VRT106 plus camrelizumab and apatinib for advanced HCC in patients who have tried prior ICIs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II/III open-label trial evaluating VRT106 in combination with camrelizumab and apatinib for advanced HCC after prior ICIs. Phase II includes a dose-escalation part to identify a safe and effective dose, followed by a dose-expansion part to assess efficacy. Phase III will compare the combination to the investigator's choice of standard care, using safety, pharmacokinetics, and pharmacodynamics data from phase II to inform the protocol. Enrollment hinges on regulatory discussions with the NMPA and will progress to OS assessment if warranted by phase II results.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Third Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Liang Peng
• Email: pliang@mail.sysu.edu.cn
• Phone: 020-85252621

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.