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Recruiting Phase 2 NCT06381960

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

Trial Parameters

Condition Lung Cancer
Sponsor Jianhui Tian
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 356
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-03-01
Completion 2025-12-31
Interventions
Fuzheng Quxie RecipeFuzhengquye Fang Recipe simulant

Brief 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 Criteria

Inclusion Criteria: 1. Patients with clinical stage IIA-IIIA lung adenocarcinoma after radical surgery (patients within 6 weeks after surgery); 2. Negative driver gene expression (no EGFR, ALK, ROS1 mutations) and PD-1/L1 expression \<1%; 3. Meets the diagnostic criteria for Qi-Yin Deficiency Syndrome. The primary symptoms include cough, low sputum, shortness of breath, hoarseness, weakness, and thirst without wanting to drink. Secondary symptoms include spontaneous, night sweat, dysphoria in chestpalms-soles, red tongue or tooth-marked tongue, and a weak pulse. At least two primary symptoms and one of the secondary symptoms are present; 4. Patients aged between 18-75 years; 5. Patients with basically normal blood and biochemical indices, etc., without serious viral or bacterial infections; patients without organ failure and serious heart disease (blood bilirubin \<68 μmol/L, aspartate aminotransferase \<90 IU/L, creatinine \<350 μmol/L, white blood cell count \>3.5 × 109/L and less th

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