envafolimab, lenvatinib combined with vp-16 in platinum-resistant recurrent epithelial ovarian cancer

Conditions: Ovarian Cancer, Epithelial

Summary: this study is a single-arm, open-label, exploratory clinical study, the main purpose is to evaluate the combination of envafolimab, lenvatinib vp-16 in the treatment of platinum-resistant recurrent epithelial ovarian cancer，primary fallopian tube cancer and primary peritoneal carcinoma.

platinum-resistant patients who have received at least 1 line chemotherapy in the past and the recurrence time is less than 6 months will receive envafolimab combined with lenvatinib and vp-16 for 6 cycles, followed by single-agent envafolimab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent

Eligibility criteria:
inclusion criteria: * ≥18 years； * ecog 0-1 * life expectancy of at least 3 months； * histologically or pathologically confirmed epithelial ovarian cancer (eoc), fallopian tube cancer, primary peritoneal cancer； ovarian cancer patients with drug-resistant recurrence after platinum-based chemotherapy； * at least one measurable objective tumor lesion by spiral ct examination, the maximum diameter ≥ 1cm（according to recist 1.1）； * satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (hgb) ≥90g/l, neutrophil count（anc） ≥1.5×109/l, platelet count（plt） ≥80×109/l, serum creatinine（cr）≤1.5 upper normal limitation (unl)，total bilirubin (tbil) ≤1.5 upper normal limitation (unl), alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤2.5 unl (for patients with liver metastasis, the ast/alt must be ≤5.0 unl), activated partial thromboplastin time (aptt), international normalized ratio (inr), prothrombin time (pt) ≤ 1.5×uln; left ventricular ejection fraction (lvef) ≥ 50%; thyroid stimulating hormone (tsh) within the normal range within: if the baseline tsh exceeds the normal range, subjects with total t3 (or ft3) and ft4 within the normal range can also be enrolled; * subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects； exclusion criteria: * suffered from other malignant tumors within 5 years before the start of treatment in this study; * grade ≥1 unresolved toxicities (according to the most recent version of the national cancer institute \[nci\] common terminology criteria for adverse events \[ctcae\]) due to any prior therapy, excluding alopecia and fatigue; neurotoxicity was recovery to ≤ grade 1 or baseline before the group; * subjects with any severe and/or uncontrolled disease ； * poorly controlled diabetes (fasting blood glucose \[fbg\] \> 10 mmol/l) ； * received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture； * serious arterial/venous thrombotic event within 6 months prior to initiation of study treatment ； * previously received drug therapy against pd-1, pd-l1 and other related immune checkpoints ； * participating in or participating in other clinical investigators within 4 weeks prior to the start of the study ； * allergic to the active ingredients or excipients of the study drug ； * unsuitable for the study or other chemotherapy determined by investigator.