Spots Global Cancer Trial Database for A Study of Sintilimab in Combination With Axitinib in Advanced Renal Cell Cancer

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Trial Identification

Brief Title: A Study of Sintilimab in Combination With Axitinib in Advanced Renal Cell Cancer

Official Title: A Single-center, Non-randomized Controlled, Single-arm, Phase II Clinical Trial of Sintilimab in Combination With Axitinib in the Treatment of Advanced Renal Cell Carcinoma

Study ID: NCT04958473

Conditions

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Interventions

Sintilimab

Axitinib

Study Description

Brief Summary: In patients with recurrent or metastatic renal cell carcinoma, a preliminary evaluation of the safety and efficacy of sintilimab combined with axitinib in patients with advanced renal cell carcinoma was conducted.Progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and disease remission rate (ORR) were evaluated.

Detailed Description: Patients with recurrent or metastatic renal cell carcinoma received axitinib tablets (5mg bid po) combined with sintilimab (200mg d1) on a 3-week (21-day) as a one-cycle regimen.6 months of continuous administration (i.e., 8 cycles of sintilimab) or until tumor progression or unacceptable toxicity or death or subject withdraws informed consent;If the drug has been discontinued or the tumor has progressed, and there are no intolerable side effects, the drug can be continued according to the judgment of the researchers and the will of the subjects. Drug safety was evaluated before each cycle.The first efficacy was evaluated after 2 cycles.The efficacy was then evaluated every 2 cycles.