solid tumor
Conditions
Interventions
Intervention group:Karelizumab combined with chemotherapy
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up; 2. Patients with stage IV solid tumor confirmed by histopathology/cytology; 3. Subjects have not received prior systemic therapy for advanced solid tumors; 4. Regulations for patients with oligometastases: 1-5 metastases appear in 1-2 distant organs; 5. No clear driver genes (including but not limited to EGFR and ALK); 6. At least one lesion suitable for radiotherapy; 7. Age 18-75; 8. ECOG score 0-1; 9. Estimated survival >=3 months; 10. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors during screening) : Neutrophil absolute count >=1.5x10^9/L; Platelet >= 100x10^9/L; Hemoglobin >=9g/dL; Serum albumin >=3g/dL; Thyroid stimulating hormone (TSH) = 60mL/min. 11. Women of non-surgical sterilization or childbearing age are required to use a medically approved contraceptive method (such as an intrauterine device, birth control pill or condom) during the study period and for three months after the study period; The serum or urine HCG test of female patients of childbearing age who were not undergoing surgical sterilization must be negative within 72 hours prior to study enrollment. And must be non lactation period; For men, they should be surgically sterilized or agree to use the appropriate method of contraception during the trial and for three months after the last trial drug is given.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); The subjects had vitiligo; Asthma with complete remission in childhood and no need for intervention in adulthood may be included, but asthma requiring medical intervention with bronchodilators may not be included); 2. The subject is taking immunosuppressant, systemic, or absorbable local hormone therapy for immunosuppression purposes (dose >10mg/ day of prednisone or other equivalent hormone) and continues to use within 2 weeks prior to enrollment; 3. Severe allergic reactions to other monoclonal antibodies; 4. Subject has clinically symptomatic central nervous system metastases (e.g. cerebral edema, need for hormonal intervention, or progression of brain metastases). Patients who have received prior treatment for brain or meningeal metastasis, such as clinical stability (MRI) for at least 1 month, and who have stopped systemic hormone therapy (dose >10mg/ day of prednisone or other equivalent therapeutic hormone) for more than 2 weeks may be included; 5. Have cardiac clinical symptoms or diseases that are not well controlled, such as:(1) nyha class 2 or more heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant ventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc>450ms (male); QTc>470ms (female); 6. Patients at risk of major bleeding; 7. Abnormal coagulation function (INR>1.5 or PT>16s), bleeding tendency or receiving thrombolytic or anticoagulant treatment; 8. Patients with ascites, pleural effusion or pericardial effusion with clinical symptoms and requiring therapeutic puncture or drainage, such as patients with pleural effusion or pericardial effusion who have been stable for at least 2 weeks from the drainage to the first medication of the first study, can be included in the study; 9. Patients with obvious hemoptysis or daily hemoptysis of half teaspoonful (2.5ml) or more in the first 2 months of randomness; 10. Genetic or known to exist. Acquired bleeding and thrombotic tendencies (such as hemophilia, cocoagulability disorder, thrombocytopenia, hypersplenism, etc.) or arteriovenous thrombotic events occurring in the last 6 months (up to the first shR-1210 medication); 11. Subject has active infection or unexplained fever >38.5 degrees during screening but before first administration; 12. Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 13. Subjects with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA test value exceeds the upper limit of normal; Hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value); 14. Those who have used other drugs in clinical trials within 4 weeks before the first medication; 15. Subject has previous or co-existing malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 16. Subjects may receive other systemic antitumor therapy during the study period; 17. Patients with bone metastases who had received palliative rad
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactYang Zhe
Shandong Provincial Hospital
Outcome results
None listed