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

Changsha Taihe Hospital

Status: Not yet enrolling

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Biological: Bevacizumab; Biological: ZG005 Powder for Injection; Drug: Donafenib Tosilate Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT06233994

ZG005-IIT-001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

ZG005+Donafenib

Experimental group

Description:

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

Treatment:

Drug: Donafenib Tosilate Tablets

Biological: ZG005 Powder for Injection

ZG005+Bevacizumab

Experimental group

Description:

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

Treatment:

Biological: ZG005 Powder for Injection

Biological: Bevacizumab