gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
Experimental group:sintilimab combined with oxaliplatin/S-1 (SOX)
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. No gender limit, aged >=18 years; 3. Histologically confirmed gastric adenocarcinoma, diagnosed as locally advanced stage according to AJCC 8th edition, cTNM diagnosed as cT3-4aN1-3M0 according to endoscopic or enhanced CT scan (combined with ultrasonography and diagnostic laparoscopy if necessary), and Resectable lesions assessed by the investigator; 4. Have not received systemic treatment for the current disease before, including surgery, anti-tumor chemoradiotherapy/immunotherapy, etc.; 5. Patients who agree to undergo radical surgery and have no contraindications to surgery as judged by the surgeon; 6. ECOG score 0-1 points; 7. Expected survival time > 6 months.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant diseases other than gastric cancer within 5 years before the first administration (excluding basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 2. Known to show signs of active hemorrhage under endoscopy; 3. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 4. The following therapies have been received in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or targeting another stimulating or synergistic inhibitory T cell receptor (including but not limited to CTLA-4, OX-40, CD137 etc.) drugs; 5. Received systemic systemic treatment of Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration; 6. Active autoimmune disease requiring systemic therapy (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete pathological response (pCR) ;Objective response rate;Disease free survival;Overall survival;Major pathological response rate;Safety; | — |
Countries
China
Contacts
Public ContactLiu Tao
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed