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ACTIVE NOT RECRUITING
NCT05831891
PHASE2

Fruquintinib Plus Serplulimab as First-Line Therapy for Metastatic Non-Clear Cell Renal Cell Carcinoma

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

Summary

This multicenter, single-arm, phase II study (FRONTIER) evaluates the efficacy and safety of fruquintinib combined with serplulimab as first-line treatment in patients with metastatic or unresectable non-clear cell renal cell carcinoma (nccRCC). Given the biological heterogeneity and lack of established standard therapies in nccRCC, this study aims to characterize clinical outcomes and explore potential predictive biomarkers associated with treatment benefit.

Official title: A Multicenter, Single-Arm, Phase II Study Evaluating the Efficacy and Safety of Fruquintinib Combined With Serplulimab as First-Line Treatment in Patients With Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2023-05-01

Completion Date

2026-12-31

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

DRUG

Fruquintinib combined with Serplulimab

Fruquintinib 5mg, qd, 2w on/1w off and Serplulimab 4.5mg/kg, IV drip, d1, q3w

Locations (1)

Renji Hospital

Shanghai, Shanghai Municipality, China