HR070803 In Combination With Oxaliplatin, S-1 Versus NALIRIFOX As Adjuvant Therapy For Pancreatic Cancer

Study Overview

HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer

The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer.

STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the 1-year disease-free survival rate. Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause. Patients without event at the time of analysis will be censored at the date of last follow-up visit. Secondary criteria include Overall survival. OS is defined as the time from date of randomization until the date of death from any cause. Patients who are still living at the time of analysis will be censored at the date of last follow-up visit. Secondary criteria also include the Disease-free survival. Tolerance Patients evaluable for toxicity must have received one investigational drug.

Efficacy and Safety

DRUG: HR070803
DRUG: Oxaliplatin
DRUG: Tegafur
DRUG: Folinic acid
DRUG: 5-Fluorouracil

MA-PC-II-012

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 2024-04-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-22
First Submitted that Met QC Criteria 2024-04-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-25
First Posted (ACTUAL) 2024-04-25	Results First Posted N/A	Last Verified 2024-04

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: HR070803+Oxaliplatin+S-1 Drug: HR070803（Irinotecan Liposome）; Oxaliplatin; Tegafur HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Tegafur The initial dose of S-1 is determined according to the body surface area，orally, D1-7. These drugs are given onc	DRUG: HR070803 HR070803 60 mg/^2 D1 over 90 minutes. DRUG: Oxaliplatin Oxaliplatin 85 mg/^2 D1 over 2 hours. DRUG: Tegafur initial dose of S-1 is determined according to the body surface area，orally, D1-7.
ACTIVE_COMPARATOR: HR070803+Oxaliplatin+5-FU/LV Drug: HR070803; Oxaliplatin; 5-Fluorouracil; Calcium folinate HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Folinic acid 400 mg/^2 D1, IV infusion over 1 hours. 5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours. These	DRUG: HR070803 HR070803 60 mg/^2 D1 over 90 minutes. DRUG: Oxaliplatin Oxaliplatin 85 mg/^2 D1 over 2 hours. DRUG: Folinic acid Folinic acid 400 mg/^2 D1 DRUG: 5-Fluorouracil 5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: HR070803+Oxaliplatin+S-1

Drug: HR070803（Irinotecan Liposome）; Oxaliplatin; Tegafur HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Tegafur The initial dose of S-1 is determined according to the body surface area，orally, D1-7. These drugs are given onc

DRUG: HR070803

HR070803 60 mg/^2 D1 over 90 minutes.

DRUG: Oxaliplatin

Oxaliplatin 85 mg/^2 D1 over 2 hours.

DRUG: Tegafur

initial dose of S-1 is determined according to the body surface area，orally, D1-7.

ACTIVE_COMPARATOR: HR070803+Oxaliplatin+5-FU/LV

Drug: HR070803; Oxaliplatin; 5-Fluorouracil; Calcium folinate HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Folinic acid 400 mg/^2 D1, IV infusion over 1 hours. 5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours. These

DRUG: HR070803

HR070803 60 mg/^2 D1 over 90 minutes.

DRUG: Oxaliplatin

Oxaliplatin 85 mg/^2 D1 over 2 hours.

DRUG: Folinic acid

Folinic acid 400 mg/^2 D1

DRUG: 5-Fluorouracil

5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours

Primary Outcome Measures	Measure Description	Time Frame
1-year Disease-free survival rate	Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause.	Up to 2 years

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival (OS)	OS is defined as the time from date of randomization until the date of death from any cause.	Up to 2 years
Disease-free survival（DFS）	Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause.	Up to 2 years

Contacts and Locations

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

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:
20 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

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

Publications

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General Publications

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Clinical Trial Record