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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
Autologous RAK cells were treated by intravenous reinfusion
Beijing Hospital Center of Biotherapy
Beijing, Beijing Municipality, China
RECRUITINGRFS
Recurrence-free survival (RFS) of postoperative TACE combined with TIM-3 block treated autologous RAK cells to prevent HCC recurrence
Time frame: two years
OS
Overall survival (OS) of postoperative TACE combined with TIM-3 blocked autologous RAK cells to prevent HCC recurrence
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.