Actively Recruiting
Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC
Led by Hunan Cancer Hospital · Updated on 2024-12-31
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of trilaciclib combined with standard treatment project as an adjuvant treatment for Head and neck cancer after surgery
CONDITIONS
Official Title
Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically or histologically confirmed locally advanced squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, larynx; excluding lip and nasopharynx cancers).
- Indications for surgery and postoperative chemotherapy plus radiotherapy.
- Staging of T1-4N0-3M0 with radical surgery performed.
- At least one of the following: positive or close surgical margin, postoperative pathological stage pT3-4 or pN2-3, positive lymph nodes in neck level IV or V, tumor invasion of nerves, blood vessels, or lymphatic vessels.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Normal major organ function with hematology: hemoglobin ≥ 90 g/L, neutrophils ≥ 1.5×10⁹/L, platelets ≥ 100×10⁹/L; biochemical: total bilirubin < 1.5× upper limit of normal, ALT and AST < 2.5× upper limit of normal, serum creatinine ≤ 1.0× upper limit of normal or creatinine clearance > 60 ml/min.
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and agree to use reliable contraception during the study and for 8 weeks after the last dose.
- Male participants must agree to use contraception during the study and for 8 weeks after the last dose or have had surgical sterilization.
- Voluntary informed consent provided.
You will not qualify if you...
- Non-squamous cell carcinoma confirmed by pathology.
- Recurrence or distant metastasis (M1).
- Prior chemotherapy, surgery, radiotherapy, molecular targeted therapy, or immune checkpoint inhibitor therapy in the head and neck area.
- Pregnant or breastfeeding women.
- Previous or concurrent other malignancies.
- Uncontrolled serious diseases.
- Abnormal vital organ function including uncontrolled hypertension, myocardial ischemia or infarction, arrhythmia, heart failure, recent stroke or cardiovascular events, abnormal coagulation or bleeding tendency, significant proteinuria.
- Active infections requiring systemic treatment including tuberculosis.
- Previous hematopoietic stem cell or bone marrow transplant.
- Known HIV infection.
- Untreated active hepatitis B or active hepatitis C infection.
- History of substance abuse or mental disorders.
- Allergy to the study drug or its components.
- Any condition judged by the investigator to affect study conduct or results.
- Participation in another therapeutic clinical study.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hunan Cancer hospital
Changsha, Hunan, China, 410000
Actively Recruiting
Research Team
F
Feng Liu, Doctoral Degree
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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