OncoMatch/Clinical Trials/NCT06356584
Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases
Is NCT06356584 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Immunotherapy (Sintilimab) and Targeted Therapy Agent (Fruquintinib) for colorectal cancer.
Treatment: Immunotherapy (Sintilimab) · Targeted Therapy Agent (Fruquintinib) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic anti-tumor therapy — first- and second-line
Previously received standard first- and second-line systemic anti-tumor therapy
Cannot have received: anti-PD-1 therapy
Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell co-stimulatory or co-inhibitory receptor (e.g., CTLA-4, OX-40, CD137), fruquintinib, etc.
Cannot have received: anti-PD-L1 therapy
Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell co-stimulatory or co-inhibitory receptor (e.g., CTLA-4, OX-40, CD137), fruquintinib, etc.
Cannot have received: anti-PD-L2 therapy
Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell co-stimulatory or co-inhibitory receptor (e.g., CTLA-4, OX-40, CD137), fruquintinib, etc.
Cannot have received: checkpoint inhibitor
drugs targeting another T cell co-stimulatory or co-inhibitory receptor (e.g., CTLA-4, OX-40, CD137)
Cannot have received: VEGFR inhibitor (fruquintinib)
fruquintinib
Lab requirements
Blood counts
Normal function of major organ systems (within 14 days before enrollment)
Kidney function
Normal function of major organ systems (within 14 days before enrollment)
Liver function
Normal function of major organ systems (within 14 days before enrollment)
Cardiac function
Normal function of major organ systems (within 14 days before enrollment)
Normal function of major organ systems (within 14 days before enrollment)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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