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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06361316
• Other study ID #: CSPC-DEY-PC-JS01
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: July 31, 2028

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: KuiRong Jiang, archiater
• Phone: 15312995688
• Email: Jiangkuirong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: July 31, 2028
• Est. primary completion date: March 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Adjuvant Therapy
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Irinotecan liposome injection
Postoperative adjuvant therapy

Locations

Country	Name	City	State
China	FirstNanjingMU	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Kuirong Jiang	CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival, DFS	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	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	Hematologic and non-hematologic adverse events during adjuvant therapy (according to NCI-CTCAE5.0);	baseline up to approximately 7 months.
Secondary	Overall Survival, OS	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.
Secondary	Quality of life, QOL	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.
Secondary	The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy	The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy	baseline up to approximately 7 months.
Secondary	he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance	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.