About this trial
The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer.
Eligibility criteria
Qualifiers
Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
ECOG performance status 0 or 1.
Life expectancy of greater than or equal to 6 months.
Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.
Disqualifiers
Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.
CA19-9 exceeding normal value within 14 days prior to enrollment.
Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
Trial design
Treatments tested in this trial
- HR070803
- Oxaliplatin
- Tegafur
- Folinic acid
- 5-Fluorouracil