Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

Not Applicable

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: Mecapegfilgrastim

• Registration Number: NCT04171986
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-10
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-19
• Last Update Submitted: 2019-11-19
• Study First Posted: 2019-11-21
• Last Update Posted: 2019-11-21
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Group	Mecapegfilgrastim	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China