Actively Recruiting
SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2024-01-16
360
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will assess the efficacy and safety of SHR-A1811 compared with treatment chosen by the investigator in participants with HER2-positive (defined as immunohistochemistry \[IHC\] 3+ or IHC 2+/in situ hybridization \[ISH\]+) gastric or GEJ adenocarcinoma (based on \[American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines who have progressed on or after a first-line anti-HER2 therapy-containing regimen.
CONDITIONS
Official Title
SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, any gender
- Confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma that is locally advanced and cannot be removed by surgery or is metastatic
- Previously treated with anti-HER2 therapy
- Cancer progression after first-line standard treatment, including progression within 6 months after neoadjuvant or adjuvant therapy
- HER2-positive status confirmed by specific laboratory tests following ASCO-CAP guidelines
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time of at least 12 weeks
- Adequate blood count and liver, kidney, and coagulation function
- Willingness to provide informed consent for participation
You will not qualify if you...
- Received any anti-cancer therapy within 4 weeks before the first dose in this study
- Known allergies to monoclonal antibodies or ingredients in the study drugs, including paclitaxel, docetaxel, or irinotecan
- Incomplete recovery from side effects of previous cancer treatments, not meeting specified safety levels
- Active brain metastases
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Significant gastrointestinal disorders, as judged by the investigator
- History of immunodeficiency or positive HIV test
- Unexplained fever over 38.5°C, severe infection, or active lung inflammation at screening
- Current or prior severe interstitial pneumonia or related lung conditions
- Active hepatitis B or hepatitis C infection above specified levels
- Significant heart disease or unstable heart conditions, including recent heart attack or stroke
- Prolonged QT interval on ECG or reduced heart function
- Uncontrolled high blood pressure
- Other cancers diagnosed within the past 5 years
- Pregnant or breastfeeding women
- Other factors that might cause study dropout as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
Y
Yang Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here