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Trial Title:
Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer
NCT ID:
NCT06361316
Condition:
Pancreatic Cancer
Adjuvant Therapy
Conditions: Official terms:
Pancreatic Neoplasms
Oxaliplatin
Irinotecan
Tegafur
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Irinotecan liposome injection
Description:
Postoperative adjuvant therapy
Arm group label:
Irinotecan liposome injection+ Oxaliplatin +Tegafur
Other name:
oxaliplatin
Other name:
Tegafur
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.
Criteria for eligibility:
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
FirstNanjingMU
Address:
City:
Nanjing
Zip:
025
Country:
China
Status:
Recruiting
Contact:
Last name:
KuiRong Jiang, archiater
Phone:
15312995688
Email:
Jiangkuirong@163.com
Investigator:
Last name:
Min Tu, associate doctor
Email:
Sub-Investigator
Start date:
April 8, 2024
Completion date:
July 31, 2028
Lead sponsor:
Agency:
Kuirong Jiang
Agency class:
Other
Collaborator:
Agency:
CSPC Ouyi Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06361316
