A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · Jul 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying new treatment combinations for people with stomach cancer or cancer where the stomach meets the esophagus (the tube that carries food from the mouth to the stomach). The study is testing whether adding certain medicines called Adebrelimab and SHR-A1811/SHR-A1904 or SHR-8068, along with chemotherapy, can help treat these cancers. The goal is to see how well these treatments work and whether they are safe and manageable for patients.

People who might be eligible are adults between 18 and 70 years old who have been recently diagnosed with stomach or gastroesophageal junction cancer and have not yet received any cancer treatment for it. Participants will need to provide recent tumor samples for testing and be in generally good health with a reasonable life expectancy. Women who can have children will need to use birth control during the study and for some time after. If accepted into the trial, participants will receive the new treatment combinations and have regular check-ups and tests to monitor their response and any side effects. This study is not yet open for enrollment but aims to find better ways to treat these types of cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma who have not received prior anti-tumor therapy for gastric/gastroesophageal junction cancer.
• • 2. Age: ≥18 and ≤70 years, both male and female.
• • 3. Ability to provide fresh tumor tissue (preferred) or archival formalin-fixed paraffin-embedded (FFPE) tumor blocks/unstained slides obtained within 6 months before enrollment.
• • 4. Availability of biomarker testing results before enrollment.
• • 5. ECOG performance status of 0-1.
• • 6. Life expectancy ≥ 6 months.
• • 7. Adequate organ and bone marrow function.
• • 8. Female participants must be either non-childbearing potential or of childbearing potential with a negative serum pregnancy test within 3 days prior to treatment initiation and not lactating. Childbearing-potential participants and their partners must agree to avoid sperm/ovum donation and comply with contraception requirements from informed consent signing until 8 months after the last dose.
• • 9. Voluntarily signed informed consent form, with willingness and ability to comply with scheduled visits, treatments, laboratory tests, and study procedures.
• Exclusion Criteria:
• • 1. Known squamous cell carcinoma, undifferentiated carcinoma, mixed adenocarcinoma with other histologic types, or other non-adenocarcinoma gastric cancers.
• • 2. 20% body weight loss within 2 months before enrollment.
• • 3. Prior treatments: Anti-tumor therapy for gastric/gastroesophageal junction cancer; Participation in other drug trials with last dose ≤4 weeks or ≤5 half-lives (whichever longer) before enrollment; Major surgery within 28 days before enrollment; Live attenuated vaccination within 28 days before enrollment or planned during/within 60 days after treatment.
• • 4. Known hypersensitivity to any study drug component (Adebrelimab, SHR-A1811, SHR-A1904, SHR-8068, fluorouracil, capecitabine, tegafur/gimeracil/oteracil) or humanized monoclonal antibodies.
• • 5. Other malignancies within 5 years, except curatively treated basal/squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, ductal breast carcinoma in situ, or papillary thyroid cancer.
• • 6. History of immunodeficiency, organ transplantation, or active autoimmune disease.
• • 7. Clinically significant bleeding within 3 months or bleeding predisposition at screening; Arterial/venous thromboembolism within 6 months or at screening.
• • 8. Non-healing wounds, active ulcers, or untreated fractures.
• • 9. Active severe gastrointestinal disorders.
• • 10. Interstitial pneumonia or lung disease.
• • 11. Severe cardiovascular/cerebrovascular diseases or metabolic disorders.
• • 12. Active HBV/HCV infection or HBV-HCV co-infection.
• • 13. Active tuberculosis (TB) within 1 year by history/CT, or prior untreated active TB \>1 year ago.
• • 14. Severe infection within 4 weeks before first dose; CTCAE ≥Grade 2 active infection requiring systemic antibiotics within 2 weeks; Chronic infections potentially affecting treatment/surgery.
• • 15. History of drug abuse or illicit substance use.
• • 16. Other conditions that may increase study risk, confound results, or render the patient unsuitable per investigator judgment.