Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC
NCT ID: NCT06752798
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2024-12-30
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trilaciclib + Cisplatin
Trilaciclib: 240 mg/m², intravenous infusion over 30 minutes, administered within 4 hours prior to each chemotherapy session.
Cisplatin: 40 mg/m², intravenous infusion over 2-3 hours, once a week, for a total of 6-7 times.
Trilaciclib + Cisplatin
Trilaciclib: 240 mg/m², intravenous infusion over 30 minutes, administered within 4 hours prior to each chemotherapy session. Cisplatin: 40 mg/m², intravenous infusion over 2-3 hours, once a week, for a total of 6-7 times.
Interventions
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Trilaciclib + Cisplatin
Trilaciclib: 240 mg/m², intravenous infusion over 30 minutes, administered within 4 hours prior to each chemotherapy session. Cisplatin: 40 mg/m², intravenous infusion over 2-3 hours, once a week, for a total of 6-7 times.
Eligibility Criteria
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Inclusion Criteria
* Indications for surgery and postoperative chemotherapy plus radiotherapy, and meeting the following conditions:
* (1) Staging of T1-4N0-3M0, having undergone radical surgery;
* (2) At least one of the following factors: positive surgical margin, tumor close to the surgical margin, postoperative pathological staging pT3-4 or pN2-3, positive lymph nodes in neck level IV or V, tumor invasion of nerves/blood vessels/lymphatic vessels.
* ECOG performance status score of 0-1.
* Normal major organ function, meeting the following criteria:
* (1) Hematology standards (no blood transfusion or blood products within 14 days): a. HB ≥ 90 g/L; b. Neu ≥ 1.5×10\^9/L; c. PLT ≥ 100×10\^9/L;
* (2) Biochemical criteria: a. TBIL \< 1.5× upper limit of normal (ULN); b. ALT and AST \< 2.5× ULN; c. Serum Cr ≤ 1.0× ULN or creatinine clearance rate \> 60 ml/min.
* Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and must agree to use reliable contraception during the study and for a specified period after the last dose of the study drug.
* Women of childbearing potential must have taken reliable contraceptive measures or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and must agree to use appropriate contraceptive methods during the study and for 8 weeks after the last dose of the study drug. For male participants, they must agree to use appropriate contraceptive methods during the study and for 8 weeks after the last dose of the study drug or have undergone surgical sterilization.
* The subjects voluntarily join this study and sign the informed consent form.
Exclusion Criteria
* Patients with recurrence or distant metastasis (M1).
* Previous chemotherapy for any reason, or prior surgery, radiotherapy, molecular targeted therapy, or immune checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, anti-PD-L2, etc.) in the head and neck region.
* Pregnant or breastfeeding women.
* Previous or concurrent other malignancies.
* Patients with other uncontrolled serious diseases.
* Abnormal function of vital organs such as the heart, brain, or lungs: Hypertension that cannot be controlled to normal range with antihypertensive drugs (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90mmHg); Grade I or higher myocardial ischemia or myocardial infarction, arrhythmia, and Grade II heart failure; stroke or cardiovascular events within 6 months prior to enrollment; abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or APTT \> 1.5 ULN), with a tendency to bleed or receiving thrombolytic or anticoagulant therapy; clear tendency to bleed; patients with positive proteinuria (urine protein test 2+ or above, or 24-hour urine protein quantification \> 1.0 g).
* Active infections requiring systemic treatment, such as tuberculosis.
* Previous hematopoietic stem cell or bone marrow transplant.
* Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive).
* Untreated active hepatitis B; Note: Hepatitis B subjects meeting the following criteria are eligible: HBV viral load must be \< 1000 copies/ml (200 IU/ml) before the first dose, and subjects should receive anti-HBV therapy throughout the study chemotherapy to prevent viral reactivation. For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary; active HCV infection subjects (HCV antibody positive and HCV-RNA levels above the detection limit).
* History of substance abuse that cannot be abstained from or mental disorders.
* Allergy to the study drug or its components.
* Any other conditions that the investigator judges may affect the conduct of the clinical study and the determination of the study results.
* Concurrent participation in another therapeutic clinical study.
18 Years
70 Years
ALL
No
Sponsors
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Hunan Cancer Hospital
OTHER
Responsible Party
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Locations
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Hunan Cancer hospital
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Feng Liu
Role: primary
Other Identifiers
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SMA-HNSCC-001
Identifier Type: -
Identifier Source: org_study_id