Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05738694

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

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
298 (estimated)
Sponsor
ZHOU FANGJIAN · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Detailed description

Given the good results of TKI plus PD-1 in our previous cases and its good effect on advanced RCC, we plan to eliminate tumor micrometastases and improve anti-tumor immunity with the neoadjuvant combination of axitinib plus PD-1, so as to improve patient outcomes. 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 and provide evidence-based medical evidence for clinical perioperative treatment of these patients.

Conditions

Interventions

TypeNameDescription
DRUGAxitinib plus ToripalimabPreoperative 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.
PROCEDUREnephrectomynephrectomy

Timeline

Start date
2023-04-19
Primary completion
2027-12-31
Completion
2027-12-31
First posted
2023-02-22
Last updated
2026-03-17

Locations

8 sites across 1 country: China

Source: ClinicalTrials.gov record NCT05738694. Inclusion in this directory is not an endorsement.