Combining Fruquintinib, Regorafenib, and Sintilimab with Radiotherapy for Advanced Colorectal Cancer
Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases: A Randomized, Controlled, Multicenter Phase II Trial
This study is testing a new combination of three cancer drugs with or without radiation to see if it helps people with advanced colorectal cancer who have already tried other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Drugs / interventions | fruquintinib, sintilimab, immunotherapy, radiation |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06356584 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combination therapy involving Fruquintinib, Regorafenib, and Sintilimab, with or without radiotherapy, for patients with metastatic colorectal cancer who have already undergone first- and second-line treatments. The study aims to assess progression-free survival, overall survival, and treatment response rates in patients with both non-liver and liver metastases. Participants will receive tailored treatment protocols based on their specific cancer characteristics, and subgroup analyses will focus on the impact of liver metastases on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed metastatic colorectal adenocarcinoma who have received prior systemic therapies and have measurable lesions.
Not a fit: Patients with other malignancies or those currently participating in other interventional studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced colorectal cancer who have limited options after standard therapies.
How similar studies have performed: While there is existing data on third-line treatments for advanced colorectal cancer, this specific combination therapy approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * At least one measurable lesion as defined by RECIST 1.1 criteria * Access to tumor samples for biomarker assessment * Expected survival of ≥3 months * Normal function of major organ systems (within 14 days before enrollment) * No systemic corticosteroid treatment within 7 days before treatment initiation, excluding physiological corticosteroid replacement therapy. * Fertile males or females with the potential for pregnancy must use highly effective contraception methods during the trial. Exclusion Criteria: * 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). * Experienced active autoimmune diseases requiring systemic therapy within the past 2 years before enrollment. Replacement therapy is not considered systemic therapy. * Diagnosed with immune deficiency or received systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of investigational treatment. After consultation with the sponsor, the use of physiological doses of corticosteroids may be approved. * Received liver radiotherapy within the past 2 weeks before enrollment. * Known presence of central nervous system metastases and/or carcinomatous meningitis. * Received systemic corticosteroid therapy within 7 days before enrollment.
Where this trial is running
Jinan, Shandong
- Jinbo Yue — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Jin Bo Yue — Shandong Cancer Hospital and Institute
- Study coordinator: Jin Bo Yue, dorctor
- Email: Len.Xu@hotmail.com
- Phone: 0531-67626442
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.