Actively Recruiting
SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2024-12-12
524
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients
CONDITIONS
Official Title
SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old (including boundary values)
- Volunteered and signed informed consent
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Diagnosed with gastric or gastroesophageal junction adenocarcinoma
- Positive Claudin18.2 expression in tumor tissue
- At least one measurable or evaluable lesion per RECIST 1.1 criteria
- Adequate bone marrow and organ function
You will not qualify if you...
- Received chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before first study dose
- HER2 positive (IHC 3+ or IHC 2+/ISH +)
- Toxicities from previous anticancer therapy not recovered to CTCAE 5.0 Grade 1 or lower
- Presence of leptomeningeal metastasis or active brain metastases
- History of gastrointestinal perforation, fistula, or unstable gastrointestinal bleeding
- History of severe cardiovascular or cerebrovascular diseases
- Any other condition deemed unsuitable for participation by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Q
Qi Shi
CONTACT
L
Liang Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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