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Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 28, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Enrollment target: 57 to 62v5 Show 7 more changesShow less
    • Interventions: Immunotherapy (Drug), Targeted Therapy Agent (Drug) to Immunotherapy (Sintilimab) (Drug), Radiotherapy (SBRT and LDRT) (Radiation), Targeted Therapy Agent (Fruquintinib) (Drug)
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: 3 to 4
    • Study description shortened, about 252 words
    • Publications: 11 to 1
    • Study arms: 2 to 3
    • Study title expanded, about 1 word
  3. Interventions: Sintilimab (Drug) to Immunotherapy (Drug), Targeted Therapy Agent (Drug)v4
  4. Study title revisedv3
  5. Enrollment target: 141 to 57
    • Publications: details revised at 10 of 11 entries
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. This prospective study will evaluate the efficacy of combined therapy involving sintilimab, fruquintinib, and radiotherapy in CRC with liver metastases. The primary objectives are to assess progression-free survival, overall survival, and treatment response rates. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for CRC with liver metastases by elucidating the efficacy and safety of this combined treatment approach.
Trial Details
NCT Number NCT06356584
Lead Sponsor Shandong Cancer Hospital and Institute
Conditions
(from sponsor)		 Colorectal Cancer, Immunotherapy, Radiotherapy, Targeted Therapy, Liver Metastasis
Related terms Colorectal Neoplasms
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov