Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-75 years old ( including both ends ), male or female ;
2. ECOG-PS score : 0 or 1;
3. Expected survival ≥ 12 weeks;
4. Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation;
5. Subjects who failed or intolerance after systemic chemotherapies;
6. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
7. The main organ function is normal, in line with the program requirements ;
8. If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be \< 500 IU / mL;
9. Consent to contraception.
Exclusion Criteria:
1. Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
2. Subjects with a history or evidence of brain metastasis or meningeal metastasis ;
3. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C ;
4. Severe trauma or major surgery was performed within 4 weeks before the first administration;
5. To study the severe heart disease within 6 months before the first administration ;
6. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage ;
7. Severe infection symptoms occurred within 2 weeks before the first administration;
8. Known hereditary or acquired bleeding and thrombotic tendency ;
9. Congenital or acquired immune defects;
10. The subjects had severe and uncontrollable concomitant diseases;
11. Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study;
Primary outcome measure(s)
ORR evaluated by IRC according to RECIST v1.1 standard — About a year
Trial sites (1)
Facility
City
Region
Status
Zhongshan Hospital,Fudan University
Shanghai
Shanghai Municipality
More Jiangsu HengRui Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.