NCT06383078

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Efficacy and Safety

Interventions

Type	Name	Description
DRUG	HR070803	HR070803 60 mg/\^2 D1 over 90 minutes.
DRUG	Oxaliplatin	Oxaliplatin 85 mg/\^2 D1 over 2 hours.
DRUG	Tegafur	initial dose of S-1 is determined according to the body surface area，orally, D1-7.
DRUG	Folinic acid	Folinic acid 400 mg/\^2 D1
DRUG	5-Fluorouracil	5-FU 2400 mg/\^2 D1 IV continuous infusion over 46 hours

Timeline

• Start date: 2024-04-20
• Primary completion: 2027-03-01
• Completion: 2027-12-30
• First posted: 2024-04-25
• Last updated: 2024-04-25