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

January 23, 2024 updated by: Changsha Taihe Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China
        • Changsha Taihe Hospital
        • Contact:
          • Xiaoli Chai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ZG005+Donafenib
Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.
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).
Other Names:
  • ZG005
Drug: Donafenib Tosilate Tablets
Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid).
Other Names:
  • Donafenib
Experimental: ZG005+Bevacizumab
Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.
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).
Other Names:
  • ZG005
Biological: Bevacizumab
Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks (Q3W).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changsha Taihe Hospital

Investigators

  • Principal Investigator: Xiaoli Chai, Changsha Taihe Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZG005-IIT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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