RecruitingPhase 2NCT06261125

Combination of SBRT, PD-L1 Inhibitor, and Lenvatinib in Hepatocellular Carcinoma (HSBRT2401)

Efficacy and Safety of Stereotactic Body Radiotherapy Followed by Adebrelimab and Lenvatinib for Hepatocellular Carcinoma With Abdominal Lymph Node Metastases: A Two-arm, Phase II Trial

Sponsor

Mian XI

Enrollment

60 participants

Start Date

Mar 10, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — stereotactic body radiation therapy (SBRT), a PD-L1 immune checkpoint inhibitor, and lenvatinib (a targeted drug) — for people with hepatocellular carcinoma (liver cancer) that has spread to nearby lymph nodes in the abdomen. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed liver cancer (HCC) with measurable lymph node spread in the abdomen - You have fewer than 3 active tumors in the liver with a total size under 10 cm - Your liver function is good (Child-Pugh class A) - Your blood counts, kidney, and liver labs meet minimum requirements - You are in good general health (ECOG score 0–2) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Your liver cancer is diffuse (spread throughout the liver without distinct masses) - You had cancer spread outside the liver and abdomen (except those lymph nodes) - You previously received lenvatinib or immunotherapy but could not tolerate it - You had prior radiation to the abdomen - You are pregnant or breastfeeding - You have a bleeding disorder or known allergy to monoclonal antibodies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic body radiotherapy

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.

DRUGAdebrelimab

All patients will reveive adebrelimab 1200 mg every 3 weeks for up to 35 cycles after the completion of SBRT.

DRUGLenvatinib

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.