Status:
UNKNOWN
TACE Combined With Iodine-125 Seeds Implantation for HCC
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsors:
ZhuHai Hospital
The First People's Hospital of Zhaoqing
Conditions:
Hepatocellular Carcinoma
Portal Vein Occlusion
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Portal vein tumour thrombus (PVTT) is a common complication of hepatocellular carcinoma (HCC). PVTT has a profound adverse effect on prognosis, with a very short median survival time (2-4 months). The...
Detailed Description
Background and purpose: Hepatocellular carcinoma (HCC) is the 5th most common cancer in the world and the 3rd most prevalent cause of tumor-related deaths. Portal vein tumor thrombus (PVTT) occurs in...
Eligibility Criteria
Inclusion
- clinical diagnosis of HCC;
- age between18 and 75 years;
- type I PVTT, type II PVTT, or type III PVTT within 1.5cm extending in the main portal vein (if obstructive PVTT involve both the left and right portal vein or main portal vein, multiple collateral vessels are required);
- Child-Pugh class A or B;
- Eastern Cooperative Group performance status (ECOG) score of 0-2;
- neutrophilic granulocyte count ≥ 1.5×10\^9/L, platelet count ≥ 30×10\^9/L, and hemoglobin level ≥ 85g/L;
- serum bilirubin ≤ 51.3 μmol/L, albumin ≥ 28g/L, ALT and AST ≤ 5 times of the upper normal limit, and creatinine ≤ 20g/L;
- prothrombin time ≤18s or international normalized ratio \< 1.7.
Exclusion
- diffuse HCC;
- extrahepatic metastasis;
- obstructive PVTT involving both the left and right portal vein or main portal vein without collateral vessels,
- type III PVTT affecting the main portal vein more than 1.5cm, or type IV PVTT;
- previously surgery (resection or liver transplantation), local-regional therapies (e.g., radiofrequency ablation), intra-arterial chemoinfusion, TACE, radiotherapy, systemic chemotherapy, or molecular targeted drug therapy for HCC;
- serious medical comorbidities.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT03322280
Start Date
July 1 2018
End Date
June 30 2022
Last Update
March 3 2022
Active Locations (1)
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1
The 2nd Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260