- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2016-05-01
2022-07-31
2023-06-30
64
NCT06363084
Ruijin Hospital
Ruijin Hospital
OBSERVATIONAL
A Retrospective Study for Nimotuzumab Plus Postoperative Adjuvant Chemotherapy for Resectable Pancreatic Cancer
This trial is a retrospective, observational study, patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS).
This trial is a retrospective, observational study based on real-world data obtained from the Health Information System (HIS) of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. Patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS).
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 |
|---|---|---|
2024-04-09 | N/A | 2024-04-09 |
2024-04-09 | N/A | 2024-04-12 |
2024-04-12 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : study arm Nimotuzumab plus adjuvant chemotherapy | DRUG: Nimotuzumab
|
| : control arm adjuvant chemotherapy alone (without Nimotuzumab) |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| overall survival (OS） | The primary endpoint is overall survival (OS), defined as the time from the start of surgery to the date of death due to any cause. | approximately 84 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| disease-free survival (DFS) | DFS is defined as the time from surgical resection to the first tumor recurrence/progression or death due to any cause. | approximately 84 months |
| locoregional recurrence-free survival (LRRFS) | LRRFS is defined as the time from surgical treatment to clinically or radiographically confirmed local recurrence and/or regional progression at follow-up. | approximately 84 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
