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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trilaciclib combined with concurrent chemoradiotherapy | Experimental | Trilaciclib is used simultaneously before the first cycle of chemotherapy during radiotherapy for limited-stage small cell lung cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trilaciclib | Drug | During concurrent chemoradiotherapy in limited-stage small cell lung cancer, Trilaciclib is administered prophylactically before the first cycle of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of severe neutropenia | Grade 3/4 decline in neutropenia after the first cycle of chemotherapy during radiotherapy | 14 days |
| Duration of severe neutropenia | Duration of severe neutropenia after the first cycle of chemotherapy during radiotherapy (ANC<1.0×10^9/L for more than 5 days) | 5 days |
| Occurrence of hematological toxicity | Grade 3/4 decline in neutrophils, platelets, and red blood cells | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinrong Lian | Contact | 010-87787692 | 15810538030@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Deng, PhD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| C000708352 | trilaciclib |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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