drugset / Trial / NCT03403101

The Combination Chemotherapy of SIRIOX as First- or Second-Line Chemotherapy for Pancreatic Cancer

NCT03403101 ↗

Phase 2 Unknown 65 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

Pancreatic cancer represents the most lethal of the common malignancies with a 5-year survival rate of less than 5%. For patients who are eligible for potentially curative resection, despite mortality and morbidity rates after surgery have improved, the recurrence rate is up to 85% within 2 years. FOLFIRINOX (fluoropyrimidine/leucovorin plus irinotecan and oxaliplatin) has been proved to significantly improve the prognosis and is recommended as first line treatment in patients with advanced pancreatic cancer. However, the regimen is limited due to the severe adverse effects. Thus, the investigators replaced 5-FU and leucovorin in the FOLFIRINOX regimen with oral S-1, a new oral fluoropyrimidine derivative which was proved to be the well-tolerated and effectively in large III phase randomized clinical trial, to form the SIRIOX regimen. A phase I clinical trial from Japan found that SOXIRI (S-1, oxaliplatin and irinotecan) works in patients with advanced pancreatic cancer. In this study, the researchers intend to investigate the activity and safety of the combination of this regimen in patients with advanced pancreatic cancer, as first- or second-line chemotherapy.

Timeline

Start
2020-07-01
Primary completion
2023-12-31
Completion
2024-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 180 mg/m2 —
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject S-1 Small molecule 40 mg Oral
Subject S-1 Small molecule 60 mg Oral
Subject S-1 Small molecule 80 mg Oral
Subject S-1 Small molecule 100 mg Oral