Actively Recruiting
HAIC Compared With TACE in Huge Hepatocellular Carcinoma
Led by Sun Yat-sen University · Updated on 2025-03-26
664
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
C
Chinese PLA General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study intends to compare the efficacy of transcatheter arterial chemical embolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) for patients with intermediate-advanced huge hepatocellular carcinoma.
CONDITIONS
Official Title
HAIC Compared With TACE in Huge Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of primary hepatocellular carcinoma (HCC).
- Age between 18 and 75 years.
- Maximum tumor size of 10 cm or larger.
- Intermediate-advanced huge HCC, including advanced HCC with portal vein tumor thrombus (PVTT) types I-III.
- Limited metastases of 5 or fewer.
- Child-Pugh liver function class A or B.
- Eastern Cooperative Group performance status (ECOG) score of 0-1.
- Hemoglobin level of at least 8.5 g/dL.
- Total bilirubin level of 30 mmol/L or less.
- Serum albumin level of at least 32 g/L.
- AST and ALT levels at or below 5 times the upper limit of normal.
- Serum creatinine level at or below 1.5 times the upper limit of normal.
- International normalized ratio (INR) of 1.5 or less or normal prothrombin time/activated partial thromboplastin time.
- Absolute neutrophil count greater than 1,500/mm3.
- Prothrombin time of 18 seconds or less or INR less than 1.7.
You will not qualify if you...
- Recurrent hepatocellular carcinoma.
- More than 5 metastases outside the liver.
- Obstructive portal vein tumor thrombus involving the mesenteric vena cava (PVTT IV).
- Serious other medical conditions.
- Signs of liver failure such as ascites, gastrointestinal bleeding, or hepatic encephalopathy.
- Eastern Cooperative Group performance status (ECOG) score of 2 or higher.
- Known or suspected allergy to the study drugs or related agents.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic treatment.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA general hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
Q
Qunfang Zhou, MD
CONTACT
F
Feng Duan, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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