HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Advanced Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.

Conditions
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First-line Treatment of Advanced Pancreatic Cancer

Intervention / Treatment
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* Drug: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
* Drug: nab-paclitaxel; gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ECOG performance status 0 or 1 Histological or cytologically confirmed pancreatic cancer that has not been previously treated in the metastatic disease. Life expectancy of greater than or equal to3 months. At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1) Able and willing to provide a written informed consent Exclusion Criteria: Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor; Known history of central nervous system (CNS) metastases. 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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: HR070803 in combination with oxaliplatin, 5-FU/LV compared with AG
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate<br> | Drug: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate<br>* HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate<br>|
| Active Comparator: nab-paclitaxel; gemcitabine<br> | Drug: nab-paclitaxel; gemcitabine<br>* nab-paclitaxel in combination with gemcitabine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 |