Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

• Status: Unknown status
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.