Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC Ouyi Pharmaceutical Co., Ltd.

About this trial

This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.

Eligibility criteria

Qualifiers

Patients able and willing to provide a written informed consent aged 18-75 years.

Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma).

Undergone radical resection and confirmed macroscopic complete resection (R0 and R1).

Full recovery after surgery; able to start adjuvant treatment within 12 weeks after surgery.

Disqualifiers

Patients with other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary tumor.

Macroscopic incomplete tumor removal (R2 resection).

Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.

Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.

Trial design

Treatments tested in this trial

  • Liposomal Irinotecan
  • Oxaliplatin
  • S-1
  • Gemcitabine
  • Capecitabine

Treatment groups

408 Participants
are divided into 2 treatment groups

Locations

This trial has no locations