Status:
RECRUITING
TACE Combined Surgery for the Resectable Huge HCC
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Hepatic Chemotherapy
Eligibility:
All Genders
18-75 years
Brief Summary
Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients wit...
Detailed Description
Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients wit...
Eligibility Criteria
Inclusion
- clinical or pathological diagnosis of primary HCC;
- tumor diameter \> 10 cm on images before inclusion;
- age 18 to 75 years;
- no macrovascular invasion or extrahepatic metastasis;
- liver resection with complete removal of the tumor and adequate remnant liver volume;
- albumin-bilirubin (ALBI) grade I and II;
- Eastern Cooperative Oncology Group performance status (ECOG) score of 0-1;
- hemoglobin level ≥ 8.5 g/dL, total bilirubin level ≤ 30 mmol/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) levels ≤ 5 × upper limit of normal, serum creatinine level ≤ 1.5 × upper limit of normal;
- prothrombin time ≤ 18 s or international normalized ratio \< 1.7.
Exclusion
- HCC with macrovascular invasion or extrahepatic metastasis;
- tumor with a maximum diameter ≤ 10 cm on images before inclusion;
- recurrent HCC;
- serious medical comorbidities;
- portal hypertension, including presence of either esophageal varices or splenomegaly with a platelet count less than 109/L;
- cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
- incomplete data or lost to follow-up within three months.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT06898398
Start Date
January 1 2025
End Date
December 30 2025
Last Update
April 3 2025
Active Locations (1)
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1
Chinese PLA general hospital
Beijing, Beijing Municipality, China, 100853