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The Clinical and Mechanism Study on the Effect of Yiqi Yangyin Decotion (YQYYD) on Prevention for Patients with Early Stage Lung Cancer

Phase 1
Recruiting
Conditions
Early Stage Lung Cancer
Registration Number
ITMCTR2000003734
Lead Sponsor
onghua Hospital, Shanghai University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Patients with stage I lung cancer who met the diagnostic criteria of primary lung cancer and were confirmed by histopathology or cytology included adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma and large cell carcinoma;
(2) ground glass nodule (GGN) was found on CT scan, which indicated that it was adenocarcinoma in situ (AIS) or minimally invasive adenocarcinoma (MIA) (mainly judged by size and density), with an average diameter of > 6 Mm, generally not exceeding 12mm, or CT scan revealed clear nodules of the same type before operation, mainly with ground glass nodules (solid nodules need more strict diagnosis and exclusion);
(3) syndrome differentiation of Qi and yin deficiency by TCM;
(4) 6 months or more after untreated or previous inhalation of budesonide;
(5) heart, liver, kidney and blood tests were all in normal range.
(6) Sign informed consent.

Exclusion Criteria

(1) Patients with other primary malignant tumors;
(2) Patients with serious heart, liver and kidney diseases and severe functional disorders;
(3) Pregnant or lactating women;
(4) Mental or cognitive disorders that affect the judgment of this study;
(5) Those who are participating in other drug trials;
(6) Those who are allergic to the drugs in this study.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Size and density of GGO;
Secondary Outcome Measures
NameTimeMethod
quality of life (QOL);Cell free DNA (TP53, EGFR, PIK3CA);Tumor markers;immune function markers;
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