ES-SCLC
Conditions
Interventions
experimental group:Immunotherapy combined with Apatinib maintenance therapy
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old (including upper limit), no gender restrictions; 2. Pathologically confirmed SCLC (small cell lung cancer) (histopathology or cytology); 3. Evidence of metastatic disease in ES-SCLC (extensive stage small cell lung cancer) confirmed by whole-body PET/CT scan, and CT or MRI scans of the chest, abdomen, pelvis, and brain with diagnostic quality or bone scan (staging method of the US Veterans Administration Lung Cancer Group (VALG): lesions found on both sides of the thorax, including malignant pleural and pericardial effusions or hematogenous metastasis); 4. No prior systemic treatment for ES-SCLC; 5. At least one measurable lesion defined by RECIST criteria v1.1 (for lesions previously treated with radiotherapy, only those with clear disease progression after radiotherapy and where the previous lesion is the only measurable lesion can be considered as measurable); 6. ECOG performance status of 0-1; 7. Life expectancy of at least 3 months; 8. Adequate organ function, defined by the following criteria (no blood transfusion or blood products within 14 days, no use of G-CSF and other hematopoietic stimulants): 1) Hematology: Hemoglobin (HGB) >= 90g/L; Platelets (PLT) >= 100×10^9/L; Absolute Neutrophil Count (ANC) >= 1.5×10^9/L; White Blood Cell Count (WBC) >= 3.0×10^9/L; 2) Biochemistry: For subjects without liver metastasis, Aspartate Transferase (AST) = 3 g/dL; Serum creatinine = 40mL/min (using the Cockcroft/Gault formula); 3) Coagulation function: International Normalized Ratio (INR) <= 1.5, Activated Partial Thromboplastin Time (APTT) <= 1.5×ULN; 9. Fertile men and women must agree to use medically approved contraceptive measures during the study and for 6 months after the last administration of the study drug; 10. Subjects must voluntarily participate in this study, sign informed consent, demonstrate good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Mixed SCLC and NSCLC confirmed by histology or cytology; 2. Spinal cord compression that cannot be relieved by surgical and/or radiation therapy, or previously diagnosed spinal cord compression that has not been clinically proven to be stable for at least 1 week after treatment before enrollment; 3. Have received any other clinical investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to the first use of the investigational drug; 4. Receive corticosteroid therapy (>10mg/day prednisone or equivalent dose) or other immunotherapy within 2 weeks prior to the first use of the investigational drug; Inhalation or topical use of steroids and adrenaline substitutes in the absence of active autoimmune diseases is not ruled out, and physiological doses of corticosteroids (= 140mmHg or diastolic blood pressure >= 90mmHg); 8. Urine routine shows that urine protein is >= ++and confirms that 24-hour urine protein quantification is>1.0 g; 9. There is a risk of bleeding: Within the first 3 months of enrollment, there have been significant clinical bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, etc; Suffering from hereditary or acquired bleeding disorders or coagulation dysfunction, such as aplastic anemia; Currently taking anticoagulant or antiplatelet drugs (such as warfarin, phenylpropanoid coumarin); 10. Clinical symptoms or diseases of the heart that cannot be well controlled, such as >= grade 2 myocardial ischemia or infarction, uncontrollable arrhythmias (including male QTc >= 450ms, female QTc >= 470ms) and >= grade 2 congestive heart failure (NYHA classification), unstable angina, myocardial infarction within 6 months, and clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 11. Highly suspected subjects of interstitial lung disease, or those who may interfere with pulmonary toxicity tests or treatment related to suspected treatment, or other moderate to severe diseases that seriously affect lung function; 12. Active or uncontrolled severe infections (>= CTC AE level 2 infection), including but not limited to hospitalization due to infection complications, bacteremia, or severe pneumonia, with unexplained fever>38.5 °C before the first dose; 13. Subjects with active pulmonary tuberculosis or a history of active pulmonary tuberculosis infection within the 12 months prior to screening, regardless of whether they have received treatment or not; 14. Active hepatitis B virus or hepatitis C virus infection (active hepatitis B reference: HBsAg positive, exceeding the upper limit of normal value [1000 copies/ml or 500 IU/ml]; Activity C Liver reference: HCV antibody positive and HCV virus titer detection value exceeding the upper limit of normal/HCV RNA or HCV Ab detection indicati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month progression free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;progression free survival;objective response rate;Duration of relief;disease control rate;Adverse events related to treatment;Serious adverse events related to treatment; | — |
Countries
China
Contacts
Public ContactChen Hualin
Guangdong Medical University Affiliated Hospital Lung Tumor Specialty in Zhanjiang City, Guangdong Prov
Outcome results
None listed