Thrombocytopenia
Conditions
Keywords
NSCLC, Chemotherapy, thrombocytopenia, rhTPO
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;
Interventions
None listed
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean minimal and maximal platelet count after rHuTPO or rHuIL-11. | 28days |
Secondary
| Measure | Time frame |
|---|---|
| The time to achieve platelet count ≥75×109/L and ≥100×109/L after rHuTPO or rHuIL-11. The duration of platelet count <50×109/L after rHuTPO or rHuIL-11. | 28days |
| The number of platelet transfusions after rHuTPO or rHuIL-11. | 28days |
Countries
China
Outcome results
None listed