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New treatment option for Head and Neck Cancer Squamous Cell Carcinoma
Official title Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC
ClinicalTrials.gov ID: NCT06752798
What this study is testing
What is Trilaciclib + Cisplatin?
Trilaciclib + Cisplatin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for head and neck cancer squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety of trilaciclib combined with standard treatment project as an adjuvant treatment for Head and neck cancer after surgery
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients must meet all of the following to be enrolled in this study:
- Pathologically or histologically confirmed locally advanced squamous cell carcinoma of the head and neck (this study includes cancers of the oral...
- 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...
You likely can't join if
- Pathologically confirmed non-squamous cell carcinoma.
- 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...
- Pregnant or breastfeeding women.
- Previous or concurrent other malignancies.
- Patients with other uncontrolled serious diseases.
See the full eligibility criteria
- Patients must meet all of the following to be enrolled in this study:
- Pathologically or histologically confirmed locally advanced squamous cell carcinoma of the head and neck (this study includes cancers of the oral cavity, oropharynx, hypopharynx, and larynx, excluding cancers of the lip...
- 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...
- 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 \ 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...
- 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...
- The people voluntarily join this study and sign the informed consent form.
- Pathologically confirmed non-squamous cell carcinoma.
- 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 \>...
- 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 people meeting the following criteria are eligible: HBV viral load must be \< 1000 copies/ml (200 IU/ml) before the first dose, and people should receive anti-HBV therapy...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.