๐ฌIn plain words
What the trial is, and whether it could suit you
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)๏ผ2) Pathological response rate (Pathological Response); 3) Proportion of patients completing living donor liver transplantation; 4) Adverse events related to DEB-TACE.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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.
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