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<p>Transarterial chemoembolization (TACE) is the standard treatment for intermediate-stage hepatocellular carcinoma (HCC), yet its efficacy as a standalone therapy remains suboptimal. This phase 2 trial (ChiCTR2100049829) evaluated the feasibility and safety of TACE combined with atezolizumab and bevacizumab in patients with intermediate-stage HCC. Participants received TACE followed by atezolizumab and bevacizumab until disease progression, unacceptable toxicity, or death. The primary endpoint was objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), ORR by modified RECIST (mRECIST), disease control rate (DCR), time to response (TTR), duration of response (DOR), and adverse events (AEs). Between August 21, 2021 and April 10, 2023, 45 patients were enrolled. As of the data cutoff on September 30, 2024, the median follow-up was 26.7 months. The ORR was 47% per RECIST v1.1 and 67% per mRECIST. Median PFS was 17.9 months, and median OS was 33.0 months. The DCR was 87% (RECIST v1.1) and 91% (mRECIST). Median TTR was 11.9 weeks (RECIST v1.1) and 4.9 weeks (mRECIST), with median DOR of 36.6 weeks (RECIST v1.1) and 44.4 weeks (mRECIST). Of the 45 patients, 44 experienced AEs of any grade, with 20 reporting grade 3-4 AEs; no grade 5 AEs were observed. TACE combined with atezolizumab and bevacizumab appears safe and feasible for intermediate-stage HCC, supporting further investigation in larger studies.</p>

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Transarterial chemoembolization plus atezolizumab and bevacizumab in patients with intermediate hepatocellular carcinoma: a single-arm, phase 2 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月6日

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  • Kang Wang,
  • Jinkai Feng,
  • Hongming Yu,
  • Yuqiang Cheng,
  • Yanjun Xiang,
  • Zonghan Liu,
  • Yingyi Qin,
  • Enyu Liu,
  • Yunfeng Shan,
  • Chen Fan,
  • Jian Zhai,
  • Dandan He,
  • Hongkun Zhou,
  • Yufu Tang,
  • Jie Shi,
  • Weixing Guo,
  • Maolin Yan,
  • Luowen Yu,
  • Masatoshi Kudo,
  • Shuqun Cheng

摘要

Transarterial chemoembolization (TACE) is the standard treatment for intermediate-stage hepatocellular carcinoma (HCC), yet its efficacy as a standalone therapy remains suboptimal. This phase 2 trial (ChiCTR2100049829) evaluated the feasibility and safety of TACE combined with atezolizumab and bevacizumab in patients with intermediate-stage HCC. Participants received TACE followed by atezolizumab and bevacizumab until disease progression, unacceptable toxicity, or death. The primary endpoint was objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), ORR by modified RECIST (mRECIST), disease control rate (DCR), time to response (TTR), duration of response (DOR), and adverse events (AEs). Between August 21, 2021 and April 10, 2023, 45 patients were enrolled. As of the data cutoff on September 30, 2024, the median follow-up was 26.7 months. The ORR was 47% per RECIST v1.1 and 67% per mRECIST. Median PFS was 17.9 months, and median OS was 33.0 months. The DCR was 87% (RECIST v1.1) and 91% (mRECIST). Median TTR was 11.9 weeks (RECIST v1.1) and 4.9 weeks (mRECIST), with median DOR of 36.6 weeks (RECIST v1.1) and 44.4 weeks (mRECIST). Of the 45 patients, 44 experienced AEs of any grade, with 20 reporting grade 3-4 AEs; no grade 5 AEs were observed. TACE combined with atezolizumab and bevacizumab appears safe and feasible for intermediate-stage HCC, supporting further investigation in larger studies.