Malignant tumor
Conditions
Interventions
single arm:Oral administration of beta glucan
Sponsors
Changzhou Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-75 years (including 18 and 75 years); 2. Understand the research steps and contents, and sign the written informed consent voluntarily; 3. Patients with malignant tumor confirmed by histopathology and / or cytology; 4. Have at least one measurable lesion according to RECIST 1.1 standard; 5. Have used or are using PD-1 / PD-L1 and the disease is progressing. 6. ECoG PS score: 0-1; 7. Expected survival time >= 3 months; 8. Good function of main organs, i.e. relevant examination indexes within 14 days before enrollment meet the following requirements: red protein >= 90 g / L (no blood transfusion within 14 days); neutrophil count > 1.5 x 10^9 / L; blood platelet count >= 100 x 10^9 / L; total bilirubin = 60 ml / min (Cockcroft Gault formula); left ventricular ejection fraction (LVEF) >= 50%; 9. Body weight above 40 kg (including 40 kg), or BMI > 18.5.
Exclusion criteria
Exclusion criteria: 1. Participated in clinical trials of other drugs within four weeks; 2. Had multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 3. Had a history of haemorrhage, and any bleeding event with severe grade of ctcae5.0 or above occurred within 4 weeks before screening; 4. Patients with known history of central nervous system metastasis or central nervous system metastasis before screening. For patients with clinically suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis; 5. Patients newly diagnosed with angina pectoris within 3 months before screening or myocardial infarction within 6 months before screening; arrhythmia (including QTCF: male >= 450 ms, female >= 470 MS) (MS) long term use of antiarrhythmic drugs and New York Heart Association classification >= II cardiac insufficiency; 6. Imaging showed that the tumor had invaded the important blood vessels or the researchers judged that the tumor was highly likely to invade the important blood vessels during the treatment, causing fatal massive hemorrhage; 7. Abnormal coagulation function, bleeding tendency (14 days before randomization must meet the following requirements: in the case of no bleeding, the patient's blood coagulation function was abnormal In the case of anticoagulants, INR is within the normal range; in patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; in the premise of prothrombin time international normalized ratio (INR) <= 1.5, it is allowed to use low-dose warfarin (1 mg orally, once a day) or low-dose aspirin (daily dose does not exceed 100 mg) for preventive purposes; 8. Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or organ transplantation history; 9. Infectious pneumonia, non infectious pneumonia, interstitial pneumonia and other patients who need to use corticosteroids; 10. Have a history of severe chronic autoimmune diseases, such as systemic lupus erythematosus; have ulcerative enteritis, Crohn's disease and other inflammatory diseases History of enteropathy, irritable bowel syndrome and other chronic diarrhea diseases; history of sarcoidosis or tuberculosis; 11. Patients with high sensitivity to human or mouse monoclonal antibodies; 12. Patients with history of psychotropic drug abuse and unable to quit or with mental disorders; 13. Pleural effusion or peritoneal effusion with clinical symptoms that need clinical intervention; 14. Patients who do not follow the doctor's advice, do not use drugs according to the regulations, or have incomplete information that may affect the efficacy or safety judgment; 16. According to the judgment of the researchers, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PD-1/PD-L1;cytokines;ct-DNA;PFS;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR; | — |
Countries
China
Contacts
Public ContactHua Jiang
Changzhou Second People's Hospital of Jiangsu Province
Outcome results
None listed