Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Biological: ATL administration
- Registration Number
- NCT05304481
- Lead Sponsor
- Lukas Biomedical Inc.
- Brief 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).
- Detailed Description
Eligible patients with HCC received curative treatment will be given ATL administration in this study. The investigational product ATL revealed great efficacy in previous clinical trials. This study aims to treat eligible patients, who had undergone curative treatment for HCC, with ATL as a preventive immunotherapy and to evaluate the effectiveness on the basis of patients' RFS rate in 12 months. The administration of the subject will be in a staggered manner for the first 3 patients. The 2nd and 3rd subject will not be dosed until the prior subject has taken the 4th dose of investigational products for at least 4 weeks. During the pretreatment period, peripheral blood for manufacturing the individualized ATL agent will be collected from patients at least 28 days before starting treatment. Patients will receive 200 mL of the ATL agent intravenously within 40 to 60 minutes without any premedication. They will be scheduled to receive the ATL 10 times at Weeks 1, 2, 3, 4, 6, 8, 10, 14, 18, and 22. A Data and Safety Monitoring Board (DSMB) will be appointed while 10% of schedule subjects were enrolled and complete 4 times of ATL infusions, the DSMB will convene a meeting to review safety data to date, including AEs and toxicities to indicate whether the study would advance unaltered, amend the protocol, or halt recruitment until a resolution of a specific issue.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 95
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment ATL administration ATL administration
- Primary Outcome Measures
Name Time Method Relapse-free survival rate the baseline (the first dosing) to 12 months later from post-treatment the Relapse-free survival rate of ATL treated HCC patients
- Secondary Outcome Measures
Name Time Method Changes in blood pressures up to 76 weeks measurements of vital sign: blood pressures including both systolic and diastolic pressure.
Changes in pulse rate up to 76 weeks measurements of vital sign: pulse rate
Changes in respiratory rate up to 76 weeks measurements of vital sign: respiratory rate
Cancer-specific survival Up to 24 months (estimated according to the average survival time) the time from baseline (the first dosing) to death resulting from HCC
Change of biomarkers up to 76 weeks α-fetoprotein (AFP) and Protein Induced by Vitamin K Absence or Antagonist-II (PIVKA-II) level
AE incidences up to 76 weeks Adverse event incidences
Relapse-free survival up to 76 weeks the time from baseline (the first dosing) to the first recurrence or death from any cause
Change in Eastern Cooperative Oncology Group (ECOG) performance status (for evaluation of change in the functional status) up to 76 weeks Assessment with Eastern Cooperative Oncology Group (ECOG) score, in a range from 0 to 5 representing a status from better to worse.
Change in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire score (for evaluation of quality of life) up to 76 weeks Assessment with European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3.0, while a higher score means a worse outcome.
Number of Participants With Abnormal Laboratory Values up to 76 weeks Number of Participants who encounter abnormal lab test results which are clinically meaningful.
Change in body weight from baseline up to 76 weeks body weight
Number of Participants With Abnormal physical examination result up to 76 weeks Number of Participants who encounter abnormal physical examination results which are clinically meaningful.
Change in ECG examination results up to 76 weeks PR, QRS, QT, QTc, and RR intervals
Changes in body temperature up to 76 weeks measurements of vital sign: body temperature
Overall survival up to 76 weeks the time from baseline (the first dosing) to death from any cause
Trial Locations
- Locations (13)
Hualien Tzu Chi Hospital
🇨🇳Hualien City, Taiwan
E-Da Cancer Treatment Hospital
🇨🇳Kaohsiung, Taiwan
Far Estern Memorial Hospital
🇨🇳New Taipei City, Taiwan
Cardinal Tien Hospital
🇨🇳New Taipei City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Chi Mei Hospital, Liouying
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei City Hospital, RENAI Branch
🇨🇳Taipei, 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