NCT04385654

Toripalimab Combined With Axitinib as Neoadjuvant Therapy for Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Neoadjuvant Therapy
• Advanced Cancer
• Metastatic Kidney Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab (240 mg,ivgtt,q3w) was administered to patients for 6 weeks and underwent surgery within 2-4 weeks
DRUG	Axitinib	Axitinib (5 mg,po,qd) was administered to patients for 6 weeks and underwent surgery within 2-4 weeks

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2020-05-13
• Last updated: 2020-05-13

Regulatory

• FDA-regulated drug study