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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

524

Participants

Timeline

Start Date

February 5, 2024

Primary Completion Date

March 30, 2027

Study Completion Date

July 30, 2028

Conditions
Pancreatic Cancer
Interventions
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 .

Trial Locations (1)

200032

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER