gastric cancer
Conditions
Interventions
Apatinib group:Immune checkpoint inhibitors: administered by clinical doctors based on actual conditions.
Apatinib Mesylate: 250mg QD
Xelox: oxaliplatin 130mg/m2 D1, capecitabine 1000mg/m2 bid D1-14,
Sponsors
Dengzhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old, regardless of gender; ECOG 0-1; Expected survival time = 12 weeks; 3. HER-2 negative gastric adenocarcinoma patients confirmed by histology or cytology (including esophageal gastric junction adenocarcinoma); 4. Patients with gastric cancer who have not undergone systematic treatment and are unable to undergo surgical resection, with a history of (new) adjuvant chemotherapy and radiation therapy completed and enrolled for more than 6 months; 5. At least one measurable lesion (according to RECIST 1.1 requirements, the spiral CT scan length of the measurable lesion should be = 10mm or the short diameter of the enlarged lymph node should be = 15mm); 6. The main organs and bone marrow function are basically normal: a) Blood routine: Neutrophils = 1.5 × 109/L, platelets = 100 × 109/L, hemoglobin = 80g/L; b) Liver function: Total bilirubin = 1.5 × ULN; ALT/AST = 2.5 × ULN (= 5ULN for liver metastasis patients); c) Renal function: serum creatinine = 1.5 × ULN and creatinine clearance rate>60mL/min; d) The international standardized ratio (INR) is = 1.5 x ULN and the activated partial thromboplastin time is = 1.5 x ULN. If the subject is receiving anticoagulant treatment, only PT needs to be within the time range specified by the anticoagulant drug; 7. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up; 8. Female participants of childbearing age or male participants whose sexual partner is a female participant of childbearing age shall take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic central nervous system diseases or meningeal metastases; For patients with brain metastases who have received previous treatment, if their clinical condition is stable and there is no evidence of disease progression on imaging within 4 weeks before the first treatment, they can be considered for enrollment; 2. Has undergone major surgery (craniotomy, thoracotomy, or laparotomy), open biopsy, or suffered significant traumatic injury within 28 days prior to enrollment, or is expected to require major surgery during the study treatment period; 3. Suffering from other malignant tumors within the past 5 years (excluding cured basal cell or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix, breast, etc.); 4. Serious medical diseases that the investigator believes will affect the ability of the subject to receive the treatment of the study plan and are not controlled, such as serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, active peptic ulcer, serious infection, etc; 5. Symptomatic congestive heart failure (New York Heart Association classification II-IV) or LVEF (left ventricular ejection fraction10mg/day prednisone or other therapeutic hormones), and is still using them within the first two weeks of enrollment; 14. Patients with uncontrollable fluid accumulation and clinical symptoms such as severe pleural and abdominal effusion; 15. Have you received the live vaccine within 4 weeks prior to the first study treatment; 16. Have experienced Grade = 2 sensory or motor neuropathy in the past; Patients with peripheral neuropathy NCT-CTCAE = grade 2; 17. Known to be allergic, highly sensitive, or into
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactKang Tairong
Dengzhou People's Hospital
Outcome results
None listed