Phase 2 / Phase 3: testing VRT106 for 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.
Official registry: https://clinicaltrials.gov/study/NCT07589244 · Guangzhou Virotech Pharmaceutical Co., Ltd. · enrollment listed as 66
What this phase means
Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are VRT106, VRT106 in combination with camrelizumab and apatinib, or Investigator's Choice of Standard of Care. The registry lists allocation as randomized. This is an open-label phase II/III clinical trial enrolling patients with advanced HCC who have failed prior ICIs.
They plan to enroll about 66 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: VRT106, VRT106 in combination with camrelizumab and apatinib, Investigator's Choice of Standard of Care
Primary outcome (registry wording): Incidence of Dose-Limiting Toxicities
Who it is for (from inclusion criteria)
- Ages 18 Years to 75 Years
- 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 the registry excludes
- 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
Public study contact (from the registry)
Liang Peng
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (recruiting)
FAQ about this NCT record
Is NCT07589244 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07589244?
Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07589244?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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