Malignant solid tumor
Conditions
Interventions
Sponsors
Department of Oncology, the First Affiliated Hospital of Xi'an jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients older than 18 years old; 2. Patients with malignant solid tumors confirmed by histopathology and / or cytology; 3. Patients with at least one measurable lesion; 4. ECoG PS score: 0-2; 5. Patients with normal function of main organs meet the following standards: (1) Blood routine examination: HB > =90 g/L ANC >= 1.5 x 10^9/L PLT >= 80 x 10^9/L (2) Biochemical examination: ALB >= 30g/L ALT and AST = 50%; 7. Women of childbearing age who had negative pregnancy test (serum or urine) within 14 days before enrollment and voluntarily used appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug; men who had surgical sterilization or agreed to use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug; 8. Subjects who volunteer to join the study, signed informed consent, had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have used immunosuppressive drugs within 14 days before the application of drugs, excluding nasal spray and inhaled corticosteroids or systemic steroids with physiological dose (i.e. no more than 10 mg / day of prednisolone or other corticosteroids with physiological dose of the same drugs); 2. Patients with any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or asthma in childhood have been completely relieved, and no intervention is required after adults Asthma requiring medical intervention with bronchodilators could not be included; 3. Patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >= 1000 IU / ml), hepatitis C (HCV antibody positive, and HCV-RNA higher than the detection limit of the analysis method), or patients with CO infection of hepatitis B and hepatitis C, who need antiviral treatment in the research process; 4. Patients with myocardial infarction, severe / unstable angina pectoris, NYHA grade 2 or above cardiac insufficiency and poor control of arrhythmias (including QTCF interval > 450 ms in men and 470 in women) within 6 months before treatment MS, QTCF interval calculated by fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); 5. Patients with severe infection within 4 weeks before medication (such as intravenous drip of antibiotics, antifungal or antiviral drugs); 6. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Patients who were not considered suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;QoL; | — |
Countries
China
Contacts
Public ContactEnxiao Li
Department of Oncology, the First Affiliated Hospital of Xi'an jiaotong University
Outcome results
None listed