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

Not Applicable

Not yet recruiting

• Conditions: Advanced Hepatocellular Carcinoma
• Interventions: Biological: ZG005 Powder for Injection; Biological: Bevacizumab; Drug: Donafenib Tosilate Tablets

• Registration Number: NCT06233994
• Lead Sponsor: Changsha Taihe Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZG005+Donafenib	ZG005 Powder for Injection	Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.
ZG005+Bevacizumab	ZG005 Powder for Injection	Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.
ZG005+Bevacizumab	Bevacizumab	Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.
ZG005+Donafenib	Donafenib Tosilate Tablets	Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	up to approximately 2 years	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.
Progression Free Survival (PFS)	up to approximately 2 years	Time from first dose of the investigational drug to PD or death from any cause.

Trial Locations

Locations (1)

Changsha Taihe Hospital; 🇨🇳 Changsha, Hunan, China