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Safety and efficacy of ablation sequential specific T cell immunotherapy for hepatocellular carcinoma

Safety and efficacy of ablation sequential specific T cell immunotherapy for hepatocellular carcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045720
Enrollment
Unknown
Registered
2021-04-23
Start date
2021-05-17
Completion date
Unknown
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

Group One:ablation sequential specific T-cell immunotherapy for hepatocellular carcinoma
Group Two:Single ablation therapy

Sponsors

Beijing Youan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged 18 to 75 years; 3. Hepatocellular carcinoma (HCC) related to HBV or HCV infection; 4. HCC confirmed by imaging or not confirmed by imaging but confirmed by pathology (AALSD diagnostic criteria); 5. BCLC stages 0, A, B; 6. Child-Pugh classification A and B (3 months; 10. Sufficient organ function, subjects need to meet the following laboratory indicators: (1) The absolute value of neutrophils (ANC) >=1.5x10^9 /L when no granulocyte colony stimulating factor is used in the past 14 days; (2) In the case of no blood transfusion in the past 14 days, platelets >=50x10^9 /L; (3) In the past 14 days without blood transfusion or erythropoietin, hemoglobin>9g/dL; (4) Total bilirubinULN but direct bilirubin= 60 ml/min; (7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 times ULN.

Exclusion criteria

Exclusion criteria: 1. Liver cancer related to autoimmune diseases; 2. Received anti-tumor Chinese patent medicines or immunomodulatory drugs within 2 weeks before the first treatment; 3. An active self that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids or immunosuppressive agents) occurred within 2 years before the first treatment Sexual immune disease. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 4. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first treatment of the study; 5. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 6. Participated in other drug trials (except traditional Chinese medicine) within the past three months; 7. Those who cannot accept intravenous injection; 8. Any other factors that the researcher thinks are not suitable for entering the experiment.

Design outcomes

Primary

MeasureTime frame
safety;

Secondary

MeasureTime frame
Recurrence-free survival;Overall survival;

Countries

China

Contacts

Public ContactZhang Yonghong

Beijing Youan Hospital Capital Medical University

13810108505@163.com+86 13810108505

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026