HCC
Conditions
Keywords
HCC
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).
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.
Interventions
DRUGVRT106
VRT106,Intravenous infusion
DRUGVRT106 in combination with camrelizumab and apatinib
VRT106: Intravenous infusion Camrelizumab: Intravenous infusion Apatinib: Oral administration
DRUGInvestigator's Choice of Standard of Care
At the investigator's discretion
Sponsors
Guangzhou Virotech Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose-Limiting Toxicities | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | About 2 years | The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. |
| Overall survival | About 2 years | Time from initial administration to death. |
Countries
China
Contacts
CONTACTLiang Peng
CONTACTChan Xie
STUDY_CHAIRLiang Peng
Third Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed