VRT106VRT106 in combination with camrelizumab and apatinibInvestigator's Choice of Standard of Care
VRT106: VRT106,Intravenous infusion
VRT106 in combination with camrelizumab and apatinib: VRT106: Intravenous infusion Camrelizumab: Intravenous infusion Apatinib: Oral administration
Investigator's Choice of Standard of Care: At the investigator's discretion
Study summary
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of Dose-Limiting Toxicities — Dose-limiting toxicity (DLT) will be assessed within 56 days following the first administration of VRT106. Safety assessments included: AEs, SAEs, physical examination, vital signs, ECOG PS, 12-lead ECG, echocardiography, and clinical laboratory evaluations.
Trial sites (1)
Facility
City
Region
Status
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou
Guangdong
Recruiting
More Guangzhou Virotech Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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