immune-resistant advanced non-small cell lung cancer
Conditions
Interventions
Low-dose irradiation of the entire small intestine at 1 Gy combined with PD-1 inhibitors
:Low-dose irradiation of the small intestine
Low-dose irradiation of the entire small intestine at 2 Gy combined with PD-1 inhibitors.:Low-dose irradiation of the small intestine
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 years and 3 months. 5. According to RECIST v1.1 criteria, subjects must have at least one measurable target lesion confirmed by CT. 6. NSCLC subjects who have previously received PD-1 inhibitors (such as sintilimab, carrelizumab, teriprizumab, or trevetenib) with or without chemotherapy, radiotherapy, and anti-angiogenic therapy, and have experienced disease progression or developed resistance to PD-1 inhibitors, requiring subsequent line treatment. 7. Patients evaluated as having stable brain metastases through multiple CT and/or MRI scans after treatment meet the inclusion criteria. 8. Patients must have complete clinical and pathological information. 9. All laboratory tests during the screening period must be conducted according to the protocol requirements and performed within 14 days before treatment. The results from these tests must meet the following criteria: 1) Complete blood count: (not transfused, treated with G-CSF, or corrective medications within 14 days prior to screening) a. Hemoglobin (HB) >= 90 g/L; b. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; c. Platelet count (PLT) >= 100 × 10^9/L; d. White blood cell count (WBC) >= 4.0 × 10^9/L and = 60 mL/min (using the Cockcroft-Gault formula); f. APTT <= 1.5 × ULN with INR or PT <= 1.5 × ULN (without anticoagulant therapy). 10. Women of childbearing potential must undergo a serum pregnancy test within 3 days prior to radiotherapy/chemotherapy, with a negative result. Women of childbearing potential and male partners must agree to use effective contraception during the study and for 180 days after the last administration of the investigational product. 11. Participation in the clinical study is voluntary, and subjects must sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with contraindications for radiotherapy and immunotherapy. 2. Patients who have previously experienced unacceptable immune-related adverse effects (such as immune-mediated myocarditis, pneumonia, etc.). 3. Patients assessed as having highly progressive disease (HPD). 4. Patients who have received pelvic and abdominal radiotherapy within the last 6 months before enrollment. 5. Adverse reactions from prior treatments that have not recovered to CTCAE v5.0 grade <= 1 (excluding well-defined low-risk toxicities such as fatigue or hair loss). 6. Patients with symptomatic bone metastases or symptomatic brain metastases. 7. Patients with severe infections. 8. Patients who are pregnant or plan to become pregnant. 9. Patients participating in other clinical studies that may affect the efficacy/safety of this clinical study. 10. Patients who have undergone major surgery within the last 30 days. 11. Patients who have received antibiotics, antifungals, antivirals, antiparasitics, or probiotics within the 4 weeks prior to enrollment. 12. Patients with severe liver disease (such as cirrhosis), kidney disease, respiratory diseases, or uncontrolled chronic systemic diseases such as diabetes or hypertension that cannot tolerate treatment. 13. Patients with active, known, or suspected autoimmune diseases and a history of autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. Type 1 diabetes (controlled by insulin) and hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy may be included; patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo skin manifestations (excluding psoriatic arthritis) may also be included if their rash covers less than 10% of body surface area, their disease is well controlled at baseline and requires only low-potency topical corticosteroid treatment, and there have been no acute exacerbations of the underlying condition in the past 12 months (not requiring PUVA, methotrexate, retinoids, biologics, oral calcineurin inhibitors, high-potency treatment, or oral steroids). 14. Patients with other malignancies within <= 5 years prior to the first administration of the investigational product, except for adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ post-surgery (hormonal treatment for non-metastatic prostate cancer or breast cancer is allowed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression free survival 2;Safety; | — |
Countries
China
Contacts
Public ContactMeng Xue
Cancer Hospital Affiliated to Shandong First Medical University (Shandong Cancer Hospital)
Outcome results
None listed