Actively Recruiting
Clinical Study on the Prevention of Driver Gene Negative Ib-IIIb Lung Cancer Recurrence and Metastasis by Staged Chinese Herbal Medicine Combined With Chemotherapy and Immune Checkpoint Inhibitors
Led by Shanghai University of Traditional Chinese Medicine · Updated on 2026-05-13
367
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
S
Shanghai University of Traditional Chinese Medicine
Lead Sponsor
S
Shanghai Pulmonary Hospital, Shanghai, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study on the Prevention of Driver Gene Negative Ib-IIIb Lung Cancer Recurrence and Metastasis by Staged Chinese Herbal Medicine Combined With Chemotherapy and Immune Checkpoint Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 2 points.
- Absolute neutrophil value >1.5�d7109 /L, platelet count >80�d7109 /L, hemoglobin >90mg/dL; no abnormal liver and kidney function test results.
- Understand and agree to participate in this study and sign the informed consent form.
You will not qualify if you...
- 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.
- Patients who are pregnant or lactating.
- Patients who are allergic to therapeutic drugs.
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Trial Site Locations
Total: 1 location
1
YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China, 200437
Actively Recruiting
Research Team
L
Ling Xu, MD & PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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