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Clinical Study on the Prevention of Driver Gene Negative II-IIIa Lung Cancer Recurrence and Metastasis by Staged Chinese Herbal Medicine Combined With Chemotherapy and Immune Checkpoint Inhibitors
Sponsor: Shanghai University of Traditional Chinese Medicine
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
367
Start Date
2023-05-01
Completion Date
2026-06-30
Last Updated
2023-04-28
Healthy Volunteers
No
Conditions
Interventions
chemotherapy plus TCM 1&ICIs plusTCM2 placebo
In 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
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.
Locations (1)
YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China