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A real-world study on the efficacy and safety of Trilaciclib in bone marrow protection before chemotherapy for advanced solid tumors

A real-world study on the efficacy and safety of Trilaciclib in bone marrow protection before chemotherapy for advanced solid tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093139
Enrollment
Unknown
Registered
2024-11-29
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced solid tumor

Interventions

Trilaciclib combined chemotherapy group:Administer Trilaciclib intravenously at a dose of 240 mg/m2 for 30 minutes within 4 hours before chemotherapy.

Sponsors

Jiujiang First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Sign a written informed consent before enrollment; 2.Age > 18 years old, both male and female; 3.Pathological examination has clearly diagnosed malignant tumors, which require chemotherapy-based treatment; 4.ECOG score = 0, expected survival = 3 months, follow-up observation for more than 3 months; 5.There were no significant abnormalities in blood routine, liver and kidney function, myocardial enzymes, and electrocardiogram; 6.The subjects voluntarily joined this study, with good compliance, safety and survival follow-up.

Exclusion criteria

Exclusion criteria: 1.History of myelogenous leukemia, myelodysplastic syndrome or associated sickle cell disease; 2.Symptomatic CNS metastasis and/or leptomeningeal disease requiring immediate radiation therapy or steroid treatment; 3.Patients who have undergone surgery or radiotherapy within 4 weeks before the first dose of study drug; 4.Patients with clinical symptoms or diseases of heart failure that cannot be well controlled, such as heart failure at NYHA class 1 or above; 2. Unstable angina pectoris; Myocardial infarction within 36 months; 4. Patients with clinically significant supraventricular or ventricular arrhythmia who require treatment or intervention; 5.History of interstitial lung disease, slowly progressive dyspnea and dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary allergic pneumonia, or multiple allergies or peripheral arterial disease such as claudication, Leo Buerger disease. 6.Radiotherapy is required at the same time; 7.Those who have a known history of allergy to the drug components in this protocol; 8.Pregnant or breastfeeding women; 9.The investigator believes that the patient is not suitable for participating in any other conditions of this study.

Design outcomes

Primary

MeasureTime frame
Incidence of neutropenia of grade 3 or higher;

Secondary

MeasureTime frame
Incidence of thrombocytopenia of grade 3 or higher;Overall survival;

Countries

China

Contacts

Public ContactZeng Lingzhi

First Peoples Hospital of Jiujiang

dawn3399@sina.com+86 138 7923 3399

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026