Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)

StatusCompleted
PhasePhase 2/3
SponsorHutchmed
Started

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Record History

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  1. Primary completion date changed from estimate of Jan 2025 to Aug 28, 2026 Show 6 more changesShow less
    • Trial completed
    • Interventions: axitinib / everolimus (Drug), fruquintinib (Drug), fruquintinib+sintilimab (Drug) to axitinib / everolimus (Drug), fruquintinib (Drug), fruquintinib+sintilimab (Drug)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: 9 to 10
    • Study description revised
    • Site details revised at 6 of 48 sites
  2. Lead sponsor: Hutchison Medipharma Limited to Hutchmedv4 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 264 to confirmed 265
    • Study sites: 1 to 48
    • Primary completion date: Nov 2024 to Jan 2025
    • Secondary endpoints: details revised at 1 of 9 entries
  3. Eligibility criteria expanded, about 91 words
    • Study title expanded, about 1 word
    v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2022 to Oct 27, 2022
    • Interventions: Axitinib / Everolimus (Drug), Fruquintinib (Drug), Fruquintinib+Sintilimab (Drug) to axitinib / everolimus (Drug), fruquintinib (Drug), fruquintinib+sintilimab (Drug)
    • Eligibility criteria shortened, about 11 words
    • Study description shortened, about 9 words
  5. Study First Submitted
  • 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.
Hutchmed
23 trials monitored
See 1 trial at risk
Kidney Cancer
891 trials monitored
See 72 trials at risk
The study consists of two parts, the first part is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy as second-line treatment for locally advanced or metastatic renal cell carcinoma. The second part is a fruquintinib monotherapy factorial cohort study to evaluate the efficacy and safety of fruquintinib monotherapy as for second-line treatment of locally advanced or metastatic renal cell carcinoma.
Trial Details
NCT Number NCT05522231
Lead Sponsor Hutchmed
Conditions
(from sponsor)		 Advanced Renal Cell Carcinoma
Enrollment 265 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov