Clinical trial · Interventional
Safety and Efficacy of "Immuncell-LC" in TACE Therapy
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
NCT02856815CI-TRIAL-00067360completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immuncell-LC | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immuncell-LC group
- description
- 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.
- interventionNames
- Biological: Immuncell-LC
- type
- NO_INTERVENTION
- label
- Non-treatment group
- description
- Non-treatment
Primary outcomes (1)
- measure
- Recurrence Free Survival (RFS)
- timeFrame
- baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.