Safety and Feasibility of CIK Cell Therapy in HCC After Tumor Resection (NCT07709299) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Safety and Feasibility of CIK Cell Therapy in HCC After Tumor Resection
Iran6 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)