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2024-02-05
2027-03-30
2028-07-30
524
NCT06217042
Fudan University
Fudan University
INTERVENTIONAL
HR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer
The purpose of this study is to look at the efficacy and safety of HR070803 in combination with 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to gemcitabine + capecitabine treatment as adjuvant therapy in patients with resected pancreatic cancer.
STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the disease-free survival. Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause. Patients without event at the time of analysis will be censored at the date of last follow-up visit. Secondary criteria include Overall survival. OS is defined as the time from date of randomization until the date of death from any cause. Patients who are still living at the time of analysis will be censored at the date of last follow-up visit. Secondary criteria also include 3-year disease-free survival rate/overall survival rate and 5-year disease-free survival rate/overall survival rate. Tolerance Patients evaluable for toxicity must have received one investigational drug.
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 |
|---|---|---|
2024-01-10 | N/A | 2024-01-18 |
2024-01-18 | N/A | 2024-01-22 |
2024-01-22 | N/A | 2024-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: HR070803+Oxaliplatin+5-FU/LV HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate | DRUG: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
|
| ACTIVE_COMPARATOR: GX gemcitabine; capecitabine | DRUG: gemcitabine; capecitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause. | From study start until 338 DFS events have occurred (approximately 21 months after last patient enrollment) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is defined as the time from date of randomization until the date of death from any cause. | From date of randomization until the date of death from any cause, assessed up to 37 months |
| 3-year disease-free survival rate | Disease-free survival within 3 years | up to 36 months following the date the first patient was randomized |
| 5-year disease-free survival rate | Disease-free survival within 5 years | up to 60 months following the date the first patient was randomized |
| 3-year overall survival rate | Overall survival within 3 years | up to 36 months following the date the first patient was randomized |
| 5-year overall survival rate | Overall survival within 5 years | up to 60 months following the date the first patient was randomized |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Si Shi, PhD Phone Number: +86 18917266285 Email: shisi@fudanpci.org |
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
