stomach cancer
Conditions
Interventions
Group 1:Camrelizumab + Apatinib + SOX
Group 2:Camrelizumab + SOX
Group 3:SOX
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. Patients with Her-2-negative, unresectable locally advanced or metastatic (liver metastasis, lymph node metastasis, etc.) gastric cancer confirmed by histopathology or cytology; 3. Not previously treated, including surgery, chemotherapy, radiotherapy, immunotherapy and targeted therapy; 4. ECOG PS score 0-1 points; 5. Expected survival period >= 3 months; 6. The main organ functions are normal, and there is no serious abnormal blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immunodeficiency patients. Laboratory examinations meet the following requirements: (1) Hemoglobin (Hb) >= 90 g/L; (2) White blood cells (WBC) >=3.0x10^9/L; neutrophil count (NEUT) >=1.5x10^9/L; (3) Platelet (PLT)>=90x10^9/L; (4) Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level <= 2.5 times the upper limit of normal (ULN); renal function (serum creatinine sCr) level <= 1.5 times the upper limit of normal (ULN); (5) Total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN); (6) Urine protein and urine occult blood <2+; fecal occult blood <2+; 7. The patients voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; 8. The investigator believes that the treatment can be beneficial.
Exclusion criteria
Exclusion criteria: 1. Those who have proved allergic to the test drug and/or its excipients; 2. Suffering from any active autoimmune disease or history of autoimmune disease; 3. Pregnant or lactating patients; 4. Patients who are judged by the investigator to be unsuitable for inclusion in this study; 5. Patients who are willing to receive Herceptin treatment; 6. Those with internal medical system diseases and psychiatric diseases who are not suitable for chemotherapy; 7. Those with acute infection requiring antibiotic treatment; 8. Patients who have participated in clinical trials of other drugs within four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Adverse events; | — |
Countries
China
Contacts
Public ContactPeng Wanren
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed