NCT06353126 DEB-TACE Prior to Liver Transplantation in the Treatment of HCC
| NCT ID | NCT06353126 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | RenJi Hospital |
| Condition | Liver Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-10-16 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2024-10-16 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Jianjun Zhang, MD
PRINCIPAL INVESTIGATOR
RenJi Hospital
Frequently Asked Questions
Who can join the NCT06353126 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Liver Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06353126 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06353126 currently recruiting?
Yes, NCT06353126 is actively recruiting participants. Contact the research team at hekang@renji.com for enrollment information.
Where is the NCT06353126 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06353126 clinical trial?
NCT06353126 is sponsored by RenJi Hospital. The principal investigator is Jianjun Zhang, MD at RenJi Hospital. The trial plans to enroll 40 participants.
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