Mecapegfilgrastim Prevents Neutropenia and Radiation Esophagitis

NCT04171986 | Unknown DMC

• 1 other identifier: E2019367
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Small Cell Lung Cancer

Keywords

Small Cell Lung Cancer; HHPG-19K

Outcome Measures

Primary Outcomes (2)

• The incidence of neutrophil radiation esophagitis begins with hyperfractionated chemoradiotherapy.

  6 weeks

• Incidence of 3 and 4 degrees neutropenia within 6 weeks from the start of hyperfractionated radiotherapy

  6 weeks

Study Arms (1)

Test Group

EXPERIMENTAL

Drug: Mecapegfilgrastim

Interventions

Mecapegfilgrastim DRUG

Mecapegfilgrastim; 6 mg, d7, q3w, total 2 cycles.

Test Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Ning bo Liu, M.D., Ph.D

CONTACT

15822117216; Liuningbo@tjmuch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: November 10, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: November 21, 2019

Record last verified: 2019-11

Locations

CN (1)