Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer
- Conditions
- Locally Advanced and Metastatic Pancreatic Cancer
- Interventions
- Registration Number
- NCT04324307
- Lead Sponsor
- Changhai Hospital
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PD-L1/CTLA4 BsAb PD-L1/CTLA4 BsAb For 2nd line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W PD-L1/CTLA4 BsAb + GP 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 PD-L1/CTLA4 BsAb + FOLFIRINOX PD-L1/CTLA4 BsAb 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 PD-L1/CTLA4 BsAb + FOLFIRINOX 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 PD-L1/CTLA4 BsAb + GP PD-L1/CTLA4 BsAb 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
- Primary Outcome Measures
Name Time Method ORR 2 years objective response rate
- Secondary Outcome Measures
Name Time Method DCR 2 years Disease Control Rate
DOR 2 years Duration of Response
PFS 2 years Progression Free Survival
TTP 2 years Time to Response
OS 2 years Overall Survival
Trial Locations
- Locations (1)
Changhai hospital
🇨🇳Shanghai, Shanghai, China