A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib Tosilate Tablets or Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06233994
• Other study ID #: ZG005-IIT-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: January 2026

Study information

• Verified date: January 2024
• Source: Changsha Taihe Hospital
• Contact: Yongsheng Chu
• Phone: +8651257309965
• Email: chuys[@]zelgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female =18 years of age.

• Fully understand the study and voluntarily sign the informed consent form.

• Histologically or cytologically confirmed diagnosis of metastatic or unresectable hepatocellular carcinoma (HCC).

• Life expectancy >= 3 months.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion Criteria:

• Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.

• Patients were deemed unsuitable for participating in the studyl by the investigator for any reasons.

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Biological:
• ZG005 Powder for Injection
ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every 3 weeks (Q3W).

Drug:
• Donafenib Tosilate Tablets
Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid).

Biological:
• Bevacizumab
Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks (Q3W).

Locations

Country	Name	City	State
China	Changsha Taihe Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Changsha Taihe Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Progression Free Survival (PFS)	Time from first dose of the investigational drug to PD or death from any cause.	up to approximately 2 years