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| Name | Class |
|---|---|
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to observe and preliminary explore the efficacy and safety of the combination of Camrelizumab and Apatinib regimen in treating advanced hepatocellular carcinoma (HCC) participants who have progressed following prior Immune Checkpoint Inhibitors (ICIs) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab+Apatinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab combined Apatinib regimen | Drug | Camrelizumab 200mg iv every 2 weeks; Apatinib,250 mg/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | Up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | Progression-free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | Up to approximately 12 months |
| Time to objective response(TTR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shanzhi Gu, MD | Contact | +86-731-88651900 | gushanzhi@hnca.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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Time to objective response(TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
| Up to approximately 12 months |
| Duration of Response (DoR) | Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | Up to approximately 12 months |
| Disease Control Rate (DCR) | Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | Up to approximately 12 months |
| 6-month survival rate | 6-month survival rate | Up to approximately 12 months |
| 9-month survival rate | 9-month survival rate | Up to approximately 12 months |
| 12-month survival rate | 12-month survival rate | Up to approximately 12 months |
| Overall survival(OS) | Up to approximately 24 months |
| Safety as measured by the rate of AEs, SAEs and laboratory abnormalities | Safety as measured by the rate of AEs, SAEs and laboratory abnormalities (e.g. Grade 3 or higher per CTCAE v4 ) | From the first assignment of informed consent form up to 90 days after the last dose |
| 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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