HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC
Hepatic Arterial Infusion Chemotherapy in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Hepatocellular Carcinoma After the Failure of Systemic Therapy Recommended by BCLC
First Hospital of China Medical University
84 participants
Sep 16, 2024
OBSERVATIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.
Eligibility
Inclusion Criteria8
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
- Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;
- Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
- HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;
- Received at least 2 cycles of HAIC；
- Has repeated measurable intrahepatic lesions;
- Child-Pugh class A or B.
Exclusion Criteria3
- The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
- With other malignant tumors;
- Unable to meet criteria of combination timeframe described above.
Interventions
Hepatic arterial infusion chemotherapy including FOLFOX and RALOX
PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06632093