Gastric
Conditions
Interventions
Experiment group:Sintilimab in combination with SOX followed by sequential proximal gastrectomy
Control group:Sintilimab in combination with SOX followed by sequential total gastrectomy
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent prior to the initiation of any trial-related procedures; 2. Male or female, aged >= 18 years; 3. Histologically confirmed adenocarcinoma of the upper stomach or gastroesophageal junction, diagnosed as locally advanced stage according to the 8th edition of the AJCC Cancer Staging Manual; cTNM stage cT3-4a or N+ M0 confirmed by endoscopic ultrasound (EUS), contrast-enhanced CT/MRI scan (combined with EUS and diagnostic laparoscopy if necessary); and resectable lesions as assessed by the investigator; 4. No prior systemic treatment for the current disease, including surgical treatment, anti-tumor radiotherapy/chemotherapy, immunotherapy, etc.; 5. Patients who agree to receive curative surgical treatment and have no surgical contraindications as determined by a surgeon; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 7. Estimated life expectancy of > 6 months; 8. Adequate organ function, with the subject meeting the following laboratory indicators: 1)Absolute neutrophil count (ANC) >= 1.5 × 10?/L without the use of granulocyte colony-stimulating factor (G-CSF) within the past 14 days; 2)latelets >= 100 × 10?/L without blood transfusion within the past 14 days; 3)Hemoglobin > 90 g/L without blood transfusion or use of erythropoietin (EPO) within the past 14 days; 4)Total bilirubin = 60 ml/min; 7)Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 × ULN; 8)Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total triiodothyronine (T3) (or free triiodothyronine, FT3) and free thyroxine (FT4) within the normal range may also be enrolled; 9)Myocardial enzyme profile within the normal range (subjects with isolated laboratory abnormalities deemed clinically insignificant by the investigator may also be enrolled); 10)For female subjects of childbearing potential, a urine or serum pregnancy test must be performed within 3 days prior to the first administration of the study drug (Cycle 1, Day 1) with a negative result. If the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required. Non-childbearing potential females are defined as those who are postmenopausal for at least 1 year, or surgically sterilized, or have undergone hysterectomy; 10. All subjects (regardless of gender) who are at risk of conception must use contraceptive methods with an annual failure rate of less than 1% during the entire treatment period and until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy drugs).
Exclusion criteria
Exclusion criteria: 1. Diagnosis of malignant diseases other than gastric cancer within 5 years prior to the first administration of the study drug (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ with radical resection); 2. Known endoscopically documented signs of active bleeding from the lesion; 3. Currently participating in treatment for an interventional clinical trial, or having received other investigational drugs or treatment with investigational medical devices within 4 weeks prior to the first administration of the study drug; 4. Prior receipt of the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); 5. Receipt of systemic treatment with traditional Chinese medicine (TCM) with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to the first administration of the study drug; 6. History of active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first administration of the study drug. Replacement therapy (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic treatment; 7. Receipt of systemic glucocorticoid therapy (excluding intranasal, inhaled, or other forms of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first administration of the study drug; Note: Use of physiological doses of glucocorticoids (<=10 mg/day of prednisone or equivalent) is permitted; 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Known hypersensitivity to any drug used in this study; 10. Failure to fully recover from toxicity and/or complications caused by any intervention prior to the start of treatment (i.e., <= Grade 1 or returned to baseline, excluding fatigue or alopecia); 11. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies); 12. Untreated active hepatitis B (defined as positive HBsAg with HBV-DNA copy number exceeding the upper limit of normal (ULN) of the laboratory department of the participating study center); Note: Hepatitis B subjects meeting the following criteria may also be enrolled: 1)HBV viral load < 1000 copies/ml (200 IU/ml) prior to the first administration of the study drug; subjects must receive anti-HBV treatment throughout the study's chemotherapy period to prevent viral reactivation; 2)For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load, prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary; 13. Subjects with active hepatitis C virus (HCV) infection (positive for HCV antibodies and HCV-RNA level above the lower limit of detection); 14. Administration of a live vaccine within 30 days prior to the first administration of the study drug (Cycle 1, Day 1); Note: Administration of an inactivated viral vaccine for seasonal influenza via injection within 30 days prior to the first administration of the study drug is permitted; however, intranasal live-attenuated influenza vaccine is not permitted;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-years disease free survival (DFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR);Clinical down-staging (T and/or N);Proportion of patients eligible for proximal resection;Overall survival; | — |
Countries
China
Contacts
Public ContactLei Zhou
China-Japan Friendship Hospital
Outcome results
None listed