gastric/gastroesophageal junction adenocarcinoma
Conditions
Interventions
Group A:Tislelizumab combined with concurrent chemoradiotherapy
Sponsors
Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent; 2. =18 years old, =75 years old; 3. Pathologically confirmed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 4. Patients with clinical stage III~IVa (AJCC 8th Edition) (T3~4aN+M0 or T4bNanyM0) determined to be resectable by CT scan; 5. Have not received anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. Able to swallow pills normally; 7. ECOG-PS score 0-1; 8. If the major organs function normally, the following criteria are met: 1) Hematological examination criteria must be met (no transfusion, no G-CSF and other cytokine drug correction treatment within 2 weeks before randomization) : - ANC=1.5×10^9/L; - PLT=100×10^9/L; - HB=90 g/L; 2) Biochemical examination must meet the following criteria: - TBil 50ml/min (Cockcroft-Gault formula); - APTT=1.5xULN; - INR or PT=1.5xULN (not receiving anticoagulant therapy); 9. Female subjects who are capable of becoming pregnant must take a serum pregnancy test within 72 hours before the first dose, with a negative result, and be willing to use a highly effective method of contraception during the test period and 120 days after the last dose. Male subjects whose partners are women of childbearing age should be surgically sterilized or consent to a highly effective method of contraception during the trial period and 120 days after the last dose;
Exclusion criteria
Exclusion criteria: 1) Those with prior or co-existing other malignancies, unless they are basal cell carcinoma of the skin, superficial bladder carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ that has achieved complete remission at least 5 years prior to screening and does not require or is not expected to require other treatment during the study period; 2) Suffering from hypertension that is not well controlled with antihypertensive medication (systolic blood pressure =140mmHg or diastolic blood pressure =90mmHg); 3) The presence of any of the following cardiac clinical symptoms or diseases: - According to the New York Heart Association (NYHA) standard for Grade 2 + heart failure or color Doppler echocardiography: left ventricular ejection Fraction (LVEF) 450 ms (male) or QTc> 470ms (female); - Resting electrocardiogram findings of clinically significant abnormalities (such as heart rate, conduction, morphological characteristics, etc.) or complete left bundle branch block or third or second degree heart block or PR-interphase > 250ms; - The presence of factors that increase the risk of prolonged QTc and abnormal heart rate, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or sudden unexplained death in an immediate family member under 40 years of age, or prolonged QT interval medication; 4) Having a history of gastrointestinal perforation, abdominal abscess, or having experienced intestinal obstruction within the recent period (within 3 months), or having imaging and clinical symptoms suggesting the presence of intestinal obstruction; 5) Abnormal coagulation function (INR> 2.0 or prothrombin time (PT) > 16s), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy (allow prophylactic use of low-dose aspirin, low-molecular weight heparin); 6) Clinically significant bleeding symptoms or definite bleeding tendency, such as digestive tract bleeding, hemorrhagic ulcer or vasculitis, occurred within 3 months before randomization; if stool occult blood was positive at baseline, it could be re-examined; if stool was still positive after re-examination, gastroscopy was required (except for those who were excluded by gastroscopy within 3 months before enrollment); 7) Arteriovenous thrombosis events occurring within 6 months before randomization, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 8) Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.); 9) With active ulcers, non-healing wounds or fractures; 10) Urine routine indicated urinary protein =++ and confirmed 24-hour urinary protein amount > 1.0 g; 11) Subjects are in the active phase of infection requiring antimicrobial treatment (for example, those requiring antibacterial, antiviral, or antifungal drugs); 12) Active hepatitis (Hepatitis B reference: HBsAg positive and HBV DNA=500 IU/ml; Hepatitis C reference: HCV antibody positive and HCV copy number > Upper limit of normal value); 13) Subjects with congenital or acquired immune deficiency (such as HIV infection); 14) Plan to receive or have previously received an organ or allogeneic bone marrow transplant; 15) Currently suffering from interstitial pneumonia or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| EFS rate;OS rate;ORR;DCR;MPR rate;R0 Rate; | — |
Countries
China
Contacts
Public ContactJia Wei
Drum Tower Hospital
Outcome results
None listed