metastatic solid tumors
Conditions
Interventions
Experimental group:HFRT/SBRT + GM-CSF + PD-1 blocker
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. The patients must conform to the advanced solid cancer with multiple metastases, have clear pathological diagnosis report or history, progress after at least first-line chemotherapy recommended by the guidelines, and have at least three measurable tumor lesions (>1 cm); 3. The hematopoietic function and general condition of the patients were acceptable (white blood cells > 2.5 x 10^9/L, platelets > 50 x 10^9/L, liver function glutamic-pyruvic transaminase and glutamic-oxaloacetic transaminase not exceeding 2.5 times the normal upper limit); 4. No congestive heart failure, unstable angina pectoris and unstable arrhythmia occurred in the past 6 months. 5. Patients'activity status was assessed by Eastern Cooperative Oncology Group (ECOG) score of 0-3, and life expectancy of more than 3 months; 6. There was no history of immune diseases in the past; 7. Abide by the plan during the study period; 8. Sign written consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients diagnosed with other malignant diseases in the past five years, except for cured skin cancer and cervical carcinoma in situ. 3. The clinical severity of uncontrolled epilepsy, central nervous system disease or mental disorder may hinder the signing of informed consent or affect the patient's compliance with medication. 4. Severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months; 5. Organ transplantation requires immunosuppressive therapy. 6. Major active infections are known, or researchers judge that there are major blood, kidney, metabolism, gastrointestinal, endocrine or metabolic disorders, or other serious uncontrolled concomitant diseases; 7. The baseline blood routine did not meet the following criteria: hemoglobin (>= 70g/L); absolute neutrophil count (ANC) (>= 1.0 x 10^9/L); platelet (>= 50 x 10^9/L); ALT, AST (<= 2.5 times normal upper limit value); 8. Anaphylaxis to any research drug ingredients; 9. Patients with a history of immunodeficiency, including HIV positive or with other acquired or congenital immunodeficiency disorders, or with a history of organ transplantation, or with other immune-related diseases requiring long-term oral hormone therapy; 10. In the period of acute and chronic tuberculosis infection (T-spot test positive, chest X-ray suspicious tuberculosis focus patients); 11. Researchers considered that it was not suitable for other situations in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;disease control rate;progression-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactZhang Liyuan
The Second Affiliated Hospital of Soochow University
Outcome results
None listed