Using DEB-TACE before liver transplantation for liver cancer treatment

A Prospective, Single Arm, Exploratory Study of Using Drug-eluting Beads Transarterial Chemoembolization Prior to Liver Transplantation in the Treatment of Hepatocellular Carcinoma

This study is testing if giving a special cancer treatment called DEB-TACE two weeks before a liver transplant can help people with liver cancer live longer without their cancer coming back.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06353126 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of Drug-Eluting Bead Transarterial Chemoembolization (DEB-TACE) administered two weeks prior to living donor liver transplantation in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory phase 4 study aimed at prolonging recurrence-free survival (RFS) among participants. The study will evaluate primary outcomes such as RFS and secondary outcomes including overall survival, pathological response rate, and the proportion of patients successfully completing transplantation. Adverse events related to DEB-TACE will also be monitored.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with hepatocellular carcinoma meeting specific diagnostic and clinical criteria.

Not a fit: Patients with advanced liver cancer beyond the specified criteria or those with poor performance status may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the chances of long-term survival without cancer recurrence for liver cancer patients undergoing transplantation.

How similar studies have performed: While this approach is exploratory, similar studies using DEB-TACE have shown promise in improving outcomes for liver cancer patients, suggesting potential for success.

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.

Where this trial is running

Shanghai

• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Jianjun Zhang, MD — RenJi Hospital
• Study coordinator: Kang He

Conditions Liver Cancer