OncoMatch/Clinical Trials/NCT05304481
Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma
Is NCT05304481 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies ATL administration for hepatocellular carcinoma.
Treatment: ATL administration — This is an open-label, single arm, multicenter, Phase II clinical study to investigate the efficacy and safety profiles of autologous ATL administration in HCC patients after curative treatment. Among all the eligible patients, ratio of 7:2:1 for Stage I:II:IIIa of the HCC will be the enrolled strategy of the study to reflect the results of the previous study (Lee, Lee et al. 2015).
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage I, II, IIIA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: curative treatment (surgical operation, percutaneous ethanol injection, microwave ablation, radiofrequency ablation) — tumor removal
tumor has been totally removed by curative treatment (surgical operation, PEI, MWA or RFA) in 12 weeks based on the agreement date for written consent and the tumor's removal should be perfectly confirmed by medical imaging (Computed tomography (CT) scan or Magnetic resonance imaging (MRI)) within 4 weeks of first dosing
Cannot have received: systemic corticosteroids
Systemic corticosteroids within 4 weeks prior to blood collection/receiving ATL or are scheduled to do so during the study
Cannot have received: immunosuppressive treatment
Immunosuppressive treatment within 4 weeks prior to blood collection/receiving ATL or are scheduled to do so during the study
Cannot have received: other anti-cancer treatments
Exception: except for curative treatment
Other anti-cancer treatments within 3 months (donor) or 4 weeks (subject) prior to blood collection/receiving ATL or are scheduled to do so during the study
Cannot have received: attenuated vaccines
Attenuated vaccines within 4 weeks prior to blood collection/administration or is scheduled to do so during the study
Lab requirements
Blood counts
WBC count > 3,000/μL; ANC ≥ 1,500/μL; Hb ≥ 9.0 g/dL; Thrombocyte count > 50,000/μL
Kidney function
Blood urea nitrogen (BUN) and serum Creatinine ≤ 1.5× ULN
Liver function
AST and ALT ≤ 5×ULN; Hepatic function of Child-Pugh class A
WBC count > 3,000/μL; ANC ≥ 1,500/μL; Hb ≥ 9.0 g/dL; Thrombocyte count > 50,000/μL; BUN and serum Creatinine ≤ 1.5× ULN; AST and ALT ≤ 5×ULN; Hepatic function of Child-Pugh class A
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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