Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe

NCT06381960 | Recruiting Phase 2 DMC

• 1 other identifier: 2022LJ014
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 5

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival, DFS

  Refers to the time between the start of randomisation and disease relapse or (for any reason) death. Imaging examination: chest CT examination before the beginning of treatment and every 6 months after the operation. Patients found to have recurrent metastases were discharged from the group for standardised treatment when the pathological diagnosis was clear. Observation and follow-up were carried out until 5 years after the operation, and the calculation of disease-free survival rate, disease-free survival period and median survival period were carried out.

  Checks were performed before the start of treatment and every 6 months after the procedure. Observational follow-up until 5 years postoperatively.

Secondary Outcomes (24)

• Overall survival,OS

  The follow-up was observed until 5 years postoperatively, and overall and median survival calculations were performed.

• Minimal residual disease, MRD

  One test was performed before and 6 months after the intervention.

• Circulating Tumour Cell Assay

  One test was performed before and 6 months after the intervention.

• Chinese Medicine Symptom Score

  Recorded once before and once 6 months after the intervention, continuing for 18 months.

• Quality of life assessment

  Recorded once before and once 6 months after the intervention, continuing for 18 months.

Study Arms (2)

Daily Chinese medicine placebo granules + regular chemotherapy;

PLACEBO COMPARATOR

Control group

Drug: Fuzhengquye Fang Recipe simulant

Daily Fuzheng Quxie Recipe granules + regular chemotherapy

EXPERIMENTAL

Treatment Group

Drug: Fuzheng Quxie Recipe

Interventions

Fuzheng Quxie Recipe DRUG

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.

Also known as: Fuzheng Quxie Formula；Yifei Sanjie Recipe；Yifei Sanjie Formula；

Daily Fuzheng Quxie Recipe granules + regular chemotherapy

Fuzhengquye Fang Recipe simulant DRUG

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.

Also known as: no other names

Daily Chinese medicine placebo granules + regular chemotherapy;

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with clinical stage IIA-IIIA lung adenocarcinoma after radical surgery (patients within 6 weeks after surgery);
• Negative driver gene expression (no EGFR, ALK, ROS1 mutations) and PD-1/L1 expression \<1%;
• 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;
• Patients aged between 18-75 years;
• 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);
• Tumour PS score ≤2 and no other serious comorbidities;
• The subjects themselves were well informed and agreed to participate in the study by signing an informed consent form and had good compliance;
• Non-pregnant and lactating patients;
• Passing the chemotherapy-related indexes;
• No allergic reaction to the ingredients in the formula.

You may not qualify if:

• Patients who are incompletely resected or whose cancer has undergone recurrence or metastasis;
• Patients who are being treated with other drugs or therapies (including other Chinese herbal medicines, immunological drugs, radiotherapy, etc.);
• Patients who are themselves mentally ill and have a lack of autonomous behaviour;
• Women who are pregnant, preparing for pregnancy or breastfeeding;
• Combined heart, lung, brain, liver, kidney and haematopoietic system and other serious diseases, psychiatric patients;
• Allergic or known hypersensitivity to the components of the drug;
• Patients who are participating in other clinical trials or have participated in other clinical trials within 3 months;
• Alcohol and/or psychoactive substances abuse, drug abusers and dependent persons;
• 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.

Sponsors & Collaborators

• Jianhui Tian: lead

Study Sites (5)

Shanghai Chest Hospital

Changning, Shanghai Municipality, China

RECRUITING

Shanghai General Hospital

Hongkou, Shanghai Municipality, China

RECRUITING

Shanghai Traditional Chinese Medicine-Integrated Hospital

Hongkou, Shanghai Municipality, China

RECRUITING

Shanghai Municipal Hospital of Traditional Chinese Medicine

Jing’an, Shanghai Municipality, 200071, China

RECRUITING

Shanghai Pulmonary Hospital

Yangpu, Shanghai Municipality, China

RECRUITING

Related Publications (1)

• Xu F, Yang Y, Luo Y, Luo B, Yao J, Zhou Y, Li M, Wu J, Shi W, Jiang L, Huang Q, Fang W, Fang Z, Li Y, Tian J. Efficacy of Fuzheng Quxie Formula Against Postoperative Metastasis of Lung Cancer in Stage IIA-IIIA With Negative Driver Genes: Protocol for a Multicenter, Double-Blind, Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 24;14:e66342. doi: 10.2196/66342.

  PMID: 41135941 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jianhui Tian, professor

  Shanghai University of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Jianhui Tian, professor

CONTACT

+8613816562972; tjhhawk@shutcm.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 24, 2024
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)