extensive small cell lung cancer
Conditions
Interventions
treatment group:Adebelizumab radiotherapy group
control group:Adebelizumab chemotherapy group
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) 18-75 years old. (2) the physical status of the Eastern American Cancer Cooperation Group (ECOG) was 0 or 1. (3) ES-SCLC subjects confirmed by histology or cytology (according to American Veterans Association of Lung Cancer, VALG staging). (4) the clinical stage is extensive cTanyNanyM1, including cT3 (multiple metastases of the same lobe), T4 (multiple metastases of the same lobe), NanyM0. (5) there is at least one measurable lesion assessed according to the RECIST v1.1 standard. (6) the expected survival time is more than 3 months. (7) have not received first-line systemic therapy for ES-SCLC or immune checkpoint inhibitors in the past. (8) there are no taboos of radiotherapy, chemotherapy and immunotherapy in patients. (9) adequate organ function: 1) Bone marrow function: absolute neutrophil count = 1.5x109 / L, platelet count = 90x109L, hemoglobin = 90g/L. 2) liver function: defined as total bilirubin level = 1.5 times normal upper limit (ULN); patients without liver metastasis, glutamic oxaloacetic transaminase (AST) and glutamic pyruvic transaminase (ALT) levels = 3 times ULN; for patients with recorded liver metastasis, AST and ALT levels = 5 times ULN. 3) Renal function: defined as serum creatinine = 1.5 times ULN; urine routine examination urine protein less than 2 grams, such as patients at the baseline level of urine protein = 2 + should collect 24-hour urine and prove that 24-hour urine protein quantitative test = 1g. 4) Coagulation function is good, defined as international standardized ratio (INR) or prothrombin time (PT) = 1.5 times ULN;. If the subject is receiving anticoagulant therapy, as long as PT is within the range of anticoagulant use. (10)The subjects signed an informed consent form and volunteered to participate in this study.
Exclusion criteria
Exclusion criteria: (1) allergic to experimental drugs; patients with transformation from non-small cell carcinoma (NSCLC) to SCLC or SCLC with mixed histology. (2) currently participating in interventional clinical research or receiving other research drugs or using research instruments within 4 weeks before the first administration. (3) have previously received any T cell costimulatory or immune checkpoint therapy, including, but not limited to, cytotoxic T lymphocyte associated antigen-4 (cytotoxic Tlymphocyte-associated antigen-4,CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other drugs targeting T cells. (4) have received transplantation of solid organs or blood system. (5) the third space effusion with clinical symptoms needs repeated drainage, such as pericardial effusion, pleural effusion and peritoneal effusion which can not be controlled by pumping or other treatment. (6) poorly controlled tumor-related pain: 1) patients who need analgesics already have a stable analgesic treatment plan when they are enrolled in this study. 2) for symptomatic lesions that can receive palliative radiotherapy (such as bone metastases or metastatic foci that lead to nerve compression), treatment should be completed before admission. Patients should recover from the effects of radiotherapy. The minimum recovery period is not required. 3) before entering the group, local treatment should be considered for metastatic lesions that are asymptomatic but may lead to functional impairment or intractable pain with further growth (such as epidural metastasis unrelated to spinal cord compression). (7) poorly controlled or symptomatic hypercalcemia (ionic calcium > 1.5mmol/L, calcium > 12mg/dL or corrected calcium exceeding ULN). (8) any disease requiring systemic treatment with corticosteroids (daily dose of prednisone or equivalent > 10 mg) or other immunosuppressive drugs within 14 days prior to randomization. (9) the adverse reactions caused by previous treatment did not recover to grade 1 or less of CTCEA (version 5.0) (except for the toxicity of grade 2 which existed for a long time, could not be recovered and did not increase the safety risk). Such as allowing immune diabetes (blood sugar can be controlled by insulin or oral drug therapy), immune hypothyroidism that only needs hormone replacement therapy, or situations that are not expected to relapse in the absence of external stimulation. Patients with eczema, psoriasis, chronic simple moss or only vitiligo (psoriatic arthritis should be excluded) if the rash covers less than 10% of the body surface area, at baseline the disease is fully controlled and only low titer topical steroids are needed. No acute exacerbation of underlying diseases in the past 12 months (no need for psoralen plus ultraviolet radiation [PUVA], methotrexate, retinoids, biological agents, oral calcineurin inhibitors, high titers or oral steroids) can be included in the study. (10) other moderate and severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function (including interstitial lung disease, radiation pneumonia requiring internal sterol treatment or drug-associated pneumonia, etc.), or have a history of such disease). (11) severe infections occurred within 4 weeks before randomization, including, but not limited to, hospitalization due to infection complications, bacteremia or severe pneumonia. (12) severe chronic or active infections (includi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective response rate;Disease Control Rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactQian Dong
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Outcome results
None listed