Adenocarcinoma of stomach and gastroesophageal junction
Conditions
Interventions
Experience group:Camrelizumab+albumin-binding paclitaxel+S-1
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. ECOG 0-1 Estimated survival time >= 12 weeks; 3. Nonresectable locally advanced or metastatic HER-2 negative gastric adenocarcinoma (including esophageal and gastric junction adenocarcinoma) confirmed by histopathological examination; 4. At least one measurable lesion (RECIST 1.1 standard); 5. Have not received systematic treatment for unresectable or metastatic gastric adenocarcinoma (including esophageal and gastric junction adenocarcinoma), and the previous (new) adjuvant chemotherapy and radiotherapy have been completed for more than 6 months; 6. The time from the end of palliative treatment (mainly local radiotherapy) for local lesions (non-target lesions) to randomization is more than 2 weeks; 7. Main organs and bone marrow functions are basically normal: a) Blood routine test: neutrophil >= 1.5*109/L, platelet >= 100*109/L, hemoglobin >= 80g/L; b) Liver function: total bilirubin 60mL/min; d) International standardization ratio (INR) <= 1.5*ULN and activated partial thromboplastin time <= 1.5*ULN, if the subject is receiving anticoagulant treatment, only PT is required to be within the proposed time range of anticoagulant drugs; 8. Subjects volunteered to join the study, signed the informed consent form, had good compliance and cooperated with follow-up; 9. Female subjects of childbearing age or male subjects whose sexual partners are female of childbearing age shall take effective contraceptive measures during the whole treatment period and 6 months after the treatment period.
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic central nervous system disease or meningeal metastasis; For patients with brain metastasis who have received treatment in the past, if the clinical condition is stable and the imaging evidence does not show the disease progression within 4 weeks before the first treatment, they can be considered into the group; 2. Patients who have previously received albumin-binding paclitaxel or paclitaxel treatment; 3. Having undergone major surgery (craniotomy, thoracotomy or laparotomy), open biopsy or major traumatic injury within 28 days before enrollment, or expected to undergo major surgery during research and treatment; 4. Have other malignant tumors in the past 5 years (except for cured skin basal cell or squamous cell carcinoma, or carcinoma in situ such as cervical and breast cancer); 5. Serious medical diseases that the investigator believes will affect the subject's ability to accept 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; 6. Symptomatic congestive heart failure (New York Heart Association grade II-IV) or LVEF (left ventricular ejection fraction= 104 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method); 13. The patient has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, vitiligo; asthma in childhood has been completely relieved, no intervention in adulthood can be included, and asthma requiring medical intervention with bronchodilator can not be included) 14. The patient is using immunosuppressive agent or systemic hormone therapy to achieve immunosuppressive effect (dose>10mg/day prednisone or other effective hormones), and is still using it within 2 weeks before enrollment; 15. Patients with uncontrollable pleural effusion, accompanied by severe pleural effusion, abdominal effusion and other clinical symptoms; 16. Whether the live vaccine has been inoculated within 4 weeks before the first study treatment; 17. Previous grade >= 2 sensory or motor neuropathy; Patients with peripheral neuropathy NCT-CTCAE >= grade 2; 18. Known to be allergic,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;overall survival;Progression-free survival;Quality of life score;Security; | — |
Countries
China
Contacts
Public ContactHou Xinfang
Henan Cancer Hospital
Outcome results
None listed