Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer

April 8, 2024 updated by: Kuirong Jiang

Efficacy and Safety of Irinotecan Liposome Injection Combined With Oxaliplatin and Tegafur (NASOX) in Adjuvant Chemotherapy for Pancreatic Cancer

The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

53

Phase

  • Not Applicable

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

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 025
        • Recruiting
        • FirstNanjingMU
        • Contact:
        • Sub-Investigator:
          • Min Tu, associate doctor

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ECOG performance status 0 or 1.
  2. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
  3. ECOG performance status 0 or 1.
  4. Life expectancy of greater than or equal to 6 months.
  5. Able and willing to provide a written informed consent.

Exclusion Criteria:

  1. Patients who cannot eat orally and have gastric emptying disorder after surgery;
  2. Patients with moderate diarrhea: diarrhea ≥4 times per day; the moderate and severe effluents from stoma increased; Or diarrhea that limits activities of daily living;
  3. Patients who cannot eat orally and have gastric emptying disorder after surgery;
  4. Patients who cannot eat orally and have gastric emptying disorder after surgery;

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Irinotecan liposome injection+ Oxaliplatin +Tegafur
Oxaliplatin: 60mg/m2, d1, ivgtt, 2h; Repeat every 15 days; Irinotecan liposomes: 50mg/m2, d1, ivgtt, 90min; Repeat every 15 days; Tegafur: 40-60mg, BID, po, d1-d10, repeat every 15 days; 30 days as one cycle, 6 treatment cycles.
Drug: Irinotecan liposome injection
Postoperative adjuvant therapy
Other Names:
  • oxaliplatin
  • Tegafur

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival, DFS
Time Frame: baseline up to approximately 21.6 months.
the time from the start of randomization (or the start of treatment in a one-arm trial) to the recurrence of disease or death from any cause, whichever occurs first.
baseline up to approximately 21.6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (aes) were determined and graded according to NCI-CTCAE version 5.0, and evaluated by the overall incidence of AE, the incidence of AE grade 3 or above, and the incidence of SAE
Time Frame: baseline up to approximately 7 months.
Hematologic and non-hematologic adverse events during adjuvant therapy (according to NCI-CTCAE5.0);
baseline up to approximately 7 months.
Overall Survival, OS
Time Frame: baseline up to approximately55 months.
the time from the start of randomization (or the start of treatment in a one-arm trial) to death from any cause.
baseline up to approximately55 months.
Quality of life, QOL
Time Frame: baseline up to approximately 55 months.
It reflects the ability of human activities to improve the survival level and survival chances, evaluated according to EORTC Quality of life measurement scale QLQ-C30 V3.0 assessment.
baseline up to approximately 55 months.
The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy
Time Frame: baseline up to approximately 7 months.
The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy
baseline up to approximately 7 months.
he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance
Time Frame: baseline up to approximately 7 months.
The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy and the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance
baseline up to approximately 7 months.

Collaborators and Investigators

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

Sponsor

Kuirong Jiang

Collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: KuiRong Jiang, archiater, The First Affiliated Hospital with Nanjing Medical University

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 Major Dates

Study Start (Estimated)

April 8, 2024

Primary Completion (Estimated)

March 25, 2025

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-DEY-PC-JS01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Irinotecan liposome injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe