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

NCT05738694 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • ZHOU FANGJIAN

    lead OTHER

Principal Investigators

  • Fangjian Zhou, Professor · Director of Dept. of Urology, Sun Yat-sen University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05738694 on ClinicalTrials.gov