Clinical trial · Interventional
Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients After Resection of Liver Cancer
A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection.
- 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)
Study hypothesis: The recurrence rate of HCC patients after radical resection is about 60-70%. This study is based on the hypothesis that CIK treatment could decrease the recurrence rate by 15% to 20%. Abstract: 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. Study treatment: Patients in group A will receive 4 cycles of CIK treatments within 3 months after their liver resection. Patients in group B will have no anti-cancer therapy. Anti-virus and other supportive therapies are available in both groups.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytokine-induced killer cell (CIK) treatment | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- B (control group)
- description
- regular treatment and follow up
- type
- EXPERIMENTAL
- label
- A (CIK group)
- description
- cytokine-induced killer cell treatment plus regular treatment and follow up
- interventionNames
- Biological: cytokine-induced killer cell (CIK) treatment
Primary outcomes (1)
- measure
- Time to recurrence (TTR)
- timeFrame
- month
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Male or female patients \> 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 \<= 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 ECOG PS of 0, or 1. * Cirrhotic status of Child-Pugh class A only. * The following laboratory parameters: * Platelet count \>= 70 x 109/L * Hemoglobin \>= 8.5 g/dL * Albumin \>= 3.5 g/dL * Total bilirubin \<= 25umol/L * Alanine transaminase (ALT) and AST \<= 2.5 x upper limit of normal * Serum creatinine \<= 1.5 x the upper limit of normal * Prothrombin time (PT) \<= 3 seconds above control. * 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 (\> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] 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