Advanced Cancer Clinical Trial
Official title:
Toripalimab Combined With Axitinib as Neoadjuvant Therapy for Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma
This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of toripalimab combined with axitinib as neoadjuvant therapy for advanced/metastatic non-clear cell renal cell carcinoma
Renal cell carcinoma (RCC) is a malignant tumor with a wide range of heterogeneity, including
heterogeneous histological types. In addition to the most common clear cell carcinoma subtype
(more than 80%), the remaining histological types are collectively referred to as non clear
cell carcinoma (non-ccRCC), including papillary renal cell carcinoma (10-15%), chromophobe
renal cell carcinoma (5%), and more rare Xp11.2 translocated RCC, unclassified as well as
collecting duct carcinoma.
Recent advances in molecular immunology have promoted the discovery of immune checkpoint
inhibitors (ICIs) and have been successfully applied in clinic. Blockade to programmed death
receptor 1(PD-1) improves survival in patients with metastatic renal cell carcinoma (mRCC),
but has not been validated in advanced RCC, especially immune combination TKIs drugs.
Preoperative immunotherapy (IO) with immune plus TKIs, that is, neoadjuvant IO plus TKIs
therapy, is of therapeutic value. Because primary tumors can serve as antigens for
tumor-specific T cell activation, diffusion, and spread, and then activate immune system to
monitor micrometastasis. Moreover, peripheral blood can be obtained during neoadjuvant
therapy, which lays a foundation for the study of the in vivo effects of PD-1 inhibitors
combined with TKIs on the microenvironment of primary tumors.
This study intends to validate the safety and feasibility of neoadjuvant immunotherapy
combined to TKIs in patients with locally advanced/metastatic renal cell carcinoma. At the
same time, this study intends to assess the relationship between somatic gene expression
profiles and pathological responses, as well as the dynamic changes in the microenvironment,
intratumoral, and immune biomarkers of primary renal cell carcinoma induced by immunotherapy.
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