lung cancer
Conditions
Interventions
treatment group:Consolidation radiotherapy
Sponsors
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Histology or cytology confirmed small cell lung cancer; 2. The number of metastatic lesions is less than 5 (oligometastatic); 3. According to the seventh edition of the American Joint Cancer Board, IV [any T, any N, M Ia/b] or T3-4 cannot be included in the same tolerable radiation program due to the widespread distribution of multiple lung nodules or the large size of tumors / lymph nodes; 4. Four to six cycles of Durvalumab combined with standard chemotherapy (platinum + etoposide) were evaluated as CR or PR before entering the group; 5. Radiation oncologists determine that chest and oligometastatic lesions can be treated with radiotherapy; 6. The age of diagnosis was 18 - 65 years; 7.The ECOG physical fitness score (PS score) was 0-1; 8. The function of bone marrow was normal: WBC count >= 3 x 10^9 /L, neutrophil count >= 1.5 x 10^9/L, hemoglobin concentration >= 90 g/L, platelet count >= 100 x 10^9/L; 9. Normal liver and kidney function: total bilirubin = 60 mL/min; 10. Female subjects with pregnancy ability must agree to use reliable contraception within 1 year from screening visit to the last administration of PD-L1 antibody, and male subjects with female partner with pregnancy ability must agree to use reliable contraception within 1 year from screening visit to the last administration of PD-L1 antibody; 11. Life expectancy >= 12 weeks.
Exclusion criteria
Exclusion criteria: 1. Previously received antibodies or drugs targeting immune checkpoint pathways, including, but not limited to, anti-PD-1, anti-PD-L1, or anti-cytotoxic T lymphocyte associated antigen 4 (anti-CTLA-4) antibodies; 2. Within 4 weeks before enrollment or within 5 half-lives of the drug (whichever is the longer), systemic immune stimulants (including but not limited to interferon, interleukin-2, tumor necrosis factor) are used (cancer vaccines are allowed in previous treatments); 3. Within 14 days before the first administration of the drug, any Chinese herbal medicine used to control cancer was used; 4. Any disease that must be treated with corticosteroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive drugs within 14 days before enrollment. Note: patients who have used or have used any of the following steroid regimens can be selected: epinephrine replacement steroids (prednisone <= 10 mg/day or equivalent). Inhaled corticosteroids with very low local, ocular, articular, nasal or systemic absorption; prophylactic use of prescription corticosteroids in a short course (<= 7 days) or for the treatment of non-autoimmune diseases (such as delayed anaphylaxis caused by contact allergens); 5. Live vaccine is given within 4 weeks before joining the group. Note: seasonal influenza vaccine is usually an inactivated vaccine, and patients who receive such vaccine are allowed to join the group. The intranasal influenza vaccine is a live vaccine, and patients vaccinated with such vaccine are not allowed to enter the group; 6. Any major surgery requiring general anesthesia was performed within 28 days before enrollment; 7. Previous allogeneic stem cell transplantation or organ transplantation; 8. Clinically uncontrolled pericardial effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before randomization. Uncontrolled brain metastasis with active leptomeningeal disease; 9. Patients with asymptomatic central nervous system (CNS) metastasis during the screening phase can be selected if all of the following conditions are met: brain imaging examinations during the screening phase show that there is no evidence of mid-term progression between completion of immunotherapy combined with chemotherapy induction therapy and enrollment; no continuous use of corticosteroids for CNS disease; and permitting stable doses of anticonvulsant therapy; 10. Suffer from active autoimmune diseases or have a history of autoimmune diseases that may recur. Note: patients with the following diseases can be further screened: well-controlled type 1 diabetic hypothyroidism (only thyroid hormone replacement therapy can be controlled); well-controlled celiac disease; any other diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia) that are not expected to recur without external triggers; 11. Has suffered from interstitial lung disease or non-communicable pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.; 12. Severe chronic or active infections that require systemic antibacterial, antifungal or antiviral therapy within 2 weeks before enrollment, including, but not limited to, tuberculosis; 13. Any active malignant tumor less than 2 years before enrollment, except for specific cancers examined in this study and any locally recurrent cancers that have been cured (such as resected basal cell or squamous cell skin cancer, s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival;disease control rate; | — |
Countries
China
Contacts
Public ContactLiao Zhiwei
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Outcome results
None listed