Safety and Feasibility of CIK Cell Therapy in HCC After Tumor Resection

Starting soon · Early Phase 1

Conditions studied: Hepatocellular Carcinoma (HCC)

In brief

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.

Key facts

Study ID

NCT07709299

Run by

Royan Institute

People needed

6

Starts

2026-07-01

Expected to finish

2028-07-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Liver Transplant and Surgery Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences — Tehran, Tehran Province, Iran

Full record on ClinicalTrials.gov

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