Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
A:Tislelizumab combined with mXELOX regimen
B:Low-dose apatinib combined with tislelizumab and mXELOX regimen
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
76 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. subjects aged >75 years; 2. Understand the steps and contents of the study and voluntarily sign a written informed consent; 3. patients with histopathologically and/or cytologically confirmed HER2-negative or unknown HER2 status adenocarcinoma of the stomach or gastro-oesophageal junction, with clinical stage IV, i.e., including clinically judged metastatic gastric carcinoma (cM1) as well as tumours with tumour invasion of adjacent organs (cT4b), and with advanced gastric carcinoma that is not resectable after clinical evaluation and multidisciplinary discussion. 4. Have at least 1 evaluable lesion according to RECIST 1.1 criteria; 5. Those who have received previous postoperative adjuvant chemotherapy with platinum or paclitaxel-based and fluorouracil-based regimens for more than 6 months after the end of recurrence without grade 2 or higher toxicity can be enrolled. 6. Physical status score (ECOG PS score): 0-1; 7. Expected survival >= 3 months; 8. Good function of major organs, i.e., the following requirements for relevant tests within 14 days prior to enrolment: erythropoietin >=80 g/L; neutrophil count > 1.5×10^9/L; platelet count >= 100×10^9/L; total bilirubin =50 mL/min (Cockcroft-Gault formula); cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >=50%; 9. Thyroid function indicators: thyroid stimulating hormone (TSH), free thyroxine (FT3/FT4) in the normal range or mild and clinically insignificant abnormalities; 10. Weight of 40 kg or more (including 40 kg) or BMI > 18.5;
Exclusion criteria
Exclusion criteria: 1. Previously or concurrently suffering from other malignant tumours, but cured early stage tumours, including basal cell carcinoma of the skin and cervical carcinoma in situ, early stage tumours such as Stage I lung cancer and Stage I colorectal cancer that do not affect the patient's life in the short term in the judgement of the investigator may be excluded after radical treatment. 2. Participating in other drug clinical trials within four weeks; 3. have multiple factors that interfere with oral administration of medications (e.g., inability to swallow, chronic diarrhoea and intestinal obstruction); 4. have a history of bleeding, with any bleeding event with a severity rating of 3 or more on the CTCAE 4.0 within 4 weeks prior to screening; 5. patients with known CNS metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, CT or MRI must be performed within 28 days prior to enrolment to exclude CNS metastases; 6. Patients with hypertension that is not well controlled by a single antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); history of unstable angina pectoris; new diagnosis of angina pectoris in the 3 months prior to the screening period or myocardial infarction in the 6 months prior to the screening period; and cardiac arrhythmias (including QTcF: >=450 ms for males and >=470 ms for females) requiring Prolonged use of antiarrhythmic drugs and New York Heart Association classification >= Class II cardiac insufficiency; 7. Prolonged unhealed wounds or fractures with incomplete healing; 8. imaging showing that the tumour has invaded a vital vascular periphery or if, in the judgement of the investigator, the patient's tumour has a very high likelihood of invading a vital vessel and causing fatal haemorrhage during treatment; 9. coagulation abnormalities with bleeding tendency (14 days prior to randomisation must be met: INR within normal values without anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues: use of small doses of warfarin (1 mg orally once a day) for prophylactic purposes is permitted, provided the International Normalised Ratio of the prothrombin time (INR) is =++ and confirmed 24-hour urine protein quantification >1.0 g; 12. Previous use of immune-targeted therapeutic agents; 13. History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 14. patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, and other patients requiring the use of corticosteroids 15. history of severe chronic autoimmune disease, such as systemic lupus erythematosus; history of inflammatory bowel disease, such as ulcerative enteritis, Crohn's disease, and chronic diarrhoeal disease, such as irritable bowel syndrome; history of tuberculosis or tuberculosis; history of active hepatitis B, hepatitis C, and patients with HIV infe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival (PFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug safety;Overall survival;Progression free survival;Disease control rate;Duration of response; | — |
Countries
China
Contacts
Public ContactXiaofeng Chen
Department of Oncology, The First Affiliated Hospital of Nanjing Medical University,
Outcome results
None listed