Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

Tianjin Medical University

Status

Unknown

Conditions

Small Cell Lung Cancer

Treatments

Drug: Mecapegfilgrastim

Study type

Interventional

Funder types

Other

Identifiers

NCT04171986

E2019367

Details and patient eligibility

About

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

Enrollment

93 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.