Tumor
Conditions
Interventions
Experimental group:BM201 & radiotherapy
Sponsors
Lishui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Male or female patients, aged 18 to 75 years; 2.Patients with advanced malignant tumors that have been clearly diagnosed by pathology and/or cytology, such as liver cancer, ovarian cancer, and prostate cancer; 3.Patients with advanced solid tumors who have failed or cannot tolerate standard treatment; 4.ECOG score 02 points; 5.The expected survival period is more than 3 months; 6.According to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1 version), the patient has at least one measurable or evaluable tumor lesion with the longest diameter at baseline >=10mm (if it is a lymph node, the short diameter is required to be >=15mm); 7.The patient should have sufficient bone marrow reserve function, or no liver and kidney coagulation dysfunction, laboratory test values must meet the following conditions: (1)Absolute neutrophil count >1.5x10^9/L, and white blood cell count >3x10^9/L; (2)Platelet count >80x10^9/L; (3)Hemoglobin >90 g/L; (4)Serum creatinine 30 mL/min; (5)AST and ALT< 2.5xuln if there was no confirmed liver metastasis; AST, ALT<5xULN if confirmed liver metastasis; (6)If no liver metastasis, total bilirubin <1.5xULN; Total bilirubin <3xULN in patients with liver metastasis or Gilbert syndrome (hyperindirect bilirubinemia); (7)International standardized ratio (INR) <1.5, and activated partial prothrombin time (APTT) <1.5xULN; 8.The patient has no brain metastases (except for patients with asymptomatic brain metastases, or patients who have had brain metastases but have been treated for more than 4 weeks of stable disease); 9.The patient voluntarily signs the informed consent form, and the expected compliance is good.
Exclusion criteria
Exclusion criteria: 1.Known or suspected allergies to study drug ingredients or their analogs; 2.The patient has any instability or any 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 diabetes.Controlled high blood pressure, severe infections, active peptic ulcers, abnormal immune function, etc.; 3.Cardiovascular and cerebrovascular diseases/symptoms/indications that meet any of the following conditions: (1)Mean resting QTc>470 ms (corrected QT interval [corrected by Fridericia formula]), mean QTc of 3 ECG, measured from the beginning of QRS compound to the end of T wave; (2)Any clinically significant resting ECG abnormality in rhythm, conduction, or morphology, such as complete left bundle branch block, degree 2 and 3 heart block, PR interval > 250 ms; (3)Any factors that increase the risk of prolonged QTc or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in first-degree relatives under 40 years of age, or any combination of medications known to prolong THE QT interval; (4)Left ventricular ejection fraction (LVEF) <50%; (5)Patients who had a history of decreased myocardial contractility and had related symptoms within 6 months before study administration, such as chronic congestive heart failure, pulmonary edema or decreased cardiac ejection fraction; (6)Patients who had a history of acute or chronic cardiovascular and cerebrovascular diseases and had related symptoms within 6 months before study administration, such as myocardial infarction, severe or unstable angina pectoris, cerebral infarction, cerebral hemorrhage, or transient ischemic attack; 4.People suffering from other malignant tumors or with a history of other malignant tumors, except for those who have been effectively controlled, non-invasive, basal cell carcinoma of the skin or squamous cell carcinoma, cervical carcinoma in situ and breast ducts that have not been recurred or metastasized for 5 years cancer; 5.The lesion cannot meet the requirement of 2 mL volume injected into the tumor; 6.For women of childbearing age (postmenopausal women must have been menopausal for at least 12 months to be considered infertile), the serum pregnancy test results are positive within 7 days before the intratumoral injection of the study drug; or the investigator judges that in the studyDuring the period and within 3 months after the last administration of the study drug, those who are willing to become pregnant, breastfeeding, or unwilling to use effective contraceptive measures (including male subjects and their female spouses of childbearing age); 7.Within 4 weeks before the first administration of the study drug: (1)Have received chemotherapy, radiotherapy, biological/targeted drug therapy, immunodrug therapy and other anti-tumor treatments; (2)Undergo major surgery; (3)Have participated in other clinical trials, have used or are currently using other experimental drugs (except non-interventional drug clinical trials); 8.Other severe, acute, or chronic clinical or mental diseases or laboratory abnormalities that may increase the risk of research and research medication, or may interfere with the results of the research; 9.Patients with active autoimmune diseases or a history of autoimmune diseases but may relapse,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability;Pharmacokinetic evaluation;Objective remission rate;Progression free survival;To explore the changes of lymphocytokine levels in peripheral blood;To explore the changes of immunohistochemical indexes in tumor tissues; | — |
Countries
China
Contacts
Public ContactJi Jiansong
Lishui Central Hospital
Outcome results
None listed