Solid malignant tumor
Conditions
Interventions
Sponsors
Inner Mongolia Autonomous Region Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and above, unlimited for men and women; 2. Patients with solid tumor confirmed by histopathology or cytology; 3. The patients who had been treated with 1-2 kinds of systemic chemotherapy for solid tumor were ineffective or advanced, or had disease progression or relapse within 6 months after receiving adjuvant chemotherapy without more than four line treatment, and had not used immunosuppressant before; 4. ECOG PS score 0-1; 5. Estimated survival time >=3 months; 6. There are measurable lesions in accordance with the RECIST 1.1 standard; 7. The function of main organs was normal, and there were no serious blood, heart, lung, liver and kidney dysfunction and immune deficiency diseases. The laboratory inspection meets the following requirements: (1) hemoglobin (Hgb) >=90g/L; (2) neutrophil count (ANC) >=1.5x10^9/L; (3) platelet count (PLT) >=100x10^9/L; (4) ALT and AST 50ml / min (Cockcroft Gault formula); (7) the urine routine was normal, or the urine protein was less than (+ +), or the 24-hour urine protein was less than 1.0 g; 8. Normal coagulation function, no active bleeding and thrombosis disease: (1) international standardized ratio INR <=1.5 ULN; (2) partial thromboplastin time APTT <=1.5 ULN; (3) prothrombin time Pt <=1.5 ULN; 9. Pregnant women of childbearing age must have negative pregnancy test (serum or urine) within 7 days before entering the group, and they should voluntarily use appropriate methods of contraception during the observation period and within 12 weeks after the last administration of the study drug; for men, they should be sterilized by operation or agree to use appropriate methods of contraception during the observation period and within 12 weeks after the last administration of the study drug; 10. The patients voluntarily joined the study and signed the informed consent form (ICF); 11. It is expected that those with good compliance can follow up the efficacy and adverse reactions according to the requirements of the plan.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, except for skin basal cell carcinoma, skin squamous cell carcinoma and / or cervical carcinoma in situ and / or breast cancer which have been effectively treated; 2. Symptomatic central nervous system metastasis; 3. It is known that it is allergic to carrizumab, apatinib or drug adjuvant, or it has serious allergic reaction to other monoclonal antibodies; 4. Have any active autoimmune disease or autoimmune disease history (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); have complete remission of childhood asthma and no intervention or vitiligo can be included in adults, need Patients who need medical intervention with bronchodilator are not included; 5. Patients with congenital or acquired immune defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >=500 IU/ml), hepatitis C (HCV antibody positive, and HCV-RNA higher than the detection limit of the analysis method), or combined hepatitis B and hepatitis C co infection; 6. Immunosuppressive drugs were used within 14 days before the first use of the study drug, excluding nasal spray and inhaled corticosteroids or systemic steroids in physiological dose (i.e. no more than 10 mg / day of prednisolone or other corticosteroids in physiological dose of the same drug); 7. Inoculate live attenuated vaccine within 4 weeks before the first administration or during the study period; 8. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever of unknown cause occurred during screening / before the first administration > 38.5 degree C; 9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 10. There is objective evidence to show that he has had or is currently suffering from pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced pneumonia, drug-related pneumonia, severe impairment of lung function, etc; 11. Patients with hypertension who still can't fall to the normal range (systolic blood pressure II); unstable or severe angina; acute myocardial infarction within 6 months; patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; left ventricular ejection fraction (LVEF) 30 ml within 3 months), hemoptysis (bleeding > 5 ml within 4 weeks) and thromboembolism events (including stroke events and / or transient ischemic attack) within 12 months; 14. Participating in other clinical trials or participating in any other drug clinical study within 4 weeks, or not more than 5 half-lives away from the last study medication; 15. Other situations that the researchers think are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR;OS;Safety; | — |
Countries
China
Contacts
Public ContactJunqing Liang
Inner Mongolia Autonomous Region Cancer Hospital
Outcome results
None listed