RecruitingNCT06881446

Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without TACE for Advanced HCC with Vascular Invasions

Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without Transarterial Chemoembolization As First-line Treatment for Advanced Hepatocellular Carcinoma with Vascular Invasions


Sponsor

Zhongda Hospital

Enrollment

1,200 participants

Start Date

Jun 1, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

Immune checkpoint inhibitors and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors with or without transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma with vascular invasions


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
  • Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of macrovascular invasion;
  • Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
  • Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
  • TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
  • Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment;
  • Has repeated measurable intrahepatic lesions;

Exclusion Criteria3

  • Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
  • Unable to meet criteria of combination timeframe described above;
  • Child-Pugh C or PS\>2 or Severe hepatic encephalopathy

Locations(1)

Zhongda Hospital

Nanjing, Jiangsu, China

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NCT06881446


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