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NCT Number: NCT07205536

Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy

This is a prospective observational study designed to observe and evaluate the safety and efficacy of mecapegfilgrastim in the treatment of moderate-to-severe myelosuppression associated with concurrent chemoradiotherapy. The project will provide more robust evidence-based medical support for the use of long-acting granulocyte-stimulating agents in patients undergoing concurrent chemoradiotherapy.

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Key information

Conditions

Myelosuppression Agranulocytosis Chemoradiotherapy Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Site Neutropenia Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location status: Recruiting

Location contact

Zhiming Chen

CONTACT

86+15851396885

About this study

Group 1: Monitor the changes in neutrophil levels during the first follow-up cycle after enrollment in this study. When the neutrophil level falls below 1.5×10⁹/L, the investigator will communicate with the patient to determine whether to use conventional leukocyte-increasing drugs such as Licorice tablets. If so, the patient will be assigned to Group 1.

Group 2: After enrollment in this study, the investigator will communicate with the patient to determine whether to use Sulfated PEG-Interferon injection to prevent and treat neutropenia. If so, 24 hours after the end of the chemotherapy cycle, the patient will receive a subcutaneous injection of Sulfated PEG-Interferon once. The recommended dose is a fixed dose of 6 mg per injection; or, based on the patient's weight, an individualized treatment dose of 100 μg/kg. The patient will then be assigned to Group 2.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-75 years at the time of giving informed consent， both sexes eligible
  • Histologically or cytologically confirmed thoracic tumor (esophageal or lung cancer)
  • Investigator judges the patient suitable for treatment with mecapegfilgrastim injection or leucogen tablets
  • Expected survival > 3 months
  • Signed informed consent; willing and able to comply with protocol-mandated visits
  • The patient is indicated for concurrent chemoradiotherapy and is currently/receiving or will receive a high-risk chemotherapy regimen for febrile neutropenia (FN risk ≥20%), or is currently/receiving or will receive an intermediate-risk chemotherapy regimen for FN (FN risk 10%~20%) with additional FN risk factors.

Exclusion criteria

  • Pregnant or lactating women
  • Known hypersensitivity to mecapegfilgrastim, pegylated or non-pegylated rhG-CSF, or any E. coli-derived product
  • Any severe comorbidity that, in the investigator's opinion, compromises patient safety or ability to complete the study
  • Any other condition that, in the investigator's judgment, could interfere with study conduct or interpretation of results

Treatment and study plan

Mecapegfilgrastim injection

Drug

After enrollment, a single subcutaneous dose of mecapegfilgrastim should be administered 24 hours following completion of each chemotherapy cycle. The recommended dose is a fixed 6 mg, or an individualized 100 μg/kg based on the patient's body weight. If neutrophil counts remain below 0.5 × 10⁹/L for more than 24 hours after mecapegfilgrastim administration, short-acting G-CSF may be used as rescue therapy at the investigator's discretion until neutrophil levels return to normal.

Oral or short-acting granulocyte-stimulating agents

Drug

In the first cycle after enrollment, patients will be followed for changes in neutrophil counts. Should the neutrophil level fall below 1.5 × 10⁹/L, the investigator may, based on clinical judgment, decide whether to intervene with leucogen tablets or other granulocyte-boosting agents. If the count remains below 1.0 × 10⁹/L, short-acting G-CSF may be administered as a rescue therapy.

Primary outcomes

  1. Incidence of hematologic toxicity

    Time frame: Day 7,Day 14

    Hematologic toxicity, assessed by CBC performed 1 day before chemotherapy and on days 7 and 14 post-chemotherapy; CBC may be done at an external facility.

Secondary outcomes

  1. The incidence of non-hematologic toxicity

    Time frame: Day 1, Day 7, and Day 14 of the first and second anti-tumor treatment cycles, and Day 30 after the completion of radiotherapy.

    Secondary Outcome Measures: Non-hematologic toxicity On Day 1 of cycles 1 and 2: vital signs, complete blood count, urinalysis, stool routine, serum chemistry, coagulation panel, and 12-lead ECG.

    On Days 7 and 14 of cycles 1 and 2: repeat complete blood count only. All patient-reported adverse events are captured through 30 days after completion of radiotherapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhiming CHEN

CONTACT

[email protected]

86+15851396885

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

A Clinical Study on the Safety and Efficacy of Mecapegfilgrastim in Preventing Myelosuppression Induced by Concurrent Chemoradiotherapy for Thoracic Malignancies

Acronym: ANC-IIT-004

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2025
Registry last updated
Dec 11, 2025

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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