This project adopts a prospective, multicenter, randomized controlled clinical study to investigate the treatment of TCM in postoperative patients with driver gene negative lung cancer, according to two phases of postoperative adjuvant therapy: (i) chemotherapy phase immunotherapy phase. In this study, 367 patients (183 in the control group and 184 in the trial group) will be observed over 4 years, and the quality of life, toxic effects and safety of this therapy will be investigated. This study will provide evidence-based evidence for the establishment and optimization of a new model of postoperative staged TCM with adjuvant chemo-immunotherapy for lung cancer.
Patients who underwent complete surgical resection (R0) with postoperative pathology confirmed as stage Ib to IIIb non-small cell lung cancer.
Patients whose tissue or blood specimens tested negative for driver genes.
Patients who received their first chemotherapy within 8 weeks postoperatively.
Age ≥ 18 years ≤ 74 years, regardless of gender.
Having unresectable or metastatic disease, pathology reports without a clear pathological diagnosis, showing the presence of residual lesions at the microscopic surgical margins, and surgical residual lesions.
Any medical condition with a life expectancy of less than 5 years, except for risk of recurrent lung cancer.
Current malignant disease or history of malignant disease (except resected NSCLC), combined with serious diseases of the heart, liver, kidney and hematopoietic system, diagnosed and/or requiring treatment within the past three years.
With a history of psychiatric disorders that are not easily controlled.
Shanghai University of Traditional Chinese Medicine
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Collaborator
Shanghai Chest Hospital
Collaborator
Fudan University
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Ruijin Hospital
Collaborator