Clinical trial · Interventional
Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy
Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy With GC/GP Regimens for Non-small-cell Lung Carcinoma Using Recombinant Human Thrombopoietin (rhTPO)
NCT01319669CI-TRIAL-00026242terminatedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): recruiting too slowly
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant human thrombopoietin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- rhTPO(recombinant human thrombopoietin) is given on the second, 4th and 9th day of the chemotherapy cycle in a dosage of 15000U once subcutaneously.
- interventionNames
- Drug: recombinant human thrombopoietin
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- 15000U of rhTPO(recombinant human thrombopoietin) is given subcutaneously 6 to 24 hours within the end of chemotherapy cycle, that is, the 8th day for 3 consecutive days (d9 to d11)
- interventionNames
- Drug: recombinant human thrombopoietin
Primary outcomes (1)
- measure
- minimum and maximum value of platelet count after chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.