Cancer of Biliary DuctPhase 2NCT07472933
Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies
A Phase 2 study testing Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumors in people with Cancer of Biliary Duct, run by West China Hospital at 1 site in China.
Trial summary
This study aims to observe the efficacy and safety of the combination of vebecotototo monoclonal antibody and putli monoclonal antibody in the treatment of EGFR-positive refractory biliary malignant tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer of Biliary Duct
- What is being tested?
- Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 29 Feb 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years, regardless of gender;
- Patients with locally advanced or metastatic biliary tract malignancies confirmed by histopathological or cytological examination;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- EGFR immunohistochemistry (IHC) score ≥1+ as assessed by pathology laboratory;
- Previously received at least one line of systemic therapy;
- At least one measurable target lesion assessable by CT or MRI according to RECIST 1.1 criteria;
Show all 17Show fewer
- Laboratory parameters meeting the following requirements:
- ① Bone marrow function: hemoglobin (Hb) ≥90 g/L; white blood cell count (WBC) ≥lower limit of normal; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count ≥75×10⁹/L;
- ② Renal function: creatinine (Cr) ≤ upper limit of normal (ULN) ×1.5; creatinine clearance (Ccr) ≥55 mL/min;
- ③ Liver function: total bilirubin ≤ULN ×1.5; ALT and AST ≤ULN ×2.5; (for intrahepatic cholangiocarcinoma or patients with liver metastases, total bilirubin must not exceed 3 times ULN, and transaminases must not exceed 5 times ULN);
- ④ Coagulation function: international normalized ratio (INR) ≤ULN ×1.5, and activated partial thromboplastin time (aPTT) within normal range;
- Female of childbearing potential agrees to use effective contraception during the study and for 6 months after study completion; negative serum or urine pregnancy test within 7 days prior to enrollment, and non-lactating; male participants agree to use effective contraception during the study and for 6 months after study completion;
- No participation in other clinical trials involving investigational drugs within 4 weeks prior to enrollment;
- The subject understands the study and voluntarily signs an informed consent form;
- No severe complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or fever >38°C unrelated to cancer;
- Expected good compliance, able to follow up for efficacy and adverse events as per protocol;
- Estimated survival time greater than 3 months.
Who cannot join
- History of another malignant tumor diagnosed within the past 5 years (except carcinoma in situ, basal cell carcinoma, etc.);
- Known central nervous system metastasis (except those with stable disease control and no symptoms after radiotherapy or surgery for at least 4 weeks), or evidence of carcinomatous meningitis;
- Presence of psychiatric or neurological disorders preventing cooperation;
- Prior exposure to ADC drugs carrying MMAE payload;
- Intention to undergo or history of organ or bone marrow transplantation;
- Active autoimmune disease or history of autoimmune disease;
Show all 14Show fewer
- Administration of live vaccines within 30 days prior to first dose (use of injectable seasonal influenza vaccine is permitted, as it is an inactivated vaccine);
- Uncontrolled cardiac symptoms or disease;
- Active infection or fever (excluding documented tumor-related fever);
- History or evidence of interstitial lung disease or active non-infectious pneumonia;
- Other medical conditions making the patient unsuitable for enrollment, such as immunodeficiency, active tuberculosis, hepatitis B (eligible if HBV-DNA <1000 IU/mL after treatment and liver function is normal), positive hepatitis C virus test, uncorrectable electrolyte disturbances, uncontrollable pericardial effusion, pleural effusion, or ascites;
- Allergy to any drug in this regimen;
- Use of immunosuppressive drugs or corticosteroids exceeding 10 mg/day prednisone equivalent dose within 14 days prior to enrollment. (14) Patients who have received radiation therapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment;
- Pregnant or breastfeeding women; (16) Patients deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Dan Cao, 86-28-85422589, caodan@scu.edu.cn
About this study
Official title: An Exploratory Study of Vedotin-tislelizumab Combined With Toripalimab in EGFR-positive Refractory Advanced Biliary Tract Malignancies
This study aims to observe the efficacy and safety of the combination of vebecotototo monoclonal antibody and putli monoclonal antibody in the treatment of EGFR-positive refractory biliary malignant tumors.
- Conditions
- Cancer of Biliary Duct
- Being tested
- Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumorsDrug
This study is a single-arm, prospective, phase II clinical trial, aiming to enroll patients with advanced biliary system tumors who have failed at least one line of standard treatment and are positive for EGFR. After the subjects sign the informed consent, those who are confirmed to meet the inclusion criteria undergo treatment with puzelimab, 200mg per dose, intravenous infusion on D1, once every 3 weeks; vibercept, 2.0mg/kg, intravenous infusion on D1, once every 3 weeks. The combination therapy will continue until disease progression or intolerable side effects occur.
| Study group | Role | What they receive |
|---|---|---|
| Vibecototamab combined with Putilimab | Experimental | This study is a single-arm, prospective, phase II clinical trial, aiming to enroll patients with advanced biliary system tumors who have failed at least one line of standard treatment and are positive for EGFR. Receives: Drug: Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate (ORR)
Description: The total number of participants in the intention-to-treat (ITT) population who achieve a complete response (CR) or partial response (PR) will be considered valid, and the statistical results were used to calculate the ORR based on imaging (CT/MRI) using the RECIST v1.1 criteria.
Measured: Up to 2 years
Secondary outcomes (3)
PFS
Progression-free survival (PFS): It refers to the period from the first day of using the study drug until the first radiological assessment of disease progression (PD) or death due to any cause. If the subject does not experience PD or death by the study's cut-off date, or has received other anti-tumor treatment, the last efficacy assessment result before the cut-off date or the start date of other anti-tumor treatment (whichever occurs first) will be used as the censored time.
Measured: Up to 2 years
Disease Control Rate (DCR)
The percentage of cases that achieved remission and stable lesion after treatment among all the evaluable cases.
Measured: Up to 2 years
Overall Survival (OS)
It refers to the period from the day the research drug was first used until death occurred for any reason. The end For the subjects who were still alive at the next follow-up, their OS was defined as data censored based on the last follow-up time. For the subjects who were lost to follow-up, their OS was defined as data censored based on the last confirmed survival time before the loss. The definition of censored OS is the time from enrollment to censoring.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Aug 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Biliary DuctStudies of the same condition, open and under way.
- More trials run by West China 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
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Cao, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472933
- Sponsor's protocol ID
- 2026（225）
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Vedotin-tislelizumab Combined With Toripalimab in EGFR-positive Refractory Advanced Biliary Tract Malignancies
- ClinicalTrials.gov ID
- NCT07472933
- Acronym / sponsor ID
- 2026（225）
- Conditions
- Cancer of Biliary Duct
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 16 Mar 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 aims to observe the efficacy and safety of the combination of vebecotototo monoclonal antibody and putli monoclonal antibody in the treatment of EGFR-positive refractory biliary malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibecototamab combined with Putilimab | Experimental | Drug: Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumorsThis study is a single-arm, prospective, phase II clinical trial, aiming to enroll patients with advanced biliary system tumors who have failed at least one line of standard treatment and are positive for EGFR. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 18 to 75 years, regardless of gender;
- Patients with locally advanced or metastatic biliary tract malignancies confirmed by histopathological or cytological examination;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- EGFR immunohistochemistry (IHC) score ≥1+ as assessed by pathology laboratory;
- Previously received at least one line of systemic therapy;
Key exclusion criteria (14 listed)
- History of another malignant tumor diagnosed within the past 5 years (except carcinoma in situ, basal cell carcinoma, etc.);
- Known central nervous system metastasis (except those with stable disease control and no symptoms after radiotherapy or surgery for at least 4 weeks), or evidence of carcinomatous meningitis;
- Presence of psychiatric or neurological disorders preventing cooperation;
- Prior exposure to ADC drugs carrying MMAE payload;
- Intention to undergo or history of organ or bone marrow transplantation;
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 |
|---|---|---|
| Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumorsThis study is a single-arm, prospective, phase II clinical trial, aiming to enroll patients with advanced biliary system tumors who have failed at least one line of standard treatment and are positive for EGFR. After the subjects sign the informed consent, those who are confirmed to meet the inclusion criteria undergo treatment with puzelimab, 200mg per dose, intravenous infusion on D1, once every 3 weeks; vibercept, 2.0mg/kg, intravenous infusion on D1, once every 3 weeks. The combination therapy will continue until disease progression or intolerable side effects occur. | Drug | Vibecototamab combined with Putilimab |
Primary outcome
overall response rate (ORR)
Time frame: Up to 2 years
Description: The total number of participants in the intention-to-treat (ITT) population who achieve a complete response (CR) or partial response (PR) will be considered valid, and the statistical results were used to calculate the ORR based on imaging (CT/MRI) using the RECIST v1.1 criteria.
3 secondary outcomes
PFS
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
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 14 Jul 2026.
Related trials for Cancer of Biliary Duct
RecruitingPhase 1/2
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
Biliary Cancer, Bile Duct Cancer
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1/2
SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET
Solid Tumor, NSCLC
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumors in people with Cancer of Biliary Duct, run by West China Hospital at 1 site in China.
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 17 inclusion and 14 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 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Dan Cao (86-28-85422589, caodan@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (ORR) (time frame: Up to 2 years). 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 14 Jul 2026.