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Trial Title:
Trilaciclib Prevents Myelosuppression With Chemoradiotherapy
NCT ID:
NCT06490081
Condition:
Myelosuppression
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trilaciclib
Description:
During concurrent chemoradiotherapy in limited-stage small cell lung cancer, Trilaciclib
is administered prophylactically before the first cycle of chemotherapy
Arm group label:
Trilaciclib combined with concurrent chemoradiotherapy
Other name:
Trilaciclib combined with concurrent chemoradiotherapy
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 microbiota changes on myelosuppression
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, was investigated in conjunction with prophylactic administration
of the CDK4/6 inhibitor Trilaciclib prior to the initiation of chemotherapy during
radiotherapy for limited stage small cell lung cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The histopathology is limited-stage small cell lung cancer.
2. ECOG score 0-2.
3. Good organ function (no blood transfusions, no hematopoietic stimulating factors, no
transfusions of albumin or blood products within 14 days prior to the examination).
4. It is suitable for patients treated with Trilaciclib combined with etoposide plus
cisplatin or carboplatin.
5. Understand and can sign informed consent
Exclusion Criteria:
1. Brain metastases with clinical symptoms require local radiotherapy or hormone
therapy.
2. Active infections require systemic treatment.
3. Subjects with active, known or suspected autoimmune disease or history of autoimmune
disease.
4. Combined with other tumors.
5. 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.
Gender:
All
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Deng, PhD
Start date:
June 26, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06490081
