Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally … (NCT06413745) | Clinical Trial Compass
UnknownPhase 2
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
China65 participantsStarted 2024-06-04
Plain-language summary
This study was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic treatment.
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 18-75 years old ( including both ends ), male or female ;
. ECOG-PS score : 0 or 1;
. Expected survival ≥ 12 weeks;
. Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation;
. Subjects who failed or intolerance after systemic chemotherapies;
. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion；
. The main organ function is normal, in line with the program requirements ;
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.
What they're measuring
1
ORR evaluated by IRC according to RECIST v1.1 standard
. If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be \< 500 IU / mL；
Exclusion criteria
. Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
. Subjects with a history or evidence of brain metastasis or meningeal metastasis ;
. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C ;
. Severe trauma or major surgery was performed within 4 weeks before the first administration;
. To study the severe heart disease within 6 months before the first administration ;
. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage ;
. Severe infection symptoms occurred within 2 weeks before the first administration;
. Known hereditary or acquired bleeding and thrombotic tendency ;