Actively Recruiting
A Phase III Study of SHR-A1811 in Combination With Chemotherapy and Adebrelimab in Previously Untreated Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-02-11
600
Participants Needed
2
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of SHR-A1811 combined with chemotherapy and immune checkpoint inhibitor versus standard first-line therapy in gastric or gastroesophageal junction adenocarcinoma.
CONDITIONS
Official Title
A Phase III Study of SHR-A1811 in Combination With Chemotherapy and Adebrelimab in Previously Untreated Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years (inclusive), male or female
- Histologically or cytologically confirmed untreated, locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
- ECOG performance status score of 0 to 1
- Body weight 65 35 kg
- Life expectancy 6512 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
- Tumor tissue samples must be provided, with newly obtained tissues preferred
- Adequate bone marrow and organ function
- Women of childbearing potential must agree to abstinence or use highly effective contraception from consent until 7 months after last dose
- Male patients with partners of childbearing potential must agree to abstinence or use highly effective contraception from consent until 7 months after last dose
- Capable of giving informed consent and willing to comply with study procedures
You will not qualify if you...
- Current or previous meningeal metastases or active brain metastases
- Ascites, pleural effusion, or pericardial effusion requiring treatment within 2 weeks before randomization
- Other malignant tumors within 3 years before randomization
- Use of traditional Chinese medicine with anti-tumor indications within 2 weeks before randomization
- Unresolved adverse reactions from previous anti-tumor treatment above Grade 1
- Use of other non-marketed clinical investigational products within 4 weeks before randomization
- Major surgery or significant trauma within 4 weeks before randomization
- Active or history of autoimmune diseases
- Known or suspected interstitial lung disease or severe lung diseases affecting respiratory function within 3 months before randomization
- History of active tuberculosis within 1 year before randomization or untreated past tuberculosis
- History of immunodeficiency including HIV, active hepatitis B or C
- Previous allogeneic hematopoietic stem cell or organ transplantation
- Severe cardiovascular or cerebrovascular diseases
- Active bleeding Grade 2 or higher
- Gastrointestinal perforation, fistula, or abdominal infection within 3 months before randomization
- Uncontrollable tumor-related pain or symptomatic hypercalcemia
- Peripheral neuropathy Grade above 1
- Vaccination with live attenuated vaccine within 28 days prior to randomization
- Previous use of anti-HER2 antibody-drug conjugates
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
2
Zhongshan Hospital，Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
S
Shi Wei SUN
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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