Solid Tumors
Conditions
Interventions
experimental group:Camrelizumab vascular intervention and intravenous injection
Sponsors
Heilongjiang General Hospital of Heilongjiang General Hospital of General Bureau of Agricultural Reclamation
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age of patients: 18-75 years old, male and female unlimited; 2. Non resectable patients; 3. Patients with measurable tumor focus (spiral CT or MR scan >= 10 mm, meeting the RECIST 1.1 standard); 4. Patients with expected survival time >= 3 months; 5. ECoG PS: Patients with 0-2 points; 6. The baseline laboratory inspection meets the following standards: (1) Bone marrow function: the absolute count of blood neutrophils (ANC) >= 1.5 * 10^9 / L, PLT >= 80 * 10^9 / L, hemoglobin (HB) >= 80g / L; (2) Liver function: serum total bilirubin (STB) and conjugated bilirubin (CB) were less than or equal to ULN * 1.5; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than or equal to ULN * 2.5 (without liver metastasis), or less than or equal to ULN * 5 (with liver metastasis); (3) Coagulation function: Pt INR <= ULN * 1.5; 7. Female: to be sterilized surgically or postmenopausal, or to be contraceptive during and after treatment for 6 months; non lactation; male: to be sterilized surgically or to be contraceptive during and after treatment for 6 months; 8. The patient volunteered to join the study and signed the informed consent. The patient had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have used immunosuppressive agents within 14 days before the first use of carrizumab, excluding nasal spray and inhaled corticosteroids or systemic steroids of physiological dose (i.e. no more than 10mg / day prednisolone or other corticosteroids of the same physiological dose); 2. Patients with previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.; 3. Patients with active, known or suspected autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases (such as vitiligo, psoriasis or alopecia) without systemic treatment can be selected; 4. Patients with myocardial ischemia or myocardial infarction above grade II and poor control of arrhythmia (including QTc interval >= 450 ms for men and 470 MS for women); 5. According to the NYHA standard, grade III-IV cardiac insufficiency or color Doppler echocardiography: LVEF (left ventricular ejection fraction) < 50%; 6. It is known that the subjects were previously allergic to macromolecular protein preparation or any component of carrizumab; 7. Patients with HIV positive; 8. Patients with a history of psychoactive substance abuse, alcoholism or drug abuse; 9. Pregnant or lactating women, patients with fertility who are unwilling or unable to take effective contraceptive measures; 10. Other factors that may affect the safety or test compliance of the subjects according to the judgment of the researchers. For example, serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, or other family or social factors, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS; | — |
Countries
China
Contacts
Public ContactFeng Gao
Heilongjiang General Hospital of General Bureau of agricultural reclamation
Outcome results
None listed