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Integrating Traditional Chinese Medicine syndrome elements to construct a prognosis prediction model for initial diagnosed driver-gene-negative advanced NSCLC

Integrating Traditional Chinese Medicine syndrome elements to construct a prognosis prediction model for initial diagnosed driver-gene-negative advanced NSCLC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025000293
Enrollment
Unknown
Registered
2025-02-16
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small lung cancer

Interventions

1:No therapeutic intervention

Sponsors

The First Affiliated Hospital of Hunan College of Traditional Chinese Medicine (Hunan Province Directly Affiliated TCM Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Initial diagnosed age is 18-75 years male or female. 2. Pathologically confirmed NSCLC AJCC Version 8 lung cancer is staged at stage IVA/B without prior systemic antitumor therapy. Patients who had previously received neoadjuvant or adjuvant chemotherapy/radiotherapy and the time from recur or metastasis since the end of treatment larger than 6 months could be enrolled. 3. At least one measurable lesion that meets the RECIST v1.1 criteria (a lesion that has been treated with radiation needs to show clear progression to be a measurable lesion). 4. ECOG PS score: 0-2. 5. Expected survival =3 months. 6. Patients should have received at least 2 full cycles of chemotherapy immunotherapy drugs can be used. Patients with adenocarcinoma may be treated with antiangiogenic therapy. 7. Complete baseline examinations should be performed before and after chemotherapy to systematically evaluate the efficacy of chemotherapy. 8. It should be possible to obtain the complete follow-up data of patients including final survival and survival outcome data. 9. Patients should have complete TCM observation smell inquiry and incision four diagnosis data before starting chemotherapy.

Exclusion criteria

Exclusion criteria: 1. The information of TCM was incomplete at the time of initial diagnosis. 2. With an EGFR-activating mutation positive ALK fusion gene or known to have a ROS1 fusion gene. 3. Untreated brain metastases or manifestations of meningeal metastasis and spinal cord compression. 4. Uncontrolled pleural effusion pericardial effusion or peritoneal effusion with clinical symptoms 5. Present with active massive hemoptysis or respiratory failure 6. There are chronic diseases that are not controlled by medical treatment such as refractory heart failure decompensated cirrhosis and severe chronic respiratory failure. 7. Abnormal function of vital organs including: a. routine blood test: hemoglobin < 90g/L; White blood cell count =3.0×109/L or white blood cell count =10×109/L; Neutrophil absolute value =1.5×109/; Platelet count =75×109/L. b. Liver function: total bilirubin =2× upper limit of normal serum albumin =25g/L aspartate aminotransferase/alanine aminotransferase =3× upper limit of normal; c. Renal function: serum creatinine =1.5× upper limit of normal value. d. Coagulation function: PT=1.5× upper limit of normal APTT=1.5× upper limit of normal. e. Cardiac function: Clinically significant arrhythmia or left ventricular ejection fraction (LVEF) =50%. 8. Survival data or chemotherapy efficacy evaluation data were incomplete 9. Had other malignancies within the past 3 years or at the same time except cured skin basal cell carcinoma superficial bladder carcinoma skin squamous cell carcinoma and breast ductal cell carcinoma.

Design outcomes

Primary

MeasureTime frame
overall survial;progress-free survival;

Secondary

MeasureTime frame
disease control rate;objective response rate;

Countries

China

Contacts

Public ContactYuejun Li

The First Affiliated Hospital of Hunan College of Traditional Chinese Medicine (Hunan Province Directly Affiliated TCM Hospital)

liyuejun97@foxmail.com13787828869

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026