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NCT Number: NCT07589244

A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC

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).

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Key information

Conditions

HCC

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Liang Peng

CONTACT

[email protected]

020-85252621

About this study

Phase II Part A: To evaluate the safety and tolerability of VRT106 in combination with camrelizumab and apatinib at different dose levels in patients with HCC who have failed prior ICIs, and to determine the recommended phase II dose (RP2D).

Phase II Part B: To evaluate the progression-free survival (PFS) of VRT106 in combination with camrelizumab and apatinib at the RP2D versus investigator's choice of standard of care in patients with advanced HCC who have failed prior ICIs.

Phase III: To evaluate the overall survival (OS) of VRT106 in combination with camrelizumab and apatinib versus investigator's choice of standard of care in patients with advanced HCC who have failed prior ICIs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Incidence of Dose-Limiting Toxicities

    Time frame: 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.

Secondary outcomes

  1. Progression-Free Survival

    Time frame: About 2 years

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

  2. Overall survival

    Time frame: About 2 years

    Time from initial administration to death.

Study contacts

Contact information is provided by the study sponsor or research team.

Chan Xie

CONTACT

Liang Peng

CONTACT

[email protected]

020-85252621

Sponsors and collaborators

Lead sponsor

Guangzhou Virotech Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-label Phase II/III Clinical Trial of VRT106 in Combination With Camrelizumab and Apatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Immune Checkpoint Inhibitor Therapy

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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