Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

November 19, 2019 updated by: Tianjin Medical University Cancer Institute and Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group
Drug: Mecapegfilgrastim
Mecapegfilgrastim; 6 mg, d7, q3w, total 2 cycles.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2019

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 19, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2019367

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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