drugset / Trial / NCT03977272
Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2019-03-27
- Primary completion
- 2022-07-01
- Completion
- 2022-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sintilimab | Monoclonal antibody | 200 mg | — |
| Comparator | Irinotecan | Small molecule | 135 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 68 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | — |
| Comparator | folic acid | Other / unclassified | 400 mg/m2 | — |