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

NCT07709299 | Not Yet Recruiting Early Phase 1 DMC

• 2 other identifiers: 404000269IRCT20201229049871N1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hepatocellular Carcinoma (HCC)

Keywords

Cytokine-induced killer cell; CIK Cells; Hepatocellular carcinoma; HCC recurrence; HCC resection; Adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events following CIK cell infusion

  Frequency, type, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs), graded per CTCAE v5.0.

  From first infusion through 6 months post-treatment (assessed at weeks 1-10 and months 3 and 6)

Secondary Outcomes (2)

• Recurrence-Free Survival (RFS)

  From date of enrollment until first documented intrahepatic or extrahepatic tumor recurrence, or death from any cause, whichever occurs first, assessed up to 6 months

• Overall Survival (OS)

  From date of enrollment until death from any cause, assessed up to 6 months

Study Arms (1)

CIK Cell Adjuvant Therapy

EXPERIMENTAL

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.

Biological: Autologous Cytokine-Induced Killer (CIK) Cells

Interventions

Autologous Cytokine-Induced Killer (CIK) Cells BIOLOGICAL

PBMCs are collected from the patient, expanded ex vivo for 14-21 days under GMP conditions administered as 6 intravenous infusions (weeks 0, 1, 2, then weeks 4, 6, 8) following release testing for sterility, viability, and phenotype.

CIK Cell Adjuvant Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Royan Institute: lead
• Bahar Tashkhis Teb: collaborator
• Kian Immune Cell Company: collaborator

Study Sites (1)

Liver Transplant and Surgery Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Cell Count

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cell Physiological Phenomena

Study Officials

• Massoud Vosough, MD, Ph.D.

  Royan Institute

  STUDY DIRECTOR

• Mohsen Nassiri-Toosi, MD

  Liver Transplant Research Center, Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massoud Vosough, MD, Ph.D.

CONTACT

98 21 2251 8388; masvos@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

IR (1)