Pancreatic Cancer Research

Clinical trialPhase 2Completed

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

Comparison of Therapeutic Effect Between Combination of Anti-PD-1 Antibody With mFOLFIRINOX and mFOLFIRINOX Alone in Metastatic Pancreatic Cancer Patients: A Randomized Clinical Trial

Outcome
Finished, no results posted
Phase
Phase 2
Status
Completed
Study type
Interventional
Start
27 March 2019
Expected end
1 July 2022
Enrollment
110 participants
Sites
1
Primary outcomes
Overall survival
Sponsor
Other
Results posted
No
Last update
27 January 2023

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Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

Metastatic pancreatic cancer patients will be enrolled in this trial. Investigators will assign patients to the treatment after randomization. The primary endpoint is overall survival. Response rate, progression-free survival, drugs related side effects and other endpoints events will be recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with metastatic pancreatic cancer.