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A study to evaluate efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Rivoceranib (Apatinib) therapy in patients with incurable hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib). |
|
| Control group | Active Comparator | TACE Alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE+Camrelizumab+Apatinib mesylate | Drug | TACE. Camrelizumab,200mg,iv,once every 3 weeks. Apatinib mesylate, 250 mg, administered orally once daily,once every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by BIRC | PFS is defined as the time from the date of randomization until the date of first objective disease progression or death (whichever occurs first). | approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | OS is defined as the time from the date of randomization until death due to any cause. | approximately 5 years |
| ORR | ORR is defined as the percentage of participants in the analysis population who have a CR or PR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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This is a Randomized, Open-Label, Multi-center phase III clinical trial。
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| TACE | Procedure | TACE Alone. |
|
| approximately 5 years |
| DCR | DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD. | approximately 5 years |
| DoR | DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. | approximately 5 years |
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 | approximately 5 years |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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