Not Yet RecruitingPhase 2/3

Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations

164 participantsStarted 2026-05-20

Plain-language summary

This study tests whether adding becotatug vedotin (EGFR-ADC) to standard chemotherapy plus immunotherapy improves outcomes compared to chemotherapy plus immunotherapy alone as first-line treatment for patients with advanced or metastatic biliary tract cancer whose tumors carry EGFR mutations. Participants will be randomly assigned to receive either the experimental combination (becotatug vedotin + pucotenlimab + gemcitabine + cisplatin) or the control combination (pucotenlimab + gemcitabine + cisplatin). The main goal is to see if the experimental group has a higher objective response rate (tumor shrinkage rate). This is a randomized, controlled, open-label, multicenter study led by Sir Run Run Shaw Hospital, Zhejiang University, with Dr. Chen Mingyu as the principal investigator.

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: * 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 …

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.

1This trial is testing becotatug vedotin added to standard treatment specifically for bile duct cancer with EGFR mutations — can you test whether my tumor has an EGFR mutation to see if this would even be relevant for me?
2Since this trial is Phase 2/3 and hasn't started recruiting yet, what does that mean for how much is already known about the safety of becotatug vedotin, and are there any earlier-phase results my care team could review?
3The trial is measuring response rate as its main goal — can you explain what that means practically, and how that would help me understand whether this drug is actually working if I were to participate?
4Because the trial isn't recruiting yet, is there a realistic timeline for when it might open, and in the meantime, what standard treatment options should I be considering so I don't delay care while waiting?
5If my cancer does have an EGFR mutation, how does this trial's approach of adding becotatug vedotin to standard treatment compare to what's already available to me, and would enrolling potentially mean I'd be giving up any current standard-of-care options?

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

ORR

Timeframe: After two treatment cycles（each cycle is 28 days）

Trial details

NCT IDNCT07598318

SponsorSir Run Run Shaw Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Mingyu Chen

+86 18757772223 mychen@zju.edu.cn

View on ClinicalTrials.gov More Cholangiocarcinoma trials