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

Sponsor
Changsha Taihe Hospital
Study ID
NCT06233994
Status
Unknown

Conditions

  • Advanced Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ZG005 Powder for Injection — BIOLOGICAL
    ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every 3 weeks (Q3W).
  • Donafenib Tosilate Tablets — DRUG
    Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid).
  • Bevacizumab — BIOLOGICAL
    Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks (Q3W).

Study Details

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.

Key Dates

First listed
Jan 31, 2024
Start date
Jan 31, 2024
Status verified
Jan 2024
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ZG005+Donafenib
    Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.
  • Experimental: ZG005+Bevacizumab
    Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to approximately 2 years ]

Central Contacts

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