Clinical trial · Interventional
CIK Treatment for HCC Patient Underwent Radical Resection
A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection
NCT01749865CI-TRIAL-00021753completedPhase 3ClinicalTrials.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)
This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who underwent radical resection will be included. The patients will be randomized to group A (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer treatment after resection of HCC, and the randomize ratio will be 1:1.
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 |
|---|---|---|---|
| Cytokine-Induced Killer Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A, CIK
- description
- Biological/Vaccine: Cytokine-Induced Killer Cells
- interventionNames
- Biological: Cytokine-Induced Killer Cells
- type
- NO_INTERVENTION
- label
- B, CONTROL
- description
- Regular follow up with no intervention
Primary outcomes (1)
- measure
- Time to recurrence
- timeFrame
- 5-year
- description
- To evaluate efficacy of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients over 18 years of age. * Without any prior anti-cancer therapy. * Patients who have a life expectancy of at least 12 weeks. * Patients already had radical resection of HCC. Definition of radical resection in this study: * All tumors were moved out, with a clean resection margin. * Number of tumors less than 3. * Without tumor invasion of the main trunk and first branch of the portal vein, or hepatic duct, or hepatic vein. * No hepatic hilum lymphnode metastasis. * No distance metastasis. * Hepatocellular carcinoma with histological diagnose. * No major post-operative complication. * Patients who have an performance status of 0, or 1. * Cirrhotic status of Child-Pugh class A only. * The following laboratory parameters: * Patients who give written informed consent. Exclusion Criteria: * Previous or concurrent cancer that is distinct in primary site or histology from HCC. * History of cardiac disease. * Active clinically serious infections ( over grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events version 3.0) * Known history of human immunodeficiency virus (HIV) infection * Known Central Nervous System tumors including metastatic brain disease. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * History of organ allograft. * Known or suspected allergy to the investigational agent or any agent given in association with this trial. * Pregnant or breast-feeding patients. * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study. * Excluded therapies and medications, previous and concomitant: Prior use of any anti-cancer treatment for HCC, eg. chemotherapy, radiotherapy. Antiviral treatment is allowed.
References
Publications (0)
Data not yet available
No reference posted for this study.