HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC
Recruiting now
Conditions studied: BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, Hepatic Arterial Infusion Chemotherapy, Lenvatinib, PD-1, Systemic Therapy
In brief
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.
Key facts
- Study ID
- NCT06632093
- Run by
- First Hospital of China Medical University
- People needed
- 84
- Starts
- 2024-09-16
- Expected to finish
- 2025-12-30
- Last updated by the study team
- 2024-10-08
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The first hospital of China medical university — Shenyang, Liaoning, China (enrolling)
Full record on ClinicalTrials.gov
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