RecruitingPhase 3NCT05738694

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

A Multicenter Randomized Controlled Clinical Study of Neoadjuvant Combination of Axitinib Plus PD-1 Monoclonal Antibody to Improve Disease Free Survival of Patients With Renal Cell Carcinoma


Sponsor

ZHOU FANGJIAN

Enrollment

298 participants

Start Date

Apr 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The study included 298 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving axitinib (a targeted therapy) plus a PD-1 immunotherapy drug before surgery can improve long-term outcomes for people with high-risk kidney cancer (renal cell carcinoma) that has not yet spread to distant organs. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with clear cell kidney cancer confirmed by biopsy or scan - Your cancer is staged as high-risk but still potentially removable (T2G4, T3–4, or lymph node involvement, without distant spread) - Your general health is good (ECOG performance status 0–1) - Your heart, blood, liver, and kidney functions are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have severe liver, kidney, or heart problems - You had a heart attack, blood clot, or stroke in the past year - You have uncontrolled high blood pressure or severe heart failure 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

DRUGAxitinib plus Toripalimab

Preoperative treatment with axitinib will be given for 3 months, 5 mg twice daily, orally. Preoperative treatment with Toripalimab will be given for 4 cycles (3 weeks considered one cycle), 240 mg, Q3W.

PROCEDUREnephrectomy

nephrectomy


Locations(8)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Peking University First Hospital

Beijing, China

Sun Yat-sen University Cancer Center

Guangzhou, China

Anhui Provincial Hospital

Hefei, China

Fudan University Cancer Hospital

Shanghai, China

West China Hospital

Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

The First Affiliated Hospital of Zhengzhou Hospital

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT05738694


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