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2023-06-13
2024-12-30
2025-12-30
778
NCT05751850
Jiangsu HengRui Medicine Co., Ltd.
Jiangsu HengRui Medicine Co., Ltd.
INTERVENTIONAL
HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced 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 nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic 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 |
|---|---|---|
2023-02-20 | N/A | 2024-05-08 |
2023-02-28 | N/A | 2024-05-09 |
2023-03-02 | N/A | 2024-05 |
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; 5Fluorouracil; Calcium folinate | DRUG: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
|
| ACTIVE_COMPARATOR: nab-paclitaxel; gemcitabine | DRUG: nab-paclitaxel; gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival (OS) | From study start until 399 OS events have occurred (approximately 15 months after last patient enrollment) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective Response rate (ORR) | ORR is defined as the percentage of participants who have a best overall response of complete response (CR) or partial response (PR), per RECIST 1.1. | up to 6 months following the date the last patient was randomized |
| Disease Control Rate | The study is designed to evaluate the disease control rate with advanced pancreatic cancer. DCR is defined as the percentage of patients with a best response of CR, PR, or stable disease (SD). | up to 6 months following the date the last patient was randomized |
| Duration of Response | DoR is defined as the time from first documentation of response (CR or PR whichever occurred first, as per RECIST version 1.1) to disease progression or death, whichever is earlier. | up to 6 months following the date the last patient was randomized |
| Progression free survival (PFS) | PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jun Zhang Phone Number: 0518-82342973 Email: Jun.zhang@hengrui.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
