Actively Recruiting
DEB-TACE Prior to Liver Transplantation in the Treatment of HCC
Led by RenJi Hospital · Updated on 2024-10-18
40
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to living donor liver transplantation can prolong the recurrence-free survival in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory study. The patients scheduled for living donor liver transplantation receive DEB-TACE 2 weeks prior to the surgery. The primary outcome: Recurrence-free survival (RFS) The secondary outcome:1) Overall survival (OS)；2) Pathological response rate (Pathological Response); 3) Proportion of patients completing living donor liver transplantation; 4) Adverse events related to DEB-TACE.
CONDITIONS
Official Title
DEB-TACE Prior to Liver Transplantation in the Treatment of HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with viral hepatitis or cirrhosis according to AASLD standards using imaging and clinical history
- Child-Pugh liver function score of grade A or B
- Tumor located in the right lobe of the liver
- Liver cancer meeting the "up to seven" criteria: tumor size plus number not exceeding 7
- ECOG performance status score of 0 or 1
- Scheduled for living donor liver transplantation as the first treatment
- Signed informed consent form
You will not qualify if you...
- Presence of cancer thrombi in the main portal vein, vena cava, or main bile duct
- Severe hepatic encephalopathy
- Moderate to high risk pulmonary arterial hypertension (WHO Grade III-IV)
- Severe allergy to contrast agents
- Irreversible shunt between hepatic artery and hepatic vein
- Special anatomical variations of portal vein (Asan type III)
- Presence of tumors outside the liver (extrahepatic metastases)
- Active hepatitis or severe infection at the time of study
- Tumor spread or distant metastasis with expected survival less than 3 months
- Kidney dysfunction with creatinine over 176.8 umol/L or low creatinine clearance below 30 ml/min
- Low white blood cell count below 3.0x10^9/L or platelet count below 50x10^6/L that cannot be corrected
- Unable to tolerate anesthesia due to severe infection, heart/lung problems, or stroke
- Severe psychiatric illness
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
K
Kang He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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