Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head… (NCT06714266) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
30 participantsStarted 2024-12-15
Plain-language summary
This prospective, single-arm, exploratory, phase II study was designed to evaluate the efficacy and safety of Trilaciclib in reducing chemotherapy-induced neutropenia in patients with recurrent or metastatic head and neck squamous cell carcinoma. Eligible subjects screened by the inclusion and exclusion criteria will receive chemotherapy alone or combined with immune/targeted therapy and Trilaciclib for 4-6 cycles of continuous treatment. If the efficacy is not progressive after 4-6 cycles of treatment, the investigators can combine with Trilaciclib during immune and/or targeted maintenance therapy according to the specific conditions of the subjects until disease progression or intolerance. The efficacy of Trilaciclib will be evaluated by the incidence of grade ≥3 neutropenia during chemotherapy as the primary endpoint.
After the progression of treatment, if the subjects were treated with chemotherapy for subsequent treatment and were considered to be able to use Trilaciclib according to the evaluation of the investigator, the use of treaclib could be considered until the subjects had disease progression again or were intolerant to treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Written informed consent was obtained before enrollment.
* 2\. Age ≥18 years old, both male and female;
* 3\. Recurrent or metastatic head and neck squamous cell carcinoma without prior systemic therapy;
* 4\. the presence of at least one measurable lesion;
* 5\. ECOG PS = 0-1;
* 6\. Expected survival time ≥ 3 months
* 7\. Laboratory tests meet the following standards: Hemoglobin ≥ 100 g/L (female), 110g/L (male) Neutrophil count ≥ 2×109/L Platelet count ≥100×109/L; Creatinine ≤ 15mg/L or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); Total bilirubin ≤ 1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or ≤5× ULN (in patients with liver metastases); Albumin ≥ 30 g/L;
* 8\. Women: all women of childbearing potential must have a negative serum pregnancy test during the screening period and must be using a reliable contraceptive method from the time of informed consent until 3 months after the last dose;
Exclusion Criteria:
* 1\. Patients with known allergies to any of the drugs in the study;
* 2\. Participated in other drug clinical trials within 4 weeks before the study;
* 3\. a history of major bleeding, with any bleeding event of CTCAE4.0 grade 3 or above within 4 weeks before screening;
* 4\. patients with hypertension that is not well controlled by single antihypertensive medication (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg); 8…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Grade ≥3 neutropenia during chemotherapy alone or combined with immune/targeted therapy