Trial Title:
Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe
NCT ID:
NCT06381960
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Fuzheng Quxie Recipe
Description:
Treatment group: Fuzheng Quxie Recipe (Yifei Sanjie Recipe) ingredients: Sheng Huang Qi
15g, Jiao Bai Zhu 15g, Bai Fu Ling 15g, Bei Sha Shen 15g, Zhe Mai Dong 15g, Dang Shen
15g, Shu Yang Quan 15g, Xia Ku Cao 15g, Sheng Mu Li 15g, Shi Jian Chuan 15g, Shi Shang
Bai 15g, and Hai Zao 15g. Combined with basic chemotherapy after lung cancer.
Arm group label:
Daily Fuzheng Quxie Recipe granules + regular chemotherapy
Other name:
Fuzheng Quxie Formula；Yifei Sanjie Recipe；Yifei Sanjie Formula；
Intervention type:
Drug
Intervention name:
Fuzhengquye Fang Recipe simulant
Description:
Control group: Fuzhengquye Fang Recipe simulant, which was prepared into control group
placebo drug according to 5% of the drug content in the treatment group. Combined with
basic chemotherapy after lung cancer.
Arm group label:
Daily Chinese medicine placebo granules + regular chemotherapy;
Other name:
no other names
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.
Detailed description:
In this study, investigators actively explored the establishment of a combined Chinese
and Western medicine prevention and treatment programme in response to the urgent
clinical need for the lack of effective diagnostic and therapeutic options for
postoperative patients with stage IIA-IIIA non-small cell lung cancer who are clinically
negative for the expression of driver genes.
1. To objectively evaluate the efficacy of "Fuzheng Quxie Recipe" in preventing and
treating postoperative metastasis in stage IIA-IIIA non-small cell lung cancer with
negative expression of driver genes, including its effects on disease-free survival,
quality of life, and regulation of immune function of the patients, by means of a
clinical study in accordance with international standards;
2. To test the immunohistology, circulating tumour cells and tiny residual lesions of
the patients, and to screen out the population with the advantages of Chinese
medicine treatment. Based on this, investigators will establish an efficacy
prediction model including the evaluation of peripheral immune function status and
the expression level of circulating tumour cells, in order to improve the level of
precision treatment after radical lung cancer surgery.
3. Through conducting high-level clinical research in line with international
standards, obtaining high-level evidence-based medical evidence, screening the
advantageous populations of Chinese medicine in treating lung cancer metastasis, and
forming a standardised diagnostic and treatment plan/guidelines on Chinese medicine
or international guidelines on combining traditional Chinese and Western medicines
for the prevention and treatment of post-surgical metastasis of lung cancer that can
be promoted and applied, so as to provide a solid scientific basis for the
transformation of clinical results and the development of new medicines, and to
promote the improvement of the efficiency of the prevention and control of lung
cancer as a whole.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Changning
Country:
China
Status:
Recruiting
Contact:
Last name:
Wentao Fang, professor
Contact backup:
Last name:
Fan Xu
Phone:
+8618762866303
Email:
1183596839@qq.com
Facility:
Name:
Shanghai General Hospital
Address:
City:
Hongkou
Country:
China
Status:
Recruiting
Contact:
Last name:
Qian Huang, professor
Contact backup:
Last name:
Fan Xu, Dr
Phone:
18762866303
Email:
1183596839@qq.com
Facility:
Name:
Shanghai Traditional Chinese Medicine-Integrated Hospital
Address:
City:
Hongkou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Zhong, professor
Contact backup:
Last name:
Fan Xu, Dr
Phone:
+8618762866303
Email:
1183596839@qq.com
Facility:
Name:
Shanghai Municipal Hospital of Traditional Chinese Medicine
Address:
City:
Jing'an
Zip:
200071
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianhui Tian, Professor
Phone:
+8613816562972
Email:
tjhhawk@shutcm.edu.cn
Contact backup:
Last name:
Fan Xu, Dr
Phone:
18762866303
Email:
1183596839@qq.com
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Yangpu
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Jiang, professor
Contact backup:
Last name:
Fan Xu, Dr
Phone:
+8618762866303
Email:
1183596839@qq.com
Start date:
March 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Jianhui Tian
Agency class:
Other
Source:
Shanghai Municipal Hospital of Traditional Chinese Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06381960
