Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

Small Cell Lung Cancer Clinical Trial

Official title:

Mecapegfilgrastim Prevents Prospective, One-arm, Single-center Study of Concurrent Hyperfractionated Chemoradiotherapy With Neutropenia and Radiation Esophagitis in Limited-stage Small Cell Lung Cance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04171986
• Other study ID #: E2019367
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2019
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Ning bo Liu, M.D., Ph.D
• Phone: 15822117216
• Email: Liuningbo[@]tjmuch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophagitis
• Neutropenia
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Mecapegfilgrastim
Mecapegfilgrastim; 6 mg, d7, q3w, total 2 cycles.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of neutrophil radiation esophagitis begins with hyperfractionated chemoradiotherapy.		6 weeks
Primary	Incidence of 3 and 4 degrees neutropenia within 6 weeks from the start of hyperfractionated radiotherapy		6 weeks