Actively Recruiting
A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-01-09
200
Participants Needed
2
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-cohort, multi-center Phase II clinical study exploring the efficacy of treatment with either Adebrelimab plus SHR-A1811/SHR-A1904 and chemotherapy, or Adebrelimab plus SHR-8068 in patients with gastric or gastroesophageal junction (GEJ) cancer. The study also evaluates the safety and tolerability of these combination regimens.
CONDITIONS
Official Title
A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma with no prior anti-tumor therapy for this cancer
- Age between 18 and 70 years, any gender
- Ability to provide fresh tumor tissue or archival tumor samples obtained within 6 months before enrollment
- Availability of biomarker testing results before enrollment
- ECOG performance status of 0 or 1
- Life expectancy of at least 6 months
- Adequate organ and bone marrow function
- Female participants must be either non-childbearing potential or have a negative pregnancy test within 3 days before treatment and not be breastfeeding
- Childbearing-potential participants and their partners must agree to avoid sperm/ovum donation and use contraception from consent signing until 8 months after last dose
- Signed informed consent and ability to comply with study visits, treatments, and procedures
You will not qualify if you...
- Diagnosis of squamous cell carcinoma, undifferentiated carcinoma, mixed adenocarcinoma with other histologic types, or other non-adenocarcinoma gastric cancers
- Weight loss of 20% or more within 2 months before enrollment
- Prior anti-tumor therapy for gastric or gastroesophageal junction cancer
- Participation in other drug trials within 4 weeks or 5 half-lives before enrollment
- Major surgery within 28 days before enrollment
- Live attenuated vaccination within 28 days before enrollment or planned within 60 days after treatment
- Known allergy to any study drug components or similar monoclonal antibodies
- Other cancers within 5 years except certain treated skin, bladder, cervical, breast, or thyroid cancers
- History of immunodeficiency, organ transplant, or active autoimmune disease
- Significant bleeding within 3 months or bleeding risk at screening; recent thromboembolism
- Non-healing wounds, active ulcers, or untreated fractures
- Active severe gastrointestinal disorders
- Interstitial pneumonia or lung disease
- Severe heart, brain vessel diseases, or metabolic disorders
- Active hepatitis B or C infection or co-infection
- Active tuberculosis within 1 year or untreated prior active tuberculosis
- Severe infection within 4 weeks before first dose or moderate active infection requiring antibiotics within 2 weeks
- Chronic infections that could affect treatment or surgery
- History of drug abuse or illicit substance use
- Other conditions increasing risk or confounding results as judged by investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050010
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
B
Bin Bai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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