malignancies
Conditions
Interventions
group A:SF-SABR+IMRT+ICI
group B:SF-SABR+ICI
Sponsors
Hainan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1, =18 years of age; 2. malignant tumors confirmed by cells or pathology; 3. Primary, recurrent or metastatic tumors, = 5 cm in diameter, or involving important organs, in patients who cannot undergo surgery, failed first-line treatment, or refused chemotherapy; 4. ECOG =60 points 5. Survival is expected to be =3 months 6. No serious comorbidities (bone marrow, liver and kidney function, coagulation function, heart function) Blood routine: WBC =3.0×109/L, ANC =1.5 ×109/L, PLT =90×109/L, HGB =8g/dL; 1 Liver function: TBIL =1.5-fold ULN, ALT/AST =2.5-fold ULN, (liver metastasis AST and ALT = 5x ULN). Renal function: Cr=1.5×ULN, Coagulation function: INR=1.5×ULN, PTT=1.5×ULN Cardiac function: EF=55%, QTcF interval=450ms; cardiac function=2 Respiratory function: lying flat, without severe ventilatory dysfunction; 7. the elution period of previous anti-tumor therapy was >4 weeks; 8. sign written informed consent; 9. agree to collect biological specimens of tissue or blood) for standby;
Exclusion criteria
Exclusion criteria: 1, received radiotherapy at the same site within 3 months; 2. in pregnancy or lactation; 3. Diffuse metastases of the central nervous system (brain, meninges, spinal cord) 4. severe comorbidities (severe infection, bone marrow depression, cardio-cerebrovascular disease, persistent or intractable epilepsy; severe cardiac insufficiency, coagulation disorder, active hemorrhage, electrolyte disturbances); 5. KPS <60 points; 6. Any arterial thrombosis, embolism, or ischemia that occurred within 6 months before enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; 7. previous history of mental illness, alcohol abuse, drug use, or substance abuse;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective relieate rate (ORR);local control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progress-free survival;Overall Survival;Safety and tolerability;side-effect; | — |
Countries
China
Contacts
Public Contactyunxiu luo
Hainan Cancer Hospital
Outcome results
None listed