Gastric/Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
Test Group:Adebrelimab+Celecoxib+Chemotherapy
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: Age: >=18 years, regardless of gender 2: Diagnosis: Histologically or cytologically confirmed locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma 3: PD-L1 Expression: Positive 4: HER2 Status: Negative 5: Prior Therapy: No prior systemic anticancer therapy or interventional tumor therapy (including therapeutic TACE, TAE, HAIC, TARE, etc.). 3 months. 8: ECOG Performance Status: 0–1. 9: Organ Function: Hematology: Hemoglobin (Hb) >=90 g/L. Absolute neutrophil count (ANC) >=1.5×10?/L. Platelet count (PLT) >=75×10?/L. White blood cell count (WBC) >=3.0×10?/L. Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =50 mL/min. Coagulation: Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) =50% (assessed by Doppler ultrasound). 10: Reproductive Requirements: Negative pregnancy test (ß-HCG) for women of childbearing potential before treatment initiation. Agreement to use effective contraception during treatment and for 6 months after the last dose for both sexes. 11: Voluntary Participation: Signed informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1: Concurrent Malignancy: Presence of other active malignancies (except adequately treated non-melanoma skin cancer, in situ carcinoma, or malignancies cured =5 years ago) 2: Prior Immunotherapy: Previous treatment with PD-1/PD-L1 inhibitors or CTLA-4-targeted agents (except 10 mg prednisone/day or equivalent). 5: Active pulmonary infection. 6: History of live attenuated vaccination within 28 days prior to first study dose or anticipated live attenuated vaccination during the study period 7: Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS) 8: Active hepatitis B (HBsAg positive with HBV DNA > ULN) or hepatitis C (HCV antibody positive with HCV RNA > ULN). 9: Transplant History: Prior allogeneic bone marrow or solid organ transplantation. 10: Uncontrolled hypertension (despite medication). NYHA Class III–IV heart failure. 11: Active bleeding, history of significant coagulation disorders, active ulcers, intestinal perforation, intestinal obstruction, within 30 days of major surgery 12: Prior history of a definite neurological or psychiatric disorder, including epilepsy or dementia, where the subject has a known history of psychotropic substance abuse, alcoholism, or drug addiction 13: Pregnant or breastfeeding women. 14: Any other condition for which the investigator believes the patient is not suitable to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;COX-2 expression;cytokine (IL-6, IL-8, IL-10); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall survival;Progression free survival;Duration of response;Safety; | — |
Countries
China
Contacts
Public ContactBin Zhang
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed