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/NCT05990803</url>
    </required_header>
    <id_info>
      <org_study_id>BL-B01D1-SI-B003-201-08</org_study_id>
      <nct_id>NCT05990803</nct_id>
    </id_info>
    <brief_title>A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in the Treatment of Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies</brief_title>
    <official_title>A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sichuan Baili Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sichuan Baili Pharmaceutical Co., Ltd.</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>
        Objective: To explore the efficacy, safety and tolerability of BL-B01D1, SI-B003 and&#xD;
        BL-B01D1+SI-B003 in patients with recurrent or metastatic cervical cancer and other&#xD;
        gynecological malignancies, and to further explore the optimal dose and mode of combination.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: To explore the efficacy of BL-B01D1 monotherapy, SI-B003 monotherapy, and&#xD;
        BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical&#xD;
        cancer. To explore the safety and tolerability of BL-B01D1 monotherapy, SI-B003 monotherapy&#xD;
        and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical&#xD;
        cancer and other gynecological malignancies, and to further explore the optimal dose and mode&#xD;
        of combination therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 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>Objective response rate (ORR)</measure>
      <time_frame>Up to approximately 24 months</time_frame>
      <description>ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recommended Phase II Dose (RP2D)</measure>
      <time_frame>Up to approximately 24 months</time_frame>
      <description>The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study .</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>Up to approximately 24 months</time_frame>
      <description>The PFS is defined as the time from the first dose of medication to disease progression or death, whichever occurred first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>Up to approximately 24 months</time_frame>
      <description>The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR)</measure>
      <time_frame>Up to approximately 24 months</time_frame>
      <description>The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment-Emergent Adverse Event (TEAE)</measure>
      <time_frame>Up to approximately 24 months</time_frame>
      <description>TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Cervical Cancer</condition>
    <arm_group>
      <arm_group_label>Study treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received BL-B01D1, SI-B003 or BL-B01D1 + SI-B003 therapy in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BL-B01D1</intervention_name>
      <description>BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.</description>
      <arm_group_label>Study treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SI-B003</intervention_name>
      <description>SI-B003 was administered by intravenous infusion every 3 weeks (Q3W).</description>
      <arm_group_label>Study treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. All subjects voluntarily participated in the study and signed informed consent;&#xD;
  &#xD;
            2. Women aged ≥18 years and ≤75 years;&#xD;
  &#xD;
            3. Expected survival time ≥3 months;&#xD;
  &#xD;
            4. ECOG 0-1;&#xD;
  &#xD;
            5. Recurrent or metastatic cervical cancer and other gynecologic malignancies (including&#xD;
               but not limited to cervical cancer, endometrial cancer, ovarian cancer, fallopian tube&#xD;
               cancer) confirmed by histopathology and/or cytology after failure or intolerance to&#xD;
               standard treatment or for which no standard treatment is currently available:&#xD;
  &#xD;
                 1. Cohort_A, Cohort_C patients who have previously failed or are intolerant to&#xD;
                    standard therapy or who currently have no standard therapy: 1) cervical or&#xD;
                    endometrial cancer (or PD-1/PD-L1 immunotherapy for eligible patients such as&#xD;
                    MSI-H) and ineligible for surgery or radiotherapy; 2) epithelial ovarian cancer,&#xD;
                    fallopian tube cancer, or primary peritoneal cancer; Patients with&#xD;
                    platinum-resistant relapse (&lt; 6 months between relapse or progression and the&#xD;
                    last (at least 4 cycles) of a previous platinum-based regimen) who had failed&#xD;
                    standard therapy after at least two lines of treatment (which could include&#xD;
                    patients with a BRCA mutation or HRD-positive who had failed PARP inhibitor&#xD;
                    therapy) met any one of the following criteria. Or patients with&#xD;
                    platinum-sensitive relapse who had failed standard therapy (≥6 months between&#xD;
                    relapse or progression and the last platinum-based chemotherapy of at least four&#xD;
                    previous cycles) after at least three lines of treatment (which could include&#xD;
                    patients with a BRCA mutation or HRD-positive who had failed PARP inhibitor&#xD;
                    therapy). Note: Disease progression or recurrence requires evidence of&#xD;
                    radiographic or clinical progression (e.g., cytological report of new ascites or&#xD;
                    pleural effusion). An increase in CA125 alone cannot be used as a criterion for&#xD;
                    disease progression or recurrence.&#xD;
  &#xD;
                 2. Cohort_B patients with failure to receive or intolerance to at least one previous&#xD;
                    standard therapy or no current standard therapy; Treatment failure was defined as&#xD;
                    disease progression during or after systemic antitumor therapy.&#xD;
  &#xD;
               Intolerance refers to the refusal of patients to continue the original regimen due to&#xD;
               grade 3-4 adverse reactions after receiving standard treatment.&#xD;
  &#xD;
               Note: Recurrence or disease progression within 6 months after the last chemotherapy of&#xD;
               multimodal therapy was considered as the first line of treatment.&#xD;
  &#xD;
            6. Consent to provide archival tumor tissue specimens (10 unstained sections (anti-slip)&#xD;
               surgical specimens (thickness 4-5μm)) or fresh tissue samples from primary or&#xD;
               metastatic lesions within 3 years. If participants cannot provide tumor tissue&#xD;
               samples, they can be enrolled if they meet other inclusion and exclusion criteria,&#xD;
               after the evaluation of the investigator;&#xD;
  &#xD;
            7. Must have at least one measurable lesion according to RECIST v1.1 definition; Lesions&#xD;
               that had been previously treated with radiation could be included in a measurable&#xD;
               lesion only if there was definite disease progression after radiation therapy;&#xD;
  &#xD;
            8. Organ function level must meet the following criteria:&#xD;
  &#xD;
                 1. Blood routine: hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (NEUT) ≥&#xD;
                    1.5×10 9 /L; Platelet count (PLT) ≥ 100×10 9 /L;&#xD;
  &#xD;
                 2. Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50&#xD;
                    mL/min (according to Cockcroft and Gault formula).&#xD;
  &#xD;
                 3. Liver function: total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT)&#xD;
                    and aspartate aminotransferase (AST) were all ≤2.5 ULN, and AST and ALT were both&#xD;
                    ≤5.0 ULN when liver metastasis was present;&#xD;
  &#xD;
                 4. coagulation function: international normalized ratio (INR) ≤1.5 and activated&#xD;
                    partial thromboplastin time (APTT) ≤1.5ULN;&#xD;
  &#xD;
                 5. no severe cardiac dysfunction with left ventricular ejection fraction ≥50%;&#xD;
  &#xD;
                 6. proteinuria ≤2+ or ≤1000mg/24h.&#xD;
  &#xD;
            9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by&#xD;
               NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities such as ALP&#xD;
               elevation, hyperuricemia, and hyperglycemia, as judged by the investigator, and&#xD;
               toxicity without safety risk, such as alopecia, grade 2 peripheral neurotoxicity, or&#xD;
               decreased hemoglobin ≥90g/L, as judged by the investigator);&#xD;
  &#xD;
           10. For premenopausal women with childbearing potential, a pregnancy test must be&#xD;
               performed within 7 days before the start of treatment, the serum or urine pregnancy&#xD;
               test must be negative, and the patient must not be lactating; All enrolled patients&#xD;
               should take adequate barrier contraception during the whole treatment cycle and for 6&#xD;
               months after the end of treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;&#xD;
  &#xD;
            2. Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy,&#xD;
               definitive radiotherapy, major surgery (investigator-defined), or targeted therapy&#xD;
               (including small-molecule tyrosine kinase inhibitors), has been administered within 4&#xD;
               weeks or 5 half-life cycles (whichever is shorter) before the first dose; Mitomycin&#xD;
               and nitrosoureas were administered within 6 weeks before the first dose; Oral&#xD;
               fluorouracil drugs such as S-1, capecitabine, or palliative radiotherapy within 2&#xD;
               weeks before the first dose;&#xD;
  &#xD;
            3. Cohort_B and Cohort_C patients with a history of immunotherapy and grade ≥3 irAE or&#xD;
               grade ≥2 immune-related myocarditis were excluded;&#xD;
  &#xD;
            4. Cohort_B and Cohort_C patients who have used immunomedulators (including but not&#xD;
               limited to thymosin, interleukin-2, interferon, etc.) within 14 days before the first&#xD;
               dose of study drug should be excluded;&#xD;
  &#xD;
            5. A history of severe cardiovascular and cerebrovascular diseases, including but not&#xD;
               limited to:&#xD;
  &#xD;
                 1. severe cardiac rhythm or conduction abnormalities, such as ventricular&#xD;
                    arrhythmias or Ⅲ degree atrioventricular block requiring clinical intervention;&#xD;
  &#xD;
                 2. prolonged QT interval at rest (QTc &gt; 450 msec in men or QTc &gt; 470 msec in women);&#xD;
  &#xD;
                 3. myocardial infarction, unstable angina, cardiac angioplasty or stent&#xD;
                    implantation, coronary artery/peripheral artery bypass grafting, New York Heart&#xD;
                    Association (NYHA) class III or IV congestive heart failure, cerebrovascular&#xD;
                    accident, or transient ischemic attack within 6 months before the first dose;&#xD;
  &#xD;
            6. Active autoimmune diseases and inflammatory diseases, such as systemic lupus&#xD;
               erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis,&#xD;
               inflammatory intestinal diseases and Hashimoto's thyroiditis, etc., excluding type I&#xD;
               diabetes mellitus, hypothyroidism that can only be controlled by replacement therapy,&#xD;
               and skin diseases without systemic treatment (such as vitiligo and psoriasis);&#xD;
  &#xD;
            7. Other malignant tumors that have progressed or require treatment within 5 years before&#xD;
               the first dose, except for radical basal cell carcinoma of the skin, squamous cell&#xD;
               carcinoma of the skin, superficial bladder cancer, radical resection of carcinoma in&#xD;
               situ, such as carcinoma in situ of the breast, and prostate cancer; Notes: Patients&#xD;
               with localized low-risk prostate cancer (defined as stage ≤T2a, Gleason score ≤6, and&#xD;
               PSA &lt; 10ng/mL at prostate cancer diagnosis (as measured) who had received radical&#xD;
               treatment and no biochemical recurrence of prostate specific antigen (PSA) were&#xD;
               eligible to participate in this study);&#xD;
  &#xD;
            8. A history of (non-infectious) interstitial lung disease (ILD)/pneumonitis requiring&#xD;
               steroid treatment, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot&#xD;
               be ruled out by imaging at screening;&#xD;
  &#xD;
            9. Prior to the initiation of study treatment, present:&#xD;
  &#xD;
                 1. Poorly controlled diabetes (fasting blood glucose ≥ 13.3 mmol/L)&#xD;
  &#xD;
                 2. Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or&#xD;
                    diastolic blood pressure ≥ 90 mmHg)&#xD;
  &#xD;
                 3. History of hypertensive crisis or hypertensive encephalopathy&#xD;
  &#xD;
           10. Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring&#xD;
               medical intervention within 6 months before screening; Infusion-related thrombosis was&#xD;
               excluded;&#xD;
  &#xD;
           11. Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis&#xD;
               (meningeal metastases). Patients who had received treatment for brain metastases&#xD;
               (radiotherapy or surgery; Patients with stable brain metastases who had stopped&#xD;
               radiotherapy or surgery 28 days before the first dose were eligible. Patients with&#xD;
               cancerous meningitis (meningeal metastases) were excluded even if they were treated&#xD;
               and judged to be stable. Stable was defined as being asymptomatic, stable, and not&#xD;
               requiring steroid medication for a full 4 weeks before starting study treatment;&#xD;
  &#xD;
           12. Patients with clinical symptoms or repeated drainage of pleural, abdominal, pelvic&#xD;
               effusion, pericardial effusion;&#xD;
  &#xD;
           13. Patients with a history of allergy to recombinant humanized antibody or human-mouse&#xD;
               chimeric antibody or to any excipients of BL-B01D1;&#xD;
  &#xD;
           14. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation&#xD;
               (Allo-HSCT);&#xD;
  &#xD;
           15. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active&#xD;
               hepatitis B virus infection (HBV-DNA copy number &gt; 103 IU/ml) or active hepatitis C&#xD;
               virus infection (HCV antibody positive and HCV-RNA &gt; detection limit);&#xD;
  &#xD;
           16. Active infection requiring systemic treatment, such as severe pneumonia, bacteremia,&#xD;
               sepsis, etc;&#xD;
  &#xD;
           17. Participated in another clinical trial within 4 weeks before the first dose&#xD;
               (calculated from the time of the last dose);&#xD;
  &#xD;
           18. Persons with a history of psychotropic drug abuse and inability to quit or mental&#xD;
               disorders;&#xD;
  &#xD;
           19. Other circumstances that the investigator deemed inappropriate for participation in&#xD;
               the trial.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lingying Wu, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hai Zhu, PHD</last_name>
      <phone>+8613980051002</phone>
      <email>zhuhai@baili-pharm.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sa Xiao, PHD</last_name>
      <phone>+8615013238943</phone>
      <email>xiaosa@baili-pharm.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cancer Hospital Chinese Academy of Medical Sciences</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Lingying Wu</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 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>
    <keyword>Gynecological malignancies</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    </condition_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/NCT05990803
  org study id: BL-B01D1-SI-B003-201-08
  nct id: NCT05990803
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objective: To explore the efficacy, safety and tolerability of BL-B01D1, SI-B003 and
        BL-B01D1+SI-B003 in patients with recurrent or metastatic cervical cancer and other
        gynecological malignancies, and to further explore the optimal dose and mode of combination.
  Objective: To explore the efficacy of BL-B01D1 monotherapy, SI-B003 monotherapy, and
        BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical
        cancer. To explore the safety and tolerability of BL-B01D1 monotherapy, SI-B003 monotherapy
        and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical
        cancer and other gynecological malignancies, and to further explore the optimal dose and mode
        of combination therapy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate (ORR)
  time frame: Up to approximately 24 months
  description: ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
  measure: Recommended Phase II Dose (RP2D)
  time frame: Up to approximately 24 months
  description: The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study .
  measure: Progression-free survival (PFS)
  time frame: Up to approximately 24 months
  description: The PFS is defined as the time from the first dose of medication to disease progression or death, whichever occurred first.
  measure: Disease control rate (DCR)
  time frame: Up to approximately 24 months
  description: The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).
  measure: Duration of response (DOR)
  time frame: Up to approximately 24 months
  description: The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
  measure: Treatment-Emergent Adverse Event (TEAE)
  time frame: Up to approximately 24 months
  description: TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment.
  arm group label: Study treatment
  arm group type: Experimental
  description: Participants received BL-B01D1, SI-B003 or BL-B01D1 + SI-B003 therapy in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
  intervention type: Drug
  intervention name: BL-B01D1
  description: BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.
  arm group label: Study treatment
  intervention type: Drug
  intervention name: SI-B003
  description: SI-B003 was administered by intravenous infusion every 3 weeks (Q3W).
  arm group label: Study treatment
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Lingying Wu, PHD
  role: Principal Investigator
  affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  last name: Hai Zhu, PHD
  phone: +8613980051002
  email: zhuhai@baili-pharm.com
  last name: Sa Xiao, PHD
  phone: +8615013238943
  email: xiaosa@baili-pharm.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Uterine Cervical Neoplasms