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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04958473
Study type Interventional
Source Tianjin Medical University Second Hospital
Contact BIN HUO, MD
Phone +86 22 88326610
Email huobin_doctor@icloud.com
Status Not yet recruiting
Phase Phase 2
Start date August 1, 2021
Completion date August 1, 2025

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