TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT: A Phase III, Randomized Clinical Trial

Status: Recruiting

Location: See location...

Intervention Type: Procedure, Drug

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 75

Healthy Volunteers: f

View:

• 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.

Locations

Other Locations

China

The Third Affiliated Hospital of Sun Yat-Sen University

RECRUITING

Guangzhou

Contact Information

Primary

Mingsheng Huang, M.D. & Ph.D.

huangmsh@mail.sysu.edu.cn

+86-02085253416

Backup

Luwen Mu, M.D.

mulw@mail.sysu.edu.cn

+86-13660534361

Time Frame

Start Date: 2023-08-30

Estimated Completion Date: 2029-08-01

Participants

Target number of participants: 234

Treatments

Experimental: TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)

TACE will be performed for the patients after randomization. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 3-7 days after the first TACE.~Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy.~TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

Active_comparator: TACE and Atezolizumab/Bevacizumab (TACE-AB)

TACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE.~TACE can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

Related Therapeutic Areas

Liver Cancer

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TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT: A Phase III, Randomized Clinical Trial

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