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This is a multicenter, Phase 3 clinical trial to evaluate the efficacy and safety of SHR-8068, Adebrelimab, and Bevacizumab and TACE versus Placebo with TACE in incurable hepatocellular carcinoma.
Participants will continue treatment until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR-8068+ Adebrelimab+ Bevacizumab +Transarterial Chemoembolization(TACE) |
|
| Treatment group B | Active Comparator | SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo+Transarterial Chemoembolization(TACE) |
|
| Treatment group C | Experimental | SHR-8068 Placebo+Adebrelimab+ Bevacizumab +Transarterial Chemoembolization(TACE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-8068+ Adebrelimab+ Bevacizumab | Drug | SHR-8068+ Adebrelimab+ Bevacizumab,intravenous infusion,Transarterial Chemoembolization(TACE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by investigator | Until progression, assessed up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by Blinded Independ Review Committee( BIRC) | Until progression, assessed up to approximately 2 years | |
| Overall survival (OS) | Until study completion, assessed up to approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junqin Yang | Contact | +86-0518-82342973 | junqin.yang@hengrui.com | |
| Huan Wang | Contact | +86-0518-82342973 | huan.wang.hw396@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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| SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo | Drug | SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo,intravenous infusion,Transarterial Chemoembolization(TACE) |
|
| SHR-8068 Placebo +Adebrelimab+ Bevacizumab | Drug | SHR-8068 Placebo +Adebrelimab+ Bevacizumab,intravenous infusion,Transarterial Chemoembolization(TACE) |
|
| Objective response rate (ORR) | Until study completion,assessed up to approximately 2 years |
| Disease control rate (DCR) | Until study completion,assessed up to approximately 2 years |
| Duration of objective tumor response (DoR) | Until study completion,assessed up to approximately 2 years |
| Adverse events (AEs) | Until study completion,assessed up to approximately 2years |
| Serious adverse events (SAEs) | Until study completion,assessed up to approximately 3 years |
| Pharmacokinetics parameters of SHR-8068 、Adebrelimab:serum concentration | Approximately 90 days post-last dose |
| Immunogenicity indicators of SHR-8068 、Adebrelimab: drug resistant antibody (ADA) and neutralizing antibody (NAb) | Approximately 90 days post-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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