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

Shenyang Sunshine Pharmaceutical

Status: Unknown

Conditions: Thrombocytopenia

Study type: Observational

Funder types: Industry

Identifiers

NCT02344979

ShenyangSunshine

Details and patient eligibility

About

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.

Full 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;

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Group rHuTPO

Description:

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

Group rHuIL-11

Description:

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