Trifluridine/Tipiracil in Combination With Capecitabine and Bevacizumab in Metastatic Colorectal … (NCT04564898) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Trifluridine/Tipiracil in Combination With Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients.
Italy48 participantsStarted 2022-01-25
Plain-language summary
The aim oh this study is to determine the safety and recommended dose of trifluridine/tipiracil plus capecitabine and bevacizumab combination (part 1, dose escalation phase) and to assess its activity in previously untreated mCRC patients who are deemed not eligible for intensive chemotherapy (part 2, expansion phase).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent to study procedures.
* Histologically proven diagnosis of colorectal cancer.
* Metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.
* At least one measurable lesion according to RECIST1.1.
* Age ≥ 18 years.
* ECOG PS ≤ 1.
* Life expectancy of at least 12 weeks.
* Previous adjuvant fluoropyrimidine-based chemotherapy allowed only if more than 12 months elapsed between the end of adjuvant and first relapse.
* Availability of archival tumour tissue (primary tumour and metastases or at least one of the two) for biomarker analysis.
* Availability of blood sample for biomarker analysis.
* Previously not eligible for a chemotherapy doublet or triplet (oxaliplatin and/or irinotecan-based combination).
* Neutrophils ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hemoglobin ≥ 9 g/dl.
* Total bilirubin ≤1.5 fold the upper-normal limits (UNL), AST (SGOT) and/or ALT (SGPT) ≤ 2.5 x UNL (or \<5 x UNL in the case of liver metastases), alkaline phosphatase ≤ 2.5 x UNL (or \<5 x UNL in case of liver metastases).
* Creatinine clearance ≥ 50 mL/min or serum creatinine ≤1.5 x UNL.
* Male subjects with female partners of childbearing potential must be willing to use adequate contraception as approved by the investigator (barrier contraceptive measure or oral contraception).
* Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. For this trial, women of childbearing potential …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is combining trifluridine/tipiracil with capecitabine and bevacizumab — both trifluridine/tipiracil and capecitabine are chemotherapy drugs that work in similar ways, so is there a higher risk of serious side effects from using them together, and how would that risk apply to my specific situation?
2Since this is a Phase 1/2 trial that is still working out the recommended dose, does that mean there's still uncertainty about what level of these drugs is safe, and what would that mean for me compared to sticking with a more established treatment regimen?
3The trial is no longer recruiting new patients — does that mean there are any results or safety data available yet that you could review with me to help us understand whether this kind of combination might ever be relevant to my care?
4Both trifluridine/tipiracil and capecitabine are oral chemotherapy drugs taken on a schedule — if this combination were ever an option for me, how demanding would the treatment schedule be, and are there monitoring requirements that could affect my day-to-day life?
5Given that this trial is for metastatic colorectal cancer specifically, where does this combination fit compared to the standard treatment options currently available to me, and would you recommend I pursue standard lines of therapy before considering an experimental combination like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.