Status:
NOT_YET_RECRUITING
Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
Lead Sponsor:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 partici...
Eligibility Criteria
Inclusion
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- The main organs function well.
Exclusion
- 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.
- CA 19-9\> 180 U / ml within 21 days before randomization.
- The toxicity of previous therapy has not recovered to Grade 1 or below.
- Known peripheral neuropathy (CTCAE ≥ Grade 2).
- Known deficiency of dihydropyrimidine dehydrogenase (DPD)
- Subjects with a confirmed diagnosis of Gilbert's syndrome
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT06571461
Start Date
September 1 2024
End Date
March 1 2029
Last Update
August 27 2024
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