An Open, Single-arm Clinical Study of Envafolimab, Lenvatinib Combined With VP-16 in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer，Primary Fallopian Tube Cancer and Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥18 years；
- •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；
排除标准
- •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.
研究组 & 干预措施
envafolimab，lenvatinib，VP-16
envafolimab：400mg，sc，d1，Q3W； lenvatinib：8 mg(BW<60 kg) OR 12 mg(BW≥60 kg)，po，qd，d1-21，Q3W； VP-16：50 mg/d, po,d1-14，Q3W
干预措施: Envafolimab (Drug)
envafolimab，lenvatinib，VP-16
envafolimab：400mg，sc，d1，Q3W； lenvatinib：8 mg(BW<60 kg) OR 12 mg(BW≥60 kg)，po，qd，d1-21，Q3W； VP-16：50 mg/d, po,d1-14，Q3W
干预措施: Lenvatinib (Drug)
envafolimab，lenvatinib，VP-16
envafolimab：400mg，sc，d1，Q3W； lenvatinib：8 mg(BW<60 kg) OR 12 mg(BW≥60 kg)，po，qd，d1-21，Q3W； VP-16：50 mg/d, po,d1-14，Q3W
干预措施: VP-16 (Drug)
结局指标
主要结局
ORR
时间窗: 6 months
objective response rate
次要结局
- PFS(12 months)
- OS(12 months)
- DCR(9 months)
- AEs AEs(12 months)
研究者
Yang Shen
chief physician
Zhongda Hospital