Phase II Study of Activated T Lymphocytes ATL Therapy After Curative Treatment for Hepatocellular Carcinoma Patients

What this Trial Is About

Researchers are evaluating the efficacy and safety of activated T lymphocytes ATL as a preventive immunotherapy for patients with hepatocellular carcinoma HCC who have undergone curative treatments. This open-label, single-arm, multicenter Phase II study focuses on patients with HCC stages I, II, or IIIa, following a specific enrollment ratio to reflect previous study results. The study aims to assess relapse-free survival over 12 months after treatment. Eligible patients receive ATL administered intravenously without premedication. The treatment schedule includes ten ATL infusions at Weeks 1, 2, 3, 4, 6, 8, 10, 14, 18, and 22. Administration for the first three patients is staggered to monitor safety, with a Data and Safety Monitoring Board reviewing adverse events after 10% of participants complete four doses. Participants provide peripheral blood at least 28 days before treatment to manufacture individualized ATL. Throughout the study, patients undergo various assessments including imaging CT or MRI, blood tests, liver and kidney function tests, and questionnaires evaluating quality of life and functional status. Safety monitoring includes tracking adverse events, laboratory values, vital signs, and physical examinations for up to 76 weeks. The primary outcome is relapse-free survival measured from first dosing to 12 months post-treatment.

Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma