Mecapegfilgrastim Prevents Neutropenia and Radiation Esop... | NCT04171986

Studies
Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

NCT04171986

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Unknown status

Last Update Posted

Nov 21, 2019Actual

Enrollment

93Estimated

Phase

Not Applicable

Conditions

Small Cell Lung Cancer

Interventions

Mecapegfilgrastim

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2019Actual

Primary Completion Date

Oct 31, 2021Estimated

Completion Date

Oct 31, 2021Estimated

First Submitted Date

Nov 19, 2019

First Submission Date that Met QC Criteria

Nov 19, 2019

First Posted Date

Nov 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2019

Last Update Posted Date

Nov 21, 2019Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Estimated

Label	Type	Description	Intervention Names
Test Group	Experimental		Drug: Mecapegfilgrastim

Name	Type	Description	Arm Group Labels	Other Names
Mecapegfilgrastim	Drug	Mecapegfilgrastim; 6 mg, d7, q3w, total 2 cycles.	Test Group

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms