NCT07589244 A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
| NCT ID | NCT07589244 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Guangzhou Virotech Pharmaceutical Co., Ltd. |
| Condition | HCC |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 66 participants in total. It began in 2026-05-13 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Liang Peng
STUDY CHAIR
Third Affiliated Hospital, Sun Yat-Sen University
Frequently Asked Questions
Who can join the NCT07589244 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying HCC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07589244 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07589244 currently recruiting?
Yes, NCT07589244 is actively recruiting participants. Contact the research team at pliang@mail.sysu.edu.cn for enrollment information.
Where is the NCT07589244 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07589244 clinical trial?
NCT07589244 is sponsored by Guangzhou Virotech Pharmaceutical Co., Ltd.. The principal investigator is Liang Peng at Third Affiliated Hospital, Sun Yat-Sen University. The trial plans to enroll 66 participants.