Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

Study acronym: SLOT
StatusUnknown
PhasePhase 2
Started

Record status This record was last updated September 24, 2024 (before its estimated April 25, 2025 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Enrollment target: 90 to 108
    • Eligibility criteria shortened, about 3 words
    v3
  3. Primary completion date: Apr 25, 2024 to Apr 25, 2025v2 Show 6 more changesShow less
    • Primary endpoint revised
    • Interventions: High/low-dose radiotherapy (Radiation), Regorafenib (Drug), Regorafenib (Drug), Toripalimab (Drug) to Radiotherapy (Radiation), Regorafenib (Drug), Regorafenib (Drug), Toripalimab (Drug)
    • Secondary endpoints revised (5)
    • Study title revised
    • Eligibility criteria expanded, about 1 word
    • Study description shortened, about 1 word
  4. 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.
The study compares the efficacy and safety of regorafenib alone or in combination with hypofractionated radiotherapy and low-dose radiotherapy (LDRT) plus toripalimab in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). Patients are randomly assigned (1:1) into the control arm and the experimental arm. Control arm: a total of 54 patients will receive regorafenib monotherapy. Experimental arm: a total of 54 patients will first receive 1 cycle of regorafenib and toripalimab followed by hypofractionated/low-dose radiotherapy. Regorafenib and toripalimab will be continued after the completion of radiotherapy. The survival benefits, response rates, and adverse effects will be analyzed.
Trial Details
NCT Number NCT05963490
Lead Sponsor Fudan University
Conditions
(from sponsor)		 Microsatellite Stable Metastatic Colorectal Cancer
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov