Solid tumor
Conditions
Interventions
Group A:Low Dose Radiotherapy (LDRT) dose was 6Gy/3f, Stereotactic Ablative Radiotherapy (SBRT) dose was 24Gy/3f , the dose of Tislelizumab was recommended in the instruction manual.
Group B:Low Dose Radiotherapy (LDRT) dose was 6Gy/3f, Stereotactic Ablative Radiotherapy (SBRT) dose was 30Gy/3f , the dose of Tislelizumab was recommended in the instruction manual.
Group C:Low Dose Radiotherapy (LDRT) dose was 6Gy/3f, Stereotactic Ablative Radiotherapy (SBRT) dose was 45Gy/3f , the dose of Tislelizumab was recommended in the instruction manual.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Eligibility Criteria Subjects must meet all of the following criteria to be enrolled in this study: 1. All subjects must sign an informed consent form before starting study-related procedures; and must be able to comply with the visits and related procedures stipulated in the protocol. 2. Male or female aged =18 years; 3. Cytologically or histologically diagnosed with malignant tumor, and staged as Stage IV (AJCC 8th edition); 4. Agree to provide tumor tissue samples, which can be archived or newly acquired, for biomarker testing; 5. Subjects who have failed first-line standard treatment, are clinically unsuitable for standard treatment, or refuse chemotherapy. 6. At least one measurable lesion (according to RECIST v1.1 standards); for a lesion previously treated with radiation, the lesion can only be considered a target lesion if there is clear disease progression after radiation. 7. Lesions treated with radiation must have a longest diameter of =5 cm 8. ECOG performance status of 0-2; 9. Expected survival >3 months 10. Important organ and bone marrow function meeting the following requirements: 10.1 Complete blood count: White blood cell count =3.5×10^9/L, absolute neutrophil count (ANC) =1.5 ×10^9/L, platelets (PLT) =90×10^9/L, hemoglobin (HGB) =9g/dL; 10.2 Liver function: Total bilirubin (TBIL) =1.5 times the upper limit of normal (ULN), Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) =2.5 times ULN, (if liver metastasis is present, AST and ALT = 5x ULN). 10.3 Renal function: Serum creatinine =1.5×ULN, or creatinine clearance =50 ml/min (calculated using the Cockcroft/Gault formula); For women: CrCl = (140 - age) x weight (kg) x 0.85 / (72 x serum creatinine [mg/dL]) For men: CrCl = (140 - age) x weight (kg) x 1.00 / (72 x serum creatinine [mg/dL]) 10.4 Coagulation function: •INR =1.5×ULN •PTT =1.5×ULN 10.5 Sufficient cardiovascular function: •Left ventricular ejection fraction (EF) =50% •QTcF interval =450ms 11. Side effects of previous treatments (excluding hair loss) = Grade 1 or have returned to baseline levels. 12. A washout period of =4 weeks for previous anticancer treatments, =5 half-lives for molecular targeted drugs, palliative radiation must have been completed at least =2 weeks prior, chest radiation must have been completed at least =4 weeks prior, and major surgeries must have been completed =4 weeks prior. 13. The investigator judges that the subject has good compliance and can complete the scheduled visits, treatments, and laboratory tests according to the study protocol. 14. Radiation oncologists assess that there is no severe pulmonary ventilatory dysfunction, no acute cardiac failure, and judge that there are no contraindications to radiation therapy. Subjects agree to receive immunotherapy and radiation therapy. 15. Subjects must take strict contraceptive measures.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Patients with any of the following conditions cannot be enrolled in this study: 1. Exclusion of subjects with active central nervous system (CNS) metastases (including but not limited to carcinomatous meningitis, spinal cord compression). If a subject's CNS metastases can be adequately treated, and the subject's neurological symptoms can return to baseline levels at least 2 weeks before enrollment (excluding residual signs or symptoms related to CNS treatment), they may participate in the study. Additionally, subjects must have ceased using corticosteroids 4 weeks prior to enrollment. 2. With tumor emergencies that require immediate treatment. 3. Biopsy pathology indicates the presence of tumor tissue with sensitive gene mutations (EGFR, ALK, ROS-1, etc.). 4. Interstitial pneumonia (ILD), drug-induced pneumonia, radiation pneumonia requiring steroid treatment, or clinically symptomatic active pneumonia or severe pulmonary dysfunction. 5. History of pulmonary fibrosis, pulmonary arterial hypertension, severe irreversible airway obstruction disease. 6. Subjects with peripheral neuropathy. 7. Clinically significant coagulation disorders deemed meaningful by the researcher, or receiving thrombolytic or anticoagulant treatment. 8. Subjects who have needed systemic use of corticosteroids (dose equivalent to >10 mg of prednisone/day) or other immunomodulators (interleukin-2, IFN-a, IFN-?, cyclosporine, G-CSF, mTOR inhibitors) within 28 days prior to the study treatment. Subjects using inhaled or topical corticosteroids, and those on adrenal cortical steroid replacement therapy equivalent to 140/100 mmHg (average of 3 consecutive measurements). - Clinically significant arrhythmias, atrial fibrillation and/or conduction abnormalities (within <6 months before screening) or current evidence, such as congenital long QT syndrome, complete atrioventricular block =Grade 2, or hypokalemia =CTCAE Grade 3. - History or current evidence of acute coronary syndrome within <6 months before screening (including myocardial infarction, unstable angina, coronary artery bypass grafting (CABG), coronary angioplasty, or stenting). - Complete left bundle branch block. - Right bundle branch block + left anterior hemiblock (LAHB) - bifascicular block. 10. With clinically symptomatic third-space effusion that cannot be controlled by drainage or other treatments, such as pericardial effusion, pleural effusion, and ascites. 11. Known allergies to drugs or excipients, known severe allergic reactions to any monoclonal antibody. 12. Severe infection occurring within 4 weeks prior to the start of the study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; having received therapeutic oral or intravenous antibiotics within 2 weeks before the start of the study treatment; patients receiving prophylactic antibiotics (e.g., for the prevention of urinary tract infections or exacerbation of chronic obstructive pulmonary disease) are eligible for the study. 13. Known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pne
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicities; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactYou Lu
West China Hospital
Outcome results
None listed