Bengbu Medical University
Conditions
Interventions
Research group:Aipalolitovo Relimab combined with SOX regimen.
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Fully understand this study and voluntarily sign the informed consent form; Histologically and/or cytologically confirmed HER-2 negative gastric or gastroesophageal junction adenocarcinoma (Siewert type II-III); Clinical stage assessed by endoscopic ultrasound, CT/MRI, etc. as cT3N+M0/cT4NxM0 (AJCC 8th edition); No gender restriction, age 18-80 years; Good general condition with ECOG score of 0-1; Organ function allows for major abdominal surgery; Expected survival >= 6 months; Laboratory test values within 7 days before enrollment must meet the following criteria: (1) WBC > 4.0×10^9/L and 1.5×10^9/L, Hb >= 75g/L, PLT >= 100×10^9/L; (2) Serum bilirubin 60ml/min; (4) INR and aPTT <= 1.5×ULN (applicable only to subjects not receiving anticoagulation therapy); Subjects receiving anticoagulation therapy should maintain a stable dose; Good compliance and able to cooperate with laboratory tests, auxiliary examinations, and corresponding specimen collection as required by the protocol; No prior surgery or chemotherapy before diagnosis. [Translated text will be output here].
Exclusion criteria
Exclusion criteria: Within 5 years or concurrently suffering from other active malignant tumors. Patients with cured basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, or breast carcinoma in situ may be enrolled; patients who are preparing for or have previously undergone organ or bone marrow transplantation; patients who have experienced myocardial infarction or poorly controlled arrhythmia within 6 months before the first dose; patients with NYHA Class III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF) 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days before the first dose or during the study period. However, the following conditions are allowed for enrollment: Patients are permitted to use topical or inhaled steroids, or adrenal hormone replacement therapy at a dose equivalent to <= 10 mg/day prednisone, in the absence of active autoimmune disease; Active infection requiring systemic anti-infective treatment within 14 days prior to the first dose; Previous treatment with other antibodies/drugs targeting immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.; Currently receiving other clinical investigational treatments; Known history of severe allergy to any monoclonal antibody or excipients of the investigational drug, oxaliplatin, Tegio, or docetaxel; Known history of psychotropic drug abuse or drug use; Patients who have ceased alcohol consumption may be enrolled; Presence of conditions that may increase the risks associated with study participation or study drug administration, or other severe, acute, or chronic diseases that, in the investigator's judgment, make the patient unsuitable for clinical research; Known gastrointestinal bleeding tendency; Pregnant or breastfeeding women. [Here output the translated text].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate (pCR).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response Rate (MPR).;Objective Response Rate (ORR).;Disease Control Rate (DCR).;R0 resection rate.;Disease-Free Survival (DFS).;Overall Survival (OS).;safety; | — |
Countries
China
Contacts
Public ContactDajun YU
The First Affiliated Hospital of Bengbu Medical University.
Outcome results
None listed