Cancer Clinical Trial
— TCMOfficial title:
Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan
Verified date | May 2017 |
Source | Shanghai University of Traditional Chinese Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to observe the efficacy of chemotherapy combined with Chinese patent drugs for patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Pathologically or cytologically confirmed of stage ?b-? NSCLC 2. Ages Eligible for Study: 18-65 years old; 3. Physical status score (ECOG PS) = 2 scores; 4. Estimated life expectancy of at least 6 months; 5. Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin =10g/dL, absolute neutrophil count (ANC) =1.5*109/L, platelets =80*109/L, Liver and kidney function is normal; 6. Informed consent from the patient. Exclusion Criteria: 1. Patient with other malignant tumor except NSCLC 5 years previous to study entry. 2. Patients who have received targeted drug treatment; 3. Serious problem of heart, liver or kidney with severe dysfunction; 4. Pregnant or child breast feeding women; 5. Mental or cognitive disorders; 6. Participating in other drug trials; 7. Who are allergic to the study drug. 8. Diabetic patients. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shanghai University of Traditional Chinese Medicine | Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival | The progression disease is assessed based on CT every 2 months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer. | From date of randomization until the date of first documented progression or date of death from any cause,up to 2 months | |
Secondary | Objective response rate | up to 2 months | ||
Secondary | Time-to-Progression | up to 2 months | ||
Secondary | Number of participants with treatment-related quality of life as assessed by FACT-L4.0 | 21 days |
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