Cervical Squamous Cell Carcinoma
Conditions
Brief summary
To explore the early intervention timing of recombinant human thrombopoietin (rhTPO) for cancer treatment-induced thrombocytopenia (CTIT) in cervical squamous cell carcinoma (CSCC) patients during concurrent chemoradiotherapy.
Interventions
DRUGrhTPO
receiving rhTPO treatment when they occurred G1(100×109/L\>PLT(Platelet)\>75×109/L) CTIT at first presentation during CCRT
Sponsors
Mei Feng
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. KPS(Karnofsky Performance Status) \>60 points; 2. histopathologically or cytologically confirmed stage I-IVa CSCC (FIGO 2018); 3.18-70 years; receiving radical CCRT; 4.receiving rhTPO treatment when they occurred G1 or G2 CTIT at first presentation during CCRT; 5.expected survival time ≥6 months
Exclusion criteria
1. patients with haematopoietic system diseases, including lymphoma, leukaemia, aplastic anaemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndromes; 2. patients who had experienced non-CTIT within 6 months before screening, including but not limited to EDTA(Ethylenediaminetetraacetic acid)-dependent pseudothrombocytopenia, hypersplenism, infection, bleeding, etc.; 3. patients who had severe visceral bleeding or intracranial haemorrhage before enrolment; any arterial or venous thrombosis within 6 months before screening; 4. patients with severe cardiovascular diseases or arrhythmias that increase the risk of thrombus formation, coronary stent placement, angioplasty, and coronary artery bypass grafts within the prior 6 months; 5. patients who had received platelet-producing drugs such as recombinant human interleukin 11(rhIL-11) within 1 week before the administration of the study drug; 6. haemoglobin \<50g/L after red blood cell transfusion or erythropoietin treatment or absolute neutrophil count \<1.0×109/L after granulocyte colony-stimulating factor treatment; 7. patients participating in clinical trials or who participated in an investigational drug trial within 4 weeks and received study treatment or investigational devices; 8. and patients who were considered by the investigator to be inappropriate for inclusion for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of severe CTIT (Cancer Treatment-Induced Thrombocytopenia , Grade 3 - Grade 5) | 6 months |
Countries
China
Outcome results
None listed