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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate | Experimental |
| |
| nab-paclitaxel; gemcitabine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate | Drug | HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | From study start until 399 OS events have occurred (approximately 15 months after last patient enrollment) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Zhang | Contact | 0518-82342973 | Jun.zhang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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HR070803 in combination with oxaliplatin, 5-FU/LV compared with AG
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| nab-paclitaxel; gemcitabine | Drug | nab-paclitaxel in combination with gemcitabine |
|
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 |
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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