Clinical trial NCT06353126: DEB-TACE Prior to Liver Transplantation in the Treatment of HCC
Official title: A Prospective, Single Arm, Exploratory Study of Using Drug-eluting Beads Transarterial Chemoembolization Prior to Liver Transplantation in the Treatment of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Liver Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2024-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Recurrence-free survival (RFS)
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
measure: Pathological response rate (Pathological Response)
timeFrame: 1 year
measure: Proportion of patients completing living donor liver transplantation
timeFrame: at the time of the surgery
measure: Adverse events related to DEB-TACE
timeFrame: from DEB-TACE to the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Jianjun Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: