A Phase 2 interventional study of Anti-PD-1 monoclonal antibody in Pancreatic Cancer, sponsored by Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Zhejiang University · Phase 2, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 392 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.
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Exclusion Criteria:
Treatment with modified-FOLFIRINOX Folic acid 400mg/m\^2, 5- fluorouracil 2400mg/m\^2 for 46h, irinotecan 135mg/m\^2 and oxaliplatin 68mg/m\^2
Treatment with modified-FOLFIRINOX and Anti-PD-1 antibody Folic acid 400mg/m\^2, 5- fluorouracil 2400mg/m\^2 for 46h, irinotecan 135mg/m\^2 and oxaliplatin 68mg/m\^2, Anti-PD-1 antibody 3mg/kg
Drug: Anti-PD-1 monoclonal antibody
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly.
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.
Carbohydrate antigen 19-9
Carbohydrate antigen 19-9 level
Time frame: Up to approximately 60 months.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Zhejiang University