Clinical Study of Adebrelimab Therapy in the Perioperative Treatment of Gastric Cancer or Gastroe… (NCT07522151) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Clinical Study of Adebrelimab Therapy in the Perioperative Treatment of Gastric Cancer or Gastroesophageal Junction Cancer
China874 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients with pathologically confirmed gastric cancer or gastroesophageal junction cancer.
✓. Age: ≥18 years old, \<75 years old, both male and female are eligible.
✓. Before entering the study, the investigator has evaluated and determined that the subject is suitable and plans to undergo neoadjuvant therapy + radical surgery for curative purposes.
✓. Gastric cancer or gastroesophageal junction cancer applicable to the 8th edition of the AJCC gastric cancer staging criteria.
✓. Fresh specimens (preferred) or formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimen sections obtained within 6 months before randomization can be provided.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1.
✓. Expected survival ≥ 6 months.
✓. Adequate organ and bone marrow function.
Exclusion criteria
✕. Gastric cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other histological types, or adenocarcinoma mixed with other histological types.
✕. Gastric esophageal junction cancer, Siewert type I; or Siewert type II with esophageal invasion length ≥ 4 cm; or other cases not suitable for clinical staging assessment using the 8th edition of the AJCC gastric cancer staging criteria, or not suitable for conventional surgical methods or approaches for gastric cancer.
. The subject's weight has decreased by more than 20% within 2 months before randomization.
✕. Previous anti-tumor treatment for gastric cancer/gastric esophageal junction cancer (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization).
✕. Known allergy to any component of the investigational drug (including adibelimab/placebo, tegafur, and oxaliplatin), or allergy to humanized monoclonal antibody products.
✕. Diagnosis of any other malignant tumor within 5 years before entering the study, except for locally treatable and cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
✕. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases) or organ transplantation (including allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, etc.); history of active autoimmune disease, except for immune disorders that do not require systemic treatment (such as vitiligo, psoriasis, etc.) or autoimmune diseases that can be improved through hormone replacement therapy (such as type 1 diabetes or hypothyroidism).
✕. Severe, unhealed or open wounds, active ulcers, or untreated fractures.