RecruitingPhase 2NCT05768464

Postoperative Adjuvant Therapy for Non-clear Renal Cell Carcinoma With High-risk Recurrence Factors

A Prospective, Multicenter, Single-arm Clinical Study of the Efficacy and Safety of Toripalimab in Combination With Axitinib for Postoperative Adjuvant Therapy for Non-clear Renal Cell Carcinoma With High-risk Recurrence Factors


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

30 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this prospective, multicenter, single-arm clinical study is to evaluate the efficacy and safety of toripalimab in combination with axitinib for postoperative adjuvant therapy for non-clear renal cell carcinoma with high-risk recurrence factors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing adjuvant (post-surgery) treatment options for patients with certain rare types of kidney cancer — non-clear cell renal cell carcinoma — that carry a high risk of coming back after surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have had surgery for a confirmed non-clear cell renal cell carcinoma (specifically papillary RCC, collecting duct carcinoma, SMARCB1-deficient renal medullary carcinoma, or FH-deficient RCC, among others) - Your cancer has certain high-risk features based on pathology results (stage, grade, or specific subtype) - Your cancer has not spread to distant organs (M0) **You may NOT be eligible if...** - You have clear cell, chromophobe, or eosinophilic RCC - Your cancer has spread beyond the kidney to distant organs - You do not have adequate organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab

240mg intravenously every 3 weeks

DRUGAxitinib

5mg orraly twice daily


Locations(2)

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Nanjing, Jiangsu, China

Hongqian Guo

Nanning, Jiangsu, China

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NCT05768464


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