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

NCT07649395 | Completed

• 1 other identifier: SCCHEC-02-2022-008
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  6 months

Study Arms (2)

Experimental group 1

EXPERIMENTAL

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

Drug: rhTPO

Experimental group 2

EXPERIMENTAL

receiving rhTPO treatment when they occurred G2(75×109/L\>PLT(Platelet)\>50×109/L) CTIT at first presentation during CCRT(Concurrent Chemoradiotherapy)

Drug: rhTPO

Interventions

rhTPO DRUG

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

Experimental group 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• KPS(Karnofsky Performance Status) \>60 points;
• histopathologically or cytologically confirmed stage I-IVa CSCC (FIGO 2018); 3.18-70 years; receiving radical CCRT;
• receiving rhTPO treatment when they occurred G1 or G2 CTIT at first presentation during CCRT; 5.expected survival time ≥6 months

You may not qualify if:

• 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;

Sponsors & Collaborators

• Mei Feng: lead

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 600000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 16, 2026
• Study Start: February 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

CN (1)