Clinical trial · Interventional
Safety and Feasibility of CIK Cell Therapy in HCC After Tumor Resection
Safety and Feasibility of Autologous Cytokine Induced Killer (CIK) Cells Infusion as an Adjuvant Therapy in Post Resection Hepatocellular Carcinoma (HCC) Patients
- 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 study tests whether it is safe and feasible to give patients with hepatocellular carcinoma (liver cancer) an infusion of their own (autologous) immune cells, called cytokine-induced killer (CIK) cells, after they have had surgery to remove their liver tumor. The patient's own blood cells are collected and grown in a laboratory to create the CIK cells, which are then given back to the patient through six intravenous infusions over about two months. Patients are followed for six months to check for side effects and early signs of whether the cancer returns.
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 (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Cytokine-Induced Killer (CIK) Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CIK Cell Adjuvant Therapy
- description
- Patients with HCC who have undergone curative surgical resection receive six intravenous infusions of autologous CIK cells (three weekly, three biweekly) in addition to standard postoperative care.
- interventionNames
- Biological: Autologous Cytokine-Induced Killer (CIK) Cells
Primary outcomes (1)
- measure
- Incidence and severity of adverse events following CIK cell infusion
- timeFrame
- From first infusion through 6 months post-treatment (assessed at weeks 1-10 and months 3 and 6)
- description
- Frequency, type, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs), graded per CTCAE v5.0.
Secondary outcomes (2)
- measure
- Recurrence-Free Survival (RFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 80 years * Documented HCC at BCLC stage 0-A, having undergone surgical tumor resection * Single tumor or ≤3 nodules, each ≤3 cm * Child-Pugh score A-B * ECOG performance status 0-1 * Confirmed cancer-free status one month after surgery * Written informed consent * Leukocyte count \> 3 × 10⁹/L * Absolute neutrophil count (ANC) ≥ 1,000/µL * Hemoglobin ≥ 8.5 g/dL * Platelet count \> 50 × 10⁹/L * BUN and serum creatinine ≤ 1.5 × upper limit of normal No extrahepatic abdominal disease spread, confirmed by abdominal CT/MRI Exclusion Criteria: * Active infection or uncontrolled viremia (particularly HBV, HCV, or HIV) * Any cell therapy or immunotherapy in the past 6 months, or current participation in another clinical study * Another malignancy (prior or concurrent) differing from HCC in primary site or histology * Clinically significant cardiovascular disease (e.g., heart failure, serious arrhythmia, symptomatic coronary artery disease) * History of organ transplantation * Primary or secondary immunodeficiency, or active autoimmune disease * Severe allergic disorder or history of anaphylaxis * Pregnancy or breastfeeding at study entry * Women of childbearing potential intending to become pregnant
References
Publications (0)
Data not yet available