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A Study of Camrelizumab in Combination With Anlotinib in Subjects Advanced Ovarian Clear Cell Carcinoma

Primary Purpose

Ovarian Clear Cell Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Camrelizumab
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Clear Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Age 18-75 years; 2. Pathohistological or cytology confirmed as ovarian transparent cell carcinoma, and FIGO stage in 2018 is stage III-IV; ≥ four courses of chemotherapy and failed to reach CR 3. ECOG score; 0-2 points; 4. Expected survival ≥ 3 months; 5. The investigator confirmed to have at least one measurable lesion (10 mm long diameter of CT scan of tumor lesions ≥10 mm, short diameter of CT scan of lymph node lesions ≥15 mm)) according to the RECIST 1.1 standard), or ascites 6. The main organs function normally, and the test results during screening must meet the following requirements: Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors to correct): A. Hemoglobin (Hb) ≥ 80 g/L; B. Number of neutrophils (ANC) ≥ 1.5 × 109/L; C. Platelet count (PLT) ≥ 80 ×109/L; Biochemical inspection must meet the following standards: A. Total bilirubin (TBIL) < 1.5 Upper limit of normal value (ULN); B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 ULL compared <with 5 ULN for patients with liver metastases; C. serum creatinine (Cr) ≤ 1.5 ULN or endogenous creatinine clearance > 60 ml/min (Cockcroft-Galt formula); D. Urine routine test results show urine protein (UPRO) < 2+ or 24-hour urine protein quantitative <1 g; 7. Women of gestational age must agree to adequate contraception for the entire duration of the study and within 6 months after the end of treatment. 8.Signed a written informed consent form with good expected adherence to the research protocol. Exclusion Criteria: Have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies acting on the T cell synergistic stimulation or checkpoint pathway); Previous exposure to other anti-angiogenic small molecule TKI drugs, such as apatinib, alotinib, sorafinil, regofinib, etc.; Patients with active brain metastases (for patients with stable symptoms after treatment of brain metastases, they can be selected if they remain in a stable state for at least 4 weeks); Immunosuppressive drugs have been used within 28 days before the first use of carirelizumab, excluding nasal and inhaled corticosteroids or systemic steroid hormones in physiological doses (i.e., prednisolone or other corticosteroids of equivalent pharmacophysiological doses not exceeding 10 mg / day); Received systematic systemic therapy with anti-tumor indications of Chinese herbal medicine or immunomodulatory effect (including thymus peptide, interferon, interleukin, except for the control of pleural effusion topical use) within 2 weeks before the first administration; Suffering from serious cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval men ≥ 450 ms, women ≥ 470 ms); Grade III. to IV. cardiac insufficiency (see Annex 3 according to the NYHA grade of the New York Cardiology Society), or if the left ventricular ejection fraction (LVEF) < 50% on cardiac color ultrasound; Complicated by severe infection within 4 weeks before the first medication (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever > during screening / before the first administration 38.5°C; or major surgical treatment within 3 weeks prior to the first medication; The presence of active autoimmune diseases or immunodeficiency, or the history of the above, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituititis, vasculitis, nephritis, etc.) shall not be included. The following exceptions are those with a history of autoimmune hypothyroidism but receiving thyroid hormone replacement therapy. After treatment with an insulin dosing regimen, patients with type 1 diabetes whose blood glucose is controlled may participate in this study. Subjects undergo systematic treatment such as bronchodilators, asthma control is not satisfactory, can not be included (asthma in childhood has been completely resolved, adults do not need any intervention can be included). Human immunodeficiency virus (HIV) infection or known to have acquired immunodeficiency syndrome (AIDS), untreated active hepatitis B, hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the lower limit of detection of analytical methods) or co-infection with hepatitis B and C; The subject has received or plans to receive a transplant of a solid organ or blood system during the study (except for corneal transplantation); Are currently participating in interventional clinical research or has been treated with other experimental drugs or research devices within 4 weeks prior to the first dose; Adequate recovery from toxicity and/or complications caused by any intervention before the first dose (i.e., ≦ grade 1 or at baseline, excluding fatigue or hair loss); Have a clear history of allergies, may be potentially allergic or intolerant to the test drug and its similar biological agents; Those with a history of psychotropic drug abuse and who cannot be withdrawn or have mental disorders; People with a history of hereditary or acquired bleeding or coagulation dysfunction (it is up to the investigator to determine whether they can be selected) Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal drug therapy); Those who have had significant coughing up blood 2 months prior to entry into the study, or who have had a daily hemoptysis volume of half a teaspoon (2.5 ml) or more; or have had clinically significant bleeding symptoms or a clear tendency to bleed within 3 months prior to the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis; or arteriovenous thrombosis events that occurred within 6 months prior to the study, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT >1.5ULN), with bleeding tendencies or being undergoing thrombolytic or anticoagulant therapy; Urine routine suggests that urine protein ≥++, or confirm that the amount of urine protein ≥ 1.0g in 24 hours; Increases the risk associated with participating in a study or trial drug and, according to the investigator's judgment, can lead to other circumstances in which the patient is unsuitable for the study to be selected.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Camrelizumab+Anlotinib

    Arm Description

    Subjects will receive carilizumab every three weeks, with alozantinib 20 mg orally daily for 9 weeks

    Outcomes

    Primary Outcome Measures

    Objective Response Rate
    Evaluated according to RECIST1.1, refers to the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time. Specifically, the proportion of the total number of treated CR+PR cases to the overall number of measurable cases.

    Secondary Outcome Measures

    Progression-free survival
    Defined as the date on which the subject begins with the first treatment to the date on which the tumor progression is first recorded or dies for any reason, whichever appears first.

    Full Information

    First Posted
    October 9, 2022
    Last Updated
    October 29, 2022
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05600998
    Brief Title
    A Study of Camrelizumab in Combination With Anlotinib in Subjects Advanced Ovarian Clear Cell Carcinoma
    Official Title
    Exploratory Clinical Study of Camrelizumab in Combination With Anlotinib in the Treatment of Patients With Advanced Ovarian Clear Cell Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 30, 2022 (Anticipated)
    Primary Completion Date
    September 30, 2023 (Anticipated)
    Study Completion Date
    February 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is prospective ,open-label, single-center phase II clinical study. Target population is patients with advanced (stage III-IV) ovarian clear cell carcinoma. Study objective is to evaluate effectiveness response of Camrelizumab + anlotinib in subjects with advanced ovarian clear cell carcinoma Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.
    Detailed Description
    In this study, eligible subjects were given a combination of carrelizumab and alozantinib at the same time, repeated every 21 days, during treatment based on imaging evaluation of the patient if disease progression, toxicity intolerance, or other reasons specified by the regimen could be terminated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Clear Cell Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Camrelizumab+Anlotinib
    Arm Type
    Experimental
    Arm Description
    Subjects will receive carilizumab every three weeks, with alozantinib 20 mg orally daily for 9 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Camrelizumab
    Other Intervention Name(s)
    Anlotinib
    Intervention Description
    Subjects will receive carilizumab every three weeks, with alozantinib 20 mg orally daily for 9 weeks
    Primary Outcome Measure Information:
    Title
    Objective Response Rate
    Description
    Evaluated according to RECIST1.1, refers to the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time. Specifically, the proportion of the total number of treated CR+PR cases to the overall number of measurable cases.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Progression-free survival
    Description
    Defined as the date on which the subject begins with the first treatment to the date on which the tumor progression is first recorded or dies for any reason, whichever appears first.
    Time Frame
    12weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Age 18-75 years; 2. Pathohistological or cytology confirmed as ovarian transparent cell carcinoma, and FIGO stage in 2018 is stage III-IV; ≥ four courses of chemotherapy and failed to reach CR 3. ECOG score; 0-2 points; 4. Expected survival ≥ 3 months; 5. The investigator confirmed to have at least one measurable lesion (10 mm long diameter of CT scan of tumor lesions ≥10 mm, short diameter of CT scan of lymph node lesions ≥15 mm)) according to the RECIST 1.1 standard), or ascites 6. The main organs function normally, and the test results during screening must meet the following requirements: Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors to correct): A. Hemoglobin (Hb) ≥ 80 g/L; B. Number of neutrophils (ANC) ≥ 1.5 × 109/L; C. Platelet count (PLT) ≥ 80 ×109/L; Biochemical inspection must meet the following standards: A. Total bilirubin (TBIL) < 1.5 Upper limit of normal value (ULN); B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 ULL compared <with 5 ULN for patients with liver metastases; C. serum creatinine (Cr) ≤ 1.5 ULN or endogenous creatinine clearance > 60 ml/min (Cockcroft-Galt formula); D. Urine routine test results show urine protein (UPRO) < 2+ or 24-hour urine protein quantitative <1 g; 7. Women of gestational age must agree to adequate contraception for the entire duration of the study and within 6 months after the end of treatment. 8.Signed a written informed consent form with good expected adherence to the research protocol. Exclusion Criteria: Have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies acting on the T cell synergistic stimulation or checkpoint pathway); Previous exposure to other anti-angiogenic small molecule TKI drugs, such as apatinib, alotinib, sorafinil, regofinib, etc.; Patients with active brain metastases (for patients with stable symptoms after treatment of brain metastases, they can be selected if they remain in a stable state for at least 4 weeks); Immunosuppressive drugs have been used within 28 days before the first use of carirelizumab, excluding nasal and inhaled corticosteroids or systemic steroid hormones in physiological doses (i.e., prednisolone or other corticosteroids of equivalent pharmacophysiological doses not exceeding 10 mg / day); Received systematic systemic therapy with anti-tumor indications of Chinese herbal medicine or immunomodulatory effect (including thymus peptide, interferon, interleukin, except for the control of pleural effusion topical use) within 2 weeks before the first administration; Suffering from serious cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval men ≥ 450 ms, women ≥ 470 ms); Grade III. to IV. cardiac insufficiency (see Annex 3 according to the NYHA grade of the New York Cardiology Society), or if the left ventricular ejection fraction (LVEF) < 50% on cardiac color ultrasound; Complicated by severe infection within 4 weeks before the first medication (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever > during screening / before the first administration 38.5°C; or major surgical treatment within 3 weeks prior to the first medication; The presence of active autoimmune diseases or immunodeficiency, or the history of the above, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituititis, vasculitis, nephritis, etc.) shall not be included. The following exceptions are those with a history of autoimmune hypothyroidism but receiving thyroid hormone replacement therapy. After treatment with an insulin dosing regimen, patients with type 1 diabetes whose blood glucose is controlled may participate in this study. Subjects undergo systematic treatment such as bronchodilators, asthma control is not satisfactory, can not be included (asthma in childhood has been completely resolved, adults do not need any intervention can be included). Human immunodeficiency virus (HIV) infection or known to have acquired immunodeficiency syndrome (AIDS), untreated active hepatitis B, hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the lower limit of detection of analytical methods) or co-infection with hepatitis B and C; The subject has received or plans to receive a transplant of a solid organ or blood system during the study (except for corneal transplantation); Are currently participating in interventional clinical research or has been treated with other experimental drugs or research devices within 4 weeks prior to the first dose; Adequate recovery from toxicity and/or complications caused by any intervention before the first dose (i.e., ≦ grade 1 or at baseline, excluding fatigue or hair loss); Have a clear history of allergies, may be potentially allergic or intolerant to the test drug and its similar biological agents; Those with a history of psychotropic drug abuse and who cannot be withdrawn or have mental disorders; People with a history of hereditary or acquired bleeding or coagulation dysfunction (it is up to the investigator to determine whether they can be selected) Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal drug therapy); Those who have had significant coughing up blood 2 months prior to entry into the study, or who have had a daily hemoptysis volume of half a teaspoon (2.5 ml) or more; or have had clinically significant bleeding symptoms or a clear tendency to bleed within 3 months prior to the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis; or arteriovenous thrombosis events that occurred within 6 months prior to the study, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT >1.5ULN), with bleeding tendencies or being undergoing thrombolytic or anticoagulant therapy; Urine routine suggests that urine protein ≥++, or confirm that the amount of urine protein ≥ 1.0g in 24 hours; Increases the risk associated with participating in a study or trial drug and, according to the investigator's judgment, can lead to other circumstances in which the patient is unsuitable for the study to be selected.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hongyan Guo, Doctor
    Phone
    +86 010-82267510
    Email
    bysyghy@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xi Zhang, Doctor
    Phone
    18811583538
    Email
    zx2015@pku.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hongyan Guo, Doctor
    Organizational Affiliation
    Peking University Third Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Study of Camrelizumab in Combination With Anlotinib in Subjects Advanced Ovarian Clear Cell Carcinoma

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