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Combination of Anti-PD-1 Antibody and Chemotherapy in Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Study on Therapeutic Effect of Combination of Anti-PD-1 Antibody and Chemotherapy in Locally Advanced or Borderline Resectable Pancreatic Cancer Patients: A Randomized Clinical Trial

NCT03983057•Zhejiang University

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
•No evidence of distant metastasis (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.
•Initial assessment for definitive borderline resectable or locally advanced tumors (resectability judgment is based on CT enhanced scan or magnetic resonance imaging, NCCN2019 first edition standard).
•ECOG score 0 or 1.
•Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.
•ALT and AST are less than 2 x ULN.
•If biliary obstruction is observed, biliary decompression should be performed when the patient is randomly assigned to receive neoadjuvant chemotherapy.
•Leukocyte count (\> 3.5 x 10\^6 /mL), neutrophil count (\> 1.5 x 10\^6 /mL), platelet count (\> 80 x 10\^6 /mL), hemoglobin (\> 9 g/dL).
•Signed informed consent.

Exclusion Criteria

•History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
•History of participation of other clinical trails within 4 weeks
•History of immunotherapy within 4 weeks
•History of receiving chemotherapy, radiotherapy and molecular target therapy within 2 weeks
•Tumor is a local recurrent lesion.
•Imaging confirmed severe portal hypertension / cavernous transformation.
•Ascites
•Gastric outlet obstruction
•Respiratory failure requires supplementation of oxygen.
•Immune deficiency syndrome, such as active tuberculosis and HIV infection.
+9 more criteria

Locations (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

April 1, 2019

Primary Completion Date

November 25, 2025

Completion Date

November 25, 2025

Last Updated

February 11, 2026

Enrollment

392

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

Anti-PD-1 monoclonal antibody

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Resilience and Equity in Aging, Cancer, and Health (REACH)

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients