Actively Recruiting
Clinical Study of Adebrelimab Therapy in the Perioperative Treatment of Gastric Cancer or Gastroesophageal Junction Cancer
Led by Shanghai Shengdi Pharmaceutical Co., Ltd · Updated on 2026-05-13
874
Participants Needed
1
Research Sites
403 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was a randomized, double-blind, multi-center phase III clinical trial to evaluate the event-free survival (EFS) of Adebrelimab with S-1 and oxaliplatin versus placebo combined with S-1 and oxaliplatin, and to evaluate the efficacy, safety and tolerability of the two combination regimens.
CONDITIONS
Official Title
Clinical Study of Adebrelimab Therapy in the Perioperative Treatment of Gastric Cancer or Gastroesophageal Junction Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pathologically confirmed gastric cancer or gastroesophageal junction cancer
- Age 18 years or older but younger than 75 years, any gender
- Investigator evaluation indicating suitability for neoadjuvant therapy plus radical surgery
- Cancer stage according to the 8th edition AJCC gastric cancer staging criteria
- Availability of fresh or recent tumor tissue specimen obtained within 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of 6 months or more
- Adequate organ and bone marrow function
- Female participants must have a negative pregnancy test and not be breastfeeding; agreement to use contraception during and for 6 months after treatment
- Signed informed consent and willingness to comply with study visits and procedures
You will not qualify if you...
- Gastric cancer types including squamous cell carcinoma, undifferentiated carcinoma, or mixed histological types
- Gastric esophageal junction cancer Siewert type I, or type II with esophageal invasion length 4 cm or more, or unsuitable for staging or surgery
- Weight loss over 20% in the 2 months before enrollment
- Previous anti-tumor treatments for gastric or gastroesophageal junction cancer
- Known allergy to study drugs or related monoclonal antibodies
- History of other cancers within 5 years except certain treated skin, bladder, cervical, breast, or thyroid cancers
- Immunodeficiency conditions or organ transplantation history
- Active autoimmune diseases requiring systemic treatment
- Severe untreated wounds, ulcers, or fractures
- Active severe digestive diseases
- Interstitial pneumonia or lung disease
- Severe cardiovascular or metabolic diseases
- Active hepatitis B or C infection or co-infection
- Active tuberculosis within 1 year or untreated past infection
- Severe infections within 4 weeks before enrollment
- History of drug abuse or addiction
- Other serious physical or mental conditions that increase risk or interfere with the study as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 10000
Actively Recruiting
Research Team
B
Bin Bai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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