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

Kuirong Jiang1 site in 1 country53 target enrollmentApril 8, 2024

ConditionsPancreatic Cancer Adjuvant Therapy

InterventionsIrinotecan liposome injection

DrugsIrinotecan liposome injection

Overview

Phase: Not Applicable
Intervention: Irinotecan liposome injection
Conditions: Pancreatic Cancer
Sponsor: Kuirong Jiang
Enrollment: 53
Locations: 1
Primary Endpoint: Disease Free Survival, DFS
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 8, 2024

End Date

July 31, 2028

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kuirong Jiang

Responsible Party

Sponsor Investigator

Principal Investigator

Kuirong Jiang

archiater

The First Affiliated Hospital with Nanjing Medical University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Patients who cannot eat orally and have gastric emptying disorder after surgery;
•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;
•Patients who cannot eat orally and have gastric emptying disorder after surgery;
•Patients who cannot eat orally and have gastric emptying disorder after surgery;

Arms & Interventions

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.

Intervention: Irinotecan liposome injection

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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(baseline up to approximately 7 months.)
Overall Survival, OS(baseline up to approximately55 months.)
Quality of life, QOL(baseline up to approximately 55 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(baseline up to approximately 7 months.)