Combining TACE and surgery for large liver tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing two treatments for large liver cancer

  This study is testing whether a new way of giving chemotherapy directly to the liver works better than a standard method for people with large liver cancer.

  Recruiting Sun Yat-sen University · Beijing, Beijing Municipality · NCT06641713

• BGB-B2033 vs Sorafenib or Lenvatinib for advanced liver cancer

  This study tests whether the investigational drug BGB-B2033 can help people with advanced hepatocellular carcinoma when given after prior PD-1/PD-L1 therapy, compared with the standard medicines sorafenib or lenvatinib.

  Recruiting at 2 sites Phase 3 BeOne Medicines · South Brisbane, Queensland and 1 other locations · NCT07836530

• Tracking immune and genomic changes in liver cancer during immunotherapy

  This study will test whether blood and tumor biomarkers can predict how people with advanced hepatocellular carcinoma respond to immunotherapy.

  Recruiting Asan Medical Center · Seoul, Song-pa · NCT07186010

• Using contrast-enhanced ultrasound to check Y-90 radioembolization response in liver cancer

  This will test whether contrast-enhanced ultrasound (CEUS) can show treatment response to Y‑90 radioembolization in people with newly diagnosed hepatocellular carcinoma who are scheduled for TARE.

  Recruiting Phase 2 Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07145801

• Assessing blood biomarkers and MRI for liver cancer patients undergoing radiation therapy

  This study is testing if using special MRI scans and blood tests can help doctors keep track of liver health in patients with liver cancer who are getting radiation therapy.

  Recruiting Montefiore Medical Center · The Bronx, New York · NCT06899152

• PSMA PET-guided Lu-177 radioligand therapy for metastatic hepatocellular carcinoma.

  This will test whether Lu-177 PSMA-617 can safely reach and shrink PSMA-positive metastatic hepatocellular carcinoma in adults whose cancer progressed after first-line treatment.

  Recruiting Phase 2 Case Comprehensive Cancer Center · Cleveland, Ohio · NCT06852820

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.