Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

Study Overview
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Brief Summary
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Evaluation of the efficacy and safety of Mecapegfilgrastim for the prevention of neutropenia and radiation esophagitis after hyperfractionation in patients with limited-stage small cell lung cancer

Official Title
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Mecapegfilgrastim Prevents Prospective, One-arm, Single-center Study of Concurrent Hyperfractionated Chemoradiotherapy With Neutropenia and Radiation Esophagitis in Limited-stage Small Cell Lung Cance

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Mecapegfilgrastim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with limited small cell lung cancer diagnosed by histopathology; ECOG 0-1 points; Weight ≥ 45 kg; Age 18-75 years old; It is expected that at least 2 cycles of EP chemotherapy will be completed as planned; once thiophene penicillin is used, chemotherapy should not be re-dosed within 12 days. Bone marrow hematopoietic function is normal, no bleeding tendency (INR<1.5); Laboratory tests are subject to: (1) Blood routine examination: Hb≥90g/L; WBC≥4.0×109/ L; ANC≥2.0×109/L; PLT≥100×109/L. (2) Liver function, biochemical examination: ALT and AST≤1.5×ULN; TBIL≤1.5×ULN; Serum creatinine≤1.5×ULN. According to the researcher's judgment, the test plan can be observed; Volunteer to participate in this clinical trial, understand the research process and be able to sign informed consent in writing. Exclusion Criteria: There are currently uncontrolled infections or systemic antibiotics within 72 hours of receiving chemotherapy; Any abnormal bone marrow hyperplasia and other hematopoietic dysfunction; Patients who have received bone marrow or hematopoietic stem cell transplantation within the past 3 months; Patients with previous malignant tumors that have not been cured or have brain metastases; Liver function tests Total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal; if due to liver metastasis, the above indicators are >5 times the upper limit of normal; Renal function test: serum creatinine (Cr) > 1.5 times the upper limit of normal; Those who are allergic to this product; suffering from mental or neurological disorders that cannot be matched; Female patients during pregnancy or lactation; women of childbearing age who refuse to receive contraception; The investigator believes that it is not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br> | Drug: Mecapegfilgrastim<br>* Mecapegfilgrastim; 6 mg, d7, q3w, total 2 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of neutrophil radiation esophagitis begins with hyperfractionated chemoradiotherapy. |  | 6 weeks | 
| Incidence of 3 and 4 degrees neutropenia within 6 weeks from the start of hyperfractionated radiotherapy |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small Cell Lung Cancer, HHPG-19K