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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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