Her2-negative advanced gastric cancer
Conditions
Interventions
Experimental group:After a six-course course of immunosuppressive therapy combined with chemotherapy (Oxaliplatin + Capecitabine) , the trial group was treated with a PD-1 inhibitor (LRB-instruction d
observe:The control group which was treated with immunosuppressant combined with chemotherapy (Oxaliplatin + Capecitabine) for 6 courses continues to observe
Sponsors
Sichuan Mianyang 404 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. All subjects should sign the informed consent form before starting the study and be able to comply with the program visit and related procedures. 2. Age =18. 3. The cytological or histological diagnosis of gastric cancer is unresectable and locally advanced or metastatic gastric cancer or cancer of the gastroesophageal junction, patients with SD and PR assessed after 4-6 cycles of first-line therapy with Oxaliplatin plus capecitabine plus PD-1 inhibitors. 4. Agree to provide tumor tissue samples, either previously archived or freshly obtained, for biomarker testing. 5. The expression of Her-2 was negative by immunohistochemistry or FISH. 6. At least one measurable lesion (RECIST v1.1 criteria) without prior radiotherapy. 7. The lesions were =5 cm in diameter. 8. ECOG scores range from 0 to 1. Life expectancy > 3 months. 10. Vital organs and bone marrow function meet the requirements. 11. Thyroid function was normal. 12.Toxic side effects (except alopecia, etc.) of previous treatment were =1 grade or returned to baseline. 13.The investigators had good judgment compliance and were able to complete prescribed visits, treatments and laboratory examinations according to the study protocol. 14. For women of reproductive age, pregnancy was excluded.
Exclusion criteria
Exclusion criteria: 1. Participants with active central nervous system (CNS) metastases (including but not limited to carcinomatous meningitis and spinal cord compression) were excluded. 2. With tumor emergency, need immediate treatment. 3. Subjects with peripheral neuropathy. 4.The investigators considered significant coagulation abnormalities or were receiving thrombolytic or anticoagulant therapy. 5. Subjects required systemic treatment with corticosteroid (10 mg of prednisone daily) or other immunomodulatory agents (interleukin-2, interferon-alpha, interferon-gamma, cyclosporine, G-CSF, mTOR inhibitor) for 28 days prior to study treatment. 6. Heart disease or impairment of cardiac function of clinical significance. 7.Third space effusions with clinical symptoms, such as pericardial effusions, pleural effusions, and abdominal effusions, which can not be controlled by drainage or other treatment. 8. Known allergies to drugs or excipients, known to cause severe allergic reactions to any of the mabs;. 9. Severe infection occurred within 4 weeks before the start of study treatment. 10.Active autoimmune disease (congenital or acquired) is known or suspected. 11.Organ Transplantation (other than keratoplasty) or Hematopoietic stem cell transplantation is known. 12.Have other serious diseases that are out of control. 13.A pregnant or lactating woman. 14.Other malignant tumors occurred within 5 years before the first dose. 15.Known mental illness, alcoholism, drug use or substance abuse. 16.Subjects who had received or planned to receive the live vaccine within 4 weeks before the first study drug were enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of relief;Overall survival; | — |
Countries
CHINA
Contacts
Public Contactsuzhou
Sichuan Mianyang 404 Hospital
Outcome results
None listed