Patients with non-small cell lung cancer
Conditions
Interventions
Experimental group:0.5g per capsule, take 6 capsules, 3.0g, three times a day
Sponsors
Lishui City Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be eligible for this program: 1) Male or female aged = 18 years; 2) Pathologically confirmed non-small cell lung cancer (adenocarcinoma + squamous cell carcinoma), advanced, locally advanced or early patients who cannot undergo surgery; 3) Suitable for radical chemoradiotherapy; 4) It is planned to receive intensity-modulated radiotherapy, daily routine fractional irradiation (1.8-2.0 Gy/time), and the total dose of radiotherapy is recommended to be 60-66 Gy; Regarding radiotherapy targets, for patients who have received induction chemotherapy, only residual primary lesions and affected lymph node areas after chemotherapy are irradiated; 5) ECOG score of 0-1; 6) Normal function of major organs: Blood count: Hemoglobin (HGB) = 90 g/L; Absolute neutrophil (ANC) =1.5×109/L; c. Platelet (PLT) =100×109/L; Coagulation function: International normalized ratio (INR) =1.5×ULN, or prothrombin time (PT) =ULN+4 seconds, or activated partial thromboplastin time (APTT) =1.5×ULN; 7) Accept more than 20 Gy lung volume percentage (V20) = 30%; 8) Patients should not receive TKI or immunotherapy during radiotherapy and chemotherapy; 9) the investigator judged that there was an expected survival period of more than 6 months; Voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be admitted to this program: 1) the patient has pleural effusion; 2) Patients have received chest and neck radiotherapy, chemotherapy, TKI and immunotherapy before screening; 3) The patient has distant metastases (brain, liver); 4) Patients with abnormal liver and kidney function in screening examination, the criteria are as follows: total bilirubin > 1.5×ULN; ALT>2.5×ULN; AST>2.5×ULN; Creatinine >1.5×ULN or creatinine clearance < 60mL/min; 5) comorbid uncontrolled diseases; 6) inability to swallow the study drug; 7) history of active malabsorption disorder or gastrointestinal resection; 8) Patients with chronic or interstitial lung disease or pneumonia; 9) Screening patients who were treated with systemic hormones in the previous 4 weeks, or who had comorbidities who may have been treated with hormones during the study; 10) Participate in other clinical trials, use other investigational drugs or research devices within 30 days before screening; 11) refusal of women or men of childbearing age to use contraception during the study; 12) pregnant or lactating women; 13) Patients suffering from autoimmune diseases such as AIDS; 14) There are any other factors that may not be suitable for participating in clinical research as judged by the investigator; 15) The patient underwent major trauma or underwent major surgery within 28 days prior to the use of study drug treatment; 16) Patients treated with traditional Chinese medicines with antitumor effects, and other cordyceps preparations within 15 days before and during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate at which = grade 2 radiation pneumonitis developed within 24 weeks of the end of radiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rates of grade 2 or greater radiation pneumonitis within 12 weeks of the end of radiotherapy;Rates of grade 3 and above radiation pneumonitis 12 weeks and 24 weeks after the end of radiotherapy;Rates of radiation esophagitis occurring at 12 and 24 weeks after the end of radiotherapy;Rates of grade 3 or higher radioesophagitis occurring at 12 weeks and 24 weeks after the end of radiotherapy;Incidence of adverse reactions up to 24 weeks after the end of radiotherapy;Serum inflammatory factor concentrations at 12 and 24 weeks after the end of radiotherapy; | — |
Countries
china
Contacts
Public Contacttujianfei
Lishui City Central Hospital
Outcome results
None listed