Combination treatment for advanced liver cancer with portal vein tumor invasion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a combination therapy involving Atezolizumab, Bevacizumab, transcatheter arterial chemoembolization (TACE), and I-125 Seeds Brachytherapy in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). It is a multicenter, open-label, randomized controlled trial that aims to compare the new treatment regimen (TACE-AB-I) against a standard treatment (TACE-AB). A total of 234 patients will be enrolled, and the study will assess survival outcomes and safety profiles of the two treatment approaches. Patients will receive TACE followed by the immunotherapy and brachytherapy as per the assigned group.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Third Affiliated Hospital of Sun Yat-Sen University
  Guangzhou, Guangzhou, China Recruiting

Study contacts

• Principal investigator: Mingsheng Huang, M.D. & Ph.D. — Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University
• Study coordinator: Mingsheng Huang, M.D. & Ph.D.
• Email: huangmsh@mail.sysu.edu.cn
• Phone: +86-02085253416

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.