Actively Recruiting
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2024-07-08
65
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old, male or female
- ECOG performance status score of 0 or 1
- Expected survival of at least 12 weeks
- Diagnosed with locally advanced or recurrent metastatic biliary tract cancer unsuitable for surgery, transplantation, or ablation
- Failed or intolerant to systemic chemotherapy
- At least one measurable lesion according to RECIST v1.1 criteria
- Normal main organ function meeting study requirements
- If active hepatitis B infection, HBV-DNA less than 500 IU/mL
- Agree to use contraception
You will not qualify if you...
- Received chemotherapy, radiotherapy, immunotherapy, biotherapy, or other clinical trial drugs within 4 weeks before starting study treatment
- History or evidence of brain or meningeal metastasis
- Acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C
- Severe trauma or major surgery within 4 weeks before study treatment
- Severe heart disease within 6 months before study treatment
- Uncontrolled moderate or severe pleural effusion, ascites, or pericardial effusion requiring drainage
- Severe infection within 2 weeks before study treatment
- Known hereditary or acquired bleeding or clotting disorders
- Congenital or acquired immune deficiencies
- Severe, uncontrolled other diseases
- Stroke, pulmonary embolism, or deep vein thrombosis within 6 months before study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital，Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
S
Shiwei Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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