Combining TACE and surgery for large liver tumors
Transcatheter Arterial Chemoembolization Combined Surgery Versus Surgery for the Resectable Huge Hepatocellular Carcinoma: a Multicenter Propensity Analysis
This study is testing if a treatment called TACE before surgery can help people with large liver tumors do better after surgery and have fewer chances of the cancer coming back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 326 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06898398 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of neoadjuvant transarterial chemoembolization (TACE) in patients with huge hepatocellular carcinoma (HCC) prior to liver resection. Huge HCC is characterized by tumors larger than 10 cm, and the study aims to improve surgical outcomes and reduce recurrence rates. By focusing on patients without vascular invasion or metastasis, the research seeks to determine if TACE can enhance long-term oncological results. The study is multicenter and involves careful patient selection based on specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a clinical or pathological diagnosis of primary HCC and tumors larger than 10 cm, without macrovascular invasion or metastasis.
Not a fit: Patients with recurrent HCC, those with tumors smaller than 10 cm, or those with serious medical comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and reduce recurrence rates for patients with large liver tumors.
How similar studies have performed: Previous studies have shown that neoadjuvant TACE can improve outcomes in HCC patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Chinese PLA general hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Feng Duan, MD — Chinese PLA General Hospital
- Study coordinator: Qunfang Zhou, MD
- Email: zhouqun988509@163.com
- Phone: 19868000115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.