Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether adding cemiplimab, an immunotherapy that helps the immune system recognise and attack cancer cells, to gemcitabine, cisplatin and nab-paclitaxel can shrink locally advanced biliary tract cancers that cannot currently be removed. The treatment is intended to make some of these tumours resectable, meaning removable by surgery.
The idea is that combining four treatments could make surgery possible when chemotherapy or immunotherapy alone might not shrink the tumour enough; surgery is the only treatment in this setting that could potentially cure the cancer. The trial will measure how often the disease becomes resectable and is then removed, rather than comparing how long people live with another treatment.
Worth knowing: This is a small, non-randomised phase 2 trial of 20 people with no comparison group, so it cannot establish whether the combination is better than standard treatment or whether making surgery possible improves survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07433673 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 20 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Columbia University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Cemiplimab
What it is measuring
Rate of conversion to resectable disease and subsequent surgical resection
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
The purpose of this study is to combine chemotherapy that has previously been shown to have activity in patients with biliary tract cancer with a drug that stimulates the body's immune system against cancer cells (immunotherapy). Previously, the combination of gemcitabine and cisplatin with immunotherapy has been shown to prolong life in patients with advanced biliary tract cancer. Adding nab-paclitaxel, another chemotherapy, to gemcitabine and cisplatin, has also been shown to prolong life in some patients with advanced biliary tract cancer. However, all four of these drugs have not before been combined. Cemiplimab is being used in an investigational manner (not for the purpose that it was approved for) in this research study. This means that cemiplimab has been approved by the Food and Drug Administration (FDA) for use in advanced or metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, and non-small cell lung cancer, but has not been approved for locally advanced biliary tract cancer that cannot be surgically removed. Since surgery is the only way to potentially cure this cancer, new treatments are needed that can shrink inoperable tumors enough to make surgery possible. This is especially important for patients with advanced biliary tract cancer that hasn't spread to other parts of the body.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
- Rectal
- Colon
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Histologically confirmed diagnosis of biliary tract adenocarcinoma (intra- or extra-hepatic, and gallbladder)
- Locally advanced, unresectable BTC without evidence of distant metastatic disease. Patients with surgically unresectable BTC on diagnostic abdominal CT scan or MRI are eligible to participate in the study. Unresectable, locally advanced, but non-metastatic BTC must be confirmed with the designated site radiologist and surgeon at the treating institution (Appendix 2) and must meet at least one of the following criteria:
- Tumor involvement of both hepatic lobes and/or vessels
- Vascular invasion of the portal vein or main hepatic artery
- For perihilar tumors: bilateral hepatic duct involvement up to secondary radicles
- Atrophy of one liver lobe with invasion of contralateral vessel and/or bile duct
- Extrahepatic organ tumor invasion, except contiguous involvement of the diaphragm
- Inadequate estimated liver remnant after surgery If resectability cannot be determined based on CT or MRI, an FDG-PET may be performed, and if it cannot be determined based on imaging alone, surgical exploration is permitted.
- Age ≥ 18 years.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07433673, registered by Columbia University on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.