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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • VRT106

    Drug

    VRT106,Intravenous infusion

  • VRT106 in combination with camrelizumab and apatinib

    Drug

    VRT106: Intravenous infusion Camrelizumab: Intravenous infusion Apatinib: Oral administration

  • Investigator's Choice of Standard of Care

    Drug

    At the investigator's discretion

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: VRT106 MonotherapyExperimental treatment 1 intervention
Group B: VRT106 CombinationExperimental treatment 1 intervention
Group C: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Dose-Limiting Toxicities

Safety assessments included: AEs, SAEs, physical examination, vital signs, ECOG PS, 12-lead ECG, echocardiography, and clinical laboratory evaluations.

Time frame
Dose-limiting toxicity (DLT) will be assessed within 56 days following the first administration of VRT106.

Secondary outcomes

1

Progression-Free Survival

The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

Time frame
About 2 years
2

Overall survival

Time from initial administration to death.

Time frame
About 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou Virotech Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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