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Recruiting NCT07589244

A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC

Phase II / Phase III Interventional HCC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VRT106, VRT106 in combination with camrelizumab and apatinib, Investigator's Choice of Standard of Care.
Who it may be relevant to
Registry conditions: HCC. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Open-label Phase II/III Clinical Trial of VRT106 in Combination With Camrelizumab and Apatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Immune Checkpoint Inhibitor Therapy

Overview

This is an open-label phase II/III clinical trial enrolling patients with advanced HCC who have failed prior ICIs. The phase II portion consists of a part A dose-escalation stage and a part B dose-expansion stage. The phase III study will be initiated following discussions with National Medical Products Administration (NMPA) regarding the phase III protocol, based on accumulated data from phase II including safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD).

Detailed description

Phase II Part A: To evaluate the safety and tolerability of VRT106 in combination with camrelizumab and apatinib at different dose levels in patients with HCC who have failed prior ICIs, and to determine the recommended phase II dose (RP2D).

Phase II Part B: To evaluate the progression-free survival (PFS) of VRT106 in combination with camrelizumab and apatinib at the RP2D versus investigator's choice of standard of care in patients with advanced HCC who have failed prior ICIs.

Phase III: To evaluate the overall survival (OS) of VRT106 in combination with camrelizumab and apatinib versus investigator's choice of standard of care in patients with advanced HCC who have failed prior ICIs.

Interventions

  • Drug VRT106
    VRT106,Intravenous infusion
  • Drug VRT106 in combination with camrelizumab and apatinib
    VRT106: Intravenous infusion Camrelizumab: Intravenous infusion Apatinib: Oral administration
  • Drug Investigator's Choice of Standard of Care
    At the investigator's discretion

Primary outcome measures

  • Incidence of Dose-Limiting Toxicities [Time frame: Dose-limiting toxicity (DLT) will be assessed within 56 days following the first administration of VRT106.]
Secondary outcome measures (2)
  • Progression-Free Survival [Time frame: About 2 years]
  • Overall survival [Time frame: About 2 years]

Eligibility criteria

Inclusion criteria

  • Voluntarily sign the informed consent form (ICF), understand the nature of this study, and agree to comply with and complete all required study procedures.
  • Be aged between 18 and 75 years (inclusive) on the date of signing the ICF, regardless of gender.
  • Have a histologically or cytologically confirmed diagnosis of advanced hepatocellular carcinoma (HCC), or a clinical diagnosis of advanced HCC according to the Standard for Diagnosis and Treatment of Primary Liver Cancer(2024 Edition).
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Have an anticipated life expectancy of ≥ 3 months.
  • Have no severe hematologic, hepatic, renal, coagulation, or cardiac function abnormalities.

Exclusion criteria

  • Prior receipt of camrelizumab, apatinib, oncolytic viruses, or other gene therapies.
  • Receipt of other unapproved investigational drugs/devices within 4 weeks or 5 half-lives (whichever is shorter) prior to first dose administration in this study, or immunocompromised status.
  • History of splenectomy.
  • Pregnant or breastfeeding women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07589244 · VRT106-CN05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗