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

Kuirong Jiang53 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer Adjuvant Therapy

Interventions

Irinotecan liposome injectionDRUG

Postoperative adjuvant therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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;

Locations (1)

FirstNanjingMU

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: baseline up to approximately 21.6 months.

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

Hematologic and non-hematologic adverse events during adjuvant therapy (according to NCI-CTCAE5.0);

Time frame: baseline up to approximately 7 months.

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.

Time frame: baseline up to approximately55 months.

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.

Time frame: 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.

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

Central Contacts

KuiRong Jiang, archiater

CONTACT

15312995688 Jiangkuirong@163.com

Data from ClinicalTrials.gov

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