Actively Recruiting
Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases
Led by Shandong Cancer Hospital and Institute · Updated on 2026-04-28
62
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status 0 to 2
- Histologically confirmed colorectal adenocarcinoma with liver metastases
- Microsatellite stable/proficient mismatch repair subtype
- Previously treated with standard first- and second-line anti-tumor therapies
- At least one measurable tumor lesion by RECIST 1.1 criteria
- Availability of tumor samples for biomarker testing
- Expected survival of at least 3 months
- Normal major organ function within 14 days before enrollment
- No systemic corticosteroid treatment within 7 days before starting treatment, except for physiological replacement
- Fertile males or females must use effective contraception during the study
You will not qualify if you...
- Diagnosis of other cancers within 3 years before enrollment
- Participation in other interventional clinical studies or use of investigational treatments within 4 weeks before enrollment
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 drugs, or other T cell receptor-targeting therapies
- Use of fruquintinib before
- Use of traditional Chinese medicine or immune-modulating anti-tumor drugs within 2 weeks prior to enrollment (except local control for pleural effusion)
- Active autoimmune disease needing systemic therapy within 2 years before enrollment
- Immune deficiency or use of systemic corticosteroids or immunosuppressives within 7 days before first study dose
- Liver radiotherapy received within 2 weeks before enrollment
- Known brain metastases or carcinomatous meningitis
- Systemic corticosteroid therapy within 7 days before enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jinbo Yue
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
J
Jin Bo Yue, dorctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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