Combining Fruquintinib and TAS-102 for advanced colorectal cancer treatment
A Single-center, Prospective Cohort Study of Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer
This study is testing whether combining two cancer treatments, Fruquintinib and TAS-102, can help people with advanced colorectal cancer live longer and feel better after their disease has progressed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | bevacizumab, cetuximab, Fruquintinib, chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06221423 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of combining Fruquintinib, a standard treatment for refractory metastatic colorectal cancer (mCRC), with TAS-102, another established therapy for mCRC. The approach aims to enhance the sensitivity of the immune system and chemotherapy, potentially improving survival outcomes for patients. Participants must have histology-confirmed mCRC and have experienced disease progression after at least two lines of chemotherapy. The study will assess the outcomes of this combination therapy in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with histology-confirmed metastatic colorectal cancer who have progressed on standard therapies.
Not a fit: Patients with liver or kidney dysfunction or those who have not received at least two lines of chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could provide a new treatment option that improves survival rates for patients with refractory metastatic colorectal cancer.
How similar studies have performed: While the combination of these specific treatments is being explored, similar approaches in combining therapies for mCRC have shown promise in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histology-confirmed metastatic CRC (mCRC) * Disease progression on standard therapy with at least two lines of chemotherapy, including fluorouracil, oxaliplatin, and irinotecan with or without biologics such as bevacizumab and cetuximab * Fruquintinib administered as salvage treatment * Age: 18-75 years old * Informed consent Exclusion Criteria: * Liver or kidney dysfunction, or other conditions unsuitable for chemotherapy * Fruquintinib and/or TAS-102 administration as second-line treatment * Drug administration stopped after less than two cycles
Where this trial is running
Shanghai, Shanghai
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jianmin Xu — Department of Colorectal Surgery, Zhongshan Hospital, Fudan University
- Study coordinator: Donghao Xu
- Email: xdh1225@yeah.net
- Phone: 17621317456
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.