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.
ECOG PS 0-2
Histologically confirmed colorectal adenocarcinoma with liver metastases (8th edition AJCC)
MSS/pMMR subtype
Previously received standard first- and second-line systemic anti-tumor therapy
Patients diagnosed with malignancies other than colorectal cancer within 3 years prior to enrollment.
Participating in an interventional clinical study or receiving other investigational drugs or treatments with study devices within the past 4 weeks before enrollment.
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.
Received traditional Chinese medicine or immune-modulating drugs with anti-tumor indications within the past 2 weeks before enrollment (excluding local use for controlling pleural effusion).
Parallel
Immunotherapy (Sintilimab)
DrugSintilimab
Targeted Therapy Agent (Fruquintinib)
DrugFruquintinib
Radiotherapy (SBRT and LDRT)
RadiationSBRT and LDRT
Progression-free survival (PFS)
Time from initial drug administration to first radiographic disease progression or death (whichever occurs first).
Overall response rate (ORR)
The proportion of subjects achieving complete response (CR) and partial response (PR) among the total subjects; includes assessment of both irradiated and non-irradiated lesions.
Disease control rate (DCR)
The proportion of subjects achieving complete response (CR), partial response (PR), and stable disease (SD) among the total subjects.
Overall survival (OS)
Time from initial drug administration to death of the subject for any reason.
The incidence and grade of adverse events
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death.
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