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.

Trial ID: NCT06217042

Interventional - Phase 3 - Not yet recruiting

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.

Conditions

• Pancreatic Cancer

Interventions

• HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
• gemcitabine; capecitabine

Eligibility

Inclusion criteria

• ECOG performance status 0 or 1
• 2. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
• 3. Life expectancy of greater than or equal to 6 months.
• 4. Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.
• 5. Acceptable hematology parameters and blood chemistry levels.
• 6. Able and willing to provide a written informed consent.

Exclusion criteria

• Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
• 2. Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.
• 3. CA 19-9> 180 U / ml within 21 days of registration on study.
• 4. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
• 5. Severe infection (> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;
• 6. Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.

Sponsor

Fudan University

Source: Clinicaltrials.gov

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