NCT02344979

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

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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;

Conditions

• Thrombocytopenia

Timeline

• Start date: 2009-05-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-01-26
• Last updated: 2015-01-26

Locations

1 site across 1 country: China