Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06261125

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

Led by Mian XI · Updated on 2024-03-12

60

Participants Needed

1

Research Sites

224 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed hepatocellular carcinoma or diagnosis by American Association for the Study of Liver Disease criteria
  • Abdominal metastatic lymph nodes confirmed by CT or MRI, total diameter ≤10 cm, with at least one measurable by RECIST 1.1
  • Previous local treatment for liver lesions and systemic anti-tumor therapy allowed regardless of progression
  • Less than 3 active intrahepatic lesions with total diameter <10 cm; portal vein invasion allowed; no other extrahepatic metastases except abdominal LNM
  • Cohort 1: no prior PD-1/PD-L1 antibody therapy; Cohort 2: tumor progression after prior PD-1/PD-L1 antibody therapy
  • Age 18 to 75 years at diagnosis
  • Eastern Cooperative Oncology Group performance status ≤ 2
  • Child-Pugh class A liver function
  • Normal liver volume greater than 700 ml
  • Estimated life expectancy ≥ 12 weeks
  • Adequate organ function including WBC ≥ 3.0×10⁹/L, ANC ≥ 1.5×10⁹/L, platelets ≥ 50×10⁹/L, hemoglobin ≥ 9 g/dL, serum albumin ≥ 2.8 g/dL, total bilirubin ≤ 1.5×ULN, ALT, AST, and/or AKP ≤ 2.5×ULN, serum creatinine ≤ 1.5×ULN or creatinine clearance > 60 mL/min
  • Ability to understand the study and provide informed consent
Not Eligible

You will not qualify if you...

  • Diffuse hepatocellular carcinoma
  • Prior treatment with lenvatinib or PD-1/PD-L1 antibody if not tolerated
  • Extrahepatic metastases other than abdominal LNM
  • History of abdominal radiotherapy
  • Known or suspected allergy or hypersensitivity to monoclonal antibodies
  • Preexisting or coexisting bleeding disorders
  • Pregnant or lactating female patients
  • Inability to provide informed consent due to psychological, familial, social, or other factors
  • History of malignancies other than hepatocellular carcinoma except certain skin, cervical, or prostate cancers
  • Diabetes exceeding 10 years with poor blood glucose control
  • Inability to tolerate radiotherapy due to severe organ dysfunction, hematopoietic disease, or cachexia
  • Active or history of autoimmune diseases, immunodeficiency, or organ/bone marrow transplantation
  • History of interstitial lung disease or non-infectious pneumonia
  • Active pulmonary tuberculosis within 1 year or untreated past infection
  • Active hepatitis B or hepatitis C infection as defined by specific viral load thresholds
  • Any unstable condition risking patient safety or study compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mian Xi

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

M

Mian Xi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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