solid tumors
Conditions
Interventions
single arm:Anti-PD1
Sponsors
The Affiliated People's Hospital of Inner Mongolia Medical University (Inner Mongolia Cancer Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old male and female; 2. Patients with malignant tumor diagnosed by histology or cytology for primary tumors or metastatic lesions; 3. >=4 malignant or metastatic lesions; 4. Patients who have not received any systematic immunological therapy before, but to receive systematic anti-tumor treatment before (including chemotherapy and targeted therapy); 5. Patients with ECoG score of 0-1; 6. The functions of important organs meet the following requirements: 1) The absolute neutrophil count >=1.5x10^9/L; 2) Platelet >=80x10^9/L; 3) Hemoglobin >=80x10^9/L; 4) Total bilirubin 6 months.
Exclusion criteria
Exclusion criteria: 1. BMI=10% in 2 months before screening; 2. Received any following treatments: (1) Patients who have received any anti-PD-1 or anti-PD-L1 therapy before; (2) Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate) within 4 weeks prior to enrollment (3) Enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or following-up of interventional clinical study; (4) Patients who had received any anti-tumor vaccine or received the living vaccine within 4 weeks for the first administration of the research drug. 3. Subjects with active, known or suspected autoimmune disease; 4. Patients who had history of immunodeficiency, including HIV infection, HBV DNA, HCV antibody positive; 5. Subjects had cardiovascular clinical symptoms or diseases that are not well controlled, including but not limited to: (1) Cardiac failure meeting NYHA II or III before; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) Symptomatic pulmonary embolism <4 weeks; 6. Subjects with insufficient heart function, liver function and kidney function; 7. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic disease, including pulmonary fibrosis, acute lung disease; 8. Subjects with severe uncontrollable psychotic symptoms; 9. Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation; 10. Concomitant disease needs anticoagulant therapy; 11. Other primary malignancy, with the exception of: radical Non-melanoma skin cancer or cured cervical in-situ carcinoma; 12. Subjects with other diseases or abnormal Lab test results which might increase the risk of enrollment and treatment; 13. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Safety and Tolerability;Progression-free survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactHao Yang
The Affiliated People's Hospital of Inner Mongolia Medical University (Inner Mongolia Cancer Hospital)
Outcome results
None listed