CholangiocarcinomaPhase 2/3NCT07598318
Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations
A Phase 2/3 study testing Becotatug Vedotin, Pucotenlimab and Gemcitabine in people with Cholangiocarcinoma, run by Sir Run Run Shaw Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Becotatug Vedotin, Pucotenlimab and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2026to 31 Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Controlled, Open-Label, Multi-center Study of Becotatug Vedotin (EGFR-ADC) Combined With Chemo and Immunotherapy vs. Chemo and Immunotherapy as First-Line Treatment in Advanced/Metastatic EGFR-Mutated Biliary Tract Cancer
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.
- Conditions
- Cholangiocarcinoma
- Being tested
- Becotatug Vedotin, Pucotenlimab, Gemcitabine, Cisplatin
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug VedotinDrug
Becotatug Vedotin：2mg/kg，IV，Q3W，D1
PucotenlimabDrug
Pucotenlimab：200mg，IV，Q3W，D1
GemcitabineDrug
Gemcitabine：1000mg/m²，IV，D1、D8，Q3W. Each course lasts for 8 weeks. The maximum treatment duration is 8 courses.
CisplatinDrug
Cisplatin：25mg/m²，IV，D1、D8，Q3W. Each course lasts for 8 weeks. The maximum treatment duration is 8 courses.
| Study group | Role | What they receive |
|---|---|---|
| Becotatug Vedotin Intervention Arm | Experimental | Becotatug Vedotin + Pucotenlimab + Gemcitabine + Cisplatin Receives: Drug: Becotatug Vedotin; Drug: Pucotenlimab; Drug: Gemcitabine; Drug: Cisplatin |
| No Becotatug Vedotin Control Arm | Active comparator | Pucotenlimab + Gemcitabine + Cisplatin Receives: Drug: Pucotenlimab; Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Measured: After two treatment cycles（each cycle is 28 days）
Secondary outcomes (4)
PFS
Measured: After two treatment cycles（each cycle is 28 days）
DCR
Measured: After two treatment cycles（each cycle is 28 days）
DOR
Measured: After two treatment cycles（each cycle is 28 days）
OS
Measured: After two treatment cycles（each cycle is 28 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start20 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598318
- Sponsor's protocol ID
- SRRSH2026-0432
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-Label, Multi-center Study of Becotatug Vedotin (EGFR-ADC) Combined With Chemo and Immunotherapy vs. Chemo and Immunotherapy as First-Line Treatment in Advanced/Metastatic EGFR-Mutated Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT07598318
- Acronym / sponsor ID
- SRRSH2026-0432
- Conditions
- Cholangiocarcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Becotatug Vedotin Intervention Arm | Experimental | Drug: Becotatug Vedotin, Drug: Pucotenlimab, Drug: Gemcitabine, Drug: CisplatinBecotatug Vedotin + Pucotenlimab + Gemcitabine + Cisplatin |
| No Becotatug Vedotin Control Arm | Active comparator | Drug: Pucotenlimab, Drug: Gemcitabine, Drug: CisplatinPucotenlimab + Gemcitabine + Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Becotatug VedotinBecotatug Vedotin：2mg/kg，IV，Q3W，D1 | Drug | Becotatug Vedotin Intervention Arm |
| PucotenlimabPucotenlimab：200mg，IV，Q3W，D1 | Drug | Becotatug Vedotin Intervention Arm, No Becotatug Vedotin Control Arm |
| GemcitabineGemcitabine：1000mg/m²，IV，D1、D8，Q3W. Each course lasts for 8 weeks. The maximum treatment duration is 8 courses. | Drug | Becotatug Vedotin Intervention Arm, No Becotatug Vedotin Control Arm |
| CisplatinCisplatin：25mg/m²，IV，D1、D8，Q3W. Each course lasts for 8 weeks. The maximum treatment duration is 8 courses. | Drug | Becotatug Vedotin Intervention Arm, No Becotatug Vedotin Control Arm |
Primary outcome
ORR
Time frame: After two treatment cycles（each cycle is 28 days）
4 secondary outcomes
PFS
Time frame: After two treatment cycles（each cycle is 28 days）
DCR
Time frame: After two treatment cycles（each cycle is 28 days）
DOR
Time frame: After two treatment cycles（each cycle is 28 days）
OS
Time frame: After two treatment cycles（each cycle is 28 days）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Becotatug Vedotin, Pucotenlimab and Gemcitabine in people with Cholangiocarcinoma, run by Sir Run Run Shaw Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingyu Chen (+86 18757772223, mychen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: After two treatment cycles（each cycle is 28 days）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.