TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT (NCT05984511) | Clinical Trial Compass
RecruitingNot Applicable
TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT
China234 participantsStarted 2023-08-30
Plain-language 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) in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). The investigators confirmed that the combination therapy yielded better survival data than the combined administration of Atezolizumab/Bevacizumab and TACE (TACE-AB) in patients with advanced HCC and Type I/II PVTT (Based on Cheng's PVTT classification).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 malignan…
What they're measuring
1
Overall survival (OS)
Timeframe: 2 years
Trial details
NCT IDNCT05984511
SponsorThird Affiliated Hospital, Sun Yat-Sen University