solid tumor
Conditions
Interventions
Experimental group:SBRT in combination with camrelizumab and GM-CSF
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 3. Life expectancy is more than 3 months; 4. Histologically or cytologically diagnosed with advanced recurrent or metastatic solid tumors (for lung cancer, EGFR and ALK mutation-positive subjects should be excluded); 5. Disease progression or unacceptable toxicity after at least one standard treatment in the past; 6. If the subject has undergone surgery, must recover adequately from the toxicity and complications of surgical intervention prior to initiating treatment; 7. Subjects with brain metastases without neurological symptoms and stable lesions can be included, and subjects with brain metastases with clinical symptoms or progression can also be included if they meet the following conditions at the same time: (1) Imaging confirmed that the lesion remains stable for at least 2 months after treatment; (2) Systemic hormone therapy (dose >10 mg/day prednisone or other equivalent hormones) has been stopped for more than 2 weeks before enrollment; 8. There are at least 2 independent lesions: one with a diameter of =1.5x10^9/L, platelet count >=100x10^9/L, and hemoglobin >=90g/L [No blood transfusion or no erythropoietin (EPO) dependence within 7 days]; (2) Good liver function, serum total bilirubin level 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 60ml/min (Cockcroft-Gault formula); serum albumin >= 30g/L; (4) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; 11. Willing and able to comply with the visits, treatment plans, laboratory tests and other research procedures of the research plan; 12. No previous history of immune diseases; 13. For female subjects of childbearing potential, a negative serum pregnancy test should be performed within 7 days prior to the administration of the first study intervention (study drug, radiation therapy). Subjects agreed to use highly effective contraception (ie, a method with a failure rate of less than 1% per year) for at least 180 days after discontinuation of study treatment.
Exclusion criteria
Exclusion criteria: 1. Previously received immune drugs other than anti-PD-1/L1 or other immune experimental drugs; 2. Received radical radiotherapy within 6 months of the first medication; 3. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 4. Subjects with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure = (++), and 24-hour urine protein amount >= 1.0g; 6. There are various factors that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction; 7. Subjects who are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before the first dose, or who have been vaccinated or planned to receive live vaccines within = 2 requiring systemic antibiotic therapy within 2 weeks prior to the first dose; 16. Myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval >=450ms for men, >=470ms for women) within the past 6 months, subjects with congestive heart failure (NYHA standard III-IV cardiac insufficiency or LVEF (left ventricular ejection fraction) <50%); 17. HBsAg positive and H
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Duration of relief;Disease control rate; | — |
Countries
China
Contacts
Public ContactLi Baisen
Sichuan Cancer Hospital
Outcome results
None listed