Solid tumor
Conditions
Interventions
Endostatin Treatment Group:(1) recombinant human endostatin (endostatin) : the dose of endostatin was 140 mg ~ 210 mg (9 ~ 14 tubes) . The dosage of endostatin was 72 h ~ 120 h by continuous intraveno
Sponsors
San Huan Cancer Hospital, Chaoyang District
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18 to 75, regardless of gender; 2. Patients with advanced solid tumors confirmed by cytology or histology 3. There must be at least one evaluable lesion judged according to the RRECIST version 1.1 criteria (required according to RECIST version 1.1 for this measurable lesion on a spiral CT scan with a long diameter =10 mm or a short diameter of an enlarged lymph node =15 mm) ; 4. ECOG PS 0-2; 5. Expected survival =3 months. 6. The normal function of the main organs means that the following criteria are met: (1) the criteria of blood routine examination should be met: a. HB =80 g/L; b. ANC =1.5 × 10^9/l; c. PLT =80 × 10^9/L; (2) the biochemical examination should meet the following criteria: a. TBIL45 ml/min (Cockcroft Gault formula) 7. EKG was normal 8. Patients had good compliance and could understand the situation of this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have severe allergic / allergic reaction to humanized antibody or fusion protein; 2. Known hypersensitivity to any component of the En or antibody preparation; 3. Diagnosis of immunodeficiency or is receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first study dose, allowing the use of physiological doses of glucocorticoids (10mg / day prednisone or equivalent); 4 Subjects with active, known or suspected autoimmune disease were excluded. Subjects with type I diabetes, hypothyroidism with only hormone replacement therapy, skin disease without systemic treatment (e. g., vitiligo, psoriasis, or alopecia), or subjects not expected to reproduce in the absence of external triggers will be selected; 5. Patients with original severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular disease; 6. Hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV Ab) is positive, indicating that there are active acute or chronic infection. 7. According to chest X-ray, sputum examination and clinical X-ray, active tuberculosis (TB) infection. Patients with a history of active TB infection within the first year should be excluded even if treated; patients with active TB infection more than one year should also be excluded unless the course and type of anti-TB therapy is appropriate. 8. Major surgical treatment and significant traumatic injury within 28 days prior to grouping; 9. Patients whose imaging shows that the tumor has invaded important blood vessels or whose tumor is likely to invade important blood vessels during the subsequent study; 10. Patients with any physical signs or medical history of bleeding regardless of severity; patients with any bleeding or bleeding event grade CTCAE 3, with unhealed wound, ulcer or fracture within 4 weeks prior to grouping; 11. Individuals who have experienced arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism; 12. According by the investigator, there are concomitant diseases that seriously harm the patient safety or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;PFS;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;OS; | — |
Countries
China
Contacts
Public ContactZuo Lijie
San Huan Cancer Hospital, Chaoyang District
Outcome results
None listed