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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab+Anlotinib | Experimental | Subjects will receive carilizumab every three weeks, with alozantinib 20 mg orally daily for 9 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Subjects will receive carilizumab every three weeks, with alozantinib 20 mg orally daily for 9 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12weeks |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongyan Guo, Doctor | Contact | +86 010-82267510 | bysyghy@163.com | |
| Xi Zhang, Doctor | Contact | 18811583538 | zx2015@pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongyan Guo, Doctor | Peking University Third Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C000625192 | anlotinib |
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