TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT

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).

Eligibility

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 malignancies.

Conditions6

Interventions1

Related trials

• Atezolizumab Plus Bevacizumab Alone or Combined with External Beam Radiotherapy for HCC with Macrovascular Invasion — Asan Medical Center
• SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis — Chinese University of Hong Kong

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