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This is a randomized, open-label study to evaluate the safety and efficacy of ZG005 in combination with Donafenib or Bevacizumab in patients with advanced hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZG005+Donafenib | Experimental | Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit. |
|
| ZG005+Bevacizumab | Experimental | Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZG005 Powder for Injection | Biological | ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every 3 weeks (Q3W). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria. | up to approximately 2 years |
| Progression Free Survival (PFS) | Time from first dose of the investigational drug to PD or death from any cause. | up to approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongsheng Chu | Contact | +8651257309965 | chuys@zelgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoli Chai | Changsha Taihe Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changsha Taihe Hospital | Changsha | Hunan | China |
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| Donafenib Tosilate Tablets | Drug | Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid). |
|
|
| Bevacizumab | Biological | Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks (Q3W). |
|
| ID | Term |
|---|---|
| D007267 | Injections |
| C000710249 | donafenib |
| D000068258 | Bevacizumab |
| 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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