Thrombocytopenia caused by tumors
Conditions
Interventions
Experimental Group:Roprostim is roprostim N01 for injection (trade name: Ruilisheng ?, manufacturer: Qilu Pharmaceutical Co., LTD.). The dose was started at 250µg (maximum, 250µg) every 7 days. If the
Control group:rhTPO (trade name: Tebiao, manufacturer: Shenyang Sansheng Pharmaceutical Co., LTD.), starting dose 300U/kg (maximum 30,000U), once daily. If the platelet count on D7 was still less than
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Disease type: histologically confirmed stage III-IV non-small cell lung cancer, gastric adenocarcinoma, colorectal cancer and other solid tumors; 2. Treatment: PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy or anti-vascular targeted therapy; 3. Thrombocytopenia: the platelet count decreased to less than 100×10^9/L for the first time during the treatment cycle, excluding other causes such as infection, liver disease, blood system diseases; Meet a specific diagnosis, symptoms and signs, or be in good general health; 4. Performance status: ECOG PS score 0-2, predicted survival time >=12 weeks; 5. Informed Consent: Provide written informed consent.
Exclusion criteria
Exclusion criteria: Subjects who met any of the following criteria were excluded from the study: 1. Underlying diseases: baseline platelet count <50×10^9/L, active bleeding (such as gastrointestinal ulcer), myelofibrosis or hypersplenism; 2. Drug interference: the use of other platelet raising drugs (such as IL-11, eltrombopag) or platelet transfusion within 14 days before enrollment; 3. Contraindication: allergy to roplostim /rhTPO, history of uncontrolled hypertension or thrombosis; 4. Poor compliance: unable to cooperate with follow-up or specimen collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The median time of platelet recovery to >=100×10^9/L;On time completion rate of antitumor therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of bleeding events;Incidence of treatment-related adverse events (trae);Quality of life score (EORTC QLQ-C30);Overall Survival (OS);Progression-free survival (PFS);AE; | — |
Countries
China
Contacts
Public ContactZhou Hairong
The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed