Clinical Study of Chinese Medicine Plus Targeted Therapy Maintenance in Advanced Pulmonary Adenocarcinoma

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators performed a randomized, double blind controlled, prospective study method on observation of Traditional Chinese Medicine (TCM) combined with targeted therapy maintenance to prolong the efficacy of long-term survival of advanced pulmonary adenocarcinoma patients. The investigators plan to involve 200 cases for observation in 3 years (100 cases for targeted therapy maintenance, 100 cases for targeted therapy maintenance plus TCM,), expecting that integrated TCM combined with targeted maintenance therapy has a better efficacy on prolonging progression-free survival time, overall survival, improving quality of life(QOL) of patients than that of targeted maintenance therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Shanghai Chest Hospital; Shanghai Pulmonary Hospital, Shanghai, China
• Treatments: Erlotinib Hydrochloride; Gefitinib

Criteria

Inclusion Criteria:

1. Pathologically or cytologically confirmed of stage IIIa-IV pulmonary adenocarcinoma;

2. The efficacy evaluation of the first-line therapy is progression-free including complete response(CR), partial response(PR) and stable disease(SD);

3. Age ≥18 years old;

4. Physical status score (ECOG PS) ≤ 2 scores;

5. Estimated life expectancy of at least 12 weeks;

6. Participants have no major organ dysfunction: hemoglobin ≥9 g/dL, absolute neutrophil count (ANC) ≥1.5*109/L, platelets ≥100 *109/L,bilirubin ≤1.5ULN, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable if liver has tumor involvement).INR≤1.5, APTT in the normal range( 1.2DLN-1.2ULN),creatinine ≤1.5ULN;

7. Planning for targeted maintenance.

8. Informed consent from the patient.

Exclusion Criteria:

1. The efficacy evaluation of the first-line therapy is progressive disease(PD);

2. Patient with other malignant tumor except NSCLC 5 years previous to study entry;

3. Patient has already received chemotherapy or other anticancer treatment;

4. Estimated life expectancy less than 12 weeks;

5. Brain metastasis (controlled brain metastasis and steroid free need is excluded);

6. History of cardiovascular disease: Congestive Heart Failure > grade II in NYHA.Unstable angina patients (have angina symptoms in rest) or a new occurrence of angina (began in the last 3 months) or myocardial infarction happens in the last 6 months;

7. Pregnant or child breast feeding women;

8. Mental or cognitive disorders;