Advanced gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
Triple Therapy Cohort:None
Sponsors
Shanxi Bethune Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18 to 75 years (inclusive), regardless of gender; 2.Histopathologically confirmed unresectable locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 3.Planned to receive PD-1 inhibitor combined with standard chemotherapy as first-line treatment, and the treating physician has decided to add ubenimex to this regimen; 4.At least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1); 5.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 6.Adequate bone marrow, hepatic, and renal function: · Hematology: Absolute neutrophil count = 1.5 × 10?/L; Platelet count = 100 × 10?/L; Hemoglobin = 90 g/L. Liver function: Total bilirubin = 1.5 × upper limit of normal (ULN); ALT and AST = 2.5 × ULN (or = 5 × ULN in case of liver metastases). Renal function: Serum creatinine = 1.5 × ULN or creatinine clearance = 60 mL/min (calculated by the Cockcroft-Gault formula); 7.Expected survival of not less than 3 months; 8.Voluntary participation and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1.Previous systemic therapy for the current advanced or metastatic disease; 2.Known HER2-positive patients; 3.Active autoimmune disease requiring systemic immunosuppressive therapy (e.g., corticosteroids); 4.Uncontrolled comorbidities, including uncontrolled infection, symptomatic brain metastases, poorly controlled pleural effusion/ascites, etc; 5.History of other active malignancies within the past 5 years (except cured conditions such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.); 6.History of allergy to any component of the study drugs; 7.Severe cardiac, pulmonary, hepatic, or renal insufficiency; 8.Pregnant or lactating women; 9.Any other condition deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month Disease Control Rate;6-month Progression-Free Survival Rate;Adverse event; | — |
Countries
China
Contacts
Public ContactYarong Guo
Shanxi Bethune Hospital
Outcome results
None listed