CELL INTELLIGENCE · 肿瘤细胞治疗研究

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

主要终点：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)
次要终点：Recurrence-Free Survival (RFS)；Overall Survival (OS)

• 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.

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.