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To evaluate the tolerability and safety of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC; To evaluate the efficacy of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adebrelimab in combination with Bevacizumab | Experimental |
| |
| Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1 | Experimental |
| |
| Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity | The observation period is 21 days after the first dose | |
| Incidence and severity of grade ≥3 drug-related adverse events and serious adverse events of the two-drug or three-drug combination | The observation period is from the time when all informed subjects signed the informed consent to the end of the safety follow-up period, up to 2 years | |
| Objective Response Rate | determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points | At the time point of every 6 or 9 weeks, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate, determined using RECIST v1.1 criteria | At the time point of every 6 or 9 weeks, up to 2 years | |
| Progression-Free-Survival assessed by investigator | up to 2 years] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Shi | Contact | 0518-82342973 | xin.shi.xs3@hengrui.com | |
| Ying Sun | Contact | 0518-82342973 | ying.sun.ys1@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital Ethics Commitee | Recruiting | Hefei | Anhui | 230000 | China |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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This study is a multicenter, open-label, dose-finding and efficacy-expansion phase Ib/II study. The phase Ib design is for dose finding and dose confirmation, using modified 3+3 design; the phase II design is for efficacy expansion through randomization.
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| Bevacizumab | Drug | intravenous infusion |
|
| SHR-8068 | Drug | intravenous infusion |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |