gastro-esophageal junction cancer
Conditions
Interventions
Perioperative Chemotherapy Group (Group A):Subjects will initially receive 3 cycles of neoadjuvant SOX/CapOX treatment, administered once every 3 weeks (Q3W). After the completion of 3 cycles of neoad
Standard Neoadjuvant Perioperative Chemotherapy Combined with PD-1 Inhibitor Treatment Group (Group B):Subjects will initially undergo 3 cycles of neoadjuvant SOX/CapOX combined with PD-1 inhibitor tr
Long-course Neoadjuvant Perioperative Chemotherapy Combined with PD-1 Inhibitor Treatment Group (Group C):Subjects will initially undergo 6 cycles of neoadjuvant SOX/CapOX combined with PD-1 inhibitor
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The subject has fully understood the study and voluntarily signed the Informed Consent Form (ICF). 2.Histologically confirmed adenocarcinoma of the esophagogastric junction, clinically staged as II/III based on enhanced CT/MRI, classified as cT1-2N+M0 or cT3-4aNanyM0. 3.Agrees to provide previously stored tumor tissue samples or to undergo a biopsy for the collection of tumor lesion tissue to be sent to the central laboratory for PD-L1, EBV, and MSI immunohistochemistry (IHC) testing. 4.Gender is unrestricted, aged 18-75 years. 5.Good general condition, with an ECOG performance status of 0-1, without contraindications to surgery. 6.Physical condition and organ functions are adequate for major abdominal surgery. 7.Expected survival of = 3 months. 8.Laboratory test values within 7 days prior to enrollment must meet the following criteria:a. WBC > 4.0×10^9/L and 1.5×10^9/L, Hb = 80g/L, PLT = 100×10^9/L;b. Serum bilirubin = 1.5× upper limit of normal (ULN), AST, ALT = 2.5× ULN;c. Creatinine = 1.5× ULN or serum clearance > 60ml/min, according to the Cockcroft-Gault glomerular filtration rate estimate: (140 - age) × (weight, kg) × (0.85 if female) / 72 × (serum creatinine, mg/dL) or: (140 - age) × (weight, kg) × (0.85 if female) / 0.818 × (serum creatinine, µmol/L);d. INR and aPTT = 1.5 × ULN, applicable only to subjects not receiving anticoagulant therapy; subjects on anticoagulant therapy should use a stable dose. 9.Good compliance, able to cooperate with the protocol's laboratory, auxiliary examinations, and corresponding specimen collection. 10.Females of childbearing potential (including those with chemically induced amenorrhea or other medical reasons for amenorrhea) must agree to use contraception from signing the informed consent form until at least 5 months after the last administration of study treatment or accompanying chemotherapy, whichever is later. Females must also agree not to breastfeed from signing the informed consent form until at least 5 months after the last administration of study drug or accompanying chemotherapy, whichever is later. Males must agree to use contraception from the administration of the study drug until at least 7 months after the last administration of the study drug or accompanying chemotherapy, whichever is later.
Exclusion criteria
Exclusion criteria: 1.Known allergies to monohydrate citric acid, sodium citrate dihydrate, mannitol, polysorbate (components of the trial medication). 2.Past or present malignancies other than completely excised basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, mucosal carcinoma, superficial bladder cancer, or any other cancer that has been in remission for at least 5 years. 3.Uncontrollable pericardial effusion, pleural effusion, or ascites, gastrointestinal bleeding, or high risk of bleeding within 2 weeks of enrollment. 4.Weight loss exceeding 20% within 2 weeks of enrollment. 5.Inability to take oral medication. 6.History of chemotherapy, radiotherapy, immunotherapy, or surgical treatment for gastric cancer. 7.Prior use of anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or any other antibodies that act on T-cell co-stimulatory or checkpoint pathways. 8.Treatment with tyrosine kinase inhibitors within 2 weeks prior to enrollment. 9.Conditions requiring long-term use of immunosuppressive medication, or systemic or local use of corticosteroids in immunosuppressive doses (dose > 10mg/day of prednisone or equivalent) for comorbidities. 10.Vaccination against any infection within 4 weeks before enrollment (e.g., influenza, varicella vaccines). 11.Uncontrolled systemic diseases such as diabetes, hypertension. 12.Receiving or requiring anticoagulant therapy (excluding low-dose aspirin for antiplatelet therapy). 13.Any active autoimmune disease or history of autoimmune disease (including, but not limited to: interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; participants with vitiligo or childhood asthma that has fully resolved and does not require any intervention in adulthood can be included; participants requiring medical intervention with bronchodilators for asthma cannot be included). 14.Participants with active tuberculosis (TB), undergoing anti-TB treatment, or who have received anti-TB treatment within 1 year prior to screening. 15.History of lung diseases confirmed by imaging (preferably CT) or clinical outcomes: interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung diseases. 16.Contraindications to the use of oxaliplatin, tegafur, or capecitabine. 17.Pregnant or breastfeeding women or women who may become pregnant. 18.No active hepatitis. 19.Positive results for any of the following tests: Human Immunodeficiency Virus-1 (HIV-1) antibody, Human Immunodeficiency Virus-2 (HIV-2) antibody, Human T-Lymphotropic Virus-1 (HTLV-1) antibody, Hepatitis C Virus (HCV) antibody. 20.Any other clinically significant disease or condition that, in the investigator's opinion, could affect compliance with the protocol, impact the ability of the subject to give informed consent, or not be suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor regression grade 0/1, TRG 0/1;Completeness of Perioperative Treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete pathological response, pCR;major pathological response, MPR;R0 resection rate;Relapse-free survival;Even-free survival;Overall survival;Safety;Quality of Life; | — |
Countries
China
Contacts
Public ContactYingbo Chen
Sun Yat-Sen University Cancer Center
Outcome results
None listed