Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies (NCT07472933) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies
China49 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 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 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;
. Laboratory parameters meeting the following requirements:
. 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;
Exclusion criteria
. History of another malignant tumor diagnosed within the past 5 years (except carcinoma in situ, basal cell carcinoma, etc.);
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
. 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;
. 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);