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

Hepatocellular Carcinoma Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

• NCT number: NCT05738980
• Study type: Interventional
• Source: Beijing Hospital
• Contact: Caixia Liu, master
• Phone: 010-85133662
• Email: liucxmm@163.com
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Completion date: December 31, 2026