Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

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

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.