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Completed

NCT Number: NCT02856815

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

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

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul St.Mary's Hospital, Seoul, Banpo-daero 222 / Seocho-go, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immuncell-LC

Biological

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

Primary outcomes

  1. Recurrence Free Survival (RFS)

    Time frame: 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 outcomes

  1. Overall Survival (OS)

    Time frame: 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

  2. Change of Alpha Feto Protein (AFP) level

    Time frame: 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

  3. Correlation of between Myeloid-derived Suppressor Cell change and Prognosis

    Time frame: 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

  4. Adverse event

    Time frame: 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

  5. Eastern Cooperative Oncology Group Performance Status (ECOG-PS)

    Time frame: 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

  6. Hematological examination

    Time frame: 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

Sponsors and collaborators

Lead sponsor

GC Cell Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Aug 5, 2016
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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