Fruquintinib Plus Serplulimab as First-Line Therapy for Metastatic Non-Clear Cell Renal Cell Carcinoma
- Sponsor
- RenJi Hospital
- Study ID
- NCT05831891
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Non-clear Renal Cell Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Fruquintinib combined with Serplulimab — DRUGFruquintinib 5mg, qd, 2w on/1w off and Serplulimab 4.5mg/kg, IV drip, d1, q3w
Study Details
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.
Key Dates
- Start date
- May 1, 2023
- Status verified
- May 2026
- Primary completion
- Jul 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 39 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Fruquintinib combine with SerplulimabPatients will receive Fruquintinib 5mg, qd, 2w on/1w off, combined with Serplulimab 4.5mg/kg, IV drip, d1, q3w.
Primary Outcome Measure
Progression-free survival [ Time Frame: Up to 2 years ]