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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06353126
Other study ID # DTACESALT
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2024
Est. completion date July 1, 2027

Study information

Verified date May 2024
Source RenJi Hospital
Contact Kang He
Phone 13621621415
Email hekang@renji.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to SALT (Sequential Adult Left Lateral 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 SALT 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 SALT; 4) Adverse events related to DEB-TACE.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date July 1, 2027
Est. primary completion date July 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Age 18-75 years; 2. Child-Pugh score A-B grade; 3. Tumor present in the right lobe of the liver; 4. Liver cancer assessment meeting the "up to seven" criteria: the sum of tumor size and number does not exceed 7; 5. ECOG-PS score 0-1; 6. Scheduled for SALT as the primary treatment; 7. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
DEB-TACE
DEB-TACE, or Drug-Eluting Bead Transarterial Chemoembolization, is a minimally invasive interventional radiology procedure primarily used in the treatment of hepatocellular carcinoma (HCC), which is the most common type of liver cancer. This procedure combines two treatment modalities: transarterial chemoembolization (TACE) and the use of drug-eluting beads (DEB). During DEB-TACE, tiny beads loaded with chemotherapy drugs are injected directly into the blood vessels supplying the tumor in the liver. These drug-eluting beads gradually release chemotherapy agents, delivering a targeted and sustained dose directly to the cancerous tissue while minimizing systemic side effects. Additionally, the beads themselves act as embolic agents, blocking the blood flow to the tumor and causing ischemia, which further contributes to the destruction of the tumor cells.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence-free survival (RFS) the time from DEB-TACE treatment until tumor recurrence in the original site, transplanted liver, other tissues and organs, or death, whichever occurs first. 2 years
Secondary Overall survival (OS) the time from DEB-TACE treatment until death from any cause. 5 years
Secondary Pathological response rate (Pathological Response) at the time of the first stage of surgery 1 year
Secondary Proportion of patients completing SALT 1 year at the time of the second stage of surgery
Secondary Adverse events related to DEB-TACE 1 year from DEB-TACE to the first stage of the surgery
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