CholangiocarcinomaPhase 2NCT07514533
The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma
A Phase 2 study testing Vibecototamab（iv）+Putilimab（iv） in people with Cholangiocarcinoma, run by Sir Run Run Shaw Hospital.
Trial summary
(1) Primary efficacy endpoint: Objective Response Rate (ORR) after 2 treatment cycles. ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) among all subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Vibecototamab（iv）+Putilimab（iv）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2026to 31 Dec 2027
- Phase
- Phase 2
- 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
- 1) Age ≥ 18 years old, both male and female are acceptable. 2) Histologically confirmed unresectable or metastatic cholangiocarcinoma (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma), or (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma, after previous chemotherapy failure); 3) ECOG PS score 0-1. 4) Normal major organ functions, without severe blood, heart, lung, liver, kidney, bone marrow, or immune deficiency diseases.
- 5) For female subjects 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 subjects, surgical sterilization or consent to use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug is required.
- 6) IHC test is positive for EGFR. 7) Expected good compliance and able to follow up on efficacy and adverse reactions as per the protocol.
- 8) Voluntary participation in this study and signing the informed consent form. If the subject is unable to read and sign the informed consent form due to lack of capacity, the guardian should act on behalf of the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (such as illiterate subjects), a witness should witness the informed process and sign the informed consent form.
Who cannot join
- 1) Received PD1, PDL1, PDL2, CTLA4 treatment before enrollment, or directly received another stimulating or co-inhibitory T cell receptor (such as CTLA-4, OX40, CD137) treatment.
- 2) Used any other study drug within 4 weeks before enrollment. 3) Has any active autoimmune disease or autoimmune disease history (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (after hormone replacement therapy can be included)); has completely resolved childhood asthma and no need for any intervention after adulthood, and can be included, but patients requiring medical intervention with bronchodilators are not included.
- 4) Has congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection.
- 5) Has uncontrolled clinical symptoms or diseases of the heart, such as NYHA II or above heart failure, unstable angina pectoris, heart attack within 1 year, patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
- 6) Had severe infection within 4 weeks before the first administration (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or had unexplained fever > 38.5℃ during screening or before the first administration.
- 7) Has a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
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- 8) Had a live attenuated vaccine administered within 4 weeks before the first administration or is planned to be administered during the study period.
- 9) Had other systemic malignant tumors within the last 5 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ and ovarian cancer).
- 10) Has known allergies to any study drug. 11) Pregnant or lactating women, subjects with reproductive capacity who are unwilling to take effective contraceptive measures.
- 12) Vulnerable groups other than the elderly or illiterate, including those with mental illness, cognitive impairment, critically ill patients, etc.
- 13) Other situations considered by the investigator as not suitable for inclusion in this study. Such as: the patient already has central nervous system metastasis. There are serious laboratory test abnormalities, accompanied by factors related to family or society, which may affect the safety of the subjects 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
(1) Primary efficacy endpoint: Objective Response Rate (ORR) after 2 treatment cycles. ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) among all subjects. (2) Secondary efficacy endpoints include Progression-Free Survival (PFS), 2-year Relapse-Free Survival Rate, Disease Control Rate (DCR), Duration of Response (DOR), Adverse Reaction Incidence, 1-year Overall Survival Rate, 2-year Overall Survival Rate. Safety assessment includes physical examination, physical condition assessment (based on ECOG score), clinical laboratory tests and concomitant medication status. All observed drug toxicities and side effects need to be classified according to NCICTCAE and evaluated for their correlation with the drug. Patient Quality of Life (QoL) assessment uses the EORTC QLQC30 questionnaire and the BIL21 questionnaire. Recurrence patterns are classified as local recurrence and distant recurrence. Local control status is defined as the local failure rate (occurrence of local recurrence or local lymph node metastasis).
- Conditions
- Cholangiocarcinoma
- Being tested
- Vibecototamab（iv）+Putilimab（iv）
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibecototamab（iv）+Putilimab（iv）Drug
- Becotatugvedotin: 2mg/kg, intravenous, every 3 weeks, on day 1
- pucotenlimab： 200mg, intravenous, every 3 weeks, on day 1 During administration, the pucotenlimab infusion should be completed at least 30 minutes before starting the Becotatugvedotin administration, via intravenous drip (60±10 minutes, the administration time for the first cycle should be ≥ 60 minutes). For patients who cannot tolerate the 60-minute infusion, the infusion time can be appropriately extended to 120 minutes. During the maintenance treatment phase, if any of the drugs is intolerable, another drug can be used for maintenance treatment. The investigator will assess whether to resume the medication based on the patient's recovery status. After 3-4 weeks after 3 courses, a re-examination and assessment will be conducted. For CR, PR, and SD, direct surgery will be performed. If PD, surgery or termination of the trial will be carried out.
| Study group | Role | What they receive |
|---|---|---|
| pucotenlimab（iv）+ Becotatugvedotin（iv） | Experimental | Not described Receives: Drug: Vibecototamab（iv）+Putilimab（iv） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: 2 year
Secondary outcomes (6)
progression-free survival (PFS)
Measured: 2 year
2-year disease-free survival rate
Measured: 2 year
duration of response (DOR)
Measured: 2 year
occurrence of adverse reactions
Measured: 2 year
1-year overall survival rate
Measured: 1 year
2-year overall survival rate
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start11 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT07514533
- Sponsor's protocol ID
- SRRSH2025-0969
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT07514533
- Acronym / sponsor ID
- SRRSH2025-0969
- Conditions
- Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 11 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Apr 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.
(1) Primary efficacy endpoint: Objective Response Rate (ORR) after 2 treatment cycles. ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) among all subjects. (2) Secondary efficacy endpoints include Progression-Free Survival (PFS), 2-year Relapse-Free Survival Rate, Disease Control Rate (DCR), Duration of Response (DOR), Adverse Reaction Incidence, 1-year Overall Survival Rate, 2-year Overall Survival Rate. Safety assessment includes physical examination, physical condition assessment (based on ECOG score), clinical laboratory tests and concomitant medication status. All observed drug toxicities and side effects need to be classified according to NCICTCAE and evaluated for their correlation with the drug. Patient Quality of Life (QoL) assessment uses the EORTC QLQC30 questionnaire and the BIL21 questionnaire. Recurrence patterns are classified as local recurrence and distant recurrence. Local control status is defined as the local failure rate (occurrence of local recurrence or local lymph node metastasis).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pucotenlimab（iv）+ Becotatugvedotin（iv） | Experimental | Drug: Vibecototamab（iv）+Putilimab（iv） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1) Age ≥ 18 years old, both male and female are acceptable. 2) Histologically confirmed unresectable or metastatic cholangiocarcinoma (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma), or (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma, after previous chemotherapy failure); 3) ECOG PS score 0-1. 4) Normal major organ functions, without severe blood, heart, lung, liver, kidney, bone marrow, or immune deficiency diseases.
- 5) For female subjects 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 subjects, surgical sterilization or consent to use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug is required.
- 6) IHC test is positive for EGFR. 7) Expected good compliance and able to follow up on efficacy and adverse reactions as per the protocol.
- 8) Voluntary participation in this study and signing the informed consent form. If the subject is unable to read and sign the informed consent form due to lack of capacity, the guardian should act on behalf of the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (such as illiterate subjects), a witness should witness the informed process and sign the informed consent form.
Key exclusion criteria (11 listed)
- 1) Received PD1, PDL1, PDL2, CTLA4 treatment before enrollment, or directly received another stimulating or co-inhibitory T cell receptor (such as CTLA-4, OX40, CD137) treatment.
- 2) Used any other study drug within 4 weeks before enrollment. 3) Has any active autoimmune disease or autoimmune disease history (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (after hormone replacement therapy can be included)); has completely resolved childhood asthma and no need for any intervention after adulthood, and can be included, but patients requiring medical intervention with bronchodilators are not included.
- 4) Has congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection.
- 5) Has uncontrolled clinical symptoms or diseases of the heart, such as NYHA II or above heart failure, unstable angina pectoris, heart attack within 1 year, patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
- 6) Had severe infection within 4 weeks before the first administration (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 |
|---|---|---|
| Vibecototamab（iv）+Putilimab（iv）1. Becotatugvedotin: 2mg/kg, intravenous, every 3 weeks, on day 1 2. pucotenlimab： 200mg, intravenous, every 3 weeks, on day 1 During administration, the pucotenlimab infusion should be completed at least 30 minutes before starting the Becotatugvedotin administration, via intravenous drip (60±10 minutes, the administration time for the first cycle should be ≥ 60 minutes). For patients who cannot tolerate the 60-minute infusion, the infusion time can be appropriately extended to 120 minutes. During the maintenance treatment phase, if any of the drugs is intolerable, another drug can be used for maintenance treatment. The investigator will assess whether to resume the medication based on the patient's recovery status. After 3-4 weeks after 3 courses, a re-examination and assessment will be conducted. For CR, PR, and SD, direct surgery will be performed. If PD, surgery or termination of the trial will be carried out. | Drug | pucotenlimab（iv）+ Becotatugvedotin（iv） |
Primary outcome
Objective response rate (ORR)
Time frame: 2 year
6 secondary outcomes
progression-free survival (PFS)
Time frame: 2 year
2-year disease-free survival rate
Time frame: 2 year
duration of response (DOR)
Time frame: 2 year
occurrence of adverse reactions
Time frame: 2 year
1-year overall survival rate
Time frame: 1 year
2-year overall survival rate
Time frame: 2 year
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 7 Apr 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 study testing Vibecototamab（iv）+Putilimab（iv） 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 4 inclusion and 11 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 7 Apr 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 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.
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?
Objective response rate (ORR) (time frame: 2 year). 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 7 Apr 2026.