Investigating Precision Medicine in the Adjuvant Setting in Biliary Tract Cancer (NCT07745296) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Investigating Precision Medicine in the Adjuvant Setting in Biliary Tract Cancer
990 participantsStarted 2027-01-02
Plain-language summary
The objective of SAFIR-IMPACT BTC is to see whether, combining or replacing the standard adjuvant chemotherapy with a targeted therapy matched to the person's cancer, is better than the standard treatment alone in delaying or preventing the return of the cancer.
Three different targeted therapies will be evaluated, each of which recognises a different type of abnormality in cancer cells:
* Ivosidenib - a drug which acts on a specific abnormality in a protein called IDH1.
* Futibatinib - a drug which acts on abnormalities in a protein called FGFR2
* Zanidatamab - a drug which acts on cancers that produce more than the usual quantity of a protein called HER2.
The trial is composed of two phases:
(i) An initial screening phase to identify a suitable patient population, during which a sample of the patient's tumour will be tested to see if it has one of the target abnormalities being studied (ii) a randomised comparative phase (for selected patients only) which consists of comparing two treatment options: some patients will receive the targeted therapy specific to the abnormality identified in their tumour, while others will receive the standard treatment. Patients will be assigned to one treatment or the other by a random draw: they will have a 2 in 3 chance of receiving the targeted therapy.
Randomised participants will:
* Take their assigned treatment for 6 months
* Visit the clinic once every 3 weeks for checkups and tests
* Keep a diary of their symptoms and the treatment they take at home Follow-up information will be collected for all participants until the end of the trial.
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
. Signed a written informed consent form prior to any trial specific procedures (Consent #1)
. Histologically-proven intrahepatic cholangiocarcinoma, perihilar or distal extrahepatic cholangiocarcinoma or gallbladder carcinoma (ampullary carcinoma is excluded)
. Macroscopically complete resection of the primary tumour (R0 or R1 surgical margin status)
. Aged ≥18 years
. Affiliated to a social security system or in possession of equivalent private health insurance (according to local country health provision arrangements).
Exclusion criteria
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Relapse-free survival
Timeframe: From randomisation to disease or death, up to 5 years
. Prior anticancer therapy in the neoadjuvant or adjuvant setting.
. Patients with gallbladder cancer which has not extended to involve the muscle layers or lymph nodes (pT1aN0)
. Planned post-operative radiation therapy
. Prior treatment with any of the MTT under investigation in the trial
. Other invasive malignancies, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 3 years or more and are deemed at negligible risk for recurrence, are eligible for the trial
. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol