Safety and Efficacy of "Immuncell-LC" in TACE Therapy

Carcinoma, Hepatocellular Clinical Trial

Official title:

Randomized, Open-label, Multi-center and Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in the Patients Undergone TACE for Intermediate Stage Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856815
• Other study ID #: ILC-IIT-05
• Status: Completed
• Phase: Phase 2
• Start date: May 28, 2018
• Est. completion date: September 22, 2022

Study information

• Verified date: June 2023
• Source: GC Cell Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of 'Immuncell-LC group' and 'non-treatment group' in the patients undergone Transarterial Chemoembolization for intermediate stage hepatocellular carcinoma

Description:

ILC-IIT-05 is randomized, open-label, multi-center phase 2 clinical trial. To confirm clinical efficacy and safety between 'Immuncell-LC group' and 'non-treatment group', primary outcome, recurrence free survival(RFS) will be evaluated.

For secondary outcome, overall survival(OS), changes of Alpha Feto Protein(AFP), correlation of between myeloid-derived suppressor cell change and prognosis, adverse event, ECOG-PS and hematological examination will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 22, 2022
• Est. primary completion date: August 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who have consented to the study by providing signature of self

• Patients who are more than 20 and less than 80 years old

• Child-Pugh Class should be A(score 5-6) or B(score 7-8)

• ECOG Performance Status (ECOG-PS) score is less than 1 or equal to

• Patients who have been diagnosed with BCLC stage B hepatocellular carcinoma by pathological/radiological test(Dynamic contrast-enhanced CT or Dynamic MRI) and tumor removal has been confirmed after TACE (When patients have been diagnosed with recurrence of hepatocellular carcinoma after surgery or local treatment, if conditions are same as above, patients could be included)

• Patients who satisfy the following conditions of the blood test and kidney, liver function test

• Absolute neutrophil count > 500/µL

• Hemoglobin = 8.5 g/dL

• Platelet count > 50,000/µL

• Blood Creatinine = 1.5xupper normal limit

• Total bilirubin < 3mg/dL

• Albumin = 2.8g/dL

Exclusion Criteria:

• Patients who have been confirmed with residual tumor or extrahepatic metastases

• Patients who have lymph node metastases or portal vein, hepatic vein invasion

• Patients who have a history of treatments or are in conditions as below

• Liver transplantation

• From Informed consent form sign date, systemic chemotherapy in 4 weeks or ongoing adverse drug reactions from anticancer drug in 6 weeks

• External beam radiation, immunotherapy, molecular target therapy

• More than 2 times of systemic chemotherapy

• Biliary reconstruction or endoscopic biliary treatment

• Patients who have a history of auto-immune diseases (Ex. Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.)

• Patients who have a history of malignant tumors in the recent 5 years prior to the study except hepatocellular carcinoma

• Patients who participated in another clinical trial and conducted treatment in 4 weeks or have a plan for administration of another clinical trial treatment since Informed consent form sign date

• Patients who have uncontrollable or serious disease

• Pregnant women or nursing mother

• Patients who intend to get pregnant during the study

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Biological:
• Immuncell-LC
Activated T lymphocyte : intravenous dripping of 200ml (1 x 10^9 ~ 2 x 10^10 lymphocytes / 60kg adult) for 1 hour

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Daehak-ro 101/Jongno-gu
Korea, Republic of	Seoul St.Mary's Hospital	Seoul	Banpo-daero 222 / Seocho-go
Korea, Republic of	Severance Hospital	Seoul	Seoul,50-1 Yonsei-ro/Seodaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
GC Cell Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence Free Survival (RFS)	Every 12 weeks from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject	baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
Secondary	Overall Survival (OS)	Every 12 weeks from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject	baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
Secondary	Change of Alpha Feto Protein (AFP) level	Every 12 weeks from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject	Every 12 weeks from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
Secondary	Correlation of between Myeloid-derived Suppressor Cell change and Prognosis	Every 12 weeks from the baseline until 4 weeks after the last dose of immunotherapy	Every 12 weeks from the baseline until 4 weeks after the last dose of immunotherapy
Secondary	Adverse event	From the time the patient provided written informed consent until drop-out or the end of the study or at least 4 weeks after the last dose of immunotherapy	From the time the patient provided written informed consent until drop-out or the end of the study or at least 4 weeks after the last dose of immunotherapy
Secondary	Eastern Cooperative Oncology Group Performance Status (ECOG-PS)	From the time the patient provided written informed consent until drop-out or the end of the study or 4 weeks after the last dose of immunotherapy	From the time the patient provided written informed consent until drop-out or the end of the study or 4 weeks after the last dose of immunotherapy
Secondary	Hematological examination	Every 12 weeks from the baseline until 4 weeks after the last dose of immunotherapy	Every 12 weeks from the baseline until 4 weeks after the last dose of immunotherapy