NCT06217042

HR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer

HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Gemcitabine in Combination With Capecitabine as Adjuvant Therapy for Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 524 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to look at the efficacy and safety of HR070803 in combination with 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to gemcitabine + capecitabine treatment as adjuvant therapy in patients with resected pancreatic cancer.

Detailed description

STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the disease-free survival. 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 3-year disease-free survival rate/overall survival rate and 5-year disease-free survival rate/overall survival rate. Tolerance Patients evaluable for toxicity must have received one investigational drug.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate	Oxaliplatin 85 mg/m² D1 over 2 hours, followed by HR070803 60 mg/m² D1 over 90 minutes, after the Folinic acid infusion is started. Folinic acid 400 mg/m² D1, IV infusion over 1 hours. 5-FU 2400 mg/m² D1 IV continuous infusion over 46 hours. These drugs are given once every 2 weeks, 12 cycles, 24 weeks.
DRUG	gemcitabine; capecitabine	Gemcitabine 1000mg/m² is given as an i.v. infusion over 30 minutes, administered on day 1, 8 and 15 out of 28 days. Capecitabine 1660mg/m²/day in two divided doses administered orally for 21 days followed by 7 days'rest .

Timeline

• Start date: 2024-02-05
• Primary completion: 2027-03-30
• Completion: 2028-07-30
• First posted: 2024-01-22
• Last updated: 2024-01-22

Locations

1 site across 1 country: China