Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06381960

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

Led by Jianhui Tian · Updated on 2024-05-03

356

Participants Needed

5

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with clinical stage IIA-IIIA lung adenocarcinoma who have undergone radical surgery within the last 6 weeks
  • Negative driver gene expression (no EGFR, ALK, ROS1 mutations) and PD-1/L1 expression <1%
  • Diagnosis of Qi-Yin Deficiency Syndrome with at least two primary symptoms and one secondary symptom
  • Age between 18 and 75 years
  • Normal blood and biochemical tests without serious infections or organ failure
  • Tumor PS score ≤2 and no serious comorbidities
  • Informed consent signed with good compliance
  • Non-pregnant and not lactating
  • Passing chemotherapy-related tests
  • No allergy to the formula ingredients
Not Eligible

You will not qualify if you...

  • Incomplete tumor resection or presence of recurrence or metastasis
  • Receiving other drugs or therapies such as Chinese herbal medicines, immunological drugs, or radiotherapy
  • Mental illness or lack of autonomous behavior
  • Pregnant, planning pregnancy, or breastfeeding women
  • Serious diseases affecting heart, lung, brain, liver, kidney, or hematopoietic system
  • Allergy or hypersensitivity to the drug components
  • Participation in other clinical trials within the last 3 months
  • Abuse of alcohol, psychoactive substances, or drugs
  • Other conditions judged by investigators to complicate enrollment or follow-up

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Shanghai Chest Hospital

Changning, Shanghai Municipality, China

Actively Recruiting

2

Shanghai General Hospital

Hongkou, Shanghai Municipality, China

Actively Recruiting

3

Shanghai Traditional Chinese Medicine-Integrated Hospital

Hongkou, Shanghai Municipality, China

Actively Recruiting

4

Shanghai Municipal Hospital of Traditional Chinese Medicine

Jing’an, Shanghai Municipality, China, 200071

Actively Recruiting

5

Shanghai Pulmonary Hospital

Yangpu, Shanghai Municipality, China

Actively Recruiting

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Research Team

J

Jianhui Tian, professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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