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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
524
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 .
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, China
Disease-free survival (DFS)
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.
Time frame: From study start until 338 DFS events have occurred (approximately 21 months after last patient enrollment)
Overall survival (OS)
OS is defined as the time from date of randomization until the date of death from any cause.
Time frame: From date of randomization until the date of death from any cause, assessed up to 37 months
3-year disease-free survival rate
Disease-free survival within 3 years
Time frame: up to 36 months following the date the first patient was randomized
5-year disease-free survival rate
Disease-free survival within 5 years
Time frame: up to 60 months following the date the first patient was randomized
3-year overall survival rate
Overall survival within 3 years
Time frame: up to 36 months following the date the first patient was randomized
5-year overall survival rate
Overall survival within 5 years
Time frame: up to 60 months following the date the first patient was randomized
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