Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without HAIC for Advanced HCC
Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without Hepatic Arterial Infusion Chemotherapy As First-line Treatment for Advanced Hepatocellular Carcinoma
Zhongda Hospital
900 participants
Jun 1, 2018
OBSERVATIONAL
Conditions
Summary
Tyrosine kinase inhibitors (TKIs) plus programmed death-1 (PD-1) inhibitors are recommended for patients with advanced hepatocellular carcinoma (HCC) in China. However, these treatments have limited survival benefit in patients with advanced HCC. We aimed to investigate whether hepatic arterial infusion chemotherapy (HAIC) in combination with TKIs and PD-1 inhibitors could improve the efficacy.
Eligibility
Inclusion Criteria7
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) stage B/C;
- 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;
- HAIC 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 HAIC 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)
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NCT06881433