]>
IRCT20201229049871N1 IRCT 2026-05-30 Royan Institute Safety and feasibility of autologous cytokine-induced killer (CIK) cell injection as adjuvant therapy in hepatocellular carcinoma Safety and feasibility of autologous cytokine induced killer (CIK) cells infusion as an adjuvant therapy in post resection hepatocellular carcinoma (HCC) patients 2026-07-23 anticipated 6 Recruiting https://irct.ir/trial/90043 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Hepatocellular Carcinoma. Intervention group: In this study, patients with hepatocellular carcinoma (HCC) who have undergone successful surgical resection of the liver tumor will receive adjuvant therapy with autologous cytokine‑induced killer (CIK) cells in addition to standard postoperative care.For cell preparation, patients mononuclear cells will be used. Peripheral blood mononuclear cells (PBMCs) are cultured under sterile, Good Manufacturing Practice (GMP) conditions and activated with interferon‑gamma (IFN‑γ), anti‑CD3 antibody, and interleukin‑2 (IL‑2) for approximately 2–3 weeks to generate the effective CIK cell population. After completing culture, the final product undergoes quality control tests for sterility, cell viability, and phenotype. Only products meeting predefined quality criteria will be used for infusion.The CIK cells will be administered through six intravenous infusions — the first three given weekly and the subsequent three every two weeks. Before each infusion, the patient’s clinical condition and basic safety laboratory results (CBC and liver enzymes) will be reviewed. All infusions will be performed in a clinical setting under supervision of the research team, and patients will be monitored for any adverse events or infusion‑related reactions.The objective of this intervention is to evaluate the safety, feasibility, and potential efficacy of adjuvant CIK therapy in reducing disease recurrence following tumor resection in HCC patients.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Alireza Beheshti Maal
No 9. East Shaghayegh Alley. Banihashem St. Resalat Highway
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2251 8388 alirezabeheshtimaal@gmail.com Royan Institute scientific Massoud Vosough
No 9. East Shaghayegh Alley. Banihashem St. Resalat Highway
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2251 8388 masvos@yahoo.com Royan Institute Iran (Islamic Republic of) Age between 18-80 Patients with Documented HCC in BCLC stage 0-A who have undergone surgical resection of the tumor. • Single or ≤ 3 nodules ≤ 3cm. • Liver function level according to Child Pugh Score A-B. • Patient performance level according to ECOG criteria 0-1 Establishment of Cancer free state one month after surgery Obtaining of Informed Consent Leukocyte count is bigger than (3 billion cells/L) Absolute Neutrophil Count (ANC) is bigger than or equal to 1,000/µL Hemoglobin is bigger than or equal to 8.5 g/dL Thrombocyte count is bigger than (50 billion cells/L) BUN and serum Creatinine is less than or equal to 1.5 multiply normal upper-limit 18 years 80 years Both Receiving any cellular or immunotherapy treatment in the past six months or participation in another study Concomitant (previous or concurrent) that differs from HCC in primary site or histological features. History of clinically significant cardiovascular disease (such as heart failure, serious arrhythmias, or symptomatic coronary artery disease) History of organ trnasplant Primary or secondary immunodeficiency, or active autoimmune diseases Having a severe allergic disorder or a history of anaphylactic reaction Presence of active infection or uncontrolled viremia (especially HBV, HCV, or HIV) Pregnancy or breastfeeding at the time of study entry Women of childbearing age who are planning to become pregnant C22.0 Liver cell carcinoma Treatment - Other Intervention group: In this study, patients with hepatocellular carcinoma (HCC) who have undergone successful surgical resection of the liver tumor will receive adjuvant therapy with autologous cytokine‑induced killer (CIK) cells in addition to standard postoperative care.For cell preparation, patients mononuclear cells will be used. Peripheral blood mononuclear cells (PBMCs) are cultured under sterile, Good Manufacturing Practice (GMP) conditions and activated with interferon‑gamma (IFN‑γ), anti‑CD3 antibody, and interleukin‑2 (IL‑2) for approximately 2–3 weeks to generate the effective CIK cell population. After completing culture, the final product undergoes quality control tests for sterility, cell viability, and phenotype. Only products meeting predefined quality criteria will be used for infusion.The CIK cells will be administered through six intravenous infusions — the first three given weekly and the subsequent three every two weeks. Before each infusion, the patient’s clinical condition and basic safety laboratory results (CBC and liver enzymes) will be reviewed. All infusions will be performed in a clinical setting under supervision of the research team, and patients will be monitored for any adverse events or infusion‑related reactions.The objective of this intervention is to evaluate the safety, feasibility, and potential efficacy of adjuvant CIK therapy in reducing disease recurrence following tumor resection in HCC patients. Safety: Safety is defined as the frequency, type, severity, and suspected relatedness of adverse events associated with intravenous infusion of autologous CIK cells. All adverse events (AEs) and serious adverse events (SAEs) will be recorded from the time of the first infusion until the end of the follow-up period and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Timepoint: Safety assessment and determination of possible adverse events (systemic, local, short-term, and serious) after intravenous injection of autologous cytokine-induced killer cells (CIK) will be performed at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, and at months 3 and 6 after injection. Method of measurement: Safety assessment and determination of possible adverse events will be performed by taking history and examination according to the Common Terminology Criteria for Adverse Events (CTCAE) v5. Recurrence-Free Survival (RFS): Defined as the time interval from the date of study enrollment to the occurrence of the first tumor recurrence (intrahepatic or extrahepatic) or death from any cause, whichever occurs first. Timepoint: Recurrence‑Free Survival (RFS) will be assessed during a 6‑month follow‑up period according to the study schedule, which includes regular clinical evaluations and imaging every 3 months. Time to recurrence or death will be measured from the date of study enrollment. Method of measurement: Recurrence will be determined based on standard imaging findings (MRI and CT scan) and clinical assessment, and the date of the event will be recorded. Overall Survival (OS): Defined as the time interval from the date of study enrollment to the date of death from any cause. Timepoint: Overall survival will be assessed at study enrollment and subsequently during regular follow‑up according to the study schedule until the end of the follow‑up period. Survival status will be recorded at each visit (weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, and months 3 and 6 after infusion). Method of measurement: Survival status will be documented through clinical follow‑up, review of medical records, and telephone contact if necessary. Cancer‑Free Survival (CFS): Defined as the time interval from the date of study enrollment to the first occurrence of cancer recurrence (intrahepatic or extrahepatic) or death from any cause, whichever occurs first. Timepoint: At study enrollment (baseline) and subsequently during regular follow‑up according to the study schedule until the end of the follow‑up period; recurrence or reappearance of cancer will be assessed and recorded at each follow‑up visit (weeks 1 through 10 after treatment initiation, and then at months 3 and 6) through clinical evaluation and periodic imaging at 3 months interval. Method of measurement: Recurrence will be determined based on standard imaging findings (MRI or CT scan) and clinical assessment, and the date of the event will be recorded. Bahar Tashkhis Teb Kian Immune Cell Royan Institute Bahar Tashkhis Teb Kian Immune Cell Approved 2026-02-17 Research Ethics Committee of Royan Research Institute 3th Floor, Block A, Ministry of Health and Medical Education Headquarters, Simaye Iran Street, between South Falamak and Zarafshan, Shahrak‑e Gharb Tehran Tehran Iran (Islamic Republic of)