1. Camrelizumab plus apatinib for previously treated advanced adrenocortical carcinoma: a single-arm phase 2 trial
- Author
-
Yu-Chun Zhu, Zhi-Gong Wei, Jing-Jing Wang, Yi-Yan Pei, Jing Jin, Dong Li, Zhi-Hui Li, Zhe-Ran Liu, Yu Min, Rui-Dan Li, Li Yang, Ji-Yan Liu, Qiang Wei, and Xing-Chen Peng
- Subjects
Science - Abstract
Abstract Adrenocortical carcinoma (ACC) is a rare, aggressive malignancy with a poor prognosis. Therapeutic options for patients with advanced ACC who have failed standard treatments are limited. Single-agent immunotherapy as a second-line treatment has shown unsatisfactory clinical outcomes. This phase II trial (NCT04318730) evaluated the efficacy and safety of the PD-1 inhibitor camrelizumab combined with the VEGFR inhibitor apatinib in previously treated advanced ACC. The primary endpoint was objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. A total of 21 patients with advanced ACC received at least one dose of camrelizumab and apatinib. The ORR was 52% (95% CI, 30−74%), meeting the primary endpoint, and the disease control rate (DCR) was 95% (95% CI, 76−100%). The median PFS was 13.3 months (95% CI, 8.4−NE), and the median OS was 20.9 months (95% CI, 11.0−NE). The most common grade 3−4 treatment-related adverse events were alanine aminotransferase elevation, aspartate aminotransferase elevation, and lymphopenia. Predefined exploratory analyses indicated that patients with higher peripheral blood CXCR3 + CD8 + T cell abundance, lower immunosuppressive CD4 + T cell abundance, and higher overlap of clonotypes between tumor-infiltrating T cells and circulating T cells, were more likely to respond favorably to the combined therapy.
- Published
- 2024
- Full Text
- View/download PDF