The prognosis of pancreatic cancer is extremely poor. Current 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 borderline resectable and locally advanced pancreatic cancer.
Investigators chose borderline resectable and locally advanced pancreatic cancer patients. The planned treatment was given to the participants after randomization. Response rate, event-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with borderline resectable and locally advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
392
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly.
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Event-free survival
Event-Free Survival assessed by the investigator according to RECIST 1.1 by investigator, defined as the interval from randomization to the first occurrence of disease progression, local or distant recurrence, or death from any cause.
Time frame: From randomization to any of the following events: disease progression, local or distant recurrence, or death from any cause, whichever occurs first. Up to approximately 60 months.
Overall survival
From randomization to death due to any cause.
Time frame: From randomization to death due to any cause. Up to approximately 60 months.
Objective response rate
The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Time frame: Up to approximately 60 months.
Disease control rate
The proportion of patients with tumor size reduction or stable
Time frame: Up to approximately 60 months.
Resection rate
The proportion of patients with surgical treatment after treatment
Time frame: Up to approximately 60 months.
R0 rate
The proportion of patients with completely tumor resection after treatment
Time frame: Up to approximately 60 months.
Adverse effects
The most common hematologic and non-hemotologic adverse events
Time frame: Up to approximately 60 months.
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Carbohydrate antigen 19-9
Carbohydrate antigen 19-9 level
Time frame: Up to approximately 60 months.