Clincosm LogoSign in Get a demo

Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

Sponsor
Tianjin Medical University Cancer Institute and Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04171986
Collaborator
(none)
93
Enrollment
1
Location
1
Arm
23.7
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
93 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Nov 10, 2019
Anticipated Primary Completion Date :
Oct 31, 2021
Anticipated Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test Group

Drug: Mecapegfilgrastim
Mecapegfilgrastim; 6 mg, d7, q3w, total 2 cycles.

Outcome Measures

Primary Outcome Measures

  1. The incidence of neutrophil radiation esophagitis begins with hyperfractionated chemoradiotherapy. [6 weeks]

  2. Incidence of 3 and 4 degrees neutropenia within 6 weeks from the start of hyperfractionated radiotherapy [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China 300060

Sponsors and Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT04171986
Other Study ID Numbers:
  • E2019367
First Posted:
Nov 21, 2019
Last Update Posted:
Nov 21, 2019
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tianjin Medical University Cancer Institute and Hospital
Small Cell Lung Cancer
HHPG-19K
Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Esophagitis
Neutropenia

Study Results

No Results Posted as of Nov 21, 2019