ED-SCLC
Conditions
Interventions
experimental group:Durvalumab+EP combined with Cyberknife sequential Durvalumab
Sponsors
Cancer Diagnosis and Treatment Center of the Sixth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. At the time of screening, the age of male or female subjects >= 18 years old; 2. Obtain written informed consent from the patient or his legal representative prior to conducting any study protocol related procedures (including screening assessment); 3. Patients with extensive stage diseases confirmed by histology or cytology (American Cancer Joint Committee, 7th Edition, stage IV SCLC [any T stage, any n stage and ml A / b]), or T3-4 stage diseases that cannot be included in a tolerable radiotherapy plan due to the wide range of multiple pulmonary nodules or the large volume of tumor / nodule; 4. Patients with brain metastasis must be asymptomatic or stable in steroid and anticonvulsant therapy at least 1 month before the study. Patients suspected of brain metastasis should be examined by CT / MRI before entering the study group; 5. Patients must think it is suitable to receive platinum based chemotherapy as the first-line treatment of ED-SCLC. Chemotherapy must include cisplatin or carboplatin, combined with etoposide; 6. Patients with life expectancy >= 12 weeks on the first day; 7. At the time of inclusion, the patients whose physical state score of who / ECoG was 0 or 1; 8. Patients whose weight is more than 30 kg; 9. According to the RECIST 1.1 guideline, at least one focus (without previous radiotherapy) was accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline, and the longest diameter was >= 10 mm (except for lymph nodes, whose short axis must be >= 15 mm); and the focus was suitable for repeated and accurate measurement. 10. Patients not previously exposed to immune-mediated therapy, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti programmed cell death ligand 2 (anti-PD-L2) antibodies, except for therapeutic anti-tumor vaccines; 11. It has sufficient organ and marrow functions, which are defined as follows: Hemoglobin >= 9.0 g / dl. Absolute neutrophil count >= 1.5 x 10^9 / L (granulocyte colony stimulating factor is not allowed in screening). Platelet count >= 100 x 10^9 / L. Serum bilirubin 60ml / min, patients receiving carboplatin treatment > 45ml / min.
Exclusion criteria
Exclusion criteria: Patients should not enter the study if they meet any of the following exclusion criteria: 1. Personnel involved in the design and / or implementation of the study. 2. Patients who have been previously assigned the investigational product (IP) in this study. 3. To be enrolled in another clinical study at the same time, unless it is an observation (non intervention) clinical study or the follow-up stage of the intervention study. 4. Patients who have participated in another clinical study and received IP administration in the last 4 weeks. 5. Patients with medical contraindications to etoposide platinum based chemotherapy (carboplatin or cisplatin). 6. Have a history of chest radiotherapy before systemic treatment. Radiotherapy outside the chest (i.e., bone metastases) for palliative treatment purposes is permitted, but must be completed before the first application of the study drug. 7. Conduct any chemotherapy, IP, biological products or hormone therapy for cancer treatment at the same time. It is acceptable to use hormone therapy for non cancer related diseases (e.g., hormone replacement therapy). 8. Major surgery (as defined by the investigator) was performed within 28 days prior to the first administration of IP. Note: for the purpose of palliative treatment, local operation for isolated lesions is acceptable. 9. Patients with a history of allogeneic organ transplantation. 10. Paraneoplastic syndrome (PNS) with autoimmune nature requiring systemic treatment (systemic steroids or immunosuppressive agents) or clinical symptoms indicating PNS aggravation. 11. Patients with active or previously recorded autoimmune or inflammatory diseases (including inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis (excluding diverticulosis), systemic lupus erythematosus, sarcoidosis syndrome, Wegener's syndrome (granulomatous vasculitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). For this standard, the following exceptions are: Patients with vitiligo or alopecia; patients with hypothyroidism (e.g. after Hashimoto syndrome) and stable condition after hormone replacement therapy; any chronic skin disease without systemic treatment; patients without active disease in the past three years can be included in the study after discussion with the research physician; they can be controlled only through diet Patients with celiac disease. 12. Patients with uncontrolled complications, including but not limited to: persistent or active infection, interstitial lung disease, symptomatic congestive heart failure, uncontrolled high blood pressure, unstable angina, arrhythmia, severe chronic gastrointestinal disease with diarrhea, or may limit compliance with the study requirements, lead to a significant increase in AE risk or affect the subjects The state of mental illness / social problems with the ability to provide written informed consent. 13. Other patients with a history of primary malignant tumor, except: Malignant tumors with no known active disease and low risk of recurrence >= 5 years before IP first administration; Fully treated non melanoma skin cancer or malignant lenticular nevus without disease evidence; Carcinoma in situ with adequate treatment and no evidence of disease. 14. Patients with a history of leptomeningeal cancer; 15. Patients with a history of active primary immunodeficiency; 16. Patients with active infection, including tuberculosis (clinical evaluation, including clini
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;APF6/APF12;OS18;OS; | — |
Countries
China
Contacts
Public ContactJuyi Wen
Cancer Diagnosis and Treatment Center of the Sixth Medical Center of PLA General Hospital
Outcome results
None listed