Immune-resistant advanced non-small cell lung cancer
Conditions
Interventions
chemotherapy-immunotherapy combined with low-dose intestinal radiotherapy group:chemotherapy-immunotherapy combined with low-dose intestinal radiotherapy
Sponsors
Cancer Hospital Affiliated of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 and 3 months. 7. According to RECIST v1.1, at least one measurable target lesion must be evaluable by CT. 8. Patients with brain metastases that have been stabilized after repeated CT and/or MRI scans are eligible. 9. Patients have complete clinical and pathological information. 10. All screening laboratory tests must be performed within 14 days before treatment and meet the following criteria: Hematology (within 14 days before screening) without transfusion, without G-CSF, and without medications to correct values a. Hemoglobin (HB) >= 90 g/L b. Absolute neutrophil count (ANC) >= 1.5 x 10^9/L c. Platelet count (PLT) >= 100 x 10^9/L d. White blood cell count (WBC) >= 4.0 x 10^9/L and = 30 g/L e. Creatinine (Cr) = 60 mL/min (Cockcroft-Gault) f. APTT <= 1.5 x ULN, and INR or PT <= 1.5 x ULN (no anticoagulation) 11. Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to radiochemotherapy. Women of childbearing potential and male partners of women of childbearing potential must agree to use highly effective contraception during the study and for 180 days after the last administration of the study drug. 12. Voluntary participation in the clinical study and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with contraindications to radiotherapy or immunotherapy. 2. Patients with severe infection or chronic diarrhea. 3. Pregnant patients or patients planning pregnancy. 4. Patients participating in other clinical studies that may affect the efficacy or safety of this study. 5. Patients who have undergone major surgery within 30 days prior to enrollment. 6. Patients who have received antibiotics, antifungals, antivirals, antiparasitics, or probiotic therapy within 4 weeks prior to enrollment. 7. Meningeal metastasis, symptomatic or asymptomatic. 8. Patients planned for radiotherapy of pelvic-abdominal bone metastases (areas may include the gastrointestinal tract). 9. Patients with severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, uncontrolled diabetes, hypertension, or other chronic systemic diseases who cannot tolerate therapy. 10. Active, known, or suspected autoimmune diseases and history of autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. Eligible: Type 1 diabetes mellitus (glycemic control achieved with insulin), residual hypothyroidism due to autoimmune thyroiditis treated with hormone replacement only, or conditions with no expected relapse in the absence of external triggers. Patients with eczema, psoriasis, chronic nonspecific lichen planus, or vitiligo without psoriatic arthritis may be enrolled if the rash covers less than 10% of body surface area, baseline disease is well controlled, only low-potency topical steroids are required, there has been no acute deterioration of the underlying condition in the past 12 months, and they do not require PUVA, methotrexate, retinoids, biologics, oral calcineurin inhibitors, high-potency or oral steroids. Enrollment requires meeting all these conditions. 11. Within 5 years prior to the first dose, a history of another malignancy, with exceptions for adequately treated cervical intraepithelial neoplasia, basal cell carcinoma or squamous cell skin cancer, locally treated prostate cancer after definitive therapy, or ductal carcinoma in situ (DCIS) after definitive therapy (hormonal therapy allowed for non-metastatic prostate or breast cancer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;overall survival;adverse events; | — |
Countries
China
Contacts
Public ContactMeng Xue
Cancer Hospital Affiliated to Shandong First Medical University (Shandong Cancer Hospital)
Outcome results
None listed