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This study is conducted to evaluate the efficacy and safety of SHR-8068 combined with Adebrelimab and Apatinib compared with Adebrelimab combined with Apatinib in perioperative treatment of resectable hepatocellular carcinoma with intermediate or high recurrence risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-8068 + Adebrelimab + Apatinib Group | Experimental | SHR-8068, Adebrelimab, Apatinib. |
|
| Adebrelimab + Apatinib Group | Active Comparator | Adebrelimab, Apatinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-8068 Injection | Drug | SHR-8068 injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response (MPR (70%)) rate. | MPR (70%) is defined as residual viable tumor cells <= 30% in the tumor bed. | After surgery, approximately 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS). | From randomization to event, approximately 2 years. | |
| 12-month and 24-month Event-free survival (EFS) rate. | From randomization to event, approximately 2 years. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Shi | Contact | +86-0518-82342973 | xin.shi.xs3@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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Participants are randomized 1:1 into two cohorts in an open-label, multicenter, phase II perioperative study.
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| Adebrelimab Injection |
| Drug |
Adebrelimab injection. |
|
| Apatinib Mesylate Tablets | Drug | Apatinib mesylate tablets. |
|
| R0 resection rate. |
| After surgery, approximately 3 months. |
| Safety endpoints, including adverse events (AEs) and serious adverse events (SAEs) by NCI-CTCAE v6.0. | Approximately 2 years. |
| Safety endpoints, including surgical complications by Clavien-Dindo. | Approximately 2 years. |
| ID | Term |
|---|---|
| C553458 | apatinib |
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