A Single-arm, Open-label, Multi-cohort, Multi-center Phase II Clinical Study of Anlotinib Combined With Penpulimab in the Treatment of Recurrent or Metastatic Gynecological Cancer
This is a single-arm, open-label, phase II clinical trial to evaluate the efficacy and safety of penpulimab combined with anlotinib in subjects with gynecological cancer, including 23 ovarian cancer，37 endometrial cancer，26 cervical cancer.
• Understood and signed an informed consent form;
• 18 years and older, female, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, life expectancy ≥3 months;
• Histopathologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer; or endometrial cancer; or cervical cancer (including squamous cell, adenocarcinoma, or adenosquamous cell carcinoma);
• Patients must also meet any of the following conditions:
‣ Platinum-resistant relapsed or platinum-refractory ovarian cancer, the patient has received at least 1 line of platinum-based chemotherapy after previous cytoreductive surgery;
⁃ With residual disease after surgery or inoperable stage III-IV endometrial cancer, and refused to receive chemoradiation/radiation/chemotherapy; or recurrent endometrial cancer unsuitable or refusing standard therapy;
⁃ Persistent cervical cancer unsuitable for curative treatment, or recurrent/metastatic cervical cancer that refuses to receive standard treatment (for recurrent disease, not yet treated).
• At least one measurable lesion according to the RECIST 1.1;
• Try to provide tumor tissue samples for PD-L1 testing (not required)；
• Demonstrates adequate organ function:
‣ Blood routine inspection: Hemoglobin (HB) \>= 90 g/L; The absolute value of neutrophil (ANC) \>= 1.5x10\^9/L;Platelets (PLT) \>= 100x10\^9/L;
⁃ Blood biochemical inspection: Serum creatinine (Cr) \<= 1.5 ULN, or creatinine clearance (CCr) \>= 60mL / min; Total bilirubin (TBIL) \<= 1.5 ULN, or direct bilirubin \<= 1.0 ULN; AST and ALT \<= 2.5 ULN.
⁃ Blood coagulation function: Activated partial thromboplastin time, international standardized ratio adn prothrombin time \<=1.5 ULN;
⁃ Cardiac Function: left ventricular ejection fraction (LVEF) \>=50%;
• Women of child-bearing potential must agree to use contraceptive measures (such as intrauterine devices or condoms) during the study and for 6 months after the end of the study, and have a negative serum pregnancy test within 7 days of enrollment, and must be non lactating subjects.