Multicenter, Open-label Clinical Study of PD-L1/CTLA4 BsAb Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer

Trial ID: NCT04324307

Interventional - Phase 1/2 - Unknown status

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

Conditions

• Locally Advanced and Metastatic Pancreatic Cancer

Interventions

• PD-L1/CTLA4 BsAb
• GP
• FOLFIRINOX

Eligibility

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,

Sponsor

Changhai Hospital

Source: Clinicaltrials.gov

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