RecruitingNCT06607120

Prognosis Stratification for Advanced HCC Receiving TACE with PD-1/PD-L1 Inhibitors and Molecular Target Therapies

Personalized Model of Prognosis Stratification for Patients with Advanced HCC Receiving TACE Combined with PD-1/PD-L1 Inhibitors Plus Molecular Target Therapies


Sponsor

Zhongda Hospital

Enrollment

950 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies.


Eligibility

Min Age: 18 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 extrahepatic spread and/or 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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NCT06607120


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