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

NCT ID: NCT02344979

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2015-06-30

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group rHuTPO

Patients were treated with recombinant human thrombopoietin(rHuTPO)on d2,d4,d6,d9 of chemotherapy cycle.

No interventions assigned to this group

Group rHuIL-11

Patients were treated with recombinant human interleukin-11(rHuIL-11)on d9-d15 after chemotherapy.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age>18 years, Male or females
• Patients with NSCLC for whom treatment with gemcitabine and cisplatin or carboplatin
• Platele counts ≤ 50×109/L during Screening chemo cycle
• ECOG PS score is ≤ 2
• The predicted life expectancy ≥3 months
• Written informed consent

Exclusion Criteria

• Pregnant or nursing women
• Known history of severe anaphylactic reaction to biologics
• Uncontrolled severe infection
• History of bone or central nervous system metastasis
• History of platelet disorder
• Active bleeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenyang Sunshine Pharmaceutical Co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ShenyangSunshine

Identifier Type: -

Identifier Source: org_study_id