Liposomal Irinotecan In Combination With Oxaliplatin And S-1 Versus Gemcitabine Combined With Capecitabine As Postoperative Adjuvant Therapy For Pancreatic Cancer

Study Overview

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

N/A

Pancreatic Cancer

DRUG: Liposomal Irinotecan
DRUG: Oxaliplatin
DRUG: S-1
DRUG: Gemcitabine
DRUG: Capecitabine

HE072-006

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-08-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-08-25
First Submitted that Met QC Criteria 2024-08-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-08-27
First Posted (ACTUAL) 2024-08-26	Results First Posted N/A	Last Verified 2024-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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 d	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 res	DRUG: Gemcitabine Gemcitabine: i.v. infusion DRUG: Capecitabine Capecitabine: Oral

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 d

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 res

DRUG: Gemcitabine

Gemcitabine: i.v. infusion

DRUG: Capecitabine

Capecitabine: Oral

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Clinical Trials Information Group officer

Phone Number: 86-0311-69085587

Email: ctr-contact@cspc.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record