Electroacupuncture, Immune Checkpoint Inhibitors, Non-Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
OTHERElectroacupuncture combined with immunotherapy
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.
DRUGZilongjin tablet combined with immunotherapy
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.
DRUGImmunotherapy
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.
Sponsors
Ministry of Science and Technology of the People´s Republic of China
Kong Fanming
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* (1) Non-tumor patients with stage Ⅱ, ⅢA, ⅢB (N2) non-small cell lung cancer diagnosed by pathology or cytology after surgery; (2) driver mutations negative patients; (3) Postoperative adjuvant chemotherapy was received for 1 to 4 cycles;(4)conforms to two qi syndrome of traditional Chinese medicine syndrome differentiation diagnosis of patients; (5) aged 18 to 80 years old; (6) expected lifetime \> 6 months; (7) ECOG 0 to 2 points; (8) patients willing to accept this solution treatment, adherence to the good.
Exclusion criteria
* (1) Patients with other malignant tumors in the past or at the same time within 5 years; (2) has a serious heart, liver and kidney damage, or other serious complications; (3) the R1, R2, need after resection, postoperative adjuvant radiotherapy patients; (4) with mental disorders; (5) has a variety of drug allergy, allergic constitution; (6) in pregnancy or lactation women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival(DFS) | 2year | Time from random start to first recurrence or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DFS | 3year | Time from random start to first recurrence or death. |
| Overall survival | 3,5year | — |
| EORTC QLQ-C30 Scale | 0,2,3,6 month | EORTC QLQ-C30 Scale |
| Immune function | 0,3 month | T lymphocyte subsets, NK cells |
| Lung cancer TCM syndrome score | 0,2,3,6 month | — |
Countries
China
Contacts
Primary ContactFanming Kong Director of Oncology Department, PhD
Outcome results
None listed