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.

Study Overview

• Status: Completed
• Conditions: Cervical Squamous Cell Carcinoma
• Intervention / Treatment: Drug: rhTPO; Drug: rhTPO

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 600000
      • Sichuan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group 1; 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; receiving rhTPO treatment when they occurred G1(100×109/L>PLT(Platelet)>75×109/L) CTIT at first presentation during CCRT; Drug: rhTPO; receiving rhTPO treatment when they occurred G1(75×109/L>PLT>50×109/L) CTIT at first presentation during CCRT
Experimental: Experimental group 2; 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; receiving rhTPO treatment when they occurred G1(100×109/L>PLT(Platelet)>75×109/L) CTIT at first presentation during CCRT; Drug: rhTPO; receiving rhTPO treatment when they occurred G1(75×109/L>PLT>50×109/L) CTIT at first presentation during CCRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the incidence of severe CTIT (Cancer Treatment-Induced Thrombocytopenia , Grade 3 - Grade 5)	6 months

Collaborators and Investigators

• Sponsor: Mei Feng

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SCCHEC-02-2022-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No