NCT03977272

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

Completed Phase 2 Last updated 27 January 2023

What this trial tests

Phase 2 trial testing Combination drug in Pancreatic Cancer in 110 participants. Completed in 1 July 2022.

Timeline

27 March 2019

Primary endpoint
1 July 2022

1 July 2022

Quick facts

Lead sponsor	Zhejiang University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	27 March 2019
Primary completion	1 July 2022
Estimated completion	1 July 2022
Sites	1 location across China

Drugs / interventions tested

• Combination drug
• Chemotherapy (chemotherapy) — full drug profile →

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Zhejiang University

Who can join

Adults 18 to 75, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology.
   Vanmeerbeek I, Sprooten J, De Ruysscher D, Tejpar S, et al · · 2020 · cited 179× · PMID 32002302 · DOI 10.1080/2162402x.2019.1703449
2. Immunotherapy in Pancreatic Cancer: Why Do We Keep Failing? A Focus on Tumor Immune Microenvironment, Predictive Biomarkers and Treatment Outcomes.
   Di Federico A, Mosca M, Pagani R, Carloni R, et al · · 2022 · cited 82× · PMID 35626033 · DOI 10.3390/cancers14102429
3. Combination therapy for pancreatic cancer: anti-PD-(L)1-based strategy.
   Liu L, Huang X, Shi F, Song J, et al · · 2022 · cited 60× · PMID 35139879 · DOI 10.1186/s13046-022-02273-w
4. Elevated protein lactylation promotes immunosuppressive microenvironment and therapeutic resistance in pancreatic ductal adenocarcinoma.
   Sun K, Zhang X, Shi J, Huang J, et al · · 2025 · cited 55× · PMID 39883522 · DOI 10.1172/jci187024
5. Hacking Pancreatic Cancer: Present and Future of Personalized Medicine.
   Di Federico A, Tateo V, Parisi C, Formica F, et al · · 2021 · cited 48× · PMID 34358103 · DOI 10.3390/ph14070677
6. Immunotherapy as a Therapeutic Strategy for Gastrointestinal Cancer-Current Treatment Options and Future Perspectives.
   Koustas E, Trifylli EM, Sarantis P, Papadopoulos N, et al · · 2022 · cited 27× · PMID 35743107 · DOI 10.3390/ijms23126664
7. Sintilimab Plus Modified FOLFIRINOX in Metastatic or Recurrent Pancreatic Cancer: The Randomized Phase II CISPD3 Trial.
   Fu Q, Chen Y, Huang D, Guo C, et al · · 2023 · cited 22× · PMID 37052821 · DOI 10.1245/s10434-023-13383-w
8. Therapeutic advances in metastatic pancreatic cancer: a focus on targeted therapies.
   Turpin A, Neuzillet C, Colle E, Dusetti N, et al · · 2022 · cited 20× · PMID 36090800 · DOI 10.1177/17588359221118019