drugset / Trial / NCT03977272

Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer

NCT03977272

Phase 2 Completed 110 enrolled Zhejiang University
RandomizedParallel-groupOpen-labelTreatment

Summary

The prognosis of pancreatic cancer is extremely poor. NCCN guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen. Studies have shown that immunotherapy with Anti-PD-1 antibody can effectively increase the response rate and prolong patient survival in a number of cancer diseases. Here investigators intend to compare the therapeutic effects of modified-FOLFIRINOX alone and the combination of modified-FOLFIRINOX and Anti-PD-1 antibody in patients with metastatic pancreatic cancer.

Timeline

Start
2019-03-27
Primary completion
2022-07-01
Completion
2022-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg
Comparator Irinotecan Small molecule 135 mg/m2
Comparator Oxaliplatin Small molecule 68 mg/m2
Comparator fluorouracil Small molecule 2400 mg/m2
Comparator folic acid Other / unclassified 400 mg/m2