Solid tumors
Conditions
Interventions
experimental group:lattice radiation therapy
Eligible patients will receive treatment using a medical linear accelerator. Within the largest tumor's gross tumor volume (GTV), spheres (0.5 - 3 cm in di
Sponsors
Tianjin Medical University Cancer Institute & Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form. 2. Histologically or cytologically confirmed malignant solid tumor. 3. Determined by a multidisciplinary tumor board or by the treating physician in consultation with a surgeon to be an advanced solid tumor patient unsuitable for surgery. 4. No standard treatment available or intolerant to standard treatment, with disease assessed as stable disease (SD) or progressive disease (PD) by imaging and clinical evaluation. 5. Age >= 18 years on the day of signing informed consent. 6. The intended radiotherapy site has not been previously irradiated, or more than 6 months have passed since the last radiotherapy. 7. Karnofsky Performance Status (KPS) >= 70. 8. At least one measurable lesion according to RECIST 1.1 criteria. Previously irradiated lesions can only be considered target lesions if there is clear progression after radiotherapy. 9. Expected survival > 3 months. 10. Adequate organ and bone marrow function: - Total bilirubin = 3500/µL. - Absolute neutrophil count (ANC) >= 1500/µL. - Platelet count >= 90,000/µL. - Hemoglobin >= 9 g/dL. - Creatinine = 50 mL/min (calculated using the Cockcroft-Gault formula). - Coagulation function: International Normalized Ratio (INR) = 50%. - Corrected QT interval (QTcF, Fridericia formula) <= 450 ms. 11. Recovery from prior treatment-related toxicities (i.e., <= Grade 1 or baseline). 12. Agreement to use appropriate contraceptive methods during the study. 13. No contraindications to radiotherapy as judged by the radiation oncologist. 14. Willingness to receive immunotherapy and radiotherapy.
Exclusion criteria
Exclusion criteria: 1.Active central nervous system (CNS) metastases, carcinomatous meningitis, or spinal cord compression. 2. Severe comorbidities such as myocardial infarction within 6 months, severe arrhythmias, or psychosis that may affect treatment completion or result in a life expectancy of <3 months. 3. Evidence of interstitial lung disease or active/non - infectious pneumonia (e.g., drug - induced, radiation - induced) requiring steroid treatment. 4. History of pulmonary fibrosis, pulmonary artery hypertension, or severe irreversible airway obstruction. 5. Presence of peripheral neuropathy. 6. Severe organ dysfunction (e.g., hepatic, cardiopulmonary failure) that is likely to make radiotherapy intolerable. 7. Known allergy to study drugs or excipients, or a history of severe allergic reaction to any PD - 1 monoclonal antibody. 8. Serious infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; or receipt of oral or intravenous antibiotics within 2 weeks prior to study treatment. Patients receiving prophylactic antibiotics (e.g., for urinary tract infections or chronic obstructive pulmonary disease exacerbations) are eligible. 9. Known or suspected active autoimmune disease (e.g., uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis). Exceptions: patients with vitiligo, cured childhood asthma; patients with well - controlled type 1 diabetes on insulin. 10. History of allogeneic organ transplant (except corneal) or allogeneic hematopoietic stem cell transplant. 11. Pregnant or breastfeeding women. 12. Any other condition that the investigator deems a valid reason for disqualification based on the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event; | — |
Countries
China
Contacts
Public ContactLiu Ningbo
Tianjin Medical University Cancer Institute & Hospital
Outcome results
None listed