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Study identifier: NCT07062055 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and/or Oligometastases

Condition: Hepatocellular Carcinoma · Portal Vein Tumor Thrombus · Oligometastases  ·  Sponsor: Shandong Cancer Hospital and Institute

PhasePhase 2
Planned participants54
Who can joinAll sexes, 18 Years to 70 Years
Healthy volunteersNo

About this study

This single-center, prospective, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of combining hepatic artery infusion chemotherapy (HAIC, for up to 4 cycles) with iparomlimab/tuvonralimab plus bevacizumab followed by stereotactic body radiotherapy (SBRT) in patients with Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma (HCC) who present with portal vein tumor thrombus (PVTT) or extrahepatic oligometastatic disease. The study aims to determine whether this combination strategy can prolong progression-free survival (PFS), while also improving overall survival (OS), objective response rate (ORR), disease control rate (DCR), and local control rate (LCR), as well as maintaining quality of life (QoL). In addition, the trial will systematically evaluate the safety profile and treatment-related toxicities associated with this regimen.

This description comes directly from the study's public registry record.

Talk to the study team

Jinbo Yue, doctor  ·  0531-67626442  ·  jbyue@sdfmu.edu.cn

Always discuss trial participation with your own doctor first.

Locations (1)

Shandong Cancer Hospital and InstituteJinan, Shandong, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07062055