Frontiers in immunology · 2025
Stereotactic body radiation therapy combined with cadonilimab and lenvatinib in the treatment of hepatocellular carcinoma with Vp3 or Vp4 portal vein tumor thrombus: a prospective, multicenter, single-arm, phase II clinical trial.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Mo Ning, Hu Kai, Zeng Zhiming, Yang Lihua, Fang Yeying, Zeng Jie, Li Ye, Yang Zhendong, Tang Jing, Zhang Tingting, Ma Fuchao, Liu Cuizhen, Zheng Haiping, Qiu Jinfeng, Jiang Yanfeng, Lv Yufeng, Liang Li, Huang Xiaofang, Liao Xiwen, Wang Yan, Lu Xiuyuan, Ning Lijun, Lao Guo Shixue, Ma Jie, Wang Rensheng
Аннотация
BACKGROUND: Hepatocellular carcinoma (HCC) patients with portal vein tumor thrombus (PVTT) exhibit a dismal prognosis, occurring in 44%-62.2% of cases at initial diagnosis. The optimal treatment for this population remains undefined.
METHODS: In this prospective, multicenter, single-arm phase II trial across three Chinese centers, eligible HCC patients with Vp3/4 PVTT received combined stereotactic body radiotherapy (SBRT), cadonilimab, and lenvatinib. Primary endpoint was objective response rate (ORR) in primary liver lesions (RECIST v1.1/mRECIST); secondary endpoints included ORR in PVTT, progression-free survival (PFS), overall survival (OS), duration of response (DOR), and safety.
RESULTS: Of 24 enrolled patients, 21 were evaluable for efficacy. ORR for primary lesions was 38.1% (RECIST v1.1) and 47.6% (mRECIST), with a disease control rate (DCR) of 100% by both criteria. For PVTT, ORR and DCR were 76.2% and 100%, respectively. At a median follow-up of 19.7 months, median PFS was 6.8 months (95% CI: 4.6-12.9), DOR was 10.4 months (95% CI: 2.9-NE), and OS was 13.4 months (95% CI: 6.8-NE). Early biomarker declines (≥75% AFP reduction or ≥50% PIVKA-II decline at 6 weeks) correlated with superior outcomes: AFP reduction predicted longer PFS (HR=0.22, p=0.006) and OS (HR=0.25, p=0.024); PIVKA-II reduction similarly predicted PFS (HR=0.28, p=0.007) and OS (HR=0.18, p=0.002). Common treatment-related adverse events (TRAEs) included hypertension (50%), thrombocytopenia (42%), and fatigue (38%).
CONCLUSIONS: The combination of SBRT, cadonilimab, and lenvatinib showed promising efficacy and manageable toxicity in HCC patients with Vp3/4 PVTT. Early AFP or PIVKA-II response at 6 weeks may serve as a prognostic biomarker.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT06040177.
METHODS: In this prospective, multicenter, single-arm phase II trial across three Chinese centers, eligible HCC patients with Vp3/4 PVTT received combined stereotactic body radiotherapy (SBRT), cadonilimab, and lenvatinib. Primary endpoint was objective response rate (ORR) in primary liver lesions (RECIST v1.1/mRECIST); secondary endpoints included ORR in PVTT, progression-free survival (PFS), overall survival (OS), duration of response (DOR), and safety.
RESULTS: Of 24 enrolled patients, 21 were evaluable for efficacy. ORR for primary lesions was 38.1% (RECIST v1.1) and 47.6% (mRECIST), with a disease control rate (DCR) of 100% by both criteria. For PVTT, ORR and DCR were 76.2% and 100%, respectively. At a median follow-up of 19.7 months, median PFS was 6.8 months (95% CI: 4.6-12.9), DOR was 10.4 months (95% CI: 2.9-NE), and OS was 13.4 months (95% CI: 6.8-NE). Early biomarker declines (≥75% AFP reduction or ≥50% PIVKA-II decline at 6 weeks) correlated with superior outcomes: AFP reduction predicted longer PFS (HR=0.22, p=0.006) and OS (HR=0.25, p=0.024); PIVKA-II reduction similarly predicted PFS (HR=0.28, p=0.007) and OS (HR=0.18, p=0.002). Common treatment-related adverse events (TRAEs) included hypertension (50%), thrombocytopenia (42%), and fatigue (38%).
CONCLUSIONS: The combination of SBRT, cadonilimab, and lenvatinib showed promising efficacy and manageable toxicity in HCC patients with Vp3/4 PVTT. Early AFP or PIVKA-II response at 6 weeks may serve as a prognostic biomarker.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT06040177.