Clinical trialPhase 3Not yet recruiting
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.
- Outcome
- Ongoing
- Phase
- Phase 3
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- 5 February 2024
- Expected end
- 30 July 2028
- Enrollment
- 524 participants
- Sites
- 1
- Primary outcomes
- Disease-free survival (DFS)
- Sponsor
- Other
- Results posted
- No
- Last update
- 22 January 2024
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.