HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

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

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

This trial has no locations