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Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

Primary Purpose

Small Cell Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mecapegfilgrastim
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Small Cell Lung Cancer focused on measuring Small Cell Lung Cancer, HHPG-19K

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test Group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 19, 2019
Last Updated
November 19, 2019
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04171986
Brief Title
Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis
Official Title
Mecapegfilgrastim Prevents Prospective, One-arm, Single-center Study of Concurrent Hyperfractionated Chemoradiotherapy With Neutropenia and Radiation Esophagitis in Limited-stage Small Cell Lung Cance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Small Cell Lung Cancer, HHPG-19K

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mecapegfilgrastim
Intervention Description
Mecapegfilgrastim; 6 mg, d7, q3w, total 2 cycles.
Primary Outcome Measure Information:
Title
The incidence of neutrophil radiation esophagitis begins with hyperfractionated chemoradiotherapy.
Time Frame
6 weeks
Title
Incidence of 3 and 4 degrees neutropenia within 6 weeks from the start of hyperfractionated radiotherapy
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning bo Liu, M.D., Ph.D
Phone
15822117216
Email
Liuningbo@tjmuch.com
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning bo Liu, MD
Phone
15822117210
Email
liuningbo@tjmuch.com
First Name & Middle Initial & Last Name & Degree
Ping Wang, MD
Phone
18622221112
Email
wangping99999@yahoo.com

12. IPD Sharing Statement

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Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

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