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Trial Title:
DEB-TACE Prior to Liver Transplantation in the Treatment of HCC
NCT ID:
NCT06353126
Condition:
Liver Cancer
Conditions: Official terms:
Liver Neoplasms
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
DEB-TACE
Description:
DEB-TACE, or Drug-Eluting Bead Transarterial Chemoembolization, is a minimally invasive
interventional radiology procedure primarily used in the treatment of hepatocellular
carcinoma (HCC), which is the most common type of liver cancer. This procedure combines
two treatment modalities: transarterial chemoembolization (TACE) and the use of
drug-eluting beads (DEB).
During DEB-TACE, tiny beads loaded with chemotherapy drugs are injected directly into the
blood vessels supplying the tumor in the liver. These drug-eluting beads gradually
release chemotherapy agents, delivering a targeted and sustained dose directly to the
cancerous tissue while minimizing systemic side effects. Additionally, the beads
themselves act as embolic agents, blocking the blood flow to the tumor and causing
ischemia, which further contributes to the destruction of the tumor cells.
Arm group label:
DEB-TACE prior to living donor liver transplantation
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years;
2. Subjects with viral hepatitis or cirrhosis are clinically diagnosed according to
AASLD standards, which require a history of viral hepatitis or cirrhosis combined
with imaging examinations (enhanced CT, MRI, second-generation ultrasound contrast
agents). When the tumor diameter is greater than 2 cm, a diagnosis can be made if
one imaging technique shows typical arterial phase rapid enhancement and rapid
washout. If the diameter is 1-2 cm, two imaging techniques must confirm this, or one
imaging technique confirms it and alpha-fetoprotein (AFP) is greater than 400 ng/ml.
For subjects who cannot be clinically diagnosed, histological or cytological biopsy
confirmation is required; original biopsy records can also be used for diagnosis.
3. Child-Pugh score A-B grade;
4. Tumor present in the right lobe of the liver;
5. Liver cancer assessment meeting the "up to seven" criteria: the sum of tumor size
and number does not exceed 7;
6. ECOG-PS score 0-1;
7. Scheduled for living donor liver transplantation as the primary treatment;
8. Signed informed consent form.
Exclusion Criteria:
1. Presence of definite cancer thrombi in the main portal vein, vena cava, or main bile
duct;
2. Severe hepatic encephalopathy;
3. Coexisting pulmonary arterial hypertension (moderate to high risk, WHO Grade
III-IV);
4. Severe contrast agent allergy;
5. Irreversible hepatic artery to hepatic vein shunt;
6. Special types of anatomical variations (Asan portal vein type III);
7. Extrahepatic metastatic tumors;
8. Concurrent active hepatitis or severe infection;
9. Tumor dissemination or distant metastasis, expected survival <3 months;
10. Renal dysfunction, creatinine >176.8 umol/L or creatinine clearance rate <30ml/min;
11. White blood cell count <3.0x109/L, platelet count <50x106/L, and unable to correct;
12. Inability to tolerate surgical anesthesia (severe infection, cardiopulmonary
insufficiency, cerebrovascular disease);
13. Severe psychiatric illness;
14. Other reasons deemed unsuitable for participation by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Kang Associate chief physician
Start date:
October 16, 2024
Completion date:
July 1, 2027
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
Boston Scientific Corporation
Agency class:
Industry
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06353126
