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HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer

Efficacy and Safety Clinical Trial

Official title:
HR070803 in Combination With Oxaliplatin Plus Tegafur Versus HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate as Adjuvant Therapy for Pancreatic Cancer: A Multicenter, Multi-cohort, Randomized, Phase II Study

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer.

Clinical Trial Description

STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the 1-year disease-free survival rate. Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause. Patients without event at the time of analysis will be censored at the date of last follow-up visit. Secondary criteria include Overall survival. OS is defined as the time from date of randomization until the date of death from any cause. Patients who are still living at the time of analysis will be censored at the date of last follow-up visit. Secondary criteria also include the Disease-free survival. Tolerance Patients evaluable for toxicity must have received one investigational drug. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06383078
Study type Interventional
Source The First Affiliated Hospital with Nanjing Medical University
Contact
Status Not yet recruiting
Phase Phase 2
Start date April 20, 2024
Completion date December 30, 2027
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