HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
|
Drug: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate
|
| Active Comparator: nab-paclitaxel; gemcitabine
|
Drug: nab-paclitaxel; gemcitabine
nab-paclitaxel in combination with gemcitabine
|
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) [From study start until 399 OS events have occurred (approximately 15 months after last patient enrollment)]
Secondary Outcome Measures
- Objective Response rate (ORR) [up to 6 months following the date the last patient was randomized]
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.
- Disease Control Rate [up to 6 months following the date the last patient was randomized]
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).
- Duration of Response [up to 6 months following the date the last patient was randomized]
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.
- Progression free survival (PFS) [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]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
ECOG performance status 0 or 1
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Histological or cytologically confirmed pancreatic cancer that has not been previously treated in the metastatic disease.
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Life expectancy of greater than or equal to3 months.
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At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)
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Able and willing to provide a written informed consent
Exclusion Criteria:
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Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
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Known history of central nervous system (CNS) metastases.
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Severe infection (> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;
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Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HR070803-301