drugset / Trial / NCT04273100

PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of HCC

NCT04273100

NaSingle-groupOpen-labelTreatment

Summary

The vast majority of primary liver cancer (90%) is hepatocellular carcinoma (HCC), and the majority of HCC patients have been locally advanced or metastatic disease when they are diagnosed in clinics. Most of them are not suitable for radical treatment. In the case of supportive treatment, the median survival time was only 7.9 months. Therefore, there is an urgent need for effective treatment for these patients. At present, the overall objective response rate (ORR) of single or sequential therapy is not satisfied, and the over survival (OS) improvement is not ideal. Therefore, combined therapy maybe the good choice for patients with advanced HCC. This study focuses on the in-operable, middle and late stage (BCLC-B and BCLC-C) HCC patients. Through the combination of immunotherapy (PD-1 monoclonal antibody), local therapy (TACE) and anti-angiogenic therapy (lenvatinib), it is expected to change the tumor microenvironment, restore the immune response, strengthen the anti-tumor effect of various treatments, and improve the therapeutic efficacy in patients with middle and late stage HCC.

Timeline

Start
2019-11-14
Primary completion
2020-12-31
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Epirubicin Small molecule 40 mg Other
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Lobaplatin Small molecule 30 mg Other