Lung Cancer Clinical Trial
Official title:
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
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.
Status | Not yet recruiting |
Enrollment | 367 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 74 Years |
Eligibility | Inclusion Criteria: 1. Patients who underwent complete surgical resection (R0) with postoperative pathology confirmed as stage II to IIIa non-small cell lung cancer. 2. Patients whose tissue or blood specimens tested negative for driver genes. 3. Patients who received their first chemotherapy within 8 weeks postoperatively. 4. Age = 18 years = 74 years, regardless of gender. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) = 2 points. 6. absolute neutrophil value >1.5×109 /L, platelet count >80×109 /L, hemoglobin >90mg/dL; no abnormal liver and kidney function test results. 7. Understand and agree to participate in this study and sign the informed consent form. Exclusion Criteria: 1. 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. 2. Any medical condition with a life expectancy of less than 5 years, except for risk of recurrent lung cancer. 3. 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. 4. With a history of psychiatric disorders that are not easily controlled. 5. Patients who are pregnant or lactating. 6. Patients who are allergic to therapeutic drugs. |
Country | Name | City | State |
---|---|---|---|
China | YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai University of Traditional Chinese Medicine | Fudan University, Ruijin Hospital, Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Zhongshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free Survival(DFS) | Time from patient enrollment to date of objective tumour recurrence from any cause. | 5 years | |
Secondary | Overall Survival(OS) | The time from patient enrollment to date of any documented death from any cause. | 5 years | |
Secondary | 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. | 5 years | |
Secondary | 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. | 5 years | |
Secondary | 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)". Significant improvement: clinical syndrome scores decreased by= 70%. Partial improvement: clinical syndrome scores decreased b=30%; No improvement: clinical syndrome scores no change, or change<30%; Exacerbation: clinical syndrome scores increases by=30%. |
5 years | |
Secondary | Laboratory Indicator Evaluation Criteria | Refer to the "Guidelines for Clinical Research of New Drugs in Traditional Chinese Medicine (Trial)" (China Medical Science and Technology Press, 2002) to develop evaluation criteria: Improve: Any increase after treatment is =10% before treatment, or from abnormal to normal; Decrease: Anyone who falls =10% after treatment or changes from normal to abnormal after treatment; Stable: Anyone who rises or falls less than 10% after treatment compared with before treatment. |
5 years | |
Secondary | Circulating Exosome PD-L1 | The circulating exosome PD-L1 evaluation will be measured before treatment, during chemotherapy, before immunotherapy, during immunotherapy, after treatment, and every 6 months during the follow-up period. | 5 years | |
Secondary | Molecular Residual Disease Circulating Tumor DNA(ctDNA-MRD) | The ctDNA-MRD evaluation will be measured before treatment, during chemotherapy, before immunotherapy, during immunotherapy, after treatment, and every 6 months during the follow-up period. | 5 years | |
Secondary | Safety Assessment Evaluated According to Common Toxicity Criteria | Percentage of Participants with Adverse Events. Safety assessment is evaluated according to common terminology criteria for adverse events(CTCAE) 5.0. | 5 years |
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