Small cell lung cancer
Conditions
Interventions
Huai 'er Granules Combined Treatment Group:Huai 'er Granules combined with chemotherapy (etoposide combined with platinum) + immunity (PD-1 monoclonal antibody)
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 78 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up; 2. Male or female patients aged between 18 and 78; 3. Patients with extensive-stage small cell lung cancer who have been pathologically confirmed and have not received previous treatment, and who have at least one lesion measurable or evaluable by imaging (CT, MRI) according to RECIST1.1 criteria; 4. Asymptomatic patients with brain metastases or those receiving treatment with stable symptoms can be included; 5. The life expectancy is at least 3 months, and the ECOG score is 0-1; 6. The main organ functions are normal, that is, they meet the following criteria: 1) The criteria for blood routine examination should be met (no blood transfusion or blood products within the previous 14 days, and no correction using G-CSF and other hematopoietic stimulating factors) : hemoglobin (HB)>=90 g/L; The absolute neutrophil count (ANC) is >=1.5×10^9/L (1500/m^3); Platelet count (PLT) >=100×10^9/L; 2) Biochemical tests should meet the following standards: total bilirubin (TBiL) =50 ml/min (cockcrot-gault formula: CrCL (mL/min) =[(140- age)* weight (kg)* F]/(SCr(mg/dL)*72). Among them, F=1 for males, F=0.85 for females, and SCr= serum creatinine; 3) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) : Lower limit of normal value (50%); 7. Patients of childbearing age (including both female and male patients' female companions) must take effective contraceptive measures;
Exclusion criteria
Exclusion criteria: 1. Lung cancer with a mixture of small cell carcinoma and non-small cell carcinoma; 2. Patients with extensive-stage small cell lung cancer who refuse to use immunotherapy or have contraindications to immunotherapy (such as interstitial changes in lung images, autoimmune diseases, active liver diseases, and uncontrollable infectious diseases); 3. Imaging studies show the presence of obvious pulmonary cavitary or necrotizing tumors; 4. Uncontrolled hypertension (systolic blood pressure >=140mmHg or diastolic blood pressure>=90mmHg, despite best drug treatment); 5. Suffering from grade II or above myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval >=450ms in men and >=470ms in women); 6. According to the NYHA standard, grade III to IV cardiac insufficiency 7. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT > 1.5×ULN), with a bleeding tendency or currently receiving thrombolytic or anticoagulant therapy; 8. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs; Note: Under the premise that the International normalized ratio of prothrombin time (INR) is = ++, or confirms 24-hour urine protein content >=1.0g; 15. Those with a history of abuse of psychotropic drugs and unable to quit, or those with mental disorders; 16. Those who have participated in clinical trials of other anti-tumor drugs within 4 weeks prior to screening; 17. Have had or concurrently suffered from other untreated malignant tumors; 18. Pregnant or lactating women; 19. Patients with any signs or history of bleeding constitution; 20. Based on the researcher's judgment, the patient may have other factors that could lead to the forced termination of this study, such as other serious diseases or significant abnormalities in laboratory tests, or be accompanied by other family or social factors that could affect the safety of the subjects, or the collection of experimental data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Progression-free survival evaluated by the researchers; | — |
Secondary
| Measure | Time frame |
|---|---|
| living quality;The Overall Response Rate;safety evaluation;DCR;OS; | — |
Countries
China
Contacts
Public ContactBin Wang/Xuefei Shi
Huzhou Central Hospital
Outcome results
None listed