NCT07589244

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
38mo left

Started May 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jun 2029

First Submitted

Initial submission to the registry

May 8, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

May 13, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

May 8, 2026

Last Update Submit

May 13, 2026

Conditions

HCC

Keywords

HCC

Outcome Measures

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.

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

Secondary Outcomes (2)

  • Progression-Free Survival

    About 2 years

  • Overall survival

    About 2 years

Study Arms (3)

VRT106 Monotherapy

EXPERIMENTAL

VRT106

Drug: VRT106

VRT106 Combination

EXPERIMENTAL

VRT106 in combination with camrelizumab and apatinib

Drug: VRT106 in combination with camrelizumab and apatinib

Standard of Care

ACTIVE COMPARATOR

Investigator's Choice of Standard of Care

Drug: Investigator's Choice of Standard of Care

Interventions

VRT106DRUG

VRT106,Intravenous infusion

VRT106 Monotherapy
VRT106 in combination with camrelizumab and apatinibDRUG

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

VRT106 Combination
Investigator's Choice of Standard of CareDRUG

At the investigator's discretion

Standard of Care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Interventions

camrelizumabapatinib

Study Officials

  • Liang Peng

    Third Affiliated Hospital, Sun Yat-Sen University

    STUDY CHAIR

Central Study Contacts

Liang Peng

CONTACT

020-85252621pliang@mail.sysu.edu.cn

Chan Xie

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 15, 2026

Study Start

May 13, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations

CN(1)