Lenalidomide to Reverse Drug Resistance After First-line Treatment of Advanced HCC
Status:
Not yet recruiting
Trial end date:
2025-10-05
Target enrollment:
Participant gender:
Summary
The ORR of the lenvatinib combination (lenvatinib combined with PD-1 inhibitor) was largely
similar to that of the "A+T" combination (bevacizumab and atelelizumab). The disease control
rate (DCR) for the combination of lenvatinib was 88%, demonstrating the efficacy of
lenvatinib in combination with immunotherapy. However, progression to second-line therapy
after first-line treatment for advanced HCC still faces many challenges.
In our clinical practice and review of the literature, we focused on lenalidomide showing
some efficacy in second-line treatment of advanced HCC. Lenalidomide is a new generation
derivative of thalidomide, which has dual anti-angiogenic and immunomodulatory anti-tumor
effects. Lenalidomide may have the potential to reverse drug resistance and increase the
efficacy of synergistic immune-targeted therapy. Based on the preliminary data of its
effectiveness in the second-line treatment of advanced HCC alone or in combination with TKI,
we propose to conduct a prospective, exploratory, single-arm, open, multicenter phase II
clinical study of advanced HCC PD-1 inhibitor in combination with lenvatinib after
progression of first-line treatment, to initially evaluate the efficacy and safety of this
regimen.