Comparing two treatments for large liver cancer
Hepatic Arterial Infusion Chemotherapy Compared With Transcatheter Arterial Chemoembolizationin Intermediate-advanced Huge Hepatocellular Carcinoma: a Multicenter Retrospective Study
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 664 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06641713 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with primary hepatocellular carcinoma and tumors measuring 10 cm or larger.
Not a fit: Patients with recurrent HCC or those with serious medical comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with large hepatocellular carcinoma.
How similar studies have performed: Previous studies have indicated that HAIC may offer better outcomes for advanced huge HCC, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Chinese PLA general hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qunfang Zhou, MD
- Email: zhouqun988509@163.com
- Phone: 86 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.