Prevention of Postoperative Recurrence of Hepatocellular Carcinoma by Blocking RAK Cells With Anti-TIM-3

Last updated: February 13, 2023
Sponsor: Beijing Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Digestive System Neoplasms

Liver Cancer

Treatment

N/A

Clinical Study ID

NCT05738980
BJH Biotherapy Center
  • Ages 18-75
  • All Genders

Study Summary

To compare the safety and efficacy of unmodified RAK cells and anti-TIM-3 blocked autologous RAK cells in preventing postoperative recurrence of HCC by postoperative TACE therapy combined with immune cell therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Patients diagnosed with HCC by histological examination; 4) According to ChinaLiver Cancer Staging (CNLC) -- Guidelines for the Diagnosis and Treatment of primaryliver Cancer of the National Health Commission of the People's Republic of China (2022edition), patients with stage Ia and stage Ib ⅱA; 5) Undergoing radical resection ofHCC; 6) For patients with hepatocellular carcinoma diagnosed by pathology afterradical resection, the clinical and pathological characteristics meet one of thefollowing conditions: A. tumor ≥5cm; B. Pathology suggested MVI (microvascularinvasion); C. Pathology suggested satellite foci or sub-foci; D. Multiple tumors (number of tumors ≥2); E. AFP & GT; 20 mu g/L; F. Accompanied by hepatic capsuleinvasion; 7) ECOG score 0 or 1; Child-pugh liver function score A/B (≤7); 8)Neutrophil count ≥1.5×109/L, lymphocyte count ≥1.1×109/L, platelet count ≥80×109/L;Cardiac echocardiography showed that cardiac ejection fraction ≥50%, and 12-lead ECGshowed no obvious abnormalities. Oxygen saturation ≥90%; Creatinine clearance rate CGformula ≥50 mL/min; ALT and AST 2.5 x ULN or less; Serum total bilirubin ≤1.5×ULN; 9)The estimated survival time is more than 6 months; 10) Fertile men or women with thepossibility of becoming pregnant agree to use effective contraceptive methods (e.g.,oral contraceptives, intrauterine devices, controlled sexual desire or barriercontraception combined with spermicide) during the trial and to continue contraceptionfor 3 months after completion of treatment.

Exclusion

Exclusion Criteria:

    1. Pregnant or lactating women; 2) Previous systemic treatment: cytotoxic chemotherapydrugs within 3 months, targeted drugs within 2 months, interferon and/or interleukin-2within 3 months, and leukocyte raising drugs within 2 weeks; Have been treated withdrugs that target immune regulatory points; 3) Have used immunosuppressive agents (e.g., azathioprine, 6-mercaptopurine, cyclosporine, tisirolimus, everolimus,rapamycin, etc.); Long-term use of corticosteroids; 4) History of thromboembolismwithin the last 3 months or high risk of pulmonary embolism; 5) Previous use of DC-CIKor CIK cells, autologous RAK/LAK cells or other adoptive immunotherapy; 6) A historyof other malignant diseases in the last 5 years (except cured skin cancer andcarcinoma in situ of the cervix); 7) Uncontrolled epilepsy, central nervous systemdiseases, cerebrovascular accidents, or accompanied by other uncontrolled diseases; Ahistory of mental disorders; 8) Clinically severe heart disease (NYHA) grade II ormore congestive heart failure or severe arrhythmias requiring medical intervention; 9)Interstitial lung disease ≥2 degrees; 10) Accompanied by fever or infection; 11)Autoimmune diseases, including uncontrolled hypothyroidism and hyperthyroidism; 12)HIV/AIDS or syphilis antibody positive; 13) Allergic to any interferon andinterleukin-2 preparations; 14) Participating in other trials within 4 weeks beforeenrollment; 15) Poor compliance or conditions deemed inappropriate for study inclusionby the investigator.

Study Design

Total Participants: 88
Study Start date:
February 01, 2023
Estimated Completion Date:
December 31, 2026

Study Description

Research process:

Initial screening period (-7 to -1 days)

• Sign an informed consent form;

• Assign screening numbers;

• Assessment of eligibility for initial screening.

  1. Day 0 (period 1)

    • Reconfirm the inclusion and exclusion criteria;

    • 50-60ml of anticoagulant peripheral blood was sampled;

    Treatment time:

  2. On (±2) days 15 and 16, Autologous RAK cells were reinfused for treatment (cycle 1).

  3. TACE was performed on day 28 (±7).

  4. Blood drawing from autologous RAK cells in the second cycle (week 10 ±7 days)

  5. The second cycle of autologous RAK cell transfusion treatment (12 weeks ±7 days after hepatocellular carcinoma surgery);

  6. Blood was drawn from autologous RAK cells in the third cycle (week 22 ±7 days);

  7. Reinfusion of autologous RAK cells in the third cycle (week 24 ±7 days);

After completing 3 cycles of treatment, the patients were assessed by the investigator to be under control or remission of disease after treatment, and then they were followed up for treatment

Connect with a study center

  • Beijing Hospital Center of Biotherapy

    Beijing, Beijing 100730
    China

    Active - Recruiting

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