Biological characteristics of Shuangshen granules for early prevention of lung cancer and metastasis and construction of nano-targeted drug delivery system

Early Phase 1

• Conditions: Pulmonary nodules

• Registration Number: ITMCTR2022000049
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Lung nodule inclusion criteria
(1) Patients with Qi deficiency and blood stasis evidence combined with the following inclusion criteria.
(2) Pulmonary nodules pathologically diagnosed as precancerous lesions such as pulmonary atypical adenomatous hyperplasia, angiogenic squamous epithelial atypia, or carcinoma in situ.
(3) Solid nodules, or sub-solid nodules with no significant change at 3-month follow-up.
(4) Nodules = 8 mm in size or those who have been closely followed up by a multidisciplinary team.
(5) Basic normal function of heart, liver, kidney and hematopoietic system.
(6) Age 18 to 75.
(7) Karnofsky score = 90.
(8) Voluntary participation in this study and signed informed consent form.
Inclusion criteria for postoperative patients with non-small cell lung cancer
(1) Patients with Qi deficiency and blood stasis evidence combined with the following inclusion criteria.
(2) Those with stage I-IIIB non-small cell lung cancer who are 1 month postoperative after conventional radiotherapy.
(3) Patients with higher ctDNA level than normal population by NGS test.
(4) Those diagnosed by pathology as squamous lung cancer or adenocarcinoma of the lung.
(5) Basic normal function of heart, liver, kidney and hematopoietic system.
(6) Age 18 to 75 years old.
(7) Karnofsky score = 90.
(8) Voluntary participation in this study and signed informed consent form.
Inclusion criteria for healthy population screening:
(1) Age: 18-75;
(2) In accordance with the above diagnostic criteria of healthy people, the TCM constitution is determined as peaceful quality;
(3) BMI of 18-24kg/m2;
(4) There is no abnormality in the physical examination.

Exclusion Criteria

(1) Those who have other gene mutations and need targeted therapy;
(2) complicated with other lung diseases (such as hypertension, diabetes, coronary heart disease, chronic obstructive pulmonary disease, asthma, interstitial lung disease, tuberculosis, etc.) and requiring long-term drug use;
(3) Patients with other primary tumors outside the lungs;
(4) Patients with autoimmune diseases;
(5) Long-term use of hormones, anti-inflammatory drugs and immunosuppressants due to disease;
(6) Alcoholics;
(7) pregnant, trying to get pregnant, breast-feeding or mentally ill;
(8) People who are allergic to Chinese medicine ingredients or cannot take Chinese medicine orally;
(9) Patients who participated in clinical studies of other drugs or are participating in other clinical studies within 1 month prior to participating in this study;
(10) Take other drugs or health food that may affect the test.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival,DFS;Target nodule morphology;Target nodule size;Target nodule density;

Secondary Outcome Measures

Name	Time	Method
living quality;Anxiety evaluation;Evaluation of depression;Evaluation of TCM syndrome;