Blocking RAK cells with anti-TIM-3 to prevent liver cancer recurrence
Prevention of Postoperative Recurrence of Hepatocellular Carcinoma by Blocking RAK Cells With Anti-TIM-3
This study is testing if using modified immune cells can help prevent liver cancer from coming back after surgery in patients who have had hepatocellular carcinoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing Hospital Government |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05738980 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of using autologous RAK cells, both unmodified and anti-TIM-3 blocked, in preventing the recurrence of hepatocellular carcinoma (HCC) after surgery. Patients will undergo a series of treatments involving the reinfusion of RAK cells and transarterial chemoembolization (TACE) therapy. The study will assess the patients' response to the treatment over multiple cycles, with follow-up evaluations to determine disease control or remission. The trial is designed to provide insights into the potential benefits of immune cell therapy in conjunction with standard postoperative care.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with hepatocellular carcinoma who have undergone radical resection and meet specific clinical and pathological criteria.
Not a fit: Patients with advanced liver disease or those who do not meet the inclusion criteria for HCC may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of postoperative recurrence of hepatocellular carcinoma in patients.
How similar studies have performed: While the use of immune cell therapies is gaining traction, this specific approach involving anti-TIM-3 blocked RAK cells is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 3\) Patients diagnosed with HCC by histological examination; 4) According to China Liver Cancer Staging (CNLC) -- Guidelines for the Diagnosis and Treatment of primary liver Cancer of the National Health Commission of the People's Republic of China (2022 edition), patients with stage Ia and stage Ib ⅱA; 5) Undergoing radical resection of HCC; 6) For patients with hepatocellular carcinoma diagnosed by pathology after radical resection, the clinical and pathological characteristics meet one of the following conditions: A. tumor ≥5cm; B. Pathology suggested MVI (microvascular invasion); 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 capsule invasion; 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 ECG showed no obvious abnormalities. Oxygen saturation ≥90%; Creatinine clearance rate CG formula ≥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 the possibility of becoming pregnant agree to use effective contraceptive methods (e.g., oral contraceptives, intrauterine devices, controlled sexual desire or barrier contraception combined with spermicide) during the trial and to continue contraception for 3 months after completion of treatment. Exclusion Criteria: * 1\) Pregnant or lactating women; 2) Previous systemic treatment: cytotoxic chemotherapy drugs within 3 months, targeted drugs within 2 months, interferon and/or interleukin-2 within 3 months, and leukocyte raising drugs within 2 weeks; Have been treated with drugs 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 thromboembolism within the last 3 months or high risk of pulmonary embolism; 5) Previous use of DC-CIK or CIK cells, autologous RAK/LAK cells or other adoptive immunotherapy; 6) A history of other malignant diseases in the last 5 years (except cured skin cancer and carcinoma in situ of the cervix); 7) Uncontrolled epilepsy, central nervous system diseases, cerebrovascular accidents, or accompanied by other uncontrolled diseases; A history of mental disorders; 8) Clinically severe heart disease (NYHA) grade II or more 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 and interleukin-2 preparations; 14) Participating in other trials within 4 weeks before enrollment; 15) Poor compliance or conditions deemed inappropriate for study inclusion by the investigator.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Hospital Center of Biotherapy — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jie Ma, Doctor — Beijing Hospital
- Study coordinator: Caixia Liu, master
- Email: liucxmm@163.com
- Phone: 010-85133662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.