DEB-TACE Prior to Liver Transplantation in the Treatment of HCC
Recruiting now · Phase 4
Conditions studied: Liver Cancer
In brief
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.
Key facts
- Study ID
- NCT06353126
- Run by
- RenJi Hospital
- People needed
- 40
- Starts
- 2024-10-16
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2024-10-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-75 years;
- 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.
- Child-Pugh score A-B grade;
- Tumor present in the right lobe of the liver;
- Liver cancer assessment meeting the "up to seven" criteria: the sum of tumor size and number does not exceed 7;
- ECOG-PS score 0-1;
- Scheduled for living donor liver transplantation as the primary treatment;
- Signed informed consent form.
You may not qualify if…
- Presence of definite cancer thrombi in the main portal vein, vena cava, or main bile duct;
- Severe hepatic encephalopathy;
- Coexisting pulmonary arterial hypertension (moderate to high risk, WHO Grade III-IV);
- Severe contrast agent allergy;
- Irreversible hepatic artery to hepatic vein shunt;
- Special types of anatomical variations (Asan portal vein type III);
- Extrahepatic metastatic tumors;
- Concurrent active hepatitis or severe infection;
- Tumor dissemination or distant metastasis, expected survival <3 months;
- Renal dysfunction, creatinine >176.8 umol/L or creatinine clearance rate <30ml/min;
- White blood cell count <3.0x109/L, platelet count <50x106/L, and unable to correct;
- Inability to tolerate surgical anesthesia (severe infection, cardiopulmonary insufficiency, cerebrovascular disease);
- Severe psychiatric illness;
- Other reasons deemed unsuitable for participation by the investigator.
Where it is running
- Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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