Gastric cancer
Conditions
Interventions
Case series:neoadjvant TACE plus islelizumab
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 to 75 years old; 2. KPS score >=80; 3. Gastric adenocarcinoma diagnosed pathologically; 4. According to endoscopic ultrasonography/enhanced CT/MRI/PET-CT examination and laparoscopic exploration, clinical staging is determined to be cT4aN0M0 or cT4aN+M0 (according to AJCC TNM 8th edition); 5. According to the RECIST1.1 standard, there is at least one evaluable lesion in the abdominal CT/MRI; 6. The surgeons participating in this study judged the lesion to be resectable; 7. Physical condition allows the surgery; 8. The blood routine and biochemical indexes of the subjects met the following standards within 7 days before enrollment: (1) Hemoglobin >=90g/L; absolute neutrophil count (ANC) >=1.5x10^9/L; platelets >=100x10^9/L (patients must not receive blood transfusion or growth factor support within 14 days of blood sample collection); (2) ALT, AST=60ml/min/1.73m2; (5) Serum albumin >=30g/L; (6) International normalized ratio (INR) or prothrombin time (PT) <=1.5 ULN, unless the patient is receiving anticoagulation therapy and the PT value is within the expected treatment range of anticoagulants; (7) Activated partial thromboplastin time (aPTT) <=1.5 ULN; 9. There are no serious concomitant diseases that make the survival time <5 years; 10. Female subjects with fertility are not allowed to get pregnant or breastfeeding; 11. Be willing and able to comply with the plan and follow-up procedures during the research period.
Exclusion criteria
Exclusion criteria: 1. There are any signs of distant metastasis or local unresectable factors; 2. Those who are allergic to contrast agents; 3. Those who have received cytotoxic chemotherapy, radiotherapy, immunotherapy or radical surgery for the treatment of this gastric cancer, except for corticosteroids; 4. Patients who have active autoimmune diseases or have a history of autoimmune diseases but may relapse; Note: Patients with the following diseases are not excluded and can enter further screening: (1) Controlled type 1 diabetes; (2) Hypothyroidism (if can be controlled by hormone replacement therapy alone); (3) Controlled celiac disease; (4) Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, hair loss); (5) Any other diseases that are not expected to recur without triggers; 5. Any active malignant tumors within 2 years, except the specific cancers under study in this trial and locally recurring cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer); 6. There is uncontrollable pleural effusion, pericardial effusion or ascites that requires frequent drainage within 14 days before enrollment; 7. Patients with gastrointestinal bleeding within two weeks prior to enrollment, or those with high bleeding risk as judged by the investigators; 8. Gastrointestinal perforation and/or fistula occurred within 6 months before enrollment; 9. Upper gastrointestinal obstruction or abnormal physiological function or suffering from malabsorption syndrome, which may affect the absorption of drugs; 10. Weight loss >=20% within 2 months before enrollment; 11. A history of the following lung diseases: interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, etc.; 12. There are uncontrollable systemic diseases including diabetes, hypertension, etc.; 13. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis, HIV infection, etc.; 14. Untreated patients with chronic hepatitis B or chronic HBV carriers with hepatitis B virus (HBV) DNA exceeding 500 IU/mL, or hepatitis C virus (HCV) RNA positive patients should be excluded; 15. Any of the following cardiovascular risk factors: (1) Cardiogenic chest pain occurred within =Grade 2 ventricular arrhythmia occurred within =NCI CTC AE Grade 1. However, patients with only the disappearance of the deep tendon reflex (DTR) need not be excluded; 17. Moderate or severe renal damage [creatinine clearance equal to or lower than 50 ml/min (calculated according to the Cockroft and Gault equation)], or serum creatinine>ULN; 18. People with known dihydropyrimidine dehydrogenase (DPD) deficiency; 19. Those who are allergic to any research drug ingredients; 20. Have had alloge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR;pRR;ORR;PFS;OS; | — |
Countries
China
Contacts
Public ContactXue-fei Wang
Zhongshan Hospital, Fudan University
Outcome results
None listed