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RECRUITING
NCT05738694
PHASE3

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

Sponsor: ZHOU FANGJIAN

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

298

Start Date

2023-04-19

Completion Date

2027-12-31

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

DRUG

Axitinib 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.

PROCEDURE

nephrectomy

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