A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
ConditionHCC
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou Virotech Pharmaceutical Co., Ltd.
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- VRT106
- VRT106 in combination with camrelizumab and apatinib
- Investigator's Choice of Standard of Care
Treatment groups
66 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov