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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

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What is being tested

ZG005 Powder for Injection

+ Bevacizumab

+ Donafenib Tosilate Tablets

BiologicalDrug
Who is being recruted

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorChangsha Taihe Hospital
Study ContactYongsheng Chu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2024

Actual date on which the first participant was enrolled.

This study is designed to assess how effective and safe a new treatment using ZG005 is when combined with two other medications, Donafenib or Bevacizumab, for people suffering from advanced liver cancer, specifically hepatocellular carcinoma. This cancer is quite serious and challenging to treat at advanced stages, so finding a new effective treatment option is crucial. The study aims to improve the current treatment strategies and provide better care for individuals affected by this condition. Participants in this study will receive the treatment combinations through oral tablets or injections, depending on the specific medication being tested. The study will monitor the participants to see how well the cancer responds to these treatments and check for any side effects. By evaluating the combination of these drugs, the study hopes to determine the best approach for treating advanced liver cancer, potentially offering new hope for those affected by this condition.

Official TitleA 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
NCT06233994
Principal SponsorChangsha Taihe Hospital
Study ContactYongsheng Chu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
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.
Show More Criteria
2 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.

Group II

Experimental
Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Changsha Taihe Hospital

Changsha, ChinaOpen Changsha Taihe Hospital in Google Maps
Recruiting soonOne Study Center