Actively Recruiting
Efficacy and Safety of Irinotecan Liposome Injection Combined With Oxaliplatin and Tegafur (NASOX) in Adjuvant Chemotherapy for Pancreatic Cancer
Led by Kuirong Jiang · Updated on 2024-04-11
53
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
Sponsors
K
Kuirong Jiang
Lead Sponsor
C
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of irinotecan liposome injection combined with oxaliplatin and tegafur (NASOX) as postoperative adjuvant chemotherapy for pancreatic cancer. This study focuses on patients who have undergone surgery to remove pancreatic ductal adenocarcinoma and aims to improve outcomes after surgery. Participants receive irinotecan liposome injection, oxaliplatin, and tegafur as their treatment. Oxaliplatin is given intravenously at 60 mg/m2 over 2 hours on day 1 and repeated every 15 days. Irinotecan liposomes are administered intravenously at 50 mg/m2 over 90 minutes on day 1, also repeated every 15 days. Tegafur is taken orally at 40-60 mg twice daily from day 1 to day 10, repeating every 15 days. One treatment cycle lasts 30 days, with a total of six cycles planned. During the study, participants will be closely monitored for disease-free survival up to about 21.6 months. Researchers will also track adverse events, overall survival, quality of life, treatment completion rates, and any need to replace tegafur due to intolerance. Safety is assessed using standard criteria over approximately seven months, while survival and quality of life are followed for up to around 55 months after treatment begins.
CONDITIONS
Brief Title
Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status 0 or 1
- Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1)
- Life expectancy of greater than or equal to 6 months
- Able and willing to provide written informed consent
- Age between 18 and 75 years
You will not qualify if you...
- Patients who cannot eat orally and have gastric emptying disorder after surgery
- Patients with moderate diarrhea (4 or more times per day) or diarrhea that limits daily activities
- Patients with severe effluents from stoma increased
- Any condition preventing oral intake after surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 treatment cycles of 30 days each
Participants receive adjuvant chemotherapy with irinotecan liposome injection combined with oxaliplatin and tegafur after surgery.
Visits every 15 days during treatment cycles
Trial Site Locations
Total: 1 location
1
FirstNanjingMU
Nanjing, Jiangsu, China, 025
Actively Recruiting
Research Team
K
KuiRong Jiang, archiater
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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