Locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma Cancer
Conditions
Interventions
Experimental intervention:
Envafolimab (subcutaneous injection, 300 mg, Q3W, three cycles before surgery)
Other interventions:
1. SOX (intravenous oxal
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals of any gender, aged between 18 and 70 years 2. Eastern Cooperative Oncology Group performance (ECOG) performance status of 0 or 1, no surgery contraindications. The individual must have no surgical contraindications and possess a physical condition along with adequate organ function to ensure the safe completion of abdominal surgery 3. Diagnosis of primary resectable, histologically confirmed cT3/4aN+M0 gastric or GEJ adenocarcinoma, as determined by CT/MRI 4. Absence of peritoneal metastases, as determined by laparoscopic exploration 5. No prior cancer treatment (e.g. radiotherapy, chemotherapy, targeted therapy, immune checkpoint inhibitors) 6. Fully informed about the study and voluntarily sign an informed consent form
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastases or primary tumors deemed non-resectable 2. Previous or concurrent other malignancies (except completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer or any other malignancies that have not recurred for at least 5 years) 3. Allergies towards drug ingredients or excipients in this study, or history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins 4. Any active autoimmune disease or documented history of serious autoimmune disease within the past 2 years requiring systemic therapy (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. 5. Prior allogeneic stem cell or solid organ transplantation, with exceptions for transplants not requiring ongoing immunosuppression, such as corneal or hair transplantation 6. History of non-infectious pneumonitis that required steroid treatment, current pneumonitis, or a history of or current interstitial lung disease 7. Conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease 8. History of gastrointestinal hemorrhage within 4 weeks before enrollment or patients with a high risk of hemorrhage 9. Pregnancy or breastfeeding or intention of becoming pregnant during study treatment or within months after the last dose of study treatment. 10. Known history of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C 11. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction or cerebrovascular accident) within 6 months before initiation of study treatment, unstable arrhythmia or unstable angina 12. Treatment with a live, attenuated vaccine within 4 weeks before initiation of study treatment or anticipation of need for such a vaccine during study treatment 13. Inadequate hematologic or organ function evidenced, defined by the following laboratory test results, obtained within 7 days before initiation of study treatment: 13.1. ALT/AST >3× upper limit of normal (ULN) 13.2. Total bilirubin > 1.5×ULN. For participants with a history of Gilbert's Syndrome, total bilirubin > 3×ULN at screening 13.3. Serum creatinine level >1.5×ULN and creatinine clearance <40 ml/min 13.4. Absolute value of neutrophils < 1.0 × 10^9 / L 13.5. Platelet count <90 × 10^9 / L 13.6. Hemoglobin <90g / L 14. Any medical or psychological condition, organ dysfunction, or significant social circumstances, including but not limited to uncontrolled diabetes, hypertension, pulmonary diseases, atrial fibrillation, pericardial effusion, mental illness, substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate (pCR i.e., 0% residual tumor per tumor bed), measured after surgical resection | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. R0 resection rate (i.e., complete removal of the tumor with a tumor-free margin) measured at the time of surgical resection 2. Major pathological response rate (MPR i.e., residual tumor cells below 10% in the resected specimen), measured after surgical resection 3. Objective response rate (ORR) by RECIST v1.1, defined as the proportion of subjects with complete response or partial response, measured radiologically after completion of neoadjuvant therapy. 4. Surgery-related outcomes such as intraoperative bleeding, operative time, time to first passage of flatus/stool, and length of postoperative hospital stay, measured using patient medical records during hospitalization 5. Safety endpoints include immune-related adverse events (irAEs), chemotherapy-related AEs, and surgical AEs (i.e., complications occurring during or within 30 days of surgery), measured according to National Cancer Institute Common Terminology Criteria for Adverse Events and Clavien-Dindo Classification | — |
Countries
China
Contacts
Public ContactZhaolun Cai
Outcome results
None listed