Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changhai Hospital
• Treatments: Albumin-Bound Paclitaxel; Calcium; Fluorouracil; Folfirinox; Folic Acid; Gemcitabine; Irinotecan; Oxaliplatin; Paclitaxel

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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,