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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
3. Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;
4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
5. HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;
6. Received at least 2 cycles of HAIC；
7. Has repeated measurable intrahepatic lesions;
8. Child-Pugh class A or B.
Exclusion Criteria:
1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
2. With other malignant tumors;
3. Unable to meet criteria of combination timeframe described above.
Primary outcome measure(s)
Overall survival — Up to approximately 2 years The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Trial sites (1)
Facility
City
Region
Status
The first hospital of China medical university
Shenyang
Liaoning
Recruiting
More First Hospital of China Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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