Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT06571461
- Lead Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 408
Inclusion Criteria:<br><br> 1. Patients able and willing to provide a written informed consent aged 18-75 years.<br><br> 2. Histologically confirmed resected ductal pancreatic adenocarcinoma (including<br> adenosquamous carcinoma).<br><br> 3. Undergone radical resection and confirmed macroscopic complete resection (R0 and<br> R1).<br><br> 4. Full recovery after surgery; able to start adjuvant treatment within 12 weeks after<br> surgery.<br><br> 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.<br><br> 6. The main organs function well.<br><br>Exclusion Criteria:<br><br> 1. Patients with other types of non-ductal tumor of the pancreas, including endocrine<br> tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary<br> tumor.<br><br> 2. Macroscopic incomplete tumor removal (R2 resection).<br><br> 3. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic<br> adenocarcinoma.<br><br> 4. Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.<br><br> 5. CA 19-9> 180 U / ml within 21 days before randomization.<br><br> 6. The toxicity of previous therapy has not recovered to Grade 1 or below.<br><br> 7. Known peripheral neuropathy (CTCAE = Grade 2).<br><br> 8. Known deficiency of dihydropyrimidine dehydrogenase (DPD)<br><br> 9. Subjects with a confirmed diagnosis of Gilbert's syndrome
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS)
- Secondary Outcome Measures
Name Time Method Overall survival (OS)