Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06397222

Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-05-07

23

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).

CONDITIONS

Official Title

Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Unresectable hepatocellular carcinoma (HCC) at BCLC stage B or C or CNLC II/III, confirmed by biopsy or clinical diagnosis
  • At least one measurable untreated tumor lesion
  • Intrahepatic tumors suitable for 1-2 sessions of selective internal radiation therapy (SIRT)
  • Child-Pugh liver function score between 5 and 7
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Patients with active hepatitis B must be on antiviral treatment to maintain HBV DNA below 10^3 IU/mL
  • Patients with hepatitis C must have completed anti-HCV treatment
Not Eligible

You will not qualify if you...

  • Tumor occupying 70% or more of the liver
  • Tumor thrombus involving the main portal vein or both first left and right portal vein branches
  • Invasion of the vena cava
  • Metastasis to the central nervous system
  • Metastatic disease affecting major airways or blood vessels
  • Previous treatment with hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, or systemic therapy for HCC
  • History of organ or cell transplantation
  • Previous bleeding from esophageal or gastric varices
  • Severe liver dysfunction such as ascites, esophagogastric varices, or hepatic encephalopathy
  • Evidence of portal hypertension with high bleeding risk
  • Use of immunosuppressive drugs within 4 weeks before starting study treatment
  • Major surgery, unhealed wounds, ulcers, or fractures within 4 weeks before starting treatment
  • Life-threatening bleeding events in the past 3 months requiring transfusion or surgery
  • Low white blood cell count (<3 x 10^9/L) and platelet count (<50 x 10^9/L)
  • Prolonged prothrombin time over 4 seconds
  • Severe heart, lung, or kidney dysfunction
  • History of other cancers
  • Co-infection with both hepatitis B and C viruses
  • HIV infection
  • Pregnant or breastfeeding women

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

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510260

Actively Recruiting

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Research Team

M

Mingyue Cai, Dr.

CONTACT

K

Kangshun Zhu, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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