Safety and Feasibility of CIK Cell Therapy in HCC After Tumor Resection
ConditionHepatocellular Carcinoma (HCC)
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRoyan Institute
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Autologous Cytokine-Induced Killer (CIK) Cells
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov