Comparing two treatments for large liver cancer

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 compares the effectiveness of transcatheter arterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) in treating patients with intermediate-advanced huge hepatocellular carcinoma, defined as tumors larger than 10 cm. The research aims to address the challenges associated with TACE, which may not fully embolize all tumor arteries, potentially leading to limited patient benefit. HAIC has shown promise in controlling tumors, especially in cases complicated by portal vein tumor thrombus. The study will involve patients diagnosed with primary HCC who meet specific eligibility criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Clinical diagnosis of primary HCC.
2. Age between 18 and 75 years;
3. The maximum tumor size ≥10 cm;
4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
5. limited metastases (≤5).
6. Child-Pugh class A or B;
7. Eastern Cooperative Group performance status (ECOG) score of 0-1;
8. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
9. Prothrombin time ≤18s or international normalized ratio \< 1.7.

Exclusion Criteria:

1. recurrent HCC;
2. Extrahepatic metastasis \>5;
3. Obstructive PVTT involving mesenteric vena cava (PVTT IV).
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
6. Eastern Cooperative Group performance status (ECOG) score of ≥2;
7. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
8. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

Where it's running

• Chinese PLA general hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Qunfang Zhou, MD
• Email: zhouqun988509@163.com
• Phone: 86 19868000115

Similar studies

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

• Combining TACE and surgery for large liver tumors

  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.

  Recruiting Sun Yat-sen University · Beijing, Beijing Municipality · NCT06898398

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

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• 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.