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

C

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)

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

Trial contacts and locations

1

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Central trial contact

Yongsheng Chu

Data sourced from clinicaltrials.gov

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