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

Launched by THIRD AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Aug 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced liver cancer, specifically those with a condition called portal vein tumor thrombosis (where the cancer has spread to the veins near the liver). The trial is testing a combination of three treatments: Atezolizumab and Bevacizumab (which help the body’s immune system fight cancer), transcatheter arterial chemoembolization (TACE, a procedure that delivers chemotherapy directly to the tumor), and I-125 seeds brachytherapy (a method that uses radiation to target the tumor). Researchers want to see if this combination leads to better survival rates compared to using Atezolizumab and Bevacizumab alongside TACE alone.

To participate in this trial, individuals should be between 18 and 75 years old and have a confirmed diagnosis of liver cancer with specific types of portal vein tumor thrombosis. They should have a good level of overall health and no prior systemic treatment for liver cancer. Participants can expect close monitoring throughout the trial and will receive the combination treatment. It's important to note that some individuals, such as those with certain other health conditions or types of liver cancer, may not be eligible to join.

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Eligibility criteria

• 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.