Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer

  • End date
    Jul 1, 2025
  • participants needed
  • sponsor
    University of Washington
Updated on 4 October 2022
renal function
neutrophil count


This study is going to test the ability to successfully obtain results from certain personalized tests for patients with biliary tract cancers that are able to be surgically removed. Through surveys, this study will also evaluate the usefulness of these tests to medical oncologists as they make decisions on what standard or experimental treatments might benefit the patient's enrolled in the study. The study is observational and does not require any change in the standard approach to treating biliary tract cancer. Results of the personalized tests will be provided to the treating medical oncologist and the medical oncologist can choose to whether or not to change management based on these results. These personalized tests include reading of the cancer DNA, testing whether a panel of drugs can kill a patient's cancer cells in a test tube, and testing for small amounts of cancer DNA in the blood as a way to check for the presence of leftover cancer in the body after it is removed surgically. This study will also give extra pieces of cancer, that would otherwise be discarded, from surgery for laboratory research into how biliary tract cancers respond to drugs and the body's immune system. The investigators hypothesize that the drug screen test will, in some cases, be useful to the medical oncologist and may lead to the use of cancer drugs that would not otherwise have been chosen based on standard guidelines or based on cancer DNA testing. The investigators hypothesize that the test tube drug screening method will correlate with how the cancer responds to the drugs in real life for those patients that end up receiving a drug that was included in the drug screen panel. The investigators hypothesize that monitoring of cancer DNA in the blood stream will help us predict which patients are most likely to have their cancer return after surgery. The investigators also hypothesize that in many cases the appearance of cancer DNA in the blood stream will happen weeks to months prior to the cancer showing up on usual body imaging or other lab tests. Finally, the investigators hypothesize that, for patients undergoing medical treatment for their cancer, trends in the amount of cancer DNA in the blood stream will correlate with the effectiveness of treatment.

Condition Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer, Intrahepatic Cholangiocarcinoma, Perihilar Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Hilar Cholangiocarcinoma, Distal Bile Duct Cancer
Treatment Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring
Clinical Study IdentifierNCT04561453
SponsorUniversity of Washington
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Subjects must meet all of the following criteria to be enrolled in the study
Be ≥18 years of age
Have a preoperative biopsy with a histopathological diagnosis consistent with a biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma or gallbladder carcinoma) or, absent a biopsy, have a clinical presentation consistent with a biliary tract cancer, and are eligible for curative resection
Surgical candidate for the requisite resection as assessed by a liver surgeon or as assessed by, if deemed necessary, a pre-operative evaluation by internal medicine, cardiology and/or anesthesia
Pre-operative imaging showing a measurable amount of disease that, per the judgement of the surgical oncologist, will be enough to allocate to at least genomic profiling as well as the organoid creation portion of this research study
Be willing to undergo surgical resection and willing to have the surgery performed at University of Washington
Be willing to follow-up with medical oncology post-operatively and allow the study team to collect longitudinal data on their course as well as longitudinal blood samples for circulating tumor DNA surveillance
Have an ECOG performance status of 0-2
Have an expected survival of ≥6 months
Have adequate bone marrow function as evidenced by
Absolute neutrophil count ≥1,000/mm3 or 1.0 ×10^9/L
Hemoglobin ≥8 g/dL
Platelets ≥60,000/mm3 or 60 × 10^9/L
Have adequate hepatic function as evidenced by the below, or are expected to have
adequate hepatic function (as defined below) post-operatively
Serum total bilirubin ≤2 × upper limit of normal (ULN), unless considered due to Gilbert's disease or a biliary obstruction
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤8 × ULN
Have adequate renal function as evidenced by the below or are expected to have
adequate renal function (as defined below) post-operatively
Serum creatinine <1.5 × ULN OR b. Creatinine clearance ≥50 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR) estimation: (140 - Age) x (weight in kg) x (0.85 if female)/72 x sCr
Be able to understand and willing to sign the informed consent form and to comply with
scheduled visits, treatment plans, procedures, and laboratory tests, including
serial peripheral blood sampling, during the study

Exclusion Criteria

Subjects who meet any of the following criteria will not be enrolled in the
Mixed hepatocellular carcinoma-cholangiocarcinoma on histology
Refuses to sign the consent
Received any prior systemic targeted therapy (excludes chemotherapy) or an investigational agent directed at their presumed cholangiocarcinoma prior to resection
Received any prior radiation or catheter-directed therapy to the malignant tumor being resected, unless there has been definitive malignant progression of that tumor since the time of the post-treatment imaging assessment after radiation or catheter-directed therapy
Received any systemic anticancer therapy or an investigational agent for another indication (a synchronous cancer of a different primary site) in the 6 months prior to discovery of their presumed cholangiocarcinoma by imaging
Have known extrahepatic metastases or locally advanced disease precluding resection of the cholangiocarcinoma
Have a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid or liquid tumor with no known active disease present that, in the opinion of the Investigator, will not affect subject outcome in the setting of current cholangiocarcinoma diagnosis
Are pregnant or breastfeeding
Have any other acute or chronic medical or psychiatric condition, including recent (within 12 months of cholangiocarcinoma diagnosis) or active suicidal ideation or behavior, or a laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
Have been committed to an institution by virtue of an order issued either by the judicial or administrative authorities
Are dependent on the Sponsor, Investigator, or study site, per local institution regulations
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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