Health Trials

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Autologous Cytokine-Induced Killer (CIK) Cells

    Biological/Vaccine

    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.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: CIK Cell Adjuvant TherapyExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Recurrence-Free Survival (RFS)

Time from study enrollment to first tumor recurrence (intrahepatic or extrahepatic) or death from any cause, whichever occurs first.

Time frame
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
2

Overall Survival (OS)

Time from study enrollment to death from any cause.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royan Institute

Lead sponsor

Bahar Tashkhis Teb

Collaborator

Kian Immune Cell Company

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: