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This study is a randomized, open-label, positive-controlled, multicenter phase II clinical trial. It evaluates the efficacy and safety of ZG005 combined with Bevacizumab compared to Sintilimab combined with Bevacizumab in first-line treatment for patients with advanced hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | ZG005 10 mg/kg administered intravenously every 3 weeks (Q3w) + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w |
|
| Group B | Experimental | ZG005 20 mg/kg administered intravenously Q3w + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w |
|
| Group C | Experimental | Sintilimab 200 mg administered intravenously Q3w + Bevacizumab (达攸同®) 15 mg/kg administered intravenously Q3w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZG005 for Injection | Biological | 10 mg/kg or 20 mg/kg administered intravenously Q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival，PFS | defined as the time from receiving treatment until disease progression or death from any cause, whichever happens first. | through study completion, up to 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Liu | Contact | +86-021-5838-2983 | liub@zelgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| Bevacizumab | Biological | 15 mg/kg administered intravenously Q3w |
|
|
| Sintilimab | Biological | 200 mg administered intravenously Q3w |
|
| Bevacizumab | Biological | 15 mg/kg administered intravenously Q3w |
|
|
| 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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| ID | Term |
|---|---|
| D007267 | Injections |
| D000068258 | Bevacizumab |
| C000632826 | sintilimab |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| 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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