An interventional study of ZG005 Powder for Injection and Donafenib Tosilate Tablets in Advanced Hepatocellular Carcinoma, sponsored by Changsha Taihe Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Changsha Taihe Hospital · Not applicable, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →This is the only study on the registry with Changsha Taihe Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.
Biological: ZG005 Powder for Injection · Drug: Donafenib Tosilate Tablets
Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.
Biological: ZG005 Powder for Injection · Biological: Bevacizumab
ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every 3 weeks (Q3W).
Also known as: ZG005
Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid).
Also known as: Donafenib
Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks (Q3W).
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.
Time frame: up to approximately 2 years
Progression Free Survival (PFS)
Time from first dose of the investigational drug to PD or death from any cause.
Time frame: up to approximately 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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