Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05831891 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Jul 31, 2026 → Oct 22, 2027
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from RenJi Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 31, 2026 to Oct 22, 2027 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Study completion pushed from Dec 31, 2026 to Oct 22, 2030
    • Enrollment target: 39 to 40
    • Eligibility criteria shortened, about 242 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 7 words
    • Collaborators: 3 to 2
  2. Primary completion date: Jun 30, 2025 to Jul 31, 2026v3 Show 8 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 31, 2026 to Dec 31, 2026
    • Eligibility criteria shortened, about 333 words
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 77 words
    • Site details revised
    • Collaborators: 1 to 3
    • Study title revised
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Mar 31, 2026 to Jun 30, 2025
    • Start date changed from estimate of Jun 30, 2023 to May 1, 2023
    • Eligibility criteria shortened, about 27 words
    • Secondary endpoints revised (3)
    • Study title shortened, about 5 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RenJi Hospital
190 trials monitored
See 2 trials at risk
Kidney Cancer
889 trials monitored
See 68 trials at risk
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.
Trial Details
NCT Number NCT05831891
Lead Sponsor RenJi Hospital
Collaborators: Shanghai Zhongshan Hospital, Sun Yat-Sen University Cancer Center
Conditions
(from sponsor)		 Non-clear Cell Renal Cell Carcinoma
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov