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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06571461

Enrollment

408

Registered

2024-08-26

Start date

2024-09-30

Completion date

2029-03-31

Last updated

2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

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 participants with pancreatic ductal adenocarcinoma after radical surgery.

Interventions

DRUGGemcitabine

Gemcitabine: i.v. infusion

DRUGLiposomal Irinotecan

Liposomal Irinotecan：i.v. infusion

DRUGOxaliplatin

Oxaliplatin;：i.v. infusion

DRUGS-1

S-1: Oral

DRUGCapecitabine

Capecitabine: Oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

This study is designed as a phase III, two-arm, open-label, multi-center, randomized clinical trial comparing combination liposomal irinotecan, oxaliplatin and S-1 with gemcitabine + capecitabine when used as adjuvant therapy following resection for pancreatic ductal adenocarcinoma.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Patients able and willing to provide a written informed consent aged 18-75 years. 2. Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma). 3. Undergone radical resection and confirmed macroscopic complete resection (R0 and R1). 4. Full recovery after surgery; able to start adjuvant treatment within 12 weeks after surgery. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 6. The main organs function well.

Exclusion criteria

1. Patients with other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary tumor. 2. Macroscopic incomplete tumor removal (R2 resection). 3. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma. 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

Design outcomes

Primary

Measure	Time frame	Description
Disease-free survival (DFS)	Approximately 3 years.	Disease-free survival is defined as the time from the date of randomization to the date of disease recurrence or death from any cause (whichever occurs first). Disease recurrence is defined as evidence of disease recurrence demonstrated by imaging assessment with CT or MRI scan and/or pathological diagnosis indicated by biopsy.

Secondary

Measure	Time frame
Overall survival (OS)	Approximately 5 years.

Contacts

Primary ContactClinical Trials Information Group officer

ctr-contact@cspc.cn86-0311-69085587

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026