>The proportion of patients whose tumors shrink or remain stable for a certain period of time, including CR, PR, and stable disease (SD) cases.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR)</measure>
      <time_frame>Baseline up to PD or death, about 24 months</time_frame>
      <description>It refers to the time between the first assessment of the tumor as CR or PR to PD or death before PD in subjects with CR or PR; If subjects with CR or PR did not present with PD or die before PD, the date of the last imaging assessment was used as the cutoff date.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>Baseline up to die, about 36 months</time_frame>
      <description>The time from the first treatment to death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PFS rate (≥6 months)</measure>
      <time_frame>Baseline up to PD or death, about 24 months</time_frame>
      <description>The proportion of patients alive and free of disease progression from the beginning of the first treatment to 6 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse event rate</measure>
      <time_frame>Baseline to the end of the study, about 2 years</time_frame>
      <description>Occurrence of all adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events (TEAEs), and immune-related adverse events (IRaes).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ -C30)</measure>
      <time_frame>Baseline to the end of the study, about 2 years</time_frame>
      <description>For questions 1 to 28, choose a number from 1 to 4, where 1 means no and 4 means very good. For questions 29 and 30, choose a number from 1 to 7, where 1 means very poor and 7 means very good.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ -CX24)</measure>
      <time_frame>Baseline to the end of the study, about 2 years</time_frame>
      <description>EORTC QLQ-CX24 is a questionnaire for measuring the quality of life of patients with cervical cancer. It has 24 items, including 3 multi-dimensional dimensions of symptoms, body image and sexual/vaginal function, and 6 single-dimensional dimensions of sexual activity, sexual enjoyment, sexual anxiety, lymphedema, menopausal symptoms and peripheral neuropathy. &quot;None&quot; to &quot;very&quot; were scored from 1 to 4, and the score was inversely proportional to the quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EuroQol 5 Dimensions (EQ-5D) Health questionnaire</measure>
      <time_frame>Baseline to the end of the study, about 2 years</time_frame>
      <description>EQ-5D is a simple health measure developed by the European Society for Quality of Life. The EQ-5D mainly consists of two parts: the EQ-5D description system and the EQ-5D Visual Analogue Scale (EQ-VAS). The EQ-5D description system describes the health status in five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. The EQ-VAS is to record the self-rated health status of the respondents. The scale is 0-100, with 0 being &quot;worst imagined health&quot; and 100 being &quot;best imagined health.&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PD-L1 and TGF-β expression</measure>
      <time_frame>At baseline</time_frame>
      <description>PD-1/TGF-β double antibody can increase Leukocyte differentiation antigen 8 (CD8+) T cells in the tumor, reduce immunosuppressive myeloid cells, and inhibit PD-1/PD-L1 pathway on the basis of targeting and neutralizing TGF-β in the tumor microenvironment, which can restore the activity of T cells, enhance the immune response, and more effectively improve the inhibition of tumor.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Human papillomavirus (HPV) expression</measure>
      <time_frame>At baseline</time_frame>
      <description>The relationship between human papillomavirus and cervical cancer is very close. Persistent infection of high-risk human papillomavirus is one of the high risk factors for cervical cancer.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">39</enrollment>
    <condition>Cervical Cancer</condition>
    <arm_group>
      <arm_group_label>TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TQB2868 injection + paclitaxel injection + cisplatin/carboplatin injection ± bevacizumab injection, 3 weeks (21 days) as a treatment cycle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TQB2868 injection</intervention_name>
      <description>TQB2868 injection is an anti-programmed cell death protein 1 (PD-1)/ transforming growth factor-β (TGF-β) dual-function fusion protein.</description>
      <arm_group_label>TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Paclitaxel injection</intervention_name>
      <description>Paclitaxel injection prevents depolymerization of microtubules, inhibits mitosis, and hinders normal cell division.</description>
      <arm_group_label>TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cisplatin injection</intervention_name>
      <description>Cisplatin injection can inhibit the DNA replication process of cancer cells</description>
      <arm_group_label>TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Carboplatin injection</intervention_name>
      <description>Carboplatin injection acts directly on DNA, thus inhibiting the vigorous division of tumor cells.</description>
      <arm_group_label>TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bevacizumab injection</intervention_name>
      <description>Bevacizumab is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF).</description>
      <arm_group_label>TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically confirmed persistent, recurrent or metastatic (International Federation&#xD;
               of Gynecology and Obstetrics (FIGO) stage IVB) cervical cancer with squamous cell&#xD;
               carcinoma, adenocarcinoma or adenosquamous carcinoma;&#xD;
  &#xD;
            -  It is not suitable for radical treatment such as surgery, radiotherapy and concurrent&#xD;
               chemoradiotherapy;&#xD;
  &#xD;
            -  No previous systemic therapy for persistent, recurrent or metastatic cervical cancer;&#xD;
  &#xD;
            -  Provide archived or freshly obtained tumor tissue samples within the past 2 years or&#xD;
               provide traceable test reports;&#xD;
  &#xD;
            -  18 years old ≤75 years old (calculated on the date of signing the informed consent);&#xD;
               Eastern Cooperative Oncology Group (ECOG) score 0-1; Expected survival ≥3 months;&#xD;
  &#xD;
            -  At least one measurable lesion according to (Response Evaluation Criteria In Solid&#xD;
               Tumors (RECIST) 1.1 criteria;&#xD;
  &#xD;
            -  The main organs function well and meet the following standards:&#xD;
  &#xD;
                 1. Blood routine test criteria (in the case of no blood transfusion and no&#xD;
                    correction by hematopoietic stimulating factor drugs within 14 days before&#xD;
                    screening) : absolute neutrophil count (ANC) ≥1.5×109 /L; Platelet ≥100×109 /L;&#xD;
                    Hemoglobin ≥100 g/L.&#xD;
  &#xD;
                 2. Blood biochemical tests should meet the following criteria: total bilirubin&#xD;
                    (TBIL) ≤2× upper limit of normal (ULN) (≤3×ULN in Gilbert syndrome patients);&#xD;
                    Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. If&#xD;
                    liver metastasis is present, ALT and AST≤5×ULN; Serum creatinine (Cr) ≤1.5×ULN or&#xD;
                    creatinine clearance ≥60 mL/min; Serum albumin (ALB) ≥30g/L.&#xD;
  &#xD;
                 3. Urine routine examination criteria: urine routine indicated that urinary protein&#xD;
                    &lt;++; If urinary protein ≥++, it should be confirmed that 24-hour urinary protein&#xD;
                    quantification ≤1.0 g.&#xD;
  &#xD;
                 4. Coagulation function test criteria: prothrombin time (PT), activated partial&#xD;
                    thromboplastin time (APTT), international normalized ratio (INR) ≤1.5×ULN (no&#xD;
                    anticoagulant therapy).&#xD;
  &#xD;
                 5. Thyroid stimulating hormone (TSH) ≤ ULN; If abnormal, T3 and T4 levels should be&#xD;
                    examined. If T3 and T4 levels are normal, they can be selected.&#xD;
  &#xD;
                 6. Echocardiographic assessment: left ventricular ejection fraction (LVEF) ≥50%.&#xD;
  &#xD;
                 7. 12-lead Electrocardiograph (ECG) assessment: Corrected QT interval prolongation&#xD;
                    (QTc)&lt;470ms (female).&#xD;
  &#xD;
            -  Female subjects of childbearing age should agree to use contraception (such as&#xD;
               intrauterine device (IUD), birth control pill or condom) during the study period and&#xD;
               within 6 months after the study. A negative serum or urine pregnancy test within 7&#xD;
               days prior to study entry and must be non-lactating.&#xD;
  &#xD;
            -  Subjects voluntarily participated in this study, signed informed consent, and had good&#xD;
               compliance.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Tumor disease and medical history:&#xD;
  &#xD;
                 1. Have developed or are currently suffering from other malignant tumors within 3&#xD;
                    years. The following two cases were included: other malignant tumors treated by&#xD;
                    single surgery, achieving R0 resection and no recurrence or metastasis; Cured&#xD;
                    non-melanoma skin cancer, nasopharyngeal carcinoma, and superficial bladder&#xD;
                    tumors&#xD;
  &#xD;
                 2. Other pathological types, such as mucinous adenocarcinoma, clear cell&#xD;
                    adenocarcinoma, neuroendocrine tumor;&#xD;
  &#xD;
                 3. tumor infiltration into the bladder or rectum;&#xD;
  &#xD;
                 4. Subjects with known central nervous system (CNS) metastases and/or carcinomatous&#xD;
                    meningitis;&#xD;
  &#xD;
                 5. Patients whose imaging showed that the tumor had invaded important blood vessels&#xD;
                    or the investigators judged that the tumor was highly likely to invade important&#xD;
                    blood vessels during the follow-up study and cause fatal hemorrhage;&#xD;
  &#xD;
                 6. Uncontrollable pleural, pericardial, or peritoneal effusions requiring repeated&#xD;
                    drainage.&#xD;
  &#xD;
            -  Previous anti-tumor therapy:&#xD;
  &#xD;
                 1. Received the last concurrent chemoradiotherapy for radical surgery or&#xD;
                    postoperative adjuvant therapy within 3 months before the first medication;&#xD;
                    Received palliative radiotherapy within 2 weeks before the first dose;&#xD;
  &#xD;
                 2. Previously received platinum-based dual agents or any other chemotherapy agents&#xD;
                    in concurrent chemoradiotherapy for radical purposes;&#xD;
  &#xD;
                 3. Received Chinese patent medicine with anti-tumor indications specified in the&#xD;
                    National Medicinal Products Administration (NMPA) approved drug instructions&#xD;
                    within 2 weeks before the first drug use;&#xD;
  &#xD;
                 4. Prior treatment with anti-angiogenic therapy, immune checkpoint inhibitor&#xD;
                    therapy, or any treatment targeting immune costimulatory factors, which target&#xD;
                    the immune mechanism of tumor immune action;&#xD;
  &#xD;
                 5. Patients who received immunoregulatory drugs within 2 weeks before the first&#xD;
                    dose;&#xD;
  &#xD;
                 6. Non-resolved toxicity of grade 1 or higher than Common Terminology Criteria for&#xD;
                    Adverse Events (CTCAE) due to any previous treatment, excluding alopecia,&#xD;
                    peripheral sensory impairment.&#xD;
  &#xD;
            -  Comorbidities and medical history:&#xD;
  &#xD;
               a. Decompensated cirrhosis and active hepatitis; b. Kidney abnormalities: i. Renal&#xD;
               failure requiring hemodialysis or peritoneal dialysis; ii. Presence of clinically&#xD;
               significant hydronephrosis that, in the judgment of the investigator, cannot be&#xD;
               resolved by nephrostomy or ureteral stent placement.&#xD;
  &#xD;
               c. Cardiovascular and cerebrovascular abnormalities: i. Myocardial ischemia or&#xD;
               myocardial infarction occurred within half a year; ≥ class 2 Congestive heart failure&#xD;
               of New York Heart Association (NYHA); Arterial thrombotic events block ≥ Grade 2;&#xD;
               Arrhythmias that cannot be stably controlled with drugs and those that may potentially&#xD;
               affect the trial treatment; ii. Arterial thrombotic events / venous thrombotic events,&#xD;
               such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism,&#xD;
               occurred within 6 months; iii. Patients with poor blood pressure control after&#xD;
               standard treatment; iv. Previous history of myocarditis or cardiomyopathy. d.&#xD;
               Gastrointestinal abnormalities: i. Active or documented inflammatory bowel disease,&#xD;
               active diverticulitis; ii. Gastrointestinal perforation, fistula, and intra-abdominal&#xD;
               abscess occurred within 6 months before the first medication; iii. The presence of&#xD;
               clinical manifestations of gastrointestinal obstruction or the need for routine&#xD;
               parenteral rehydration, parenteral nutrition, or indwelling gastric tube.&#xD;
  &#xD;
               e. History of immunodeficiency: i. A history of immunodeficiency, including Human&#xD;
               Immunodeficiency Virus (HIV) positive or other acquired or congenital immunodeficiency&#xD;
               diseases, or a history of organ transplantation; ii. Active autoimmune disease&#xD;
               requiring systemic therapy occurred within 2 years before the first dose. Alternative&#xD;
               therapies are not considered systemic treatments; iii. is diagnosed with&#xD;
               immunodeficiency or is receiving systemic glucocorticoid therapy or any other form of&#xD;
               immunosuppressive therapy (at a dose &gt;10mg/ day of prednisone or other iso-efficacy&#xD;
               hormone) and continues to use it within 2 weeks of the first dose.&#xD;
  &#xD;
               f. Risk of bleeding: i. Bleeding, clotting disease, or current use of warfarin,&#xD;
               aspirin, or other antiplatelet drugs within 28 days before the first dose; ii.&#xD;
               Patients with any history of bleeding or coagulopathy, regardless of severity; iii.&#xD;
               Major surgical treatment or significant traumatic injury within 28 days prior to the&#xD;
               first dose, or locally invasive procedure within 1 week), or elective major surgical&#xD;
               treatment required during the study; iv. Wounds or fractures that have not healed for&#xD;
               a long time. g. Poorly controlled diabetes: fasting blood glucose (FBG) &gt; 10mmol/L; h.&#xD;
               Severe active or uncontrolled infection (≥CTC AE grade 2 infection); i. People with&#xD;
               known active syphilis and active tuberculosis; j. Previous or existing interstitial&#xD;
               pneumonia, (non-infectious) pneumonia requiring corticosteroid therapy, or other&#xD;
               pneumonia of grade ≥2; k. Severe hypersensitivity reaction after the use of monoclonal&#xD;
               antibodies; l. Known to have any contraindications to cisplatin/carboplatin or&#xD;
               paclitaxel or to be allergic to any of their components; m. Those who have a history&#xD;
               of psychotropic drug abuse and cannot quit or have mental disorders; n. Those who&#xD;
               suffer from epilepsy and need treatment.&#xD;
  &#xD;
            -  Those who participated in clinical trials of other anti-tumor drugs within 4 weeks&#xD;
               before the first drug use or did not exceed 5 drug half-lives.&#xD;
  &#xD;
            -  History of live attenuated vaccine vaccination within 28 days before the first dose or&#xD;
               planned live attenuated vaccine vaccination during the study period.&#xD;
  &#xD;
            -  According to the investigator's judgment, there are concomitant diseases that&#xD;
               seriously endanger the safety of the subjects or affect the completion of the study,&#xD;
               or there are other reasons that the subjects are not suitable for enrollment.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Qin Xu, Doctor</last_name>
      <phone>+86 13950419396</phone>
      <email>13950419396@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chongqing University Cancer Hospital</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ying Tang, Master</last_name>
        <phone>+86 13983250752</phone>
        <email>2645264434@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Fujian Cancer Hospital</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <zip>350014</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Qin Xu, Doctor</last_name>
        <phone>+86 13950419396</phone>
        <email>13950419396@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Bevacizumab</mesh_term>
      <mesh_term>Carboplatin</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05998941
  org study id: TQB2868-II-01
  nct id: NCT05998941
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study used a single-arm, open phase II multicenter trial design. All eligible subjects
        received TQB2868 plus platinum-based chemotherapy with or without bevacizumab. A total of 39
        subjects will be enrolled.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Investigator-assessed objective response rate (ORR)
  time frame: Baseline to CR or PR ,about 12 months
  description: The proportion of subjects who achieve a prespecified reduction in tumor volume and maintain the minimum time requirement, including complete response (CR) and partial response (PR).
  measure: Progression free survival (PFS)
  time frame: Baseline up to PD or death, about 24 months
  description: The time between the first dose of medication and disease progression (PD) or death before PD; If there was no PD or death before PD, the date of the last imaging assessment was used as the cutoff date.
  measure: Disease control rate (DCR)
  time frame: Baseline up to PD or death, about 24 months
  description: The proportion of patients whose tumors shrink or remain stable for a certain period of time, including CR, PR, and stable disease (SD) cases.
  measure: Duration of response (DOR)
  time frame: Baseline up to PD or death, about 24 months
  description: It refers to the time between the first assessment of the tumor as CR or PR to PD or death before PD in subjects with CR or PR; If subjects with CR or PR did not present with PD or die before PD, the date of the last imaging assessment was used as the cutoff date.
  measure: Overall survival (OS)
  time frame: Baseline up to die, about 36 months
  description: The time from the first treatment to death from any cause.
  measure: PFS rate (≥6 months)
  time frame: Baseline up to PD or death, about 24 months
  description: The proportion of patients alive and free of disease progression from the beginning of the first treatment to 6 months.
  measure: Adverse event rate
  time frame: Baseline to the end of the study, about 2 years
  description: Occurrence of all adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events (TEAEs), and immune-related adverse events (IRaes).
  measure: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ -C30)
  time frame: Baseline to the end of the study, about 2 years
  description: For questions 1 to 28, choose a number from 1 to 4, where 1 means no and 4 means very good. For questions 29 and 30, choose a number from 1 to 7, where 1 means very poor and 7 means very good.
  measure: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ -CX24)
  time frame: Baseline to the end of the study, about 2 years
  description: EORTC QLQ-CX24 is a questionnaire for measuring the quality of life of patients with cervical cancer. It has 24 items, including 3 multi-dimensional dimensions of symptoms, body image and sexual/vaginal function, and 6 single-dimensional dimensions of sexual activity, sexual enjoyment, sexual anxiety, lymphedema, menopausal symptoms and peripheral neuropathy. "None" to "very" were scored from 1 to 4, and the score was inversely proportional to the quality of life.
  measure: EuroQol 5 Dimensions (EQ-5D) Health questionnaire
  time frame: Baseline to the end of the study, about 2 years
  description: EQ-5D is a simple health measure developed by the European Society for Quality of Life. The EQ-5D mainly consists of two parts: the EQ-5D description system and the EQ-5D Visual Analogue Scale (EQ-VAS). The EQ-5D description system describes the health status in five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. The EQ-VAS is to record the self-rated health status of the respondents. The scale is 0-100, with 0 being "worst imagined health" and 100 being "best imagined health."
  measure: PD-L1 and TGF-β expression
  time frame: At baseline
  description: PD-1/TGF-β double antibody can increase Leukocyte differentiation antigen 8 (CD8+) T cells in the tumor, reduce immunosuppressive myeloid cells, and inhibit PD-1/PD-L1 pathway on the basis of targeting and neutralizing TGF-β in the tumor microenvironment, which can restore the activity of T cells, enhance the immune response, and more effectively improve the inhibition of tumor.
  measure: Human papillomavirus (HPV) expression
  time frame: At baseline
  description: The relationship between human papillomavirus and cervical cancer is very close. Persistent infection of high-risk human papillomavirus is one of the high risk factors for cervical cancer.
  arm group label: TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection
  arm group type: Experimental
  description: TQB2868 injection + paclitaxel injection + cisplatin/carboplatin injection ± bevacizumab injection, 3 weeks (21 days) as a treatment cycle.
  intervention type: Drug
  intervention name: TQB2868 injection
  description: TQB2868 injection is an anti-programmed cell death protein 1 (PD-1)/ transforming growth factor-β (TGF-β) dual-function fusion protein.
  arm group label: TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection
  intervention type: Drug
  intervention name: Paclitaxel injection
  description: Paclitaxel injection prevents depolymerization of microtubules, inhibits mitosis, and hinders normal cell division.
  arm group label: TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection
  intervention type: Drug
  intervention name: Cisplatin injection
  description: Cisplatin injection can inhibit the DNA replication process of cancer cells
  arm group label: TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection
  intervention type: Drug
  intervention name: Carboplatin injection
  description: Carboplatin injection acts directly on DNA, thus inhibiting the vigorous division of tumor cells.
  arm group label: TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection
  intervention type: Drug
  intervention name: Bevacizumab injection
  description: Bevacizumab is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF).
  arm group label: TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Qin Xu, Doctor
  phone: +86 13950419396
  email: 13950419396@qq.com
  facility: 
  contact: 
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Uterine Cervical Neoplasms
  mesh term: Paclitaxel
  mesh term: Bevacizumab
  mesh term: Carboplatin