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OncoMatch/Clinical Trials/NCT06463522

Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma

Is NCT06463522 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies non-drug interventions for hepatocellular carcinoma.

Phase 1/2RecruitingBeijing 302 HospitalNCT06463522Data as of May 2026

This is a Phase 1, open label clinical trial of tumor-infiltrating lymphocytes for the treatment of patients with hepatocellular carcinoma. The purpose of this study is to assess the safety of tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: immune cell therapy (CIK, DC, DC-CIK, LAK therapy)

Exception: allowed if >28 days since last treatment

Subjects who have previously used immune cell therapy (CIK, DC, DC-CIK, LAK therapy) and are less than 28 days from the end of treatment to screening

Lab requirements

Blood counts

Absolute neutrophil count >1.0 x 10^9/L; White blood cell count > 2.0 x 10^9/L; Platelet count > 60 x 10^9/L; Hgb > 8.0 g/dL

Liver function

Liver function grade Child-Pugh A or B, without hepatic encephalopathy; ALT and AST ≤ 5x ULN; Serum total bilirubin (TBiL) ≤ 51 mmol/L, or < 3x ULN

Cardiac function

Left ventricular ejection fraction (LVEF) ≥ 50%

Liver function grade Child-Pugh A or B, without hepatic encephalopathy; Absolute neutrophil count >1.0 x 10^9/L; White blood cell count > 2.0 x 10^9/L; Platelet count > 60 x 10^9/L; Hgb > 8.0 g/dL; ALT and AST ≤ 5 times the upper limit of normal (ULN), Serum total bilirubin (TBiL) ≤ 51 mmol/L, or < 3 times the ULN; Left ventricular ejection fraction (LVEF) ≥ 50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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