New hope for bile duct cancer: targeted drug combo trial launches
NCT ID NCT07598318
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if adding a targeted drug (becotatug vedotin) to standard chemotherapy and immunotherapy helps shrink tumors better than standard treatment alone in people with advanced bile duct cancer that has a specific gene change (EGFR mutation). About 164 adults with this cancer will be randomly assigned to one of two treatment groups. The main goal is to see if the new combination leads to a higher rate of tumor shrinkage.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 164 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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: * Age ≥ 18 years old, both genders are eligible. * Histologically confirmed unresectable or metastatic cholangiocarcinoma (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma), histologically confirmed unresectable or metastatic cholangiocarcinoma (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma, after previous chemotherapy failure), and at least one assessable lesion. * IHC test is positive for EGFR. * ECOG PS score 0-1, normal major organ functions, no severe abnormalities in blood, heart, lungs, liver, kidneys, bone marrow and immune deficiency diseases. * For female participants of childbearing age, a pregnancy test (serum/urine) result must be negative within 14 days before enrollment, and they must voluntarily use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug; for male participants, they should be surgically sterilized or agree to use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug. * Expected good compliance, able to follow up on efficacy and adverse reactions as per the protocol requirements. * Voluntary participation in this study and signing the informed consent form. If the participant is unable to read and sign the informed consent form due to lack of capacity, their guardian should act on their behalf in the informed process and sign the informed consent form. If the participant is unable to read the informed consent form (such as illiterate participants), a witness should witness the informed process and sign the informed consent form. Exclusion Criteria: * Within the 3 months prior to enrollment, the participant has not participated in any other clinical studies. * Has any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (after hormone replacement therapy can be included)); Has completely recovered from childhood asthma and does not require any intervention after adulthood or vitiligo can be included, but patients requiring bronchodilators for medical intervention are not included. * Has congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infected individuals. * Has uncontrolled clinical symptoms or diseases of the heart, such as NYHA II or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinical significance of supraventricular or ventricular arrhythmias requiring clinical intervention. * Had severe infection within 4 weeks before the first medication (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or had unexplained fever \> 38.5℃ during screening or before the first administration. * Has a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * Had vaccination with attenuated live vaccines within 4 weeks before the first administration or planned during the study period. * Has had or is currently suffering from other systemic malignant tumors within the last 5 years (excluding cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer). * Has known allergies to any study drug. * Pregnant or lactating women, or subjects with reproductive capacity who are unwilling to take effective contraceptive measures. * Vulnerable groups other than the elderly or illiterate, including those with mental illness, cognitive impairment, critically ill patients, etc. * Other situations that the investigator deems unsuitable for inclusion in this study. Such as: the patient has central nervous system metastasis, has severe laboratory test abnormalities, is accompanied by family or social factors, which may affect the safety of the subject or the collection of data/samples.
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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 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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 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 new drug shrink advanced solid tumors?
- Can adding immunotherapy to standard cancer care be safe for indian patients?
- App-based symptom tracking may cut hospital visits for advanced cancer patients
- Can a new gemcitabine formulation outsmart advanced solid tumors?