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.
Parallel
chemotherapy plus TCM 1&ICIs plusTCM2
DrugIn China,TCM herbs are given on the basis of the TCM syndrome differentiation as diagnosed by the TCM herbal specialist. Prescriptions formulated into granules origin from Professor Liu Jia-xiang and Xu Ling. Package of granules is made into two types with functions such as tonifying the stomach and nourishing the blood recipe, benefiting Qi Yin and detoxification and resolving masses recipe. The herbal treatment is adapted to the syndromes. Chemotherapy：Vincristine/paclitaxel/docetaxel/pemetrexed/gemcitabine plus cisplatin/carboplatin：administrated for patients with NSCLC requiring post-operative adjuvant therapy. ICIs：Nivolumab/Pembrolizumab/Durvalumab/Atezolizumab/ Camrelizumab/Dupilumab/Sintilimab/Tislelizumab：administrated for patients with NSCLC requiring post-operative adjuvant therapy.
chemotherapy plus TCM 1placebo &ICIs plus TCM2 placebo
DrugChemotherapy：Vincristine/paclitaxel/docetaxel/pemetrexed/gemcitabine plus cisplatin/carboplatin：administrated for patients with NSCLC requiring post-operative adjuvant therapy. ICIs：Nivolumab/Pembrolizumab/Durvalumab/Atezolizumab/ Camrelizumab/Dupilumab/Sintilimab/Tislelizumab：administrated for patients with NSCLC requiring post-operative adjuvant therapy.
Disease-free Survival(DFS)
Time from patient enrollment to date of objective tumour recurrence from any cause.
Overall Survival(OS)
The time from patient enrollment to date of any documented death from any cause.
Quality of Life Measurement Scale (EORTC QLQ-C30)
EORTC QLQ-C30 is assessed using and developed by the European Organzation for Research and Treatment of Cancer（EORTC）.QOL is evaluated by comparing changes in the quality of life scales before enrollment and every 1 month after treatment.The maximum score of QLQ-C30 scale is 100 and the minimum score is 0.Higher scores in functional areas and overall health represent better quality of life.Higher scores in the symptom area mean poorer quality of life.
Quality of Life Measurement Specific Module Scale for Patients with Lung Cancer (EORTC QLQ-LC13)
QOL is evaluated by comparing changes in the quality of life scales before enrollment and every 1 month after treatment.The maximum score of QLQ-LC13 scale is 100 and the minimum score is 0.Higher scores mean poorer quality of life.
TCM Symptoms Changes
TCM symptoms changes are according to the lung cancer symptom classification quantization table in "Guiding Principles for Clinical Research of Traditional Chinese Medicine in the Treatment of Lung Cancer (2002 Edition)". 1. Significant improvement: clinical syndrome scores decreased by≥ 70%. 2. Partial improvement: clinical syndrome scores decreased b≥30%; 3. No improvement: clinical syndrome scores no change, or change\<30%; 4. Exacerbation: clinical syndrome scores increases by≥30%.
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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
