Solid tumor
Conditions
Interventions
Experimental group:After SBRT treatment, patients were treated with piamprilizumab combined with anrotinib for maintenance treatment
Sponsors
Shanxi Bethune Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years, no gender limit; 2. The activity status score of patients was 0 to 1 in the Eastern Cooperative Oncology Group (ECOG); 3. Life expectancy assessment >3 months; 4. Enrolled patients had recurrent or metastatic advanced solid tumors that progressed after at least second-line treatment, and had a clear pathological diagnosis report or history; 5. Currently, the patient has no standard treatment plan recommended by the guidelines; 6. According to RECIST 1.1 criteria, all patients should have measurable or evaluable target lesions; 7. If the major organs function normally, the following criteria are met: (1) The standard of blood routine examination must meet: (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct) : 1) WBC>3.0x10^9/L; 2) HB>=90g/L; 3) ANC>=1.5x10^9/L; 4) PLT>=75x10^9/L; (2) Biochemical examination shall meet the following standards: 1) TBIL50ml/min (Cockcroft-Gaut formula); (3) Blood coagulation test: 1) Activated partial thromboplastin time (APTT) <=1.5xULN; 2) International Standardized ratio (INR) <= 1.5xULN; 3) Prothrombin time (PT) <= 1.5xULN; 8. No congestive heart failure, unstable angina pectoris, or unstable arrhythmia occurred in the past 6 months; 9. The patients voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients; A fertile patient who is unwilling or unable to take effective contraceptive measures; 2. History of other malignant diseases in the last 5 years, excluding cured skin cancer and cervical carcinoma in situ; 3. Have any active autoimmune disease or history of autoimmune disease (the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy)); Have vitiligo or childhood asthma that has been completely resolved and can be included as an adult without any intervention; Patients requiring medical intervention with bronchodilators are not included; 4. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or other immune-related diseases requiring long-term oral hormone therapy; 5. A known major active infection, or a major hematological, renal, metabolic, gastrointestinal, endocrine, or metabolic disorder determined by the investigator, or other serious uncontrolled concomitant disease; 6. Use of immunosuppressive drugs within 14 days prior to the first use of the study drug, excluding nasal and inhaled corticosteroids or systemic steroid hormones at physiological doses (i.e., not exceeding 10 mg/ day of prednisone or its equivalent); 7. In the period of acute or chronic tuberculosis infection (T-spot test positive, chest radiograph with suspicious tuberculosis lesions); 8. The patients had active hepatitis B (HBV DNA>=500 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower detection limit of the analytical method); 9. Clinically significant hemoptysis (more than 50 mL of hemoptysis per day) within 3 months before the study, or clinically significant bleeding symptoms or significant bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occultive blood ++ or above baseline, or vasculitis); 10. It should be prohibited for patients with intestinal obstruction, uncontrolled hypertension within 30 days after major surgery, and grade 3-4 cardiac insufficiency (NYHA criteria), and other conditions deemed unsuitable for inclusion by the investigators; 11. The patient has a known history of psychotropic substance abuse, alcohol abuse, or drug use; 12. Have a history of severe allergy to other monoclonal antibodies, antirotinib or its prophylaxis; 13. Patients who are participating in another clinical study or whose first dose is less than 4 weeks after the end of the previous clinical study (last dose), or the five half-lives of the investigational drug; 14. The investigator believes that there is any condition that may harm the patient or cause the patient to be unable to meet or perform the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Disease control rate;Duration of response; | — |
Countries
China
Contacts
Public ContactMei Qi
Shanxi Bethune Hospital
Outcome results
None listed