NCT06381960 Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe
| NCT ID | NCT06381960 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jianhui Tian |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 356 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 356 participants in total. It began in 2023-03-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 than 12 × 109/L, platelet count \>80 × 109/L, and (erythrocyte pressure area \>0.20); 6. Tumour PS score ≤2 and no other serious comorbidities; 7. The subjects themselves were well informed and agreed to participate in the study by signing an informed consent form and had good compliance; 8. Non-pregnant and lactating patients; 9. Passing the chemotherapy-related indexes; 10. No allergic reaction to the ingredients in the formula. Exclusion Criteria: 1. Patients who are incompletely resected or whose cancer has undergone recurrence or metastasis; 2. Patients who are being treated with other drugs or therapies (including other Chinese herbal medicines, immunological drugs, radiotherapy, etc.); 3. Patients who are themselves mentally ill and have a lack of autonomous behaviour; 4. Women who are pregnant, preparing for pregnancy or breastfeeding; 5. Combined heart, lung, brain, liver, kidney and haematopoietic system and other serious diseases, psychiatric patients; 6. Allergic or known hypersensitivity to the components of the drug; 7. Patients who are participating in other clinical trials or have participated in other clinical trials within 3 months; 8. Alcohol and/or psychoactive substances abuse, drug abusers and dependent persons; 9. Other pathologies or conditions that, in the judgement of the investigator, have the effect of reducing the likelihood of enrolment or complicating enrolment, e.g., frequent changes in the work environment, unstable living conditions, and other conditions that predispose to loss of visits.
Contact & Investigator
Jianhui Tian, professor
STUDY DIRECTOR
Shanghai University of Traditional Chinese Medicine
Frequently Asked Questions
Who can join the NCT06381960 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06381960 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06381960 currently recruiting?
Yes, NCT06381960 is actively recruiting participants. Contact the research team at tjhhawk@shutcm.edu.cn for enrollment information.
Where is the NCT06381960 trial being conducted?
This trial is being conducted at Changning, China, Hongkou, China, Hongkou, China, Jing’an, China and 1 additional location.
Who is sponsoring the NCT06381960 clinical trial?
NCT06381960 is sponsored by Jianhui Tian. The principal investigator is Jianhui Tian, professor at Shanghai University of Traditional Chinese Medicine. The trial plans to enroll 356 participants.
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