Status:
RECRUITING
TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsors:
Sun Yat-sen University Cancer Center (SUSUCC)
Fifth Affiliated Hospital, Sun Yat-Sen University
Conditions:
Hepatocellular Carcinoma
Hepatic Portal Vein Tumor Invasion
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The present study aimed to assess the effectiveness of the combination treatment of Atezolizumab/Bevacizumab, transcatheter arterial chemoembolization (TACE) and I-125 Seeds Brachytherapy (TACE-AB-I) ...
Detailed Description
This is a multicenter, open-label trial, randomized controlled to evaluate the efficacy and safety of TACE-AB-I compared with TACE-AB for the treatment of HCC with branch PVTT. 234 HCC patients with b...
Eligibility Criteria
Inclusion
- Age between18 and 75 years;
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Type I PVTT or type II PVTT;
- Child-Pugh class A;
- Eastern Cooperative Group performance status (ECOG) score of 0-1;
- No prior systemic therapy for HCC.
- Adequate hematologic and end-organ function;
- At least one measurable intrahepatic target lesion.
Exclusion
- Diffuse HCC;
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible;
- Evidence of extrahepatic spread (EHS);
- Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators;
- Evidence or history of bleeding diathesis or any hemorrhage or bleeding event \>CTCAE grade 3 within 4 weeks prior to randomization;
- Active or history of autoimmune disease or immune deficiency;
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding;
- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment;
- Evidence of bleeding diathesis or significant coagulopathy;
- Pregnant or breastfeeding females;
- Significant cardiovascular disease;
- Severe infection, such as active tuberculosis;
- Serious medical comorbidities;
- History of organ or cells transplantation;
- History of other uncurable malignancies.
Key Trial Info
Start Date :
August 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT05984511
Start Date
August 30 2023
End Date
August 1 2029
Last Update
February 11 2025
Active Locations (1)
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1
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangzhou, China, 510630