Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis
China93 participantsStarted 2019-11-10
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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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 o…
What they're measuring
1
The incidence of neutrophil radiation esophagitis begins with hyperfractionated chemoradiotherapy.
Timeframe: 6 weeks
2
Incidence of 3 and 4 degrees neutropenia within 6 weeks from the start of hyperfractionated radiotherapy
Timeframe: 6 weeks
Trial details
NCT IDNCT04171986
SponsorTianjin Medical University Cancer Institute and Hospital