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/NCT06020755</url>
    </required_header>
    <id_info>
      <org_study_id>TA7-GTN-001</org_study_id>
      <nct_id>NCT06020755</nct_id>
    </id_info>
    <brief_title>Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 7</brief_title>
    <acronym>TA7</acronym>
    <official_title>Efficacy and Safety of Toripalimab Plus Actinomycin-D as Fist-Line Treatment in Patients With Gestational Trophoblastic Neoplasia With FIGO Score 7: A Single-Arm, Multicenter, Phase II Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Obstetrics &amp; Gynecology Hospital of Fudan University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shengjing Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Henan Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Gansu Provincial Maternal and Child Health Care Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Dalian Maternity and Child Care Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Xiamen University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sichuan Cancer Hospital &amp; Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanghai Junshi Bioscience Co., Ltd.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab plus&#xD;
        actinomycin-D as fist-line treatment in patients with gestational trophoblastic neoplasia&#xD;
        with FIGO score 7. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Whether toripalimab plus actinomycin-D as fist-line treatment can achieve a high&#xD;
             complete response rate.&#xD;
  &#xD;
          -  Whether an equally high cure rate can be achieved by multi-drug chemotherapy as&#xD;
             second-line treatment in patients who have failed fist-line treatment with toripalimab&#xD;
             plus actinomycin-D.&#xD;
  &#xD;
        Participants will receive toripalimab plus actinomycin-D. Treatment will be continued until&#xD;
        disease progression, unacceptable toxicity, or withdrawal of consent. Treatment will be&#xD;
        completed after 4 consolidation cycles.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab plus&#xD;
        actinomycin-D as fist-line treatment in patients with gestational trophoblastic neoplasia&#xD;
        with FIGO score 7.&#xD;
  &#xD;
        Eligible Participants will receive toripalimab (200mg q2w intravenous) plus actinomycin-D&#xD;
        (1.25mg/m2，2mg max dose, intravenous). After normalization of serum β-human chorionic&#xD;
        gonadotropin (β-hCG) levels, patients will receive 4 cycles of consolidation treatment.&#xD;
        Treatment will be continued until completion of treatment, disease progression, unacceptable&#xD;
        toxicity, or withdrawal of consent. The primary endpoint is complete remission rate (the&#xD;
        proportion of patients achieving complete remission). Secondary endpoints include objective&#xD;
        response rate (the proportion of patients achieving complete remission and partial&#xD;
        remission), progression-free survival (time from the treatment initiation to disease&#xD;
        progression or death, whichever comes first), disease control rate, duration of response,&#xD;
        overall survival (time from the treatment initiation to the date of death or last follow-up),&#xD;
        duration of response (time from the first evidence of response to disease progression or&#xD;
        death, whichever comes first) safety, biomarker, ovarian function and quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 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>Complete remission rate</measure>
      <time_frame>up to one year</time_frame>
      <description>The proportion of patients achieving complete remission. Complete remission is defined as normal serum β-hCG level measured for 4 consecutive weeks.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective response rate</measure>
      <time_frame>up to one year</time_frame>
      <description>The proportion of patients with complete or partial response according to serum β-hCG level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>up to one year</time_frame>
      <description>The time from the treatment initiation to disease progression or death, whichever comes first. Disease progression is defined as any increase in serum β-hCG level from baseline after 2 cycles of treatment or the presence of new metastatic lesions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate</measure>
      <time_frame>up to one year</time_frame>
      <description>The proportion of patients with complete response, partial response, or stable disease according to serum β-hCG level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response</measure>
      <time_frame>up to one year</time_frame>
      <description>The time from the first evidence of response to disease progression or death, whichever comes first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>up to one year</time_frame>
      <description>The time from the treatment initiation to the date of death or last follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
      <time_frame>up to one year</time_frame>
      <description>Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 5.0) .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ovarian function</measure>
      <time_frame>up to one year</time_frame>
      <description>Determine ovarian function as assessed by anti-Müllerian hormone (AMH)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life of cancer patients</measure>
      <time_frame>up to one year</time_frame>
      <description>Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cancer specific rehabilitation</measure>
      <time_frame>up to one year</time_frame>
      <description>Assessed by Cancer rehabilitation evaluation system-short form (CARES-SF)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reproductive concerns after cancer</measure>
      <time_frame>up to one year</time_frame>
      <description>Assessed by Reproductive Concerns After Cancer (RCAC) scale</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">17</enrollment>
    <condition>Gestational Trophoblastic Neoplasia</condition>
    <arm_group>
      <arm_group_label>Toripalimab Plus Actinomycin-D</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Toripalimab 200mg intravenously(IV) every 2 weeks (Q2W) Actinomycin-D 1.25mg/m2，2mg max dos, intravenously(IV) every 2 weeks (Q2W)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Toripalimab</intervention_name>
      <description>200mg q2w intravenous</description>
      <arm_group_label>Toripalimab Plus Actinomycin-D</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Actinomycin-D</intervention_name>
      <description>1.25mg/m2，2mg max dose, q2w, intravenous</description>
      <arm_group_label>Toripalimab Plus Actinomycin-D</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Diagnosed as GTN:&#xD;
  &#xD;
               There is a histologic diagnosis of choriocarcinoma or invasive mole. Postmolar GTN:&#xD;
               The plateau of β-hCG (±10%) lasts for four measurements over a period of 3 weeks or&#xD;
               longer (days 1, 7, 14, 21). There is a rise (&gt;10%) in β-hCG for three consecutive&#xD;
               weekly measurements over at least a period of 2 weeks or more (days 1, 7, 14).&#xD;
  &#xD;
               GTN after nonmolar pregnancy: There is a rise after decease, or a plateau of β-hCG 4&#xD;
               weeks after abortion, ectopic pregnancy, or term delivery. Pregnancy residue or new&#xD;
               pregnancy have been ruled out.&#xD;
  &#xD;
            2. Patients with a FIGO score of 7.&#xD;
  &#xD;
            3. Signed informed consent.&#xD;
  &#xD;
            4. No previous immunotherapy, chemotherapy, or radiotherapy.&#xD;
  &#xD;
            5. Woman aged 18-60 years.&#xD;
  &#xD;
            6. Expected survival ≥ 6 months.&#xD;
  &#xD;
            7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days&#xD;
               before first dose.&#xD;
  &#xD;
            8. The function of vital organs meets the following requirements:&#xD;
  &#xD;
          hemoglobin ≥90 g/L, absolute neutrophil count ≥1·5×109/L, platelets ≥100×109/L; creatinine&#xD;
          ≤1·5 × upper limit of normal (ULN), urea nitrogen ≤2·5×ULN; total bilirubin ≤1.5×ULN,&#xD;
          alanine aminotransferase and aspartate aminotransferase ≤2·5×ULN, INR, PT or APTT ≤1.5×ULN,&#xD;
          thyroid stimulating hormone ≤ULN (if thyroid stimulating hormone is abnormal, normal T3 and&#xD;
          T4 can also be acceptable).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Histologically confirmed placental-site trophoblastic tumor (PSTT) or epithelioid&#xD;
               trophoblastic tumor (ETT).&#xD;
  &#xD;
            2. Histologically confirmed primary choriocarcinoma.&#xD;
  &#xD;
            3. Other malignancies in the past 3 years.&#xD;
  &#xD;
            4. Prior systemic anti-cancer treatment, including chemotherapy and radiotherapy.&#xD;
  &#xD;
            5. Live vaccines injected within 30 days before the first dose of study drug;&#xD;
  &#xD;
            6. Systemic immune stimulant agent (such as a bacterial or viral vaccine,&#xD;
               colony-stimulating factors, interferon, interleukin, and combined vaccine) was used 6&#xD;
               weeks before administration or within the 5 half-lives of the drug, whichever is&#xD;
               shorter.&#xD;
  &#xD;
            7. Previous treatment with immunotherapy drugs (including antibodies targeting PD-1,&#xD;
               PD-L1, PD-L2, cytotoxic T-lymphocyte-associated protein 4, T-cell receptor, chimeric&#xD;
               antigen receptor T-cell therapy, and other immunotherapy).&#xD;
  &#xD;
            8. Known hypersensitivity or allergy to actinomycin-D, toripalimab or any of their&#xD;
               excipients.&#xD;
  &#xD;
            9. Any active autoimmune disease requiring systemic treatment during the past 2 years.&#xD;
  &#xD;
           10. History or current status of non-infectious pneumonia requiring steroid treatment.&#xD;
  &#xD;
           11. Receiving steroid hormones (prednisone dose &gt; 10mg/ day) or other immunosuppressants&#xD;
               within 14 days before enrollment, excluding those on hormone replacement therapy.&#xD;
  &#xD;
           12. Active infection that requires systemic treatment.&#xD;
  &#xD;
           13. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome,&#xD;
               active hepatitis B, hepatitis C.&#xD;
  &#xD;
           14. History of psychotropic drug abuse and are unable to withdraw the psychotropic drug,&#xD;
               or have mental disorders.&#xD;
  &#xD;
           15. Grade II or higher myocardial ischemia, myocardial infarction or poorly controlled&#xD;
               arrhythmia (females with QTc interval ≥470 ms); grade III to IV cardiac insufficiency&#xD;
               according to New York Heart Association (NYHA) criteria, or cardiac color Doppler&#xD;
               ultrasound evidence of left ventricular ejection fraction &lt;50%; myocardial infarction,&#xD;
               NYHA grade II or above heart failure, uncontrolled angina, uncontrolled severe&#xD;
               ventricular arrhythmia, clinically significant pericardial disease, or&#xD;
               electrocardiogram suggesting acute ischemia or abnormal active conduction system&#xD;
               occurring within 6 months before enrolment.&#xD;
  &#xD;
           16. Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood&#xD;
               pressure ≥90 mmHg, despite with the optimal drug therapy).&#xD;
  &#xD;
           17. Abnormal coagulation (international normalized ratio &gt;1·5×ULN or prothrombin time&#xD;
               &gt;ULN+4 seconds or activated partial thromboplastin time &gt;1·5×ULN), with bleeding&#xD;
               tendency or undergoing thrombolysis or anticoagulant therapy.&#xD;
  &#xD;
           18. History of cerebrovascular accident (including transient ischemic attack, cerebral&#xD;
               hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 3&#xD;
               months before enrolment.&#xD;
  &#xD;
           19. Obvious factors affecting oral drug absorption, such as inability to swallow, chronic&#xD;
               diarrhea and intestinal obstruction, or sinus or perforation of empty organs within 6&#xD;
               months.&#xD;
  &#xD;
           20. A history of allogeneic stem cell transplantation or organ transplantation.&#xD;
  &#xD;
           21. Other reasons as judged by the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yang Xiang</last_name>
      <phone>+861069156068</phone>
      <email>xiangy@pumch.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
      <investigator_full_name>xiang yang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Gestational Trophoblastic Neoplasia</keyword>
    <keyword>International Federation of Gynecology and Obstetrics</keyword>
    <keyword>Toripalimab</keyword>
    <keyword>Actinomycin-D</keyword>
    <keyword>Efficacy</keyword>
    <keyword>Safety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Gestational Trophoblastic Disease</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dactinomycin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06020755
  org study id: TA7-GTN-001
  nct id: NCT06020755
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab plus
        actinomycin-D as fist-line treatment in patients with gestational trophoblastic neoplasia
        with FIGO score 7. The main questions it aims to answer are:
  
          -  Whether toripalimab plus actinomycin-D as fist-line treatment can achieve a high
             complete response rate.
  
          -  Whether an equally high cure rate can be achieved by multi-drug chemotherapy as
             second-line treatment in patients who have failed fist-line treatment with toripalimab
             plus actinomycin-D.
  
        Participants will receive toripalimab plus actinomycin-D. Treatment will be continued until
        disease progression, unacceptable toxicity, or withdrawal of consent. Treatment will be
        completed after 4 consolidation cycles.
  The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab plus
        actinomycin-D as fist-line treatment in patients with gestational trophoblastic neoplasia
        with FIGO score 7.
  
        Eligible Participants will receive toripalimab (200mg q2w intravenous) plus actinomycin-D
        (1.25mg/m2，2mg max dose, intravenous). After normalization of serum β-human chorionic
        gonadotropin (β-hCG) levels, patients will receive 4 cycles of consolidation treatment.
        Treatment will be continued until completion of treatment, disease progression, unacceptable
        toxicity, or withdrawal of consent. The primary endpoint is complete remission rate (the
        proportion of patients achieving complete remission). Secondary endpoints include objective
        response rate (the proportion of patients achieving complete remission and partial
        remission), progression-free survival (time from the treatment initiation to disease
        progression or death, whichever comes first), disease control rate, duration of response,
        overall survival (time from the treatment initiation to the date of death or last follow-up),
        duration of response (time from the first evidence of response to disease progression or
        death, whichever comes first) safety, biomarker, ovarian function and quality of life.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Complete remission rate
  time frame: up to one year
  description: The proportion of patients achieving complete remission. Complete remission is defined as normal serum β-hCG level measured for 4 consecutive weeks.
  measure: Objective response rate
  time frame: up to one year
  description: The proportion of patients with complete or partial response according to serum β-hCG level.
  measure: Progression-free survival
  time frame: up to one year
  description: The time from the treatment initiation to disease progression or death, whichever comes first. Disease progression is defined as any increase in serum β-hCG level from baseline after 2 cycles of treatment or the presence of new metastatic lesions.
  measure: Disease control rate
  time frame: up to one year
  description: The proportion of patients with complete response, partial response, or stable disease according to serum β-hCG level.
  measure: Duration of response
  time frame: up to one year
  description: The time from the first evidence of response to disease progression or death, whichever comes first.
  measure: Overall survival
  time frame: up to one year
  description: The time from the treatment initiation to the date of death or last follow-up.
  measure: Treatment-Emergent Adverse Events [Safety and Tolerability]
  time frame: up to one year
  description: Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 5.0) .
  measure: Ovarian function
  time frame: up to one year
  description: Determine ovarian function as assessed by anti-Müllerian hormone (AMH)
  measure: Quality of life of cancer patients
  time frame: up to one year
  description: Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30)
  measure: Cancer specific rehabilitation
  time frame: up to one year
  description: Assessed by Cancer rehabilitation evaluation system-short form (CARES-SF)
  measure: Reproductive concerns after cancer
  time frame: up to one year
  description: Assessed by Reproductive Concerns After Cancer (RCAC) scale
  arm group label: Toripalimab Plus Actinomycin-D
  arm group type: Experimental
  description: Toripalimab 200mg intravenously(IV) every 2 weeks (Q2W) Actinomycin-D 1.25mg/m2，2mg max dos, intravenously(IV) every 2 weeks (Q2W)
  intervention type: Drug
  intervention name: Toripalimab
  description: 200mg q2w intravenous
  arm group label: Toripalimab Plus Actinomycin-D
  intervention type: Drug
  intervention name: Actinomycin-D
  description: 1.25mg/m2，2mg max dose, q2w, intravenous
  arm group label: Toripalimab Plus Actinomycin-D
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Yang Xiang
  phone: +861069156068
  email: xiangy@pumch.cn
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Peking Union Medical College Hospital
  investigator full name: xiang yang
  investigator title: Professor
  mesh term: Neoplasms
  mesh term: Gestational Trophoblastic Disease
  mesh term: Dactinomycin
  sharing ipd: No