Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT02346318
Eligibility Criteria:
Inclusion Criteria:
* Before the start of the study, All patients have been fully understood the reseach and the must sign the informed consent
* To be aged from 18 to 75 years old, both gender
* The lung cancer diagnosis must be proved by pathology
* According to RECIST (version 1.1), At least 1 objectively measurable Tumor lesion (iconography: CT, MRI), the assessable lesion can be measured accurately, maximum diameter more than at least 10mm (Malignant lymph nodes on CT scans short diameter less than at least 15 mm)
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Lung function FEV1 more than at least 1Land more than 50% A normal value
* The function of each organ is basically normal :ANC more than 1.5\*10\^9/L, Platelet count more than 100\*10\^9/L, Hb more than 9.0g/dl, BIL at normal level or less than 1.5\*ULN, AST (SGOT), ALT (SGPT) less than 2.5\*ULN(less than 5\*ULN, if with liver metastases), SCr less than 1.5\*ULN
* The expected survival tme must more than 6 months.
Exclusion Criteria:
* Lung or mediastinal have received radiotherapy before or ever treated with Compound Kushen Injection within 2weeks
* Pregnancy or lactation women
* Patients with severe, uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy - Participating or within the last 30 days participated in other clinical trials
* Hypersensitiveness to any kind of trial regime
* Had a history of serious Psychological or Psychiatric disorders, Drug addiction or Alcohol dependence
* Estimating the compliance of patients to participate in this clinical trial is insufficient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02346318
Study Brief:
Protocol Section:
NCT02346318