Actively Recruiting
A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-03-06
54
Participants Needed
2
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open, multicenter Phase II clinical trial to evaluate the efficacy and safety of the SHR-A1811 combination in HER2 positive patients with locally advanced or metastatic biliary tract cancer.
CONDITIONS
Official Title
A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old, male or female
- ECOG-PS score of 0 or 1
- Expected survival of at least 12 weeks
- Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology
- No prior systemic antitumor therapy; previous radical therapy allowed if last dose was at least 6 months before disease recurrence
- At least one measurable lesion according to RECIST v1.1
- Normal main organ function per study requirements
- Consent to contraception
You will not qualify if you...
- Other active cancers within 5 years or at the same time
- Local antitumor therapy within 4 weeks before starting treatment
- Presence of biliary obstruction
- Active autoimmune disease or history of autoimmune disease that may recur
- Known or suspected interstitial pneumonia or interstitial lung disease, or history requiring hormone therapy
- Severe infection within 4 weeks before starting treatment
- Active hepatitis B virus infection
- Serious cardiovascular and cerebrovascular diseases
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Actively Recruiting
2
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
T
Tingting Lei, BM
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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