Gastric and Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
Treatment group:Adebrelimab plus SOX and nab-paclitaxel
Sponsors
The First Affiliated Hospital of Dalian Medical Uniersity
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The subjects voluntarily participate the study and signed an informed consent form; 2.Age: 18 to 75 years; 3.Histologically confirmed gastric or gastroesophageal junction adenocarcinoma; 4.Disease confirmed by CT or MRI as capable of radical resection and Clinical staging as T3-4aN+M0 (according to AJCC 8th edition cancer staging) 5.Anti-tumor treatment-naive (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6.Plan to undergo surgical treatment after completion of neoadjuvant therapy 7.Able to swallow tablets; 8.Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 9.Life expectancy >=12 months 10.Adequate organ function defined as follows:: (1)Blood routine examination should meet the following standards: (No blood transfusion or blood products within 14 days, no G-CSF or other hematopoietic stimulating factors) Absolute neutrophil count (ANC)=1.5×10^9/L Platelet count (PLT)=80×10^9/L Haemoglobin =80g/L (2)Biochemical tests are subject to the following criteria: Serum bilirubin <1.5 ×upper limit of normal (ULN) aspartate aminotransferase (AST) and/or alanine transaminase (ALT) <2.5×ULN Serum creatinine=1.5×ULN,creatinine clearance=50ml/min (Male: Endophytic creatinine clearance rate=((140- age) × Weight))/(72 × Serum Cr); Female: Endophytic creatinine clearance rate=((140- age) × Weight))/(72 × Serum Cr) × 0.85; Body weight unit: kg; Serum Cr unit: mg/mL 11.Negative pregnancy test for women of childbearing potential within 72 hours before commencing study treatment. Male and female subjects must agree to practice adequate contraceptive measures during the trial and 120 days after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1.Gastroesophageal junction cancer involving EGJ with the tumor center located at the proximal end of the stomach = 2cm away from EGJ 2.Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition cancer staging) 3.Subjects with non resectable factors include tumor causes, contraindications to surgery or those who refuse surgery 4.Previously or simultaneously suffering from other malignant tumors, except for radical cutaneous basal cell carcinoma , cervical in situ carcinoma and breast in situ carcinoma; 5.The subject suffers from hypertension and cannot achieve good control after treatment with antihypertensive drugs (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg) 6.Existence of any of the following cardiac clinical symptoms or diseases: Heart failure with NYHA grade = 2 or Color Doppler echocardiography: LVEF (left ventricular ejection fraction)450 ms (male) or QTc>470ms (female) Discovering clinically significant abnormalities during resting state electrocardiogram examination (such as abnormalities in heart rate, conduction, morphological features, etc.) or complete left bundle branch block or third degree atrioventricular block or second degree atrioventricular block or PR interval>250 ms; There are factors that increase the risk of QTc prolongation and heart rate abnormalities, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death of immediate family members under the age of 40, or concomitant medication for prolonged QT interval. 7.The subject has previously experienced gastrointestinal perforation, abdominal abscess, recent (within 3 months) intestinal obstruction or imaging and clinical symptoms suggest presence of intestinal obstruction 8.Abnormal coagulation function (INR>2.0 or prothrombin time (PT)>16s), with a tendency to bleed or undergoing thrombolytic or anticoagulant treatment (allowing prophylactic use of low-dose aspirin or low-molecular-weight heparin) 9.The subject has experienced clinically significant bleeding symptoms or a clear tendency to bleed within the first 3 months of enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis,etc,If there is a positive stool occult blood test during the baseline period, a follow-up examination can be conducted. If the test is still positive after the follow-up examination, a gastroscopy examination is required (except for those who undergo gastroscopy examination within 3 months before enrollment and rule out such cases) 10.Arterial/venous thrombotic events that occurred within 6 months prior to enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism,etc; 11.Known genetic or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, etc.) 12.Subjects with active ulcers, unhealed wounds or fractures 13.Urinary routine tests indicate that urine protein =++and it has been confirmed that the 24-hour urine protein content is>1.0 g 14.Patients who are in the active stage of infection and require antimicrobial treatment (such as those who require treatment with antibacterial, antiviral or anti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response(pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathologic response(MPR);Objective response rate(ORR);R0 resection rate;Disease-free survival(DFS);Overall Survival(OS);Safety; | — |
Countries
China
Contacts
Public ContactPin Liang, Jie Zhang
The First Affiliated Hospital of Dalian Medical Uniersity
Outcome results
None listed