An Open-Label, Phase I Clinical Trial of Super CAR-T With GPC3-Positive Advanced Hepatocellular Carcinoma
Trial Parameters
Brief Summary
This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
Eligibility Criteria
Inclusion Criteria: 1. Understand and voluntarily sign the informed consent form prior to participating in any trial-related activities; 2. Be between 18 and 75 years of age; gender is not restricted; 3. Diagnosed with hepatocellular carcinoma (HCC) based on histopathological or cytological examination: Patients classified as inoperable Stage IIa, IIb, IIIa, or IIIb according to the Chinese National Liver Cancer (CNLC) staging system, or Stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system, or Stage B patients who are inoperable or unsuitable for local treatment; Child-Pugh liver function score ≤ 7; 4. Previous failure of or intolerance to at least two lines of standard systemic therapy; 5. The subject must provide a tumor sample or biopsy specimen collected within the past 2 years that meets the requirements and tests positive for GPC3 expression via immunohistochemistry; 6. At least one measurable lesion according to RECIST 1.1 criteria; 7. ECOG performance st