TACE Combined Surgery for the Resectable Huge HCC

Launched by SUN YAT-SEN UNIVERSITY · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for patients with large liver tumors known as hepatocellular carcinoma (HCC), specifically those tumors that are bigger than 10 centimeters. The study aims to see if giving a type of chemotherapy called neoadjuvant TACE before surgery can help improve outcomes for patients undergoing surgery to remove these tumors. The goal is to reduce the chances of the cancer returning after surgery, especially for those at higher risk.

To be eligible for this trial, participants must be between 18 and 75 years old, have a confirmed diagnosis of primary HCC with tumors larger than 10 cm, and have no signs of cancer spreading to other parts of the body. They should also have good liver function and overall health. Participants can expect to receive neoadjuvant TACE prior to their surgery, and the study is currently recruiting patients across multiple centers. It’s important to know that this trial is specifically looking at ways to make surgery safer and more effective for those with large liver tumors, and all genders are welcome to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. clinical or pathological diagnosis of primary HCC;
• • 2. tumor diameter \> 10 cm on images before inclusion;
• • 3. age 18 to 75 years;
• • 4. no macrovascular invasion or extrahepatic metastasis;
• • 5. liver resection with complete removal of the tumor and adequate remnant liver volume;
• • 6. albumin-bilirubin (ALBI) grade I and II;
• • 7. Eastern Cooperative Oncology Group performance status (ECOG) score of 0-1;
• • 8. 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;
• • 9. prothrombin time ≤ 18 s or international normalized ratio \< 1.7.
• Exclusion Criteria:
• • 1. HCC with macrovascular invasion or extrahepatic metastasis;
• • 2. tumor with a maximum diameter ≤ 10 cm on images before inclusion;
• • 3. recurrent HCC;
• • 4. serious medical comorbidities;
• • 5. portal hypertension, including presence of either esophageal varices or splenomegaly with a platelet count less than 109/L;
• • 6. cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
• • 7. incomplete data or lost to follow-up within three months.