Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06313190

Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma (HSBRT2402)

Led by Sun Yat-sen University · Updated on 2024-11-18

140

Participants Needed

1

Research Sites

316 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

F

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborating Sponsor

AI-Summary

What this Trial Is About

For inoperable small hepatocellular carcinoma (HCC), stereotactic body radiotherapy (SBRT) is an effective and safe local treatment. Despite satisfactory local control rate, the incidence of recurrence out the field remains substantial, with 2-year PFS of 31.9% to 60.9%. Therefore, a more effective treatment mode is urgently needed. Immune checkpoint inhibitors targeting PD-1/PD-L1 have shown substantial clinical benefits in advanced HCC as well as resected high-risk HCC. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC, but its utility in small HCC is unclear. The aim of this study was to investigate the efficacy and safety of SBRT followed by sintilimab (an anti-PD-1 antibody) in patients with recurrent or residual small HCC.

CONDITIONS

Official Title

Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma (HSBRT2402)

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
  • Presence of recurrent or residual HCC lesions without vascular invasion or extrahepatic metastasis confirmed by CT or MRI
  • Sum of maximum tumor diameter 5 cm or less, with no more than 2 lesions, at least one measurable by RECIST 1.1
  • Previous molecular targeted therapy or intravenous chemotherapy allowed if stopped at least 6 months before study treatment
  • Age between 18 and 75 years at diagnosis
  • Eastern Cooperative Oncology Group performance status 2 or less
  • Child-Pugh class A liver function
  • Normal liver volume greater than 700 ml
  • Estimated life expectancy of at least 24 weeks
  • Adequate organ function including WBC ≥ 3.0 x10⁹/L, ANC ≥ 1.5 x10⁹/L, platelets ≥ 50 x10⁹/L, hemoglobin ≥ 9 g/dL, serum albumin ≥ 2.8 g/dL, total bilirubin ≤ 1.5 times upper limit of normal, ALT, AST and/or AKP ≤ 2.5 times upper limit of normal, serum creatinine ≤ 1.5 times upper limit of normal or creatinine clearance > 60 mL/min
  • Ability to understand the study and provide informed consent
Not Eligible

You will not qualify if you...

  • Previous treatment with immune checkpoint inhibitors
  • Presence of extrahepatic metastasis
  • History of abdominal radiotherapy
  • Known or suspected allergy to monoclonal antibodies
  • Preexisting or coexisting bleeding disorders
  • Pregnant or breastfeeding females
  • Inability to provide informed consent due to psychological, social, or other factors
  • History of malignancies other than hepatocellular carcinoma before enrollment, except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer
  • History of diabetes for more than 10 years with poorly controlled blood sugar
  • Inability to tolerate radiotherapy due to severe heart, lung, liver, kidney dysfunction, hematopoietic disease, or cachexia
  • Active or history of autoimmune diseases or immunodeficiency, including positive HIV test or history of organ/bone marrow transplant
  • History of interstitial lung disease or non-infectious pneumonia
  • History of active pulmonary tuberculosis within 1 year or untreated tuberculosis
  • Active hepatitis B or C infection as defined by viral load criteria
  • Any unstable condition that threatens 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

Sun Yat-sen University Cancer Center

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

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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