NCT05738980

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Beijing Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Autologous RAK cells	Autologous RAK cells were treated by intravenous reinfusion

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2023-02-22
• Last updated: 2023-02-22

Locations

1 site across 1 country: China