NCT06353126RecruitingPhase 4
DEB-TACE Prior to Liver Transplantation in the Treatment of HCC
A Prospective, Single Arm, Exploratory Study of Using Drug-eluting Beads Transarterial Chemoembolization Prior to Liver Transplantation in the Treatment of Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 18 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 28 Mar 2024
- Start date
- 16 Oct 2024
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- RenJi Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06353126
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 16 Oct 2024 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent active hepatitis or severe infection;
Other illness
- Presence of definite cancer thrombi in the main portal vein, vena cava, or main bile duct;
- Coexisting pulmonary arterial hypertension (moderate to high risk, WHO Grade III-IV);
- Severe contrast agent allergy;
- Inability to tolerate surgical anesthesia (severe infection, cardiopulmonary insufficiency, cerebrovascular disease);
- Severe psychiatric illness;
Lab values
- 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;
Other
- Severe hepatic encephalopathy;
- Irreversible hepatic artery to hepatic vein shunt;
- Special types of anatomical variations (Asan portal vein type III);
- Extrahepatic metastatic tumors;
- Tumor dissemination or distant metastasis, expected survival \<3 months;
- Other reasons deemed unsuitable for participation by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renji Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.