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The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer.
STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the 1-year disease-free survival rate. 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 the Disease-free survival.
Tolerance Patients evaluable for toxicity must have received one investigational drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR070803+Oxaliplatin+S-1 | Experimental | Drug: HR070803(Irinotecan Liposome); Oxaliplatin; Tegafur HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Tegafur The initial dose of S-1 is determined according to the body surface area,orally, D1-7. These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles. |
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| HR070803+Oxaliplatin+5-FU/LV | Active Comparator | Drug: HR070803; Oxaliplatin; 5-Fluorouracil; Calcium folinate HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Folinic acid 400 mg/^2 D1, IV infusion over 1 hours. 5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours. These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR070803 | Drug | HR070803 60 mg/^2 D1 over 90 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| 1-year Disease-free survival rate | 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. | Up to 2 years |
| 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. | Up to 2 years |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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There is not a plan to make individual participant data (IPD) available to other researchers.
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| ID | Term |
|---|---|
| C584112 | irinotecan sucrosofate |
| D000077150 | Oxaliplatin |
| D005641 | Tegafur |
| C079198 | S 1 (combination) |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
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| Oxaliplatin | Drug | Oxaliplatin 85 mg/^2 D1 over 2 hours. |
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| Tegafur | Drug | initial dose of S-1 is determined according to the body surface area,orally, D1-7. |
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| Folinic acid | Drug | Folinic acid 400 mg/^2 D1 |
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| 5-Fluorouracil | Drug | 5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours |
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| Up to 2 years |
| 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 |