Tumor
Conditions
Interventions
Experimental group:JN101&RT
Sponsors
Lishui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 70 years; 2.Patients with advanced malignant tumor confirmed by pathology and/or cytology; 3.The expected survival time is not less than 3 months; 4.At least one injectable, measurable lesion (>=10 mm); 5.The patient should have sufficient bone marrow reserve function, or no liver and kidney coagulation dysfunction, and the laboratory test value must meet the following conditions: (1)Absolute neutrophil count > 1.5x10^9/L and WBC count > 3x10^9/L; (2)Platelet count > 80x10^9/L; (3)Hemoglobin > 90g/L; (4)Serum creatinine 30 mL/min; (5)AST and ALT < 2.5xULN if there is no confirmed liver metastasis; If there is confirmed liver metastasis, AST and ALT < 5xULN; (6)Total bilirubin < 1.5xULN in the absence of liver metastasis;In patients with liver metastasis or Gilbert syndrome (high indirect bilirubinemia), total bilirubin < 3xULN; (7)International standardized ratio (INR) < 1.5, and activated partial prothrombin time (APTT) < 1.5xULN; 6.ECOG physical condition score: 0-2; 7.Patients who are willing to participate in the study can understand and have the ability to sign the informed consent, and good compliance is expected.
Exclusion criteria
Exclusion criteria: 1.Known or suspected allergies to study drug ingredients or their analogs; 2.The patient has any unstable or other diseases or medical conditions that may affect its safety or research compliance, any serious or uncontrolled systemic diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, and uncontrolled high blood pressure, severe infections, active peptic ulcers, abnormal immune function, etc.; 3.Female patients who are pregnant or breastfeeding; 4.Patients with brain metastases; 5.Patients with hepatic encephalopathy in the past or currently; 6.Patients with active infectious diseases (including HIV antibody positive, Treponema pallidum specific antibody positive, active tuberculosis, etc.); 7.Patients with a history of central nervous system diseases; 8.Patients with autoimmune diseases; 9.Patients who are still in the clinical observation period of other drugs within one month before the first administration; 10.Patients who have not recovered from acute side effects from previous treatments; 11.Suffer from a heart disease that has not been effectively controlled and needs to be treated; 12.Patients with organ failure or insufficiency: (1)Heart function: Heart function grade 3 or above (according to the NYHA standard of the New York College of Cardiology); (2)Pulmonary function: respiratory failure; (3)Brain function: abnormal central nervous system or impaired consciousness; 13.Patients suffering from any serious, uncontrollable disease (including but not limited to: unstable angina, congestive heart failure, grade 3 or grade 4 heart disease, severe arrhythmia, severe metabolic disease, etc.); 14.With a history of acute drug allergy, especially patients who are allergic to immunoglobulin drugs; 15.Patients who are participating in other clinical trials; 16.The investigator believes that it is not suitable for patients participating in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reaction;Vital signs;Blood routine examination;Liver disease/tumor-related blood indicators;Hepatorenal function;Coagulation function;Laboratory detection;Computed tomography/magnetic resonance imaging; | — |
Countries
China
Contacts
Public ContactJi Jiansong
Lishui Central Hospital
Outcome results
None listed