Status:
UNKNOWN
Efficacy and Safety of TACE on Downstaging Hepatocellular Carcinoma Beyond UCSF Criteria;
Lead Sponsor:
Beijing Tsinghua Chang Gung Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This is a multicenter, randomized, parallel controlled study to determine the efficacy and safety of transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma beyond Univ...
Eligibility Criteria
Inclusion
- 18 to 70 years of age, of any sex;
- 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);
- 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;
- Patients with stage Ib，IIa，IIb in China liver cancer staging (CNLC) ;
- Child-Pugh's grade A or B (no more than 7 score);
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
- Patients with hepatitis B virus (HBV) infection should receive routine antiviral therapy;
- 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
- Patients with extrahepatic metastasis or main portal vein /main hepatic vein invasion;
- Patients with diffuse liver cancer;
- 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%;
- 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;
- Patients unsuitable for the study in the opinion of the Investigator;
- Pregnant or breastfeeding women; women of childbearing ages unless using effective contraception;
- Patients with mental disorders or history of abuse of psychotropic substances;
- Infection with human immunodeficiency virus (HIV);
- A history of liver resection, liver transplantation, interventional therapy, or combined with other malignant tumors;
- Patients with active infection;
- Patients with contraindications to TACE or epirubicin;
- Floating population or with poor compliance;
- Patients in other clinical trials conducting with experimental-related drugs or devices within 4 weeks.
Key Trial Info
Start Date :
March 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT04738188
Start Date
March 18 2020
End Date
December 1 2025
Last Update
February 4 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Tsinghua Chang Gung Hospital
Beijing, China