๐ฌIn plain words
What the trial is, and whether it could suit you
This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Age 18-75 years old (including both ends), male or female;
2. ECOG-PS score: 0 or 1;
3. Expected survival โฅ 12 weeks;
4. Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
5. CLDN18.2 positive expression;
6. Subjects who failed or intolerance after systemic chemotherapies;
7. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
8. The main organ function is normal, in line with the program requirements;
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. Other active malignancies within 5 years or at the same time;
3. Subjects with a history or evidence of brain metastasis or meningeal metastasis;
4. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C;
5. Severe trauma or major surgery was performed within 4 weeks before the first administration;
6. To study the severe heart disease within 6 months before the first administration;
7. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage;
8. Severe infection symptoms occurred within 2 weeks before the first administration;
9. Known hereditary or acquired bleeding and thrombotic tendency;
10. Congenital or acquired immune defects;
11. The subjects had severe and uncontrollable concomitant diseases;
12. Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Zhongshan Hospital, Fudan University
Shanghai, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.