Abdominal lymph node metastasis (LNM) is one of the major modes of extrahepatic metastasis in hepatocellular carcinoma (HCC). Immunotherapy targeting the PD-1/PD-L1 checkpoints combined with targeted therapy is the standard treatment for HCC with abdominal LNM, but the outcome remains very poor, with an objective response rate of 5% to 30%. Previous studies have demonstrated that stereotactic body radiotherapy (SBRT) is an effective local treatment for HCC with abdominal LNM, with a high response rate of 60% to 80%. However, intrahepatic dissemination and distant metastasis remains the major recurrence pattern after SBRT in these patients, suggesting radiotherapy should be combined with systematic treatment. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC. The aim of this study was to investigate the efficacy and safety of SBRT followed by adebrelimab (an anti-PD-L1 antibody) and lenvatinib in HCC patients with portal abdominal LNM.
A total of 60 HCC patients (2 cohorts) with abdominal LNM will be enrolled to receive SBRT followed by adebrelimab (an anti-PD-L1 antibody) and lenvatinib. Arm A included the patients who previously had not received PD-1/PD-L1 antibody, and Arm B included the patients who had progressed after receiving PD-1/PD-L1 antibody. Patients in both cohorts will receive stereotactic body radiotherapy (SBRT) using volumetric arc therapy. The prescribed dose is 33-48 Gy in 6 fractions over 2 weeks. Then all patients will receive lenvatinib (12 mg/day for bodyweight ≥60 kg or 8 mg/day for bodyweight \<60 kg) orally once daily in combination with adebrelimab 1200 mg every 3 weeks for up to 35 cycles. The first course of adebrelimab will be given within 1 week after completion of SBRT.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients in both cohorts will receive stereotactic body radiotherapy (SBRT) using volumetric arc therapy. The prescribed dose is 33-48 Gy in 6 fractions over 2 weeks.
All patients will reveive adebrelimab 1200 mg every 3 weeks for up to 35 cycles after the completion of SBRT.
All patients will receive lenvatinib (12 mg/day for bodyweight ≥60 kg or 8 mg/day for bodyweight \<60 kg) orally once daily after the completion of SBRT.
Mian Xi
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival (PFS)
Three-year follow-up from the date of enrollment to the date of disease progression or last follow-up
Time frame: From date of enrollment until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 36 months.
Overall survival (OS)
Three-year follow-up from the enrollment to the date of death from any cause or date of lost follow-up
Time frame: From date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 36 months.
Overall response rate (ORR)
Tumor response was evaluated every 9 weeks after the completion of radiotherapy based on CT or MRI scan.
Time frame: From date of enrollment to the date of last follow-up, assessed up to 36 months.
Disease control rate (DCR)
The proportion of patients with complete response, partial response, or stable disease according to RECIST criteria.
Time frame: From date of enrollment to the date of last follow-up, assessed up to 36 months.
Duration of response (DOR)
From the date of first CR/PR to the date of first PD.
Time frame: From date of first CR/PR to the date of first PD according to RECIST criteria, assessed up to 36 months.
Treatment-related adverse events
Incidence of treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: From date of enrollment to the date of last follow-up, assessed up to 36 months.
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