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

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer; Adjuvant Therapy
• Interventions: Drug: Irinotecan liposome injection

• Registration Number: NCT06361316
• Lead Sponsor: Kuirong Jiang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-25
• Status Verified: 2024-04
• Study Start: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-03-25
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Irinotecan liposome injection+ Oxaliplatin +Tegafur	Irinotecan liposome injection	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.

Primary Outcome Measures

Name	Time	Method
Disease Free Survival, DFS	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 Outcome Measures

Name	Time	Method
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.	Hematologic and non-hematologic adverse events during adjuvant therapy (according to NCI-CTCAE5.0);
Overall Survival, OS	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.
Quality of life, QOL	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.
The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy	baseline up to approximately 7 months.	The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy
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.	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

Trial Locations

Locations (1)

FirstNanjingMU; 🇨🇳 Nanjing, Jiangsu, China