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A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group (Camrelizumab Plus Rivoceranib (Apatinib)) | Experimental | Drug: Camrelizumab; Drug: Rivoceranib (Apatinib) |
|
| Control group (Active surveillance) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC) | RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first). | Randomization up to approximately 43 months |
| Measure | Description | Time Frame |
|---|---|---|
| RFS Rate at 24 and 36 Months, as Assessed by the Investigator | Randomization up to 24 months and up to 36 months | |
| Time to Recurrence (TTR) as determined by the investigator and by BIRC | TTR defined as the time from randomization to first documented occurrence of local, regional, or metastatic HCC |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China | |||
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Camrelizumab Combined with Rivoceranib (Apatinib) Versus Active Surveillance
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| Rivoceranib (Apatinib) | Drug | Subjects receive Rivoceranib (Apatinib) orally, Dosage form: tablet |
|
| Randomization up to approximately 43 months |
| Overall Survival (OS) | OS is defined as the time from randomization to death from any cause | Randomization up to approximately 43 months |
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 | Baseline up to approximately 43 months |
| Guangxi Medical University Affiliated Tumor Hospital |
| Nanjin |
| Guangzhou |
| China |
| Guizhou Cancer Hospital | Guiyang | Guizhou | China |
| Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | China |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | China |
| 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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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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