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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.

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 .

gemcitabine; capecitabine

Si Shi, PhD

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.

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.

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.

study protocol and ICF, CSR will be shared.

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.

OS is defined as the time from date of randomization until the date of death from any cause.

Fudan University

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
HR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer	NCT06217042	Pancreatic Canc...	HR070803; Oxali... gemcitabine; ca...	18 Years - 75 Years	Fudan University
HR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer	NCT06217042	Pancreatic Canc...	HR070803; Oxali... gemcitabine; ca...	18 Years - 75 Years	Fudan University

Spots Global Cancer Trial Database for hr070803; oxaliplatin; 5fluorouracil; calcium folinate