The Study of rHuTPO/rHuIL-11 in the Treatment for Chemotherapy-induced Thrombocytopenia in Patients With NSCLC

Thrombocytopenia Clinical Trial

Official title: The Study of rHuTPO/rHuIL-11 in the Treatment for Chemotherapy-induced Thrombocytopenia in Patients With NSCLC Receiving Gemcitabine and Cisplatin or Carboplatin Chemotherapy

Status Active, not recruiting

Clinical Trial Summary

Purpose: To evaluate the efficacy and safety of rHuTPO/rHuIL-11 in the treatment for chemotherapy-induced thrombocytopenia in patients with NSCLC receiving gemcitabine and cisplatin or carboplatin chemotherapy.

Clinical Trial Description

Inclusion Criteria:

1. Patients aged 18 years -75 years, male or female;

2. histologically or cytologically confirmed non-small cell lung cancer;

3. consistent with the indication of chemotherapy

4. the decrease of platelets appeared in the screen chemotherapy period and the platelet count is less than 50 * 109/ L;

5. the expected survival was more than 3 months;

6. patients must have the ability to understand and the willingness to sign a written informed consent;

7. to be able to follow the study and follow-up procedures

Exclusion Criteria:

1. pregnant or lactating women;

2. patients who had severe allergic history on biological preparation;

3. the existing serious acute infection without control;

4. Patients receiving radiotherapy;

5. more than 3 metastatic tumor of bone were found in the screening period, and the platelet count did not restore to 100 * 109/ L on the screening period on the seventeenth day of the screening period;

6. with a history of pulmonary embolism, myocardial infarction patients, thrombus history of thrombosis or activity in the past 3 months;

7. Sepsis, disseminated intravascular coagulation (DIC); hypersplenism or any other illness sickness that can exacerbate thrombocytopenia appeared in the previous cycles of chemotherapy;

8. tumor metastasis was found in the central nervous system; ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thrombocytopenia
• Thrombocytosis

• NCT number: NCT02344979
• Study type: Observational
• Source: Shenyang Sunshine Pharmaceutical Co., LTD.
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 2009
• Completion date: June 2015