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

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

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).

Study Overview

• Status: Recruiting
• Conditions: HCC
• Intervention / Treatment: Drug: VRT106; Drug: VRT106 in combination with camrelizumab and apatinib; Drug: Investigator's Choice of Standard of Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Liang Peng; Phone Number: 020-85252621; Email: pliang@mail.sysu.edu.cn
• Study Contact Backup: Name: Chan Xie

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Third Affiliated Hospital of Sun Yat-sen University
      • Contact: Liang Peng; Phone Number: 020-85252621; Email: pliang@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VRT106 Monotherapy; VRT106	Drug: VRT106; VRT106,Intravenous infusion
Experimental: VRT106 Combination; VRT106 in combination with camrelizumab and apatinib	Drug: VRT106 in combination with camrelizumab and apatinib; VRT106: Intravenous infusion Camrelizumab: Intravenous infusion Apatinib: Oral administration
Active Comparator: Standard of Care; Investigator's Choice of Standard of Care	Drug: Investigator's Choice of Standard of Care; At the investigator's discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Dose-Limiting Toxicities	Safety assessments included: AEs, SAEs, physical examination, vital signs, ECOG PS, 12-lead ECG, echocardiography, and clinical laboratory evaluations.	Dose-limiting toxicity (DLT) will be assessed within 56 days following the first administration of VRT106.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time from initial administration to death.	About 2 years
Progression-Free Survival	The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.	About 2 years

Collaborators and Investigators

• Sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Estimated): May 13, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: HCC
• Additional Relevant MeSH Terms: camrelizumab; apatinib
• Other Study ID Numbers: VRT106-CN05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No