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2024-04-08
2025-03-25
2028-07-31
53
NCT06361316
The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital with Nanjing Medical University
INTERVENTIONAL
Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-03-25 | N/A | 2024-04-08 |
2024-04-08 | N/A | 2024-04-11 |
2024-04-11 | N/A | 2024-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Irinotecan liposome injection+ Oxaliplatin +Tegafur 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. | DRUG: Irinotecan liposome injection
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: KuiRong Jiang, archiater Phone Number: 15312995688 Email: Jiangkuirong@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
