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A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib

NCT06699472 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-11-21

No results posted yet for this study

Summary

This study is a prospective, open label, randomized controlled clinical trial aimed at patients with Ewing's sarcoma who have not received systematic anti-tumor treatment in the past. The aim is to evaluate the efficacy and safety of prophylactic use of Trilaciclib before VDC+IE chemotherapy.

Patients with Ewing's sarcoma who have not received systemic anti-tumor therapy in the past will be screened for qualified subjects who meet the inclusion criteria after signing informed consent. Eligible patients will be randomly divided into an experimental group and a control group in a 1:1 ratio. The control group will receive alternating VDC+IE chemotherapy for 3 weeks, a total of 17 cycles, or until disease progression, intolerable adverse reactions, or withdrawal of informed consent occur. The experimental group received VDC+IE alternating chemotherapy combined with Trilaciclib, with 3 weeks as one course of treatment, for a total of 17 cycles or until disease progression, intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other situations specified in the protocol where treatment should be discontinued. Both the control group and the experimental group can receive supportive nursing treatment according to clinical needs.

Conditions

  • Ewing Sarcoma
  • Myelosuppression

Interventions

DRUG

Chemotherapy

Vincristine (V), intravenous injection, 1.5 mg/m2 (maximum not exceeding 2mg), D1, odd cycle administration Doxorubicin (D), intravenous infusion, 75mg/m2, D1, odd cycle administration When the cumulative dose of doxorubicin is ≥ 375mg/m2, replace it with actinomycin D 1.25mg/m2 Cyclophosphamide (C), intravenous infusion, 1200mg/m2, D1, odd cycle administration Ifosfamide (I), intravenous infusion, 1800mg/m2, D1-5, even cycle administration Etoposide (E), intravenous infusion, 100mg/m2, D1-5, even cycle administration

DRUG

Trilaciclib Injection [Cosela]

Trilaciclib, intravenous infusion, 240 mg/m2, administered following chemotherapy (2 hours after completion of vincristine administration and within 4 hours before administration of other chemotherapy drugs)

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-09-30
Completion
2027-09-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06699472 on ClinicalTrials.gov