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Can matching drugs to tumor genes beat biliary cancer?
NCT ID NCT07729917
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This umbrella trial is testing whether assigning treatment based on a person's tumor genetics can improve outcomes for advanced biliary tract cancers. Participants receive one of several targeted therapies or immunotherapy, depending on their genetic test results. The study aims to see if this precision approach leads to tumor shrinkage and better survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of targeted drugs and immunotherapy matched to tumor genetics
- What this could lead to
- If successful, this approach could make treatment for biliary tract cancers more personalized and effective by matching drugs to each tumor's genetic makeup.
- What could go wrong
- This is an early-phase trial with many treatment arms, so results may not apply broadly. Some targeted drugs may cause side effects or not work for certain genetic profiles.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The patient voluntarily joins this study and signs the informed consent form. * Age: ≥18 years, male or female. * Histologically or cytologically confirmed advanced biliary tract malignancies, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer. * No prior systemic therapy for advanced BTC (biliary tract cancer). * At least one measurable lesion as per RECIST v1.1 (spiral CT scan long diameter ≥10 mm or short diameter of enlarged lymph node ≥15 mm; lesions previously treated with local therapy may be considered target lesions only after documented progression according to RECIST v1.1). * ECOG performance status: 0-1. * Expected survival ≥12 weeks. * Adequate major organ function. * Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before the first dose, must not be breastfeeding, and must voluntarily agree to use effective contraceptive measures during the study period and for 6 months after the last dose of chemotherapy. For male subjects with a female partner of childbearing potential, they must be surgically sterile or agree to use effective contraceptive measures during the study period and for 3 months after the last dose of chemotherapy; sperm donation is not allowed during the study. * Subjects are expected to have good compliance and be able to follow the protocol requirements for efficacy and adverse event follow-up. Exclusion Criteria: * Has another active malignancy other than BTC within 5 years or concurrently. * Has poorly controlled cardiac clinical symptoms or diseases. * Has hypertension that cannot be reduced to normal range with antihypertensive medication; has a history of hypertensive crisis or hypertensive encephalopathy. * Any clinically significant gastrointestinal disorders, including bleeding, inflammation, obstruction, or diarrhea \> grade 2. * Has experienced thrombotic or embolic events within 6 months before the start of study treatment. * Use of strong CYP3A4/CYP2C19 inducers (including rifampin and its analogues, and St. John's Wort) or strong CYP3A4/CYP2C19 inhibitors and/or strong UGT1A inhibitors within 14 days prior to signing the informed consent form. * Has uncontrolled infection at screening. * Patients with congenital or acquired immunodeficiency. * Has a history of brain metastases or has brain metastases. * Women who are pregnant or plan to become pregnant during the study treatment period. * Other patients deemed unsuitable for inclusion by the treating physician.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can Re-Assessing bile duct cancer treatment open the door to surgery?
- Radiation beads plus immunotherapy: a new way to attack liver cancer?
- Burning away bile duct blockages: a new weapon against cholangiocarcinoma?
- Can a Three-Drug chemo cocktail before surgery stop biliary tract cancer from coming back?
- Can a targeted pill shrink hard-to-treat bile duct cancers?