RecruitingPhase 2NCT05304481

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

A Phase II Study to Evaluate the Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma (HCC) Patients After Curative Treatment

Sponsor

Lukas Biomedical Inc.

Enrollment

95 participants

Start Date

May 14, 2022

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma

Summary

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).

Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a treatment called Activated T Lymphocytes (ATL) — immune cells grown from a donor's blood and trained to fight cancer — for patients with liver cancer (hepatocellular carcinoma, HCC) after they have received curative treatment such as surgery or ablation. **You may be eligible if...** - You are 20 or older with a confirmed liver cancer diagnosis at stage I, II, or IIIa - You have recently had or are scheduled for a curative treatment (surgery, ablation, or similar) - Your blood counts and liver and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your liver cancer is at a more advanced stage - You have not received or are not eligible for a curative procedure - Your organ function is too poor for the treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALATL administration

Subjects have ATL administration using intravenous infusion

Locations(13)

Hualien Tzu Chi Hospital

Hualien City, Taiwan, Taiwan

Cardinal Tien Hospital

New Taipei City, Taiwan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Taipei City Hospital, RENAI Branch

Taipei, Taiwan, Taiwan

E-Da Cancer Treatment Hospital

Kaohsiung City, Taiwan

Far Estern Memorial Hospital

New Taipei City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Chi Mei Hospital, Liouying

Tainan, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Shin Kong Wu Ho Su Memorial Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05304481

Related Trials

A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis

NCT0609677961 locations

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

NCT065031461 location

Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma

NCT044727671 location

SBRT Plus Systemic Therapy vs Systemic Therapy Alone in BCLC C Hepatocellular Carcinoma

NCT072747741 location

Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma

NCT069022461 location