Using TACE to treat advanced liver cancer

Efficacy and Safety of TACE on Downstaging Hepatocellular Carcinoma Beyond UCSF Criteria: a Multi-center, Randomized, Parallel-controlled Study

This study is testing if a treatment called TACE can help people with advanced liver cancer feel better and possibly shrink their tumors.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 226 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Tsinghua Chang Gung Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT04738188 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, parallel controlled study aims to evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) for downstaging hepatocellular carcinoma (HCC) that exceeds the University of California, San Francisco (UCSF) criteria. The study will involve patients with specific tumor characteristics and will utilize interventions such as drug-eluting beads and epirubicin. By comparing outcomes in treated patients against a control group, the study seeks to determine the effectiveness of TACE in managing advanced HCC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed hepatocellular carcinoma that exceeds UCSF criteria and who are not eligible for surgical resection or liver transplantation.

Not a fit: Patients with hepatocellular carcinoma that can be treated with surgical options or those with Child-Pugh grade C liver function will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with advanced liver cancer who do not qualify for surgery.

How similar studies have performed: Other studies have shown promising results with TACE for hepatocellular carcinoma, indicating that this approach is supported by prior research.

Eligibility criteria

Inclusion Criteria:

1. 18 to 70 years of age, of any sex;
2. Patients who have histopathological or cytological proof of hepatocellular carcinoma (HCC) or meet the diagnostic criteria of Diagnosis, management, and treatment of hepatocellular carcinoma(V2017);
3. Beyond UCSF criteria: Diameter of single HCC lesion is between 6.5 cm and 10 cm; The number of tumors ≤3 with the maximum diameter of 4.5-5cm and the total diameter ≤10cm; Multiple HCC lesions ≤5 nodules, each lesion diameter≤4 cm with a total diameter ≤10 cm. Patients cannot be treated with resection or liver transplantation;
4. Patients with stage Ib，IIa，IIb in China liver cancer staging (CNLC) ;
5. Child-Pugh's grade A or B (no more than 7 score);
6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
7. Patients with hepatitis B virus (HBV) infection should receive routine antiviral therapy;
8. The function of main organs is normal and meet the following criteria:

1) Outcome of blood routine must meet the following criteria (No blood transfusion or blood products were performed within 4 days, and no g-CSF or other hematopoietic stimulants were used for correction): i. Hemoglobin(HB)≥90 g/L; ii. Absolute neutrophil count (ANC)≥1.5×109/L； iii. Platelet (PLT)≥80×109/L; 2) Outcome of hemal biochemistry examination meet the following criteria: i. Albumin (ALB) ≥29 g/L; ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\<2.5 × upper limit of normal (ULN); iii. Total bilirubin (TBIL) ≤2 × ULN; iv. Serum creatinine (SCr) ≤1.25 × ULN, or endogenous creatinine clearance \> 45 ml/min (Cockcroft-Gault formula); 3) Patients who have normal livers with an Remnant Liver Volume (RLV)/Standard Liver Volume(SLV) \>20% ; Patients who have cirrhosis with an RLV/SLV\>40%; 9. Life expectancy of \> 3 months; 10. Patients volunteered to participate in this study and signed informed consent, with good compliance.Exclusion Criteria.

Exclusion Criteria:

1. Patients with extrahepatic metastasis or main portal vein /main hepatic vein invasion;
2. Patients with diffuse liver cancer;
3. Patients with myocardial ischemia, myocardial infarction or poor controlled arrhythmia (including QTc≥470 ms) beyond stage Ⅱ; according to New York Heart Association (NYHA) standard, patients with heart failure in stage Ⅲ～Ⅳ; patients with an left ventricular ejection fraction(LVEF) \<50%;
4. Abnormal coagulation （International Normalized Ratio(INR)\>1.5, Prothrombin Time(PT)\>ULN+4s or Activated Partial Thromboplastin Time (APTT) \>1.5 ×ULN）,or patients with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
5. Patients unsuitable for the study in the opinion of the Investigator;
6. Pregnant or breastfeeding women; women of childbearing ages unless using effective contraception;
7. Patients with mental disorders or history of abuse of psychotropic substances;
8. Infection with human immunodeficiency virus (HIV);
9. A history of liver resection, liver transplantation, interventional therapy, or combined with other malignant tumors;
10. Patients with active infection;
11. Patients with contraindications to TACE or epirubicin;
12. Floating population or with poor compliance;
13. Patients in other clinical trials conducting with experimental-related drugs or devices within 4 weeks.

Where this trial is running

Beijing

• Beijing Tsinghua Chang Gung Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jiahong Dong, MD

Conditions Hepatocellular Carcinoma