Gastric adenocarcinoma
Conditions
Interventions
Observation group:None
Sponsors
Shanghai Tongren Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Histologically diagnosed as HER2-negative unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma; (2) Age ranges from 18 to 75 years old, male or female; (3) Eastern Cooperative Oncology Group (ECOG) scale 0-2 points; (4) Have not received neoadjuvant or adjuvant therapy (including chemotherapy, radiation, and immunotherapy) in the past 6 months; (5) Agree to provide fresh tumor tissue samples (gastroscopy, puncture, or surgical biopsy specimens) for organoid culture and determination of HER-2, PD-L1, and dMMR status by immunohistochemistry (IHC) prior to the start of treatment in this study; (6) At least one measurable lesion according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1); (7) Function of vital organs in accordance with the following requirements: a. Neutrophil count =1.5 × 109/L b. Hemoglobin = 90g/L c. Platelet count = 100 × 109 / L d. Total bilirubin = 1.5 × upper limit of normal (ULN), AST and ALT <2.5 × ULN e. Blood creatinine muscle = 1.5 × ULN or creatinine clearance = 60 ml / min (8) Women of childbearing potential must have had a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an appropriate method of contraception for the duration of the trial and for 8 weeks after the last administration of the test drug. For males, should be surgically sterilized or agree to use an appropriate method of contraception for the duration of the trial and for 8 weeks after the final administration of the test drug; (9) Expected survival = 12 weeks; (10) Subjects voluntarily agree to enroll in this study by signing an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Suspected active bleeding or obstructive phenomena with difficulty swallowing pills and food; (2) Previous treatment for unresectable locally advanced, recurrent, or metastatic gastric cancer/adenocarcinoma of the gastroesophageal junction; (3) Known DPD enzyme deficiency (previous fluorouracil therapy with grade =3 mucosal toxicity); (4) Live vaccination within 4 weeks prior to enrollment or plan to receive live vaccine during the study period; (5) Known symptomatic central nervous system (CNS) metastases; (6) Known history of grade =3 allergic or hypersensitivity reaction to oxaliplatin, capecitabine, or any monoclonal antibody; (7) Patients with known history of human immunodeficiency virus (HIV) infection (HIV antibody positive); (8) Active or poorly controlled serious infection; (9) Patients with clinically significant (i.e., active) cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, arrhythmia, etc.) or myocardial infarction within the past 12 months; (10) Other primary malignancies, except clinically cured (disease-free survival = 5 years) malignancies and adequately treated carcinoma in situ; (11) The researchers determined that there were other conditions that were not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of organoid drug sensitivity prediction for ORR; | — |
Countries
China
Contacts
Public ContactJianjun Zhang
Shanghai Tongren Hospital
Outcome results
None listed