Locally Advanced Proximal Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
Neoadjuvant Serplulimab and SOX Chemotherapy with Lymph Node-Sparing Short-Course Radiotherapy:Neoadjuvant Serplulimab and SOX Chemotherapy with Lymph Node-Sparing Short-Course Radiotherapy
Neoadjuvant Serplulimab and SOX Chemotherapy:Neoadjuvant Serplulimab and SOX Chemotherapy
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The participant voluntarily joins this study, is able to complete the signing of the informed consent form, and demonstrates good compliance; 2. Age 18-75 years (at the time of signing the informed consent), regardless of gender; 3. Adenocarcinoma confirmed by histology and/or cytology, diagnosed as locally advanced according to the AJCC 8th edition criteria, with cTNM staged as cT3-4 or N M0 based on endoscopic ultrasound or contrast-enhanced CT/MRI, and the patient agrees to receive neoadjuvant therapy; the lesion is assessed by the investigator as resectable or potentially resectable; after MDT evaluation, radical resection is planned with standard D2 lymph node dissection. 4. Primary lesion site restrictions: (1) Adenocarcinoma of the gastroesophageal junction: Siewert type II–III; (2) Upper stomach cancer: the lower edge of the tumor is located within the upper third of the stomach, mainly involving the cardia, fundus, or upper part of the stomach body; 5. Has not previously received systemic treatment for the current disease, including anti-tumor radiotherapy/chemotherapy or immunotherapy; 6. ECOG score 0-1; 7. Estimated survival period >= 6 months; 8. Preoperative chest, abdominal, and pelvic CT, as well as FAPI PET or PET-CT, to rule out distant metastasis; 9. Major organ function is satisfactory and meets the following criteria: (1) Complete blood count (without blood transfusion or use of hematopoietic growth factors within 14 days to correct status): hemoglobin (Hb) >=90 g/L; absolute neutrophil count (ANC) >=1.5 × 10^9/L; platelets (PLT) >=80 × 10^9/L; (2) Biochemical tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60 mL/min; (3) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) =50%. 10. The doctor clinically determines that there is sufficient organ function; 11. Subjects of reproductive potential must use appropriate contraception during the study and for 120 days after the study ends, have a negative serum pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding.
Exclusion criteria
Exclusion criteria: 1. Undergo radiotherapy within 4 weeks before enrollment, or radionuclide therapy within 8 weeks; 2. Within 6 months before enrollment: esophageal or gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, fistulas, intestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding; 3. Diagnosis of malignancies other than gastric cancer within 5 years prior to first administration (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or completely resected carcinoma in situ); 4. Presence of distant metastasis (M1), including but not limited to: peritoneal metastasis (confirmed by imaging or laparoscopy), ascites or positive peritoneal lavage cytology, metastasis to organs such as liver, lung, or bone; cases where imaging suggests metastasis to para-aortic lymph nodes (No.16); 5. Imaging suggests excessive regional lymph node burden: suspicious/positive lymph node involvement in >=3 anatomical stations; or multiple lymph nodes are fused/form a cluster (matted nodes); or any lymph node has a short axis >=15 mm; 6. The tumor lesion has a serious tendency to bleed (such as the presence of an active deep large ulcer, a history of vomiting blood or black stools within 2 months before signing the informed consent, or a risk of major gastrointestinal bleeding as determined by the investigator), or has received blood transfusion treatment within 4 weeks prior to the study medication; 7. Inability to swallow oral medications, malabsorption syndrome, or other conditions affecting gastrointestinal absorption; 8. Currently participating in interventional clinical research treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to the first administration; 9. Previously received systemic or local anti-tumor treatment for gastric cancer, including curative surgery, chemotherapy, radiotherapy, immunotherapy (such as immune checkpoint inhibitors, agonists, or cell therapy), biological agents, or small molecule targeted drugs; 10. Systemic therapy with traditional Chinese medicine having anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukins, except for local use to control pleural effusion) within 2 weeks prior to the first dose; 11. Active autoimmune disease that required systemic treatment (such as disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first administration. Replacement therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatment; 12. The participant is receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other forms of topical corticosteroids) or any other form of immunosuppressive therapy within the 7 days prior to the first study drug administration; Note: The use of physiological doses of corticosteroids (= grade 2; 16. Known history of human immuno
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Incidence of adverse reactions;3-year event-free survival;Major Pathological Response, MPR;Quality of Life;3-year disease-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactHu Junbo
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed