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

Last updated: August 25, 2024
Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Pancreatitis

Digestive System Neoplasms

Pancreatic Cancer

Treatment

Gemcitabine

Liposomal Irinotecan

S-1

Clinical Study ID

NCT06571461
HE072-006
  • Ages 18-75
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

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

  2. Histologically confirmed resected ductal pancreatic adenocarcinoma (includingadenosquamous carcinoma).

  3. Undergone radical resection and confirmed macroscopic complete resection (R0 andR1).

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

  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

  6. The main organs function well.

Exclusion

Exclusion Criteria:

  1. Patients with other types of non-ductal tumor of the pancreas, including endocrinetumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillarytumor.

  2. Macroscopic incomplete tumor removal (R2 resection).

  3. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreaticadenocarcinoma.

  4. Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.

  5. CA 19-9> 180 U / ml within 21 days before randomization.

  6. The toxicity of previous therapy has not recovered to Grade 1 or below.

  7. Known peripheral neuropathy (CTCAE ≥ Grade 2).

  8. Known deficiency of dihydropyrimidine dehydrogenase (DPD)

  9. Subjects with a confirmed diagnosis of Gilbert's syndrome

Study Design

Total Participants: 408
Treatment Group(s): 5
Primary Treatment: Gemcitabine
Phase: 3
Study Start date:
September 01, 2024
Estimated Completion Date:
March 31, 2029