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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly
modified-FOLFIRINOX
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Overall survival
The period from the first study treatment to any cause of death
Time frame: Through the study peirod, for 3 years
Resection rate
The number of cases received surgery / the total number of evaluable cases (%)
Time frame: Through the study peirod, for 3 years
Objective response rate
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)
Time frame: Through the study peirod, for 3 years
Disease control rate
The number of cases in which response (PR + CR) and stable disease (SD) are achieved from the start of cell infusion/the total number of evaluable cases (%)
Time frame: Through the study peirod, for 3 years
Progression-free survival
The period from the first treatment to the first evaluation of PD or any cause of death
Time frame: Through the study peirod, for 3 years
Adverse effects
Adverse events occurring through the study treatment, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.
Time frame: Through the study peirod, for 3 years
Carbohydrate antigen 19-9
The change of CA 199
Time frame: Through the study peirod, for 3 years
EORTC QLQ - PAN26 score
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The change of the quality of life
Time frame: Through the study peirod, for 3 years