Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy and safety of administration of rhTPO at different time in the treatment of thrombocytopenia caused by first-line GC/GP regimen for non small cell lung cancer (NSCLC)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Society of Lung Cancer

Criteria

Inclusion Criteria:

1. Male or female patients at the age of 18 to 75 years old

2. Histologically or cytologically diagnosed NSCLC cases

3. Thrombocytopenia occurred in the selected chemotherapy cycle confirmed by double test results with platelet count lower than 75×109/L

4. Fit for chemotherapy (WBC ≥ 4.0×109/L；neutrophil count> 1.5×109/L；PLT ≥ 80×109/L；ALT ≤ 3 times the upper limit of normal range；AST ≤ 3 times the upper limit of normal range；TBil ≤ twice the upper limit of normal range；ECOG PS ≤ 2；without severe cardiopulmonary defects)

5. Expected lifespan over 12 weeks

6. With understanding ability and voluntarily sign informed consent form

7. Be able to comply with the study and follow-up process

Exclusion Criteria:

1. With any unstable systemic diseases including active infection, uncontrolled hypertension, liver diseases, renal diseases or metabolic diseases

2. With uncontrolled brain metastasis symptoms (patients whose brain metastasis controlled over 4 weeks without hormone therapy can still be enrolled)

3. With heart cerebrovascular diseases, congestive heart failure with NYHA above II degree, with unstable angina pectoris, with acute myocardial infarction or cerebral infarction within 6 months

4. Breast-feeding or pregnant women

5. Platelet count over 300×109/L