Can a Patient's own immune cells keep liver cancer at bay?
NCT ID NCT05304481
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests whether giving patients their own activated T lymphocytes (ATL) after curative treatment for liver cancer can reduce the chance of the cancer coming back. The study enrolls adults with stage I, II, or IIIa hepatocellular carcinoma who have had or will have curative treatment such as surgery. Participants receive ATL through an intravenous infusion, and researchers track relapse-free survival, overall survival, and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Activated T lymphocytes (ATL), a type of immune cell taken from the patient's own blood, grown in the lab, and given back by intravenous infusion
- What this could lead to
- If it works, this could offer a way to lower the chance of liver cancer returning after curative treatment, potentially improving long-term survival.
- What could go wrong
- This is a phase II trial with a single group and no placebo, so results may not be definitive. The treatment involves infusing lab-grown immune cells, which carries risks like infusion reactions or immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 95 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for Donor 1. Patients must be able to understand and sign the informed consent documents and aware of the investigational nature of the study. 2. Patient is ≥ 20 years old. 3. Patient has been diagnosed as HCC by pathological data or radiological test in the stage of I, II or IIIa according to the American Joint Committee on Cancer staging system (8th Edition). 4. Patient is scheduled to or has received tumor removal by curative treatments (e.g., surgical operation, percutaneous ethanol injection \[PEI\], microwave ablation \[MWA\], or radiofrequency ablation \[RFA\]). 5. Patient meets below conditions by blood test, kidney and liver function test: White blood cell (WBC) count \> 3,000/μL Absolute neutrophil count (ANC) ≥ 1,500/μL Hemoglobin (Hb) ≥ 9.0 g/dL Thrombocyte count \> 50,000/μL Blood urea nitrogen (BUN) and serum Creatinine ≤ 1.5× Upper Limit of Normal (ULN) AST and ALT ≤ 5×ULN 6. Female patient with childbearing potential should be confirmed of not being pregnant at the screening and during the study. Exclusion Criteria for Donor 1. Patient with syphilis, human immunodeficiency virus I/II (HIV-I/II), human T-lymphotropic virus I/II (HTLV-I/II), or an increased risk (or has been diagnosed) for human transmissible spongiform encephalopathy (TSE); including Creutzfeldt-Jakob disease (CJD) 2. Patient with ongoing active hepatitis including acute or active chronic HBV/HCV infection, alcohol-associated hepatitis, and autoimmune hepatitis, etc., according to site-specific diagnostic criteria and laboratory parameters at screening 3. Patient who has clinically significant and unstable gastrointestinal, renal, endocrine, pulmonary, or cardiovascular disease judged by the investigator 4. Patient who has disease history of malignancy other than HCC except for curatively treated non-melanoma skin cancer, cervical carcinoma in situ, or superficial bladder tumors within 5 years before participating in this clinical trial 5. Patient who has medical history of immune deficiency or auto-immune disease (including but not limited to: rheumatoid arthritis , Burger's disease, multiple sclerosis and Type I diabetes) 6. Patient with the following medication or treatment should be excluded as the donor: 1. Systemic corticosteroids within 4 weeks prior to blood collection 2. Immunosuppressive treatment within 4 weeks prior to blood collection 3. Other anti-cancer treatments within 3 months prior to blood collection 4. Attenuated vaccines within 4 weeks prior to blood collection 7. Patient who has participated in other investigational studies and received any investigational therapy within 4 weeks prior to blood collection 8. Patient who has known or suspected hypersensitivity to any ingredient in the product (e.g. kanamycin, streptomycin or albumin, etc.) Inclusion Criteria for subject 1. Patient must be able to understand and has signed the informed consent documents and been aware of the investigational nature of the study. 2. Patient who has the histopathological or cytological proof (e.g. liver biopsy test) of HCC in the stage of I, II or IIIa. Patient's 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. 3. Hepatic function of Child-Pugh class A 4. ECOG Performance status (ECOG-PS) score ≤ 1 5. Patient's remaining life-time is expected at least more than 3 months. 6. Patient meets below conditions by blood test, kidney and liver function test: 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 7. Female patient with childbearing potential should be confirmed of not being pregnant or not lactating at the screening and during the study. 8. Patient is willing to comply with protocol-stated requirements, instructions and restrictions. 9. All male and female patients with child-bearing potential (between puberty and 2 years after menopause) are willing to use at least any one of the appropriate contraception methods shown below, for during and at least 24 weeks after ATL treatment. 1. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception). 2. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. 3. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject 4. Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or d.2+d.3): d.1Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception. d.2Placement of an intrauterine device (IUD) or intrauterine system (IUS). d.3Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). Exclusion Criteria for Subjects 1. Patient who has clinically significant and unstable gastrointestinal, renal, endocrine, pulmonary, or cardiovascular disease judged by the investigator 2. Patient with ongoing active hepatitis including acute or active chronic HBV/HCV infection, alcohol-associated hepatitis, and autoimmune hepatitis, etc., according to site-specific diagnostic criteria and laboratory parameters at screening. 3. Patient who has known or suspected hypersensitivity to any ingredient in the product (e.g. kanamycin, streptomycin or albumin, etc.) 4. Patient with the following medication or treatment should be excluded: 1. Systemic corticosteroids within 4 weeks prior to receiving ATL or are scheduled to do so during the study. 2. Immunosuppressive treatment within 4 weeks prior to receiving ATL or are scheduled to do so during the study. 3. Other anti-cancer treatment within 4 weeks except for curative treatment prior to receiving ATL or are scheduled to do so during the study. 4. Attenuated vaccines within 4 weeks prior to administration or is scheduled to do so during the study 5. Patient who fails to provide blood collection as a self-donor whose blood collection sample fails to generate adequate amount of ATL 6. Patient who is not able to take MRI or CT scan examination 7. Patient who has serious mental, social or psychological factors that may interfere with compliance and assessments of the study in the investigator's opinion 8. Patient who has participated in other investigational studies and received any investigational therapy within 4 weeks prior to the study dosing.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cardinal Tien Hospital
WITHDRAWNNew Taipei City, Taiwan, 23148, Taiwan
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Chang Gung Memorial Hospital, Linkou
RECRUITINGTaoyuan, 333, Taiwan
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Chi Mei Hospital, Liouying
RECRUITINGTainan, 73657, Taiwan
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E-Da Cancer Treatment Hospital
RECRUITINGKaohsiung City, 82445, Taiwan
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Far Estern Memorial Hospital
RECRUITINGNew Taipei City, 220216, Taiwan
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Hualien Tzu Chi Hospital
RECRUITINGHualien City, Taiwan, 97002, Taiwan
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MacKay Memorial Hospital Tamsui Branch
RECRUITINGNew Taipei City, Taiwan, 251020, Taiwan
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National Taiwan University Hospital
RECRUITINGTaipei, Taiwan, 100225, Taiwan
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Shin Kong Wu Ho Su Memorial Hospital
RECRUITINGTaipei, 111, Taiwan
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Taichung Veterans General Hospital
RECRUITINGTaichung, 407219, Taiwan
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Taipei City Hospital, RENAI Branch
RECRUITINGTaipei, Taiwan, 10341, Taiwan
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Taipei Medical University Hospital
RECRUITINGTaipei, 110301, Taiwan
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Taipei Veterans General Hospital
RECRUITINGTaipei, 112201, Taiwan
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Tri-Service General Hospital
RECRUITINGTaipei, 114202, Taiwan
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