Advanced bulky lung cancer
Conditions
Interventions
Lattice SFRT group:Lattice radiotherapy guided by [18F]AlF-NOTA-FAPI-04 PET/CT combined with DWI-MRI
Conventional Radiotherapy Group:Conventional Palliative Radiotherapy
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and provide written informed consent; 2. Age 18–75 years, gender unrestricted; 3. Patients with histologically or cytologically confirmed advanced non-small cell lung cancer (including adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, large cell carcinoma, sarcomatoid carcinoma, etc.) and primary pulmonary sarcoma, regardless of PD-L1 expression status; 4. Diameter of primary tumor or metastatic lesion > 40 mm and volume > 50 cm³, with indication for palliative radiotherapy (excluding patients with brain metastases as the radiotherapy site); 5. The intended radiotherapy sites have not received prior radiotherapy, or at least 6 months have elapsed since the last radiotherapy; 6. At least one measurable lesion according to RECIST 1.1 criteria; 7. ECOG performance status 0–1; 8. Life expectancy > 3 months; 9. Subjects agree to provide 10 mL of fasting peripheral blood at specified time points during treatment; 10. Adequate organ and bone marrow function: Complete blood count: a) Hemoglobin (HGB) >= 90 g/L b) Absolute neutrophil count (ANC) >= 1.5 × 10?/L c) Platelet count (PLT) >= 100 × 10?/L Blood biochemistry: d) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 45 mL/min (calculated by Cockcroft-Gault formula) g) APTT = 1.2 L or > 40% of predicted value; 11. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use adequate contraception during the observation period and for 180 days after the last treatment. Men must be surgically sterile or agree to use adequate contraception during the observation period and for 180 days after the last treatment; 12. Willing and able to undergo follow-up until death, study completion, or study termination.
Exclusion criteria
Exclusion criteria: 1. Patients with unresolved residual toxicity from prior treatment greater than CTCAE Grade 1 at the start of study treatment, excluding alopecia and Grade 2 neurotoxicity caused by previous chemotherapy; 2. Patients with other malignancies (except adequately treated non-melanoma skin cancer or lentigo maligna, effectively treated carcinoma in situ, or other effectively treated solid tumors with no evidence of disease for >5 years after treatment completion and at low risk of recurrence per treating physician) requiring standard treatment or major surgery within 2 years after the first study treatment; 3. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 4. Inability to lie supine, remain still during PET scanning, or intolerance to PET scanning; 5. Previous administration of radionuclides with an interval of less than 10 physical half-lives from the date of study drug administration; 6. Patients with contraindications to MRI examination, such as metal implants, foreign bodies, electronic devices, etc; 7. Patients with positive HIV test result or diagnosed with Acquired Immunodeficiency Syndrome (AIDS); 8. Patients with active hepatitis B or hepatitis C infection; 9. Patients with active bleeding prior to treatment; 10. Patients with severe cardiac, pulmonary, hepatic, or renal insufficiency; 11. Severe infection (e.g., requiring intravenous antibiotics, antifungals, or antivirals) within 4 weeks prior to dosing, or unexplained fever >38.5°C during screening or before the first dose; 12. Patients with known hypersensitivity or allergic reaction to any component of the study treatment; 13. Pregnant or lactating women; 14. Patients with known and unmanageable psychoactive substance abuse or psychiatric disorders; 15. Patients considered ineligible for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate of Target Lesions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival of Target Lesions;Duration of Response of Target Lesions;Disease Control Rate of Target Lesions;Adverse Events; | — |
Countries
China
Contacts
Public ContactMeng Xue
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed