Gastric cancer
Conditions
Interventions
Group A:Capecitabine and oxaliplatin (XELOX) applied in the perioperative period
Group B:Cardonilizumab combined with capecitabine and oxaliplatin (XELOX) applied in the perioperative period
Group C:Neoadjuvant Radiotherapy Combined with Cadonilimab, Oxaliplatin, and Capecitabine (XELOX) applied in the perioperative period
Sponsors
The First Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Able to understand and voluntarily sign the written informed consent form (ICF), which must be signed before undergoing any study procedures required by the protocol. 2 Aged >=18 and =6 months. 8 Women of childbearing potential must confirm a negative serum pregnancy test within 7 days before the first dose and agree to use effective contraception during the study and for 120 days after the last dose of study drug. 9 Laboratory values within the following ranges within 7 days prior to enrollment: a) WBC >4.0×10^9/L and 1.5×10^9/L, Hb >=90 g/L, PLT >=100×10^9/L; b) Serum bilirubin 60 mL/min (calculated using Cockcroft-Gault equation); d) INR and APTT <=1.5×ULN, for participants not receiving anticoagulation therapy; those receiving anticoagulation should be on a stable dose. 10 Good compliance and able to cooperate with laboratory tests, ancillary procedures, and specimen collection required by the protocol.
Exclusion criteria
Exclusion criteria: 1 Evidence of distant organ metastasis. 2 Clinical symptoms of cancer-related pleural effusion, pericardial effusion, or ascites requiring frequent drainage. 3 History of other malignancies. 4 Poor nutritional status, BMI 10 mg/day prednisone or equivalent) or other immunosuppressive agents within 14 days prior to first dose; c) Administration of live vaccines within 30 days prior to first dose or planned live vaccine administration during the study; d) Major surgery or severe trauma within 30 days prior to first dose; e) History of major abdominal surgery or planned major surgery during the study; f) Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., anti-ICOS, anti-CD40, anti-CD137, anti-GITR, anti-OX40 antibodies), or immune cell therapies targeting tumor immunity mechanisms. 7 History of gastrointestinal perforation, fistulas, active diverticulitis, abdominal abscess, or gastrointestinal obstruction within 6 months; active or previous inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis). Inability to swallow, malabsorption syndrome, or uncontrolled nausea, vomiting, diarrhea, or other severe gastrointestinal diseases that affect drug intake and absorption. 8 Investigator-assessed autoimmune disease with risk of relapse or requiring treatment. 9 History of immunodeficiency, including HIV-positive status, other acquired or congenital immunodeficiencies, or history of organ or allogeneic bone marrow transplantation. 10 Any of the following cardiovascular or cerebrovascular diseases or risk factors: a) Myocardial infarction, unstable angina, stroke, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (NYHA class >= II), symptomatic or poorly controlled arrhythmias, or any arterial thromboembolic events within 6 months before the first dose; b) Deep vein thrombosis, pulmonary embolism, or other severe thromboembolic events within 3 months prior to first dose; c) Aortic aneurysm, aortic dissection, internal carotid artery stenosis, or other life-threatening or major vascular diseases requiring surgery within 6 months; d) History of myocarditis or cardiomyopathy; e) Left ventricular ejection fraction (LVEF) 2) within 30 days prior to first dose, including severe pneumonia, bacteremia, or infection requiring hospitalization; active pulmonary inflammation on baseline chest X-ray; infection symptoms and signs within 14 days prior to first dose requiring systemic antibiotic treatment (excluding prophylactic antibiotics). 12 History or CT findings of active tuberculosis, or active tuberculosis within 1 year prior to enrollment, or untreated active tuberculosis for over 1 year. 13 Active hepatitis B (HBV DNA >=2000 IU/mL or 104 copies/mL) or hepatitis C (HCV antibody positive, HCV RNA above detection threshold). 14 Known active syphilis infection. 15 Pregnant or breastfeeding women. 16 Participation in another clinical tr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathologic response rate;R0 Resection Rate;Event-Free Survival;Objective Response Rate;Overall Survival;Disease-Free Survival; | — |
Countries
China
Contacts
Public ContactGuangyong Zhang
The First Affiliated Hospital of Shandong First Medical University
Outcome results
None listed