Combining Lonsurf with chemotherapy for metastatic colorectal cancer in Taiwan
The Efficacy of Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer: Multi-center Prospective Study in Taiwan
This study is testing if combining Lonsurf with chemotherapy can help people with metastatic colorectal cancer live longer and feel better after other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Linkou) |
| Trial ID | NCT06495463 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Lonsurf® (trifluridine/tipiracil) in combination with chemotherapy for patients with metastatic colorectal cancer. It aims to determine the disease control rate, progression-free survival, overall survival, and safety profile of this treatment approach. A total of 70 patients will be recruited, with a two-stage design to assess the response rates and determine the success of the treatment. The study will include patients who have previously undergone standard chemotherapy and biological therapies.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed metastatic colorectal cancer who have previously been treated with standard chemotherapy and biological therapies.
Not a fit: Patients with untreated metastatic colorectal cancer or those who have not received prior chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve disease control and survival outcomes for patients with metastatic colorectal cancer.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in metastatic colorectal cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the metastatic colorectal cancer; 2. Previously treated with fluorouracil-, oxaliplatin-, and irinotecan-based chemotherapy, and anti-vascular endothelial growth factor (anti-VEGF) biological therapy; 3. The RAS wild-type patients need to receive anti-EGFR therapy; 4. Presence of at least one measurable tumor lesion which is defined as lesion that can be measured in at least one dimension (longest diameter) with a minimum size of : 10mm by CT scan, MRI and PET-CT(no less than double the slice thickness and a minimum of 10mm)(according to RECIST guideline version 1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2; 6. Investigators prescribe Lonsurf® for metastatic colorectal cancer patients who had prior treatment with Anti-VEGF and Anti-EGFR agent on routine basis. Depending on RAS status, patients with RAS mutant receive Lonsurf® as 3rd line treatment, those with RAS wild type receive Lonsurf® as 3rd/4th line treatment; 7. Patients received either oxaliplatin or irinotecan. Exclusion Criteria: 1. Patients previously received Lonsurf® (Trifluridine／Tipiracil) or regorafenib; 2. With active central nervous system (CNS) metastasis (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth); 3. With clinically significant gastrointestinal hemorrhage; 4. Previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years; 5. The patient at high risk from treatment complications including but not limited to symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, uncontrolled diabetes, liver or renal failure and psychiatric illness or social situation that would preclude study compliance; 6. Active infection.
Where this trial is running
Linkou
- Chang-Gung Memorial Hospital, Linkou — Linkou, Taiwan (Recruiting)
Study contacts
- Principal investigator: Hung-Chih Hsu — Chang Gung Memorial Hospital, Linkou, Taiwan
- Study coordinator: Hung-Chih Hsu
- Email: dannyhsuyoyo@gmail.com
- Phone: +886 33281200
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.