Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liposomal Irinotecan, Oxaliplatin, S-1, Gemcitabine.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Open-label, Multi-center Phase III Clinical Study of Liposomal Irinotecan Combined With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine for Postoperative Adjuvant Treatment of Pancreatic Cancer
Overview
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.
Interventions
- Drug Liposomal Irinotecan
Liposomal Irinotecan：i.v. infusion - Drug Oxaliplatin
Oxaliplatin;：i.v. infusion - Drug S-1
S-1: Oral - Drug Gemcitabine
Gemcitabine: i.v. infusion - Drug Capecitabine
Capecitabine: Oral
Primary outcome measures
- Disease-free survival (DFS) [Time frame: Approximately 3 years.]
Secondary outcome measures (1)
- Overall survival (OS) [Time frame: Approximately 5 years.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06571461 · HE072-006