Clinical study on prevention and treatment of postoperative recurrence and metastasis of lung cancer with traditional Chinese medicine based on Registration Platform

Guang'anmen Hospital, China Academy of Chinese Medical Sciences0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

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•? Postoperative patients with stage ii-iiia NSCLC diagnosed by pathology or cytology;
•? Patients without tumor after adjuvant therapy were enrolled within 1 month after adjuvant therapy;
•? The adjuvant chemotherapy regimen is the cycle of scheme 4 specified in NCCN guidelines
•? Age 18-75 years old;
•? Ecog0-1 for physical condition score;
•? Estimated survival period = 6 months;
•? The subjects had no dysfunction of major organs, normal blood routine, liver, kidney and heart functions, liver function: blood bilirubin = 2.0uln, blood alanine aminotransferase and glutamic oxaloacetic aminotransferase = 5uln; Renal function: serum creatinine = 2.0uln, blood urea nitrogen = 2.0uln; Bone marrow reserve: WBC = 3.0 × 109/l, absolute value of neutrophils (ANC) = 1.5 × 109/l, PLT = 80 × 109/l, hemoglobin (Hgb) = 80g/l.

•? Preoperative neoadjuvant chemotherapy;
•? Adenocarcinoma ex19del/l858r (+) patients
•? In other clinical trials;
•? Have a birth plan within one year and have been pregnant or breast-feeding patients;
•? Those who cannot cooperate with the follow-up and are allergic to the study drug;
•? Using immunotherapy or targeted therapy
•? Any situation that may prevent the subjects from completing the follow-up process, including but not limited to severe and uncontrollable organic diseases or infections, unstable angina pectoris, congestive heart failure, etc; Severe liver and kidney dysfunction (serum creatinine = 1.5 times ULN; ALT or AST = 5 times ULN; bilirubin = 1.5 times ULN); Patients with nervous, mental disease or mental disorder accompanied by symptoms and difficult to control; The patients with central nervous metastasis whose condition is not controlled and who have obvious cranial hypertension or neuropsychiatric symptoms;

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