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Completed

NCT Number: NCT07649395

A Prospective Study of the Early Treatment of Recombinant Human Thrombopoietin for Chemoradiation Induced Thrombocytopenia in Cervical Squamous Cell Carcinoma Patient

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sichuan Cancer Hospital

Chengdu, Sichuan, 600000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • KPS(Karnofsky Performance Status) >60 points;
  • 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

  • patients with haematopoietic system diseases, including lymphoma, leukaemia, aplastic anaemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndromes;
  • 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.;
  • patients who had severe visceral bleeding or intracranial haemorrhage before enrolment; any arterial or venous thrombosis within 6 months before screening;
  • 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;
  • 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;
  • 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;
  • patients participating in clinical trials or who participated in an investigational drug trial within 4 weeks and received study treatment or investigational devices;
  • and patients who were considered by the investigator to be inappropriate for inclusion for other reasons.

Treatment and study plan

rhTPO

Drug

receiving rhTPO treatment when they occurred G1(100×109/L>PLT(Platelet)>75×109/L) CTIT at first presentation during CCRT

Primary outcomes

  1. the incidence of severe CTIT (Cancer Treatment-Induced Thrombocytopenia , Grade 3 - Grade 5)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mei Feng

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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