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 Cell Renal Cell Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Fruquintinib combined with Serplulimab — DRUGFruquintinib 5 mg once daily, 2 weeks on/1 week off, and serplulimab 4.5 mg/kg by intravenous infusion on day 1 every 3 weeks.
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 biomarkers associated with treatment benefit.
Key Dates
- First listed
- Apr 26, 2023
- Start date
- May 1, 2023
- Status verified
- Sep 2026
- Primary completion
- Oct 22, 2027
- Completion
- Oct 22, 2030
Study Design
- Enrollment
- 40 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Fruquintinib combine with SerplulimabPatients receive fruquintinib 5 mg once daily, 2 weeks on/1 week off, combined with serplulimab 4.5 mg/kg by intravenous infusion on day 1 every 3 weeks.
Primary Outcome Measure
Investigator-assessed progression-free survival (PFS) [ Time Frame: Up to 2 years ]