Actively Recruiting
Prevention of Postoperative Recurrence of Hepatocellular Carcinoma by Blocking RAK Cells With Anti-TIM-3
Led by Beijing Hospital · Updated on 2023-02-22
88
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention of Postoperative Recurrence of Hepatocellular Carcinoma by Blocking RAK Cells With Anti-TIM-3
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hepatocellular carcinoma by histological examination
- Classified as stage Ia or Ib according to China Liver Cancer Staging guidelines
- Have undergone radical resection of hepatocellular carcinoma
- Tumor characteristics meeting at least one: tumor size 6 cm, microvascular invasion, satellite foci, multiple tumors (2 or more), AFP > 20 mu g/L, or hepatic capsule invasion
- ECOG performance status score of 0 or 1
- Child-Pugh liver function score A or B (7 or less)
- Neutrophil count 1.5 x 10^9/L, lymphocyte count 1.1 x 10^9/L, platelet count 80 x 10^9/L
- Cardiac ejection fraction 5% and no significant abnormalities on 12-lead ECG
- Oxygen saturation 90% or higher
- Creatinine clearance rate at least 50 mL/min
- ALT and AST levels 2.5 times upper limit of normal or less
- Serum total bilirubin 1.5 times upper limit of normal or less
- Estimated survival time longer than 6 months
- Fertile men or women agree to use effective contraception during the trial and for 3 months after treatment completion
You will not qualify if you...
- Pregnant or lactating women
- Previous systemic treatments: cytotoxic chemotherapy within 3 months, targeted drugs within 2 months, interferon or interleukin-2 within 3 months, leukocyte-raising drugs within 2 weeks
- Use of immune checkpoint inhibitors or immunosuppressive agents such as azathioprine, cyclosporine, or corticosteroids
- History of thromboembolism within 3 months or high risk for pulmonary embolism
- Previous adoptive immunotherapy including DC-CIK, CIK cells, autologous RAK/LAK cells
- History of other cancers in the last 5 years except cured skin cancer or cervical carcinoma in situ
- Uncontrolled epilepsy, central nervous system diseases, cerebrovascular accidents, or other uncontrolled diseases
- History of mental disorders
- Severe heart disease (NYHA class II or higher), severe arrhythmias needing treatment
- Interstitial lung disease grade 2 or higher
- Fever or active infection
- Autoimmune diseases including uncontrolled thyroid disorders
- Positive for HIV/AIDS or syphilis antibodies
- Allergy to interferon or interleukin-2 preparations
- Participation in other clinical trials within 4 weeks before enrollment
- Poor compliance or conditions unsuitable for study inclusion as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Hospital Center of Biotherapy
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
C
Caixia Liu, master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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