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A prospective single center study on the safety and efficacy of TACE + lovastatinib + PD1 monoclonal antibody in trans transplantation of hepatocellular carcinoma beyond Hangzhou standard

A prospective single center study on the safety and efficacy of TACE + lovastatinib + PD1 monoclonal antibody in trans transplantation of hepatocellular carcinoma beyond Hangzhou standard

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036467
Enrollment
Unknown
Registered
2020-08-23
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-09-14

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

Conditions

Hepatocellular carcinoma

Interventions

Experimental group:Combined intervention of PD-1 mAb + lovastatin + TACE
Control group:TACE intervention alone

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 75 years old; 2) There was no history of serious arrhythmia and heart failure. 3) There was no history of severe ventilation dysfunction and severe pulmonary infection. 4) There was no acute or chronic renal failure. The creatinine clearance rate was more than 40 ml / min. 5) Good liver function: child Pugh grade A or B (= 28 g/L, AST, alt, ALP =1.5x10^9/L, Hb >=8.5 g/L, PLT >=75x10^9/L (no blood transfusion and drug treatment correction within 14 days before screening); 7) Coagulation function INR < = 2.3; 8) The pathological results were hepatocellular carcinoma (HCC); 9) Understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women; 2) Those who have suffered from or are suffering from other malignant tumors; 3) Recurrent hepatocellular carcinoma; 4) Patients with mental illness were combined; 5) It is estimated that targeted drugs such as PD-1 monoclonal antibody sorafenib may be used after surgery; 6) Human immunodeficiency virus (HIV) carriers; 7) Patients with unresectable liver cancer or liver cancer who need liver transplantation; 8) Advanced hepatocellular carcinoma with systemic metastasis.

Design outcomes

Primary

MeasureTime frame
disease free survival;CD4+ / CD8+ ratio;

Secondary

MeasureTime frame
overall survival;time to recurrence;

Countries

China

Contacts

Public ContactTao Yifeng

Huashan Hospital Affiliated to Fudan University

taoyifenghsh@126.com+86 13916672668

Outcome results

None listed

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