RecruitingPhase 2NCT06381960

Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe

Clinical Study on the Prevention and Treatment of Postoperative Metastasis in Stage IIA-IIIA Lung Cancer With Negative Expression of Driver Genes by Fuzheng Quxie Recipe

Sponsor

Jianhui Tian

Enrollment

356 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

Summary

To address the clinical challenge of postoperative metastasis in stage IIA-IIIA non-small cell lung cancer with negative driver gene expression, there is a lack of effective diagnostic and therapeutic measures. Based on this, investigators propose to carry out a clinical study on the prevention and treatment of postoperative metastasis of IIA-IIIA stage lung cancer with negative driver gene expression with the formula of supporting the positive and dispelling the evil.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a traditional Chinese herbal medicine formula called Fuzheng Quxie Recipe can help prevent lung cancer from coming back or spreading after surgery. It is being studied in patients who had surgery for early-stage lung cancer (stage IIA-IIIA adenocarcinoma) without certain gene mutations. **You may be eligible if...** - You are between 18 and 75 years old - You had surgery for stage IIA-IIIA lung adenocarcinoma within the past 6 weeks - Your tumor does not have EGFR, ALK, or ROS1 gene mutations and has low PD-L1 expression - You have symptoms consistent with a specific Chinese medicine pattern (Qi-Yin Deficiency Syndrome: cough, fatigue, shortness of breath, and other defined symptoms) - Your blood tests are within normal ranges **You may NOT be eligible if...** - Your tumor has EGFR, ALK, or ROS1 mutations - You do not have the required symptom pattern - You have serious infections or other major health issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFuzheng Quxie Recipe

Treatment group: Fuzheng Quxie Recipe (Yifei Sanjie Recipe) ingredients: Sheng Huang Qi 15g, Jiao Bai Zhu 15g, Bai Fu Ling 15g, Bei Sha Shen 15g, Zhe Mai Dong 15g, Dang Shen 15g, Shu Yang Quan 15g, Xia Ku Cao 15g, Sheng Mu Li 15g, Shi Jian Chuan 15g, Shi Shang Bai 15g, and Hai Zao 15g. Combined with basic chemotherapy after lung cancer.

DRUGFuzhengquye Fang Recipe simulant

Control group: Fuzhengquye Fang Recipe simulant, which was prepared into control group placebo drug according to 5% of the drug content in the treatment group. Combined with basic chemotherapy after lung cancer.