Activity of Regorafenib in Combination With Chemotherapy in Patients With Advanced Biliary Tract … (NCT02386397) | Clinical Trial Compass
CompletedPhase 1/2
Activity of Regorafenib in Combination With Chemotherapy in Patients With Advanced Biliary Tract Cancer
France66 participantsStarted 2014-09
Plain-language summary
This study is to determine the Regorafenib Dose (RD) for the phase II trial of Regorafenib administered in combination with mGEMOX in patients with advanced biliary tract cancer.
Who can participate
Age range
18 Years – 75 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:
* Adenocarcinoma of the biliary tract
* Metastatic disease with no curative surgery option or metastatic recurrence after resection.
* Only for phase II: At least one measurable lesion in a non-irradiated area according to Response Evaluation Criteria in Solid Tumors
* No biliary obstruction.
* Age between 18 and 75 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy higher than 3 months.
* No prior chemotherapy for advanced disease. Previous adjuvant chemotherapy including Gemcitabine and/or platinum based is allowed if completed at least 6 months previously and relapsing after completion of the last dose.
* Total bilirubin ≤ 2.5 times the upper limit of the normal range. Patients with jaundice or evidence of bile duct obstruction, in whom the biliary tree can be decompressed by endoscopic or percutaneous endoprothesis (at least 15 days before inclusion) with subsequent reduction in total bilirubin ≤ 3 ULN, will be eligible for the study.
* Aminotransferases (AST, ALT) ≤ 2.5 ULN (≤ 5 ULN in case of diffuse hepatic involvement), INR \< 1.5 (following vitamin K1 injection in patients with current or recent history of jaundice or bile duct obstruction), serum creatinine clearance calculated \> 50 mL/min/1.73m² according to the Modification of Diet in Renal Disease (MDRD) formula, neutrophils ≥ 1.5.109/L, platelets ≥ 100.109/L, hemoglobin ≥ 9 g/dL (red blood cell transfusion is allowed if needed).
* Signed infor…
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 combined regorafenib with chemotherapy for biliary tract cancer — since it was a Phase 1/2 study focused on measuring 'limiting toxicity,' what does that tell us about how much was still unknown about safety when the trial was running, and does the completed data show whether the combination was tolerable?
2Since the trial has been completed, have the results been published, and if so, what did they find about how well regorafenib plus chemotherapy worked for patients with advanced biliary tract cancer?
3Regorafenib is known to have significant side effects on its own — given that this trial was specifically designed to look at toxicity limits when combining it with chemotherapy, how would those combined side effects compare to what I might experience on standard treatment alone?
4For someone with advanced biliary tract cancer today, would you recommend looking at this completed trial's findings as a reason to consider regorafenib-based combinations, or are there newer studies or approved treatments that might be a better starting point for my situation?
5This was a Phase 1/2 trial, which typically involves smaller numbers of patients and is still building evidence — does that mean the results should be considered preliminary, and how much weight should we give them when making decisions about my treatment plan?
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.
What they're measuring
1
Limiting toxicity
Timeframe: up to 5 years
Trial details
NCT IDNCT02386397
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle