HCCPhase 2/3NCT07589244
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
A Phase 2/3 study testing VRT106 and VRT106 in combination with camrelizumab and apatinib in people with HCC, run by Guangzhou Virotech Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC
- What is being tested?
- VRT106 and VRT106 in combination with camrelizumab and apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2026to 30 Jun 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chan Xie contact
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Liang Peng, 020-85252621, pliang@mail.sysu.edu.cn
About this study
Official 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
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).
Read the 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.
- Conditions
- HCC
- Being tested
- VRT106, VRT106 in combination with camrelizumab and apatinib, Investigator's Choice of Standard of Care
- Keywords
- HCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRT106Drug
VRT106,Intravenous infusion
VRT106 in combination with camrelizumab and apatinibDrug
VRT106: Intravenous infusion Camrelizumab: Intravenous infusion Apatinib: Oral administration
Investigator's Choice of Standard of CareDrug
At the investigator's discretion
| Study group | Role | What they receive |
|---|---|---|
| VRT106 Monotherapy | Experimental | VRT106 Receives: Drug: VRT106 |
| VRT106 Combination | Experimental | VRT106 in combination with camrelizumab and apatinib Receives: Drug: VRT106 in combination with camrelizumab and apatinib |
| Standard of Care | Active comparator | Investigator's Choice of Standard of Care Receives: Drug: Investigator's Choice of Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities
Safety assessments included: AEs, SAEs, physical examination, vital signs, ECOG PS, 12-lead ECG, echocardiography, and clinical laboratory evaluations.
Measured: Dose-limiting toxicity (DLT) will be assessed within 56 days following the first administration of VRT106.
Secondary outcomes (2)
Progression-Free Survival
The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: About 2 years
Overall survival
Time from initial administration to death.
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start13 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liang Peng, Study chair, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589244
- Sponsor's protocol ID
- VRT106-CN05
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07589244
- Acronym / sponsor ID
- VRT106-CN05
- Conditions
- HCC
- Keywords
- HCC
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 May 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VRT106 Monotherapy | Experimental | Drug: VRT106VRT106 |
| VRT106 Combination | Experimental | Drug: VRT106 in combination with camrelizumab and apatinibVRT106 in combination with camrelizumab and apatinib |
| Standard of Care | Active comparator | Drug: Investigator's Choice of Standard of CareInvestigator's Choice of Standard of Care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRT106VRT106,Intravenous infusion | Drug | VRT106 Monotherapy |
| VRT106 in combination with camrelizumab and apatinibVRT106: Intravenous infusion Camrelizumab: Intravenous infusion Apatinib: Oral administration | Drug | VRT106 Combination |
| Investigator's Choice of Standard of CareAt the investigator's discretion | Drug | Standard of Care |
Primary outcome
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.
2 secondary outcomes
Progression-Free Survival
Time frame: About 2 years
Overall survival
Time frame: About 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chan Xie contact
Liang Peng study chair
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VRT106 and VRT106 in combination with camrelizumab and apatinib in people with HCC, run by Guangzhou Virotech Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Peng (020-85252621, pliang@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (time frame: Dose-limiting toxicity (DLT) will be assessed within 56 days following the first administration of VRT106.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.