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THis study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab or Atezolizumab combined with Bevacizumab for the first-line treatment of advanced HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-8068 combined with Adebrelimab and Bevacizumab | Experimental |
| |
| Sintilimab combined with Bevacizumab or Atezolizumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-8068 | Drug | SHR-8068: injection, 50 mg/10 mL, intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months) | |
| Overall survival (OS) | OS is defined as the time from randomization to death from any cause. | From randomization to death from any cause (whichever occurs first) (up to approximately 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) | TTP is defined as the time from randomization to the until first evidence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. | From randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)] |
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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 | |
| Ying Sun | Contact | +86-0518-82342973 | ying.sun.ys1@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Recruiting | Hefei | Anhui | 230000 | China |
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The study is a randomized, controlled, open-label phase III study designed for efficacy evaluation.
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| Adebrelimab | Drug | Adebrelimab: injection, 600 mg/12 mL, intravenous infusion |
|
| Bevacizumab | Drug | Bevacizumab: injection, 100 mg/4 mL, intravenous infusion |
|
| Sintilimab | Drug | Sintilimab: injection, 100 mg/10 mL, intravenous infusion |
|
| Atezolizumab injection | Drug | Atezolizumab injection. |
|
| Disease Control Rate (DCR) | DCR is defined as the proportion of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD), as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. | From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months) |
| Objective Response Rate (ORR) | ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. | From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months) |
| Duration of Response (DoR) | DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first). | From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months) |
| Time to Response (TTR) | TTR is defined as time from the randomization of Complete Response (CR) or Partial Response (PR) by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1. | From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months) |
| The incidence, severity and relevance to investigational drugs of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE v5.0 | From the ICF date until the end of the safety follow-up or initiation of new anti-tumor therapy (up to approximately 36 months) |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C000632826 | sintilimab |
| C000594389 | atezolizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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