Multicenter, Open-label Clinical Study of PD-L1/CTLA4 BsAb Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
To evaluate the efficacy of PD-L1/CTLA4 BsAb for the second line treatment and the combination with chemotherapy for the first line treatment in pancreatic cancer
详细描述
Subjects who signed the informed consent were assigned to three cohorts according to the actual treatment status. Cohort 1 enrolled subjects receiving PD-L1/CTLA4 BsAb 5mg/kg iv Q2W for 2nd treatment; cohort 2 enrolled subjects receiving PD-L1/CTLA4 BsAb in combination with gemcitabine/albumin- paclitaxel as 1st treatment for 4-6 cycles with PD-L1/CTLA4 BsAb monotherapy maintainence; cohort 3 enrolled subjects received systemic chemotherapy, receiving PD-L1/CTLA4 BsAb combined with oxaliplatin / irinotecan / leucovorin / fluorouracil (FOLFIRINOX) as 1st treatment for 4-6 cycles withPD-L1/CTLA4 BsAb monotherapy maintainence; until disease progression according to RECIST 1.1, intolerable toxicity, withdrawal, death, 2-yr treatment,who comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology or cytology confirmed as pancreatic ductal adenocarcinoma;
- •ECOG 0-1;
- •adequate organ function (absolute neutrophil count ≥1.5 x 109/L; platelet count ≥100 x 109/L; creatinine < 1.5 x ULN (upper normal) or calculated creatinine clearance ( CRCI) ≥ 60mL/min; albumin ≥ 30g/L; total bilirubin <1.5 x ULN; aspartate aminotransferase (AST) < 2.5 x ULN; alanine aminotransferase (ALT) < 2.5x ULN; INR or PT < 1.5x ULN, and aPTT <1.5x ULN);
- •no obvious symptoms of jaundice and ascites;
- •no other serious underlying diseases
排除标准
- •patients with active brain metastases;
- •history of autoimmune diseases, or need to be treated with corticosteroids and immunosuppressive agents;
- •past history of unstable angina, symptomatic congestive heart failure, severe arrhythmia, myocardial infarction within 6 months, QT interval prolongation (>450ms);
- •other malignant tumors within the last 5 years;
- •pregnant or lactating women;
- •NRS ≥ 4 points;
- •unintentional weight loss ≥ 5% within 1 month before the first dose even if peripheral or central vein nutrition support,
研究组 & 干预措施
PD-L1/CTLA4 BsAb
For 2nd line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W
干预措施: PD-L1/CTLA4 BsAb (Drug)
PD-L1/CTLA4 BsAb + GP
For 1st line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W in combination with Gemcitabine 1000 mg/m2 and Nab-paclitaxel 125 mg/m2 , 28days/cycle
干预措施: PD-L1/CTLA4 BsAb (Drug)
PD-L1/CTLA4 BsAb + GP
For 1st line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W in combination with Gemcitabine 1000 mg/m2 and Nab-paclitaxel 125 mg/m2 , 28days/cycle
干预措施: GP (Combination Product)
PD-L1/CTLA4 BsAb + FOLFIRINOX
For 1st line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W in combination with Oxaliplatin 68 or 85 mg/m2, Irinotecan 135 or 150 or 180 mg/m2, Calcium Folate 400 mg/m2, Fluorouracil 2400mg/m2, 14 days/cycle
干预措施: PD-L1/CTLA4 BsAb (Drug)
PD-L1/CTLA4 BsAb + FOLFIRINOX
For 1st line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W in combination with Oxaliplatin 68 or 85 mg/m2, Irinotecan 135 or 150 or 180 mg/m2, Calcium Folate 400 mg/m2, Fluorouracil 2400mg/m2, 14 days/cycle
干预措施: FOLFIRINOX (Combination Product)
结局指标
主要结局
ORR
时间窗: 2 years
objective response rate
次要结局
- DCR(2 years)
- DOR(2 years)
- PFS(2 years)
- TTP(2 years)
- OS(2 years)