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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Liposomal Irinotecan; Drug: Oxaliplatin; Drug: S-1; Drug: Gemcitabine; Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Estimated): 408
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: 86-0311-69085587; Email: ctr-contact@cspc.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NASOX：Liposomal Irinotecan; Oxaliplatin; S-1; Liposomal irinotecan at a dose of 50 mg/m² is administered intravenously over 90 minutes on D1. Oxaliplatin is administered at a dose of 60 mg/m² intravenously over 2 hours on D1. S-1 at a dose of 40 to 60mg twice daily is taken orally for 7 consecutive days, followed by a 7-day break. These medications are administered once every 2 weeks for a total of 12 cycles.	Drug: Liposomal Irinotecan; Liposomal Irinotecan：i.v. infusion; Drug: Oxaliplatin; Oxaliplatin;：i.v. infusion; Drug: S-1; S-1: Oral
Active Comparator: GX：Gemcitabine; Capecitabine; Gemcitabine at a dose of 1000mg/m² is administered via intravenous infusion over 30 minutes on D1, 8, and 15 of a 28-day cycle. Capecitabine at a dose of 1660mg/m² per day in two divided oral doses is taken for 21 consecutive days, followed by a 7-day rest period. These medications are administered once every 4 weeks for a total of 6 cycles.	Drug: Gemcitabine; Gemcitabine: i.v. infusion; Drug: Capecitabine; Capecitabine: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival (DFS)	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.	Approximately 3 years.

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	Approximately 5 years.

Collaborators and Investigators

• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 25, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Capecitabine; Oxaliplatin; Irinotecan; Gemcitabine
• Other Study ID Numbers: HE072-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No