Clinical Trials List
Protocol NumberLUKACTZ20171215
NCT Number(ClinicalTrials.gov Identfier)NCT05304481
Active
2021-09-01 - 2027-12-31
Phase II
Not yet recruiting5
Recruiting9
A Phase II Study to Evaluate the Efficacy and Safety of Activated T Lymphocytes (ATL) in Hepatocellular Carcinoma (HCC) Patients After Curative Treatment
-
Trial Applicant
-
Sponsor
Lukas Biomedical Inc.
-
Trial scale
Taiwan Multiple Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 周書正 Division of General Surgery
- Yi-Hsiang Huang Digestive System Department
- 夏振源 Division of General Surgery
- San-Chi Chen Division of Hematology & Oncology
- Gar-Yang Chau Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 蕭智陽 Division of General Surgery
- 吳志宏 Division of Radiation Therapy
- Shih-Jer Hsu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yu-Min Huang Division of Gastroenterological Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 周宏學 Division of Gastroenterological Surgery
- 吳宗翰 Division of Gastroenterological Surgery
- 鄭志軒 Division of General Surgery
- 吳庭榕 Division of Gastroenterological Surgery
- Kun-Ming Chan Division of Gastroenterological Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Kuan-Der Lee Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 許耀峻 Digestive System Department
- 陳耀森 Division of General Surgery
- 李蕙鳴 Division of General Surgery
- 陳仁隆 Division of General Surgery
- 羅錦河 Digestive System Department
- 張肇松 Division of Hematology & Oncology
- 陳志城 Digestive System Department
- 饒坤銘 Division of Hematology & Oncology
- 陳子皓 Digestive System Department
- 蔡英楠 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Hepatocellular Carcinoma
Objectives
The primary objective is:
To evaluate the efficacy of ATL treatment to increase the
recurrence free survival (RFS) rate in HCC patients with
curative treatment.
The secondary objectives are:
To evaluate the efficacy and safety profiles of ATL in HCC
patients with curative treatment.
Test Drug
ATL
Active Ingredient
ATL
Dosage Form
Injection
Dosage
2*10^9 - 7*10^9
Endpoints
Primary endpoint
The primary endpoint is to demonstrate the RFS rate of
ATL treated HCC patients from baseline (the first dosing)
to 12 months post-treatment.
Secondary endpoints
Efficacy
1. RFS
RFS is defined as time from baseline (the first dosing)
to the first recurrence or death from any cause (time
frame: First dosing to the data cut-off date). Data cut-off date is defined as the date of Last Subject Last
Visit (LSLV).
2. Overall survival (OS)
OS is defined as time from baseline (the first dosing)
to death from any cause (time frame: First dosing to
the data cut-off date). Data cut-off date is defined as
the date of LSLV.
3. Cancer-specific survival
Cancer-specific survival is defined as time from
baseline (the first dosing) to death resulting from HCC
(time frame: First dosing to the data cut-off date). Data
cut-off date is defined as the date of LSLV.
4. Change of biomarkers of α-fetoprotein (AFP) and
Protein Induced by Vitamin K Absence or
Antagonist-II (PIVKA-II) level from baseline (the
first dosing) until last visit available.
5. Change in the quality of life assessed with Eastern
Cooperative Oncology Group (ECOG) and European
Organization for Research and Treatment of Cancer
(EORTC) QLQ-C30 version 3.0 from baseline until
last visit available.
cut-off date is defined as the date of Last Subject Last
Visit (LSLV).
2. Overall survival (OS)
OS is defined as time from baseline (the first dosing)
to death from any cause (time frame: First dosing to
the data cut-off date). Data cut-off date is defined as
the date of LSLV.
3. Cancer-specific survival
Cancer-specific survival is defined as time from
baseline (the first dosing) to death resulting from HCC
(time frame: First dosing to the data cut-off date). Data
cut-off date is defined as the date of LSLV.
4. Change of biomarkers of α-fetoprotein (AFP) and
Protein Induced by Vitamin K Absence or
Antagonist-II (PIVKA-II) level from baseline (the
first dosing) until last visit available.
5. Change in the quality of life assessed with Eastern
Cooperative Oncology Group (ECOG) and European
Organization for Research and Treatment of Cancer
(EORTC) QLQ-C30 version 3.0 from baseline until
last visit available.
cut-off date is defined as the date of Last Subject Last
Visit (LSLV).
2. Overall survival (OS)
OS is defined as time from baseline (the first dosing)
to death from any cause (time frame: First dosing to
the data cut-off date). Data cut-off date is defined as
the date of LSLV.
3. Cancer-specific survival
Cancer-specific survival is defined as time from
baseline (the first dosing) to death resulting from HCC
(time frame: First dosing to the data cut-off date). Data
cut-off date is defined as the date of LSLV.
4. Change of biomarkers of α-fetoprotein (AFP) and
Protein Induced by Vitamin K Absence or
Antagonist-II (PIVKA-II) level from baseline (the
first dosing) until last visit available.
5. Change in the quality of life assessed with Eastern
Cooperative Oncology Group (ECOG) and European
Organization for Research and Treatment of Cancer
(EORTC) QLQ-C30 version 3.0 from baseline until
last visit available.
cut-off date is defined as the date of Last Subject Last
Visit (LSLV).
2. Overall survival (OS)
OS is defined as time from baseline (the first dosing)
to death from any cause (time frame: First dosing to
the data cut-off date). Data cut-off date is defined as
the date of LSLV.
3. Cancer-specific survival
Cancer-specific survival is defined as time from
baseline (the first dosing) to death resulting from HCC
(time frame: First dosing to the data cut-off date). Data
cut-off date is defined as the date of LSLV.
4. Change of biomarkers of α-fetoprotein (AFP) and
Protein Induced by Vitamin K Absence or
Antagonist-II (PIVKA-II) level from baseline (the
first dosing) until last visit available.
5. Change in the quality of life assessed with Eastern
Cooperative Oncology Group (ECOG) and European
Organization for Research and Treatment of Cancer
(EORTC) QLQ-C30 version 3.0 from baseline until
last visit available.
Safety
1. Laboratory data changes from baseline to subsequent
scheduled visits until last visit available
2. Change in body weight from baseline
3. AE incidences over the study period
4. Changes in physical examination from baseline to
subsequent scheduled visits until last visit available
5. Changes in vital signs from baseline to subsequent
scheduled visits until last visit available
6. Change in ECG examination results (including PR,
QRS, QT, QTc, and RR intervals) from baseline until
last visit available
The primary endpoint is to demonstrate the RFS rate of
ATL treated HCC patients from baseline (the first dosing)
to 12 months post-treatment.
Secondary endpoints
Efficacy
1. RFS
RFS is defined as time from baseline (the first dosing)
to the first recurrence or death from any cause (time
frame: First dosing to the data cut-off date). Data cut-off date is defined as the date of Last Subject Last
Visit (LSLV).
2. Overall survival (OS)
OS is defined as time from baseline (the first dosing)
to death from any cause (time frame: First dosing to
the data cut-off date). Data cut-off date is defined as
the date of LSLV.
3. Cancer-specific survival
Cancer-specific survival is defined as time from
baseline (the first dosing) to death resulting from HCC
(time frame: First dosing to the data cut-off date). Data
cut-off date is defined as the date of LSLV.
4. Change of biomarkers of α-fetoprotein (AFP) and
Protein Induced by Vitamin K Absence or
Antagonist-II (PIVKA-II) level from baseline (the
first dosing) until last visit available.
5. Change in the quality of life assessed with Eastern
Cooperative Oncology Group (ECOG) and European
Organization for Research and Treatment of Cancer
(EORTC) QLQ-C30 version 3.0 from baseline until
last visit available.
cut-off date is defined as the date of Last Subject Last
Visit (LSLV).
2. Overall survival (OS)
OS is defined as time from baseline (the first dosing)
to death from any cause (time frame: First dosing to
the data cut-off date). Data cut-off date is defined as
the date of LSLV.
3. Cancer-specific survival
Cancer-specific survival is defined as time from
baseline (the first dosing) to death resulting from HCC
(time frame: First dosing to the data cut-off date). Data
cut-off date is defined as the date of LSLV.
4. Change of biomarkers of α-fetoprotein (AFP) and
Protein Induced by Vitamin K Absence or
Antagonist-II (PIVKA-II) level from baseline (the
first dosing) until last visit available.
5. Change in the quality of life assessed with Eastern
Cooperative Oncology Group (ECOG) and European
Organization for Research and Treatment of Cancer
(EORTC) QLQ-C30 version 3.0 from baseline until
last visit available.
cut-off date is defined as the date of Last Subject Last
Visit (LSLV).
2. Overall survival (OS)
OS is defined as time from baseline (the first dosing)
to death from any cause (time frame: First dosing to
the data cut-off date). Data cut-off date is defined as
the date of LSLV.
3. Cancer-specific survival
Cancer-specific survival is defined as time from
baseline (the first dosing) to death resulting from HCC
(time frame: First dosing to the data cut-off date). Data
cut-off date is defined as the date of LSLV.
4. Change of biomarkers of α-fetoprotein (AFP) and
Protein Induced by Vitamin K Absence or
Antagonist-II (PIVKA-II) level from baseline (the
first dosing) until last visit available.
5. Change in the quality of life assessed with Eastern
Cooperative Oncology Group (ECOG) and European
Organization for Research and Treatment of Cancer
(EORTC) QLQ-C30 version 3.0 from baseline until
last visit available.
cut-off date is defined as the date of Last Subject Last
Visit (LSLV).
2. Overall survival (OS)
OS is defined as time from baseline (the first dosing)
to death from any cause (time frame: First dosing to
the data cut-off date). Data cut-off date is defined as
the date of LSLV.
3. Cancer-specific survival
Cancer-specific survival is defined as time from
baseline (the first dosing) to death resulting from HCC
(time frame: First dosing to the data cut-off date). Data
cut-off date is defined as the date of LSLV.
4. Change of biomarkers of α-fetoprotein (AFP) and
Protein Induced by Vitamin K Absence or
Antagonist-II (PIVKA-II) level from baseline (the
first dosing) until last visit available.
5. Change in the quality of life assessed with Eastern
Cooperative Oncology Group (ECOG) and European
Organization for Research and Treatment of Cancer
(EORTC) QLQ-C30 version 3.0 from baseline until
last visit available.
Safety
1. Laboratory data changes from baseline to subsequent
scheduled visits until last visit available
2. Change in body weight from baseline
3. AE incidences over the study period
4. Changes in physical examination from baseline to
subsequent scheduled visits until last visit available
5. Changes in vital signs from baseline to subsequent
scheduled visits until last visit available
6. Change in ECG examination results (including PR,
QRS, QT, QTc, and RR intervals) from baseline until
last visit available
Inclution Criteria
Donor inclusion criteria
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 or ALT ≤ 5×ULN
6. Female patient with childbearing potential should be confirmed of not being pregnant at the screening and during the study.
Administration inclusion criteria
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)) prior to 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 or 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.
a. 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).
b. 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.
c. 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
d. Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or
d.2+d.3):
d.1 Use 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.2 Placement of an intrauterine device (IUD) or intrauterine system (IUS).
d.3 Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal
suppository.
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 or ALT ≤ 5×ULN
6. Female patient with childbearing potential should be confirmed of not being pregnant at the screening and during the study.
Administration inclusion criteria
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)) prior to 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 or 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.
a. 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).
b. 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.
c. 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
d. Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or
d.2+d.3):
d.1 Use 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.2 Placement of an intrauterine device (IUD) or intrauterine system (IUS).
d.3 Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal
suppository.
Exclusion Criteria
Donor exclusion criteria
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 who shows acute HBV or HCV infection
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:
a. Systemic corticosteroids within 4 weeks prior to blood collection
b. Immunosuppressive treatment within 4 weeks prior to blood collection
c. Other anti-cancer treatments within 3 months prior to blood collection
d. 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
Administration exclusion criteria
1. Patient who has clinically significant and unstable gastrointestinal, renal, endocrine,
pulmonary, or cardiovascular disease judged by the investigator
2. Patient who has known or suspected hypersensitivity to any ingredient in the product
3. Patient with the following medication or treatment should be excluded:
a. Systemic corticosteroids within 4 weeks prior to receiving ATL or are scheduled
to do so during the study.
b. Immunosuppressive treatment within 4 weeks prior to receiving ATL or are scheduled to do so during the study.
c. Other anti-cancer treatment within 4 weeks except for curative treatment prior to
receiving ATL or are scheduled to do so during the study.
d. Attenuated vaccines within 4 weeks prior to administration or is scheduled to do
so during the study
4. Patient who fails to provide blood collection as a self-donor whose blood collection
sample fails to generate adequate amount of ATL
5. Patient who is not able to take MRI or CT scan examination
6. Patient who has serious mental, social or psychological factors that may interfere with
compliance and assessments of the study in the investigator’s opinion
7. Patient who has participated in other investigational studies and received any
investigational therapy within 4 weeks prior to the study dosing.
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 who shows acute HBV or HCV infection
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:
a. Systemic corticosteroids within 4 weeks prior to blood collection
b. Immunosuppressive treatment within 4 weeks prior to blood collection
c. Other anti-cancer treatments within 3 months prior to blood collection
d. 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
Administration exclusion criteria
1. Patient who has clinically significant and unstable gastrointestinal, renal, endocrine,
pulmonary, or cardiovascular disease judged by the investigator
2. Patient who has known or suspected hypersensitivity to any ingredient in the product
3. Patient with the following medication or treatment should be excluded:
a. Systemic corticosteroids within 4 weeks prior to receiving ATL or are scheduled
to do so during the study.
b. Immunosuppressive treatment within 4 weeks prior to receiving ATL or are scheduled to do so during the study.
c. Other anti-cancer treatment within 4 weeks except for curative treatment prior to
receiving ATL or are scheduled to do so during the study.
d. Attenuated vaccines within 4 weeks prior to administration or is scheduled to do
so during the study
4. Patient who fails to provide blood collection as a self-donor whose blood collection
sample fails to generate adequate amount of ATL
5. Patient who is not able to take MRI or CT scan examination
6. Patient who has serious mental, social or psychological factors that may interfere with
compliance and assessments of the study in the investigator’s opinion
7. Patient who has participated in other investigational studies and received any
investigational therapy within 4 weeks prior to the study dosing.
The Estimated Number of Participants
-
Taiwan
95 participants
-
Global
95 participants
