A Phase 3 interventional study of HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate and gemcitabine; capecitabine in Pancreatic Cancer, sponsored by Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by Fudan University · Phase 3, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.
This study's planned enrollment of 524 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
Drug: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
gemcitabine; capecitabine
Drug: gemcitabine; capecitabine
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 .
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
Plan to share: Yes — study protocol and ICF, CSR will be shared.
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Fudan University