Actively Recruiting
A Multicenter, Open-label Phase II/III Trial of VRT106 with Camrelizumab and Apatinib in Advanced Hepatocellular Carcinoma Who Have Failed Immune Checkpoint Inhibitor Therapy
Led by Guangzhou Virotech Pharmaceutical Co., Ltd. · Updated on 2026-05-15
66
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates treatments for patients with advanced hepatocellular carcinoma (HCC) who have not responded to prior immune checkpoint inhibitors (ICIs). It is an open-label phase II/III clinical trial aiming to assess the safety, effectiveness, and appropriate dosing of the drug VRT106 in combination with camrelizumab and apatinib. The study includes dose-escalation and dose-expansion stages, with a phase III portion planned based on data gathered from phase II. The trial involves three treatment groups: VRT106 alone given by intravenous infusion, VRT106 combined with camrelizumab (intravenous infusion) and apatinib (oral administration), and a group receiving the investigator's choice of standard care. Phase II Part A focuses on determining a recommended dose by evaluating safety and tolerability. Part B compares progression-free survival between the combination treatment and standard care. The phase III segment will assess overall survival between these treatments. Participants will be monitored through assessments including dose-limiting toxicities within 56 days of starting VRT106, as well as progression-free and overall survival over about two years. Eligibility includes adults aged 18 to 75 with confirmed advanced HCC and good performance status. The study involves regular clinical evaluations and treatment administration according to assigned groups, with safety and effectiveness data collected throughout the trial period.
CONDITIONS
Brief Title
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and agree to complete all required study procedures.
- Be aged between 18 and 75 years (inclusive).
- Have a confirmed diagnosis of advanced hepatocellular carcinoma (HCC) by histology, cytology, or clinical criteria.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Have an expected life expectancy of at least 3 months.
- Have no severe abnormalities in blood, liver, kidney, coagulation, or heart function.
You will not qualify if you...
- Prior treatment with camrelizumab, apatinib, oncolytic viruses, or other gene therapies.
- Use of other unapproved investigational drugs or devices within 4 weeks or 5 half-lives before starting this study, or immunocompromised status.
- History of splenectomy.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Dose-limiting toxicity assessment within 56 days following the first administration; treatment continues as per study protocol
Participants receive VRT106 alone, VRT106 combined with camrelizumab and apatinib, or standard of care treatment as assigned to help treat advanced hepatocellular carcinoma.
Multiple visits during treatment period for infusions and evaluations
Duration - About 2 years
Participants are followed up to evaluate progression-free survival and overall survival for about 2 years after treatment.
Regular follow-up visits during this period
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
L
Liang Peng
C
Chan Xie
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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