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RecruitingNCT05738980Updated Feb 22, 2023

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

An interventional study of Autologous RAK cells in Hepatocellular Carcinoma, sponsored by Beijing Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-22.

Sponsored by Beijing Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 88 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Beijing Hospital is the lead sponsor of 51 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
88 participants (estimated)

Study arms

  • Experimental
    anti-Tim3-blocked RAK cells

    ubjects were randomly assigned to receive anti-TIM-3 blocked RAK cells or untreated RAK cells.

    Biological: Autologous RAK cells

  • Experimental
    Unblocked RAK cells

    ubjects were randomly assigned to receive anti-TIM-3 blocked RAK cells or untreated RAK cells.

    Biological: Autologous RAK cells

Interventions

  • BiologicalAutologous RAK cells

    Autologous RAK cells were treated by intravenous reinfusion

06

What researchers measure

Primary outcomes

  1. RFS

    Recurrence-free survival (RFS) of postoperative TACE combined with TIM-3 block treated autologous RAK cells to prevent HCC recurrence

    Time frame: two years

Secondary outcomes

  1. OS

    Overall survival (OS) of postoperative TACE combined with TIM-3 blocked autologous RAK cells to prevent HCC recurrence

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Beijing Hospital Center of Biotherapy
    Beijing, Beijing 100730, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — After the article was published

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05738980
Lead sponsor
Beijing Hospital
Responsible party
Sponsor
First posted
Feb 22, 2023
Start date
Feb 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 22, 2023

Study contacts

Caixia Liu, master
Contact
liucxmm@163.com
010-85133662
Jie Ma, Doctor
principal investigator · Beijing Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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