Status:
RECRUITING
Trilaciclib Prevents Myelosuppression With Chemoradiotherapy
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Myelosuppression
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
To evaluate the protective effect of Trilaciclib on myelosuppression in patients with limited-stage small cell lung cancer associated with concurrent chemoradiotherapy and discuss the effect of gut mi...
Detailed Description
The occurrence of myelosuppression following chemotherapy, including severe neutropenia and hematological toxicity (Grade 3/4), as well as its association with dynamic changes in the gut microbiota, w...
Eligibility Criteria
Inclusion
- The histopathology is limited-stage small cell lung cancer.
- ECOG score 0-2.
- Good organ function (no blood transfusions, no hematopoietic stimulating factors, no transfusions of albumin or blood products within 14 days prior to the examination).
- It is suitable for patients treated with Trilaciclib combined with etoposide plus cisplatin or carboplatin.
- Understand and can sign informed consent
Exclusion
- Brain metastases with clinical symptoms require local radiotherapy or hormone therapy.
- Active infections require systemic treatment.
- Subjects with active, known or suspected autoimmune disease or history of autoimmune disease.
- Combined with other tumors.
- The current or previous presence of a clinically significant and medically unstable condition, which in the investigator's professional judgment may compromise subject safety, interfere with study evaluation or endpoint assessment, or otherwise impact the reliability of study results.
Key Trial Info
Start Date :
June 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06490081
Start Date
June 26 2024
End Date
June 30 2026
Last Update
September 24 2024
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021