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

NCT02856815 | Completed Phase 2

• 1 other identifier: ILC-IIT-05
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Carcinoma, Hepatocellular

Keywords

Immuncell-LC; Transarterial Chemoembolization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall Survival (OS)

  baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject

• 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

• 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

• 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

• 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

Study Arms (2)

Immuncell-LC group

EXPERIMENTAL

Adjuvant adoptive immune therapy using a CIK cell agent(Immuncell-LC) 12 times(5 treatments at a frequency of once per week, followed by 5 treatments every 2 weeks, and finally 2 treatments every 4 weeks.

Biological: Immuncell-LC

Non-treatment group

NO INTERVENTION

Non-treatment

Interventions

Immuncell-LC BIOLOGICAL

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

Immuncell-LC group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GC Cell Corporation: lead

Study Sites (3)

Seoul St.Mary's Hospital

Seoul, Banpo-daero 222 / Seocho-go, 06591, South Korea

Location

Seoul National University Hospital

Seoul, Daehak-ro 101/Jongno-gu, 03080, South Korea

Location

Severance Hospital

Seoul, Seoul,50-1 Yonsei-ro/Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jung Hwan Yoon, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 5, 2016
• Study Start: May 28, 2018
• Primary Completion: August 11, 2020
• Study Completion: September 22, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)