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This is a Phase 2/3 study evaluating the efficacy and safety of Pracytarabine versus regorafenib in patients with advanced hepatocellular carcinoma (HCC) who have experienced treatment failure with standard systemic therapies involving targeted drugs and immune checkpoint inhibitors, or dual immune checkpoint inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pracytarabine | Experimental | Treatment with 1200 mg/m²/d Pracytarabine |
|
| regorafenib | Active Comparator | Treatment with regorafenib 160 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pracytarabine | Drug | Pracytarabine 1200 mg/m²/d, administered as a continuous intravenous infusion for 7 days (Days 1 to 7), followed by a 21-day treatment-free observation period; each treatment cycle is 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 9-month Overall Survival (OS) rate | 9-month Overall Survival (OS) rate:The proportion of the total number of subjects who survived for 9 months from randomization. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by investigator per RECIST v1.1 | PFS is defined as the time from randomization till the first documented disease progression (Per RECIST v1.1 assessed by the investigator) or death due to any cause, whichever occurs first. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Tianyinshan Hospital | Nanjing | Jiangsu | 211100 | China |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
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| regorafenib | Drug | Regorafenib 160 mg, once daily, administered continuously for 3 weeks followed by 1 week of rest, i.e., each cycle is 4 weeks. |
|