Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
Not provided
Not provided
Not provided
Postoperative immunoadjuvant therapy has been proven to significantly reduce the risk of recurrence after resectable NSCLC, and has become a new standard of postoperative adjuvant therapy for stage II-III NSCLC. Immunotherapy faces challenges such as immune resistance, heterogeneity of biomarker expression, and limitation of immune-suitable population. How to reduce the rate of recurrence and metastasis after surgery, enhance the therapeutic effect of immunotherapy, and then prolong the survival period and improve the quality of life, has become an urgent problem facing the current clinical. Based on the standards of evidence-based medicine, this study for the first time carried out a large sample, multi-center, randomized parallel controlled clinical study to obtain high-quality clinical evidence of the effectiveness and safety of electro-acupuncture and Zilongjin tablet synergic treatment, and formed a standard treatment plan of traditional Chinese medicine.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture combined with immunotherapy | Experimental |
| |
| Zilongjin tablet combined with immunotherapy | Experimental |
| |
| Immunotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture combined with immunotherapy | Other | Connect the electroacupuncture therapy instrument, select the density wave 2 Hz/100 Hz, the current intensity should be tolerated by the patient, leave the needle for 20 min.Immunotherapy including but not limited to pabolizumab and attilizumab were repeated every 21 days for treatment weeks.The period is 1 year, and maintenance treatment can be carried out in accordance with the drug instructions and guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival(DFS) | Time from random start to first recurrence or death. | 2year |
| Measure | Description | Time Frame |
|---|---|---|
| DFS | Time from random start to first recurrence or death. | 3year |
| Overall survival | 3,5year | |
| EORTC QLQ-C30 Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fanming Kong Director of Oncology Department, PhD | Contact | + 86 22 27986525 | kongfanming08@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Recruiting | Tianjin | 300381 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Zilongjin tablet combined with immunotherapy | Drug | Take Zilongjin tablets orally, 4 tablets each time, 3 times a day.Immunotherapy including but not limited to pabolizumab and attilizumab were repeated every 21 days for treatment weeks.The period is 1 year, and maintenance treatment can be carried out in accordance with the drug instructions and guidelines. |
|
| Immunotherapy | Drug | Immunotherapy including but not limited to pabolizumab and attilizumab were repeated every 21 days for treatment weeks.The period is 1 year, and maintenance treatment can be carried out in accordance with the drug instructions and guidelines. |
|
EORTC QLQ-C30 Scale |
| 0,2,3,6 month |
| Immune function | T lymphocyte subsets, NK cells | 0,3 month |
| Lung cancer TCM syndrome score | 0,2,3,6 month |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided