Could a Pre-Chemo drug shield bone marrow in head and neck cancer?
NCT ID NCT07679997
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This trial tests whether giving trilaciclib before chemotherapy and immunotherapy can protect bone marrow in people with advanced head and neck cancer. The goal is to reduce dangerous drops in blood cell counts, allowing patients to receive their full chemo doses on schedule. About 32 adults with recurrent or metastatic head and neck squamous cell carcinoma will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- trilaciclib
- What this could lead to
- If it works, this could help people with advanced head and neck cancer complete chemotherapy on time with fewer side effects like low blood cell counts.
- What could go wrong
- This is a small, early-phase trial with only 32 participants, so results may not apply to everyone. The drug may not reduce side effects as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1.Age ≥18 and ≤75 years, male or female. 2.Histologically or cytologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC). 3.Recurrent and/or metastatic HNSCC not suitable for locoregional therapy. Patients with recurrent-only disease (without metastasis) must have previously received radiotherapy (either as adjuvant therapy after surgery or as treatment for locally advanced SCCHN) as "locoregional therapy," and radiotherapy must have been completed more than 6 months prior to screening imaging. 4.At least one measurable lesion per RECIST 1.1 criteria. 5.Laboratory tests meeting the following criteria: 1. Hemoglobin ≥ 100 g/L (female) / 110 g/L (male) 2. Absolute neutrophil count ≥ 2.0 × 10⁹/L 3. Platelet count ≥ 100 × 10⁹/L 4. Serum creatinine ≤ 15 mg/L or creatinine clearance (CrCl) ≥ 60 mL/min (calculated by Cockcroft-Gault formula) 5. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) 6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, or ≤ 5 × ULN in patients with liver metastases 7. Albumin ≥ 30 g/L 6.ECOG Performance Status score of 0 or 1. 7.Expected survival time ≥ 3 months. 8.No plans for conception or breastfeeding from 2 weeks before the start of study treatment until 3 months after the end of the study. 9.Ability to understand and willingness to sign the informed consent form. Exclusion Criteria: * 1.Diagnosis of a malignancy other than HNSCC within 5 years before the first dose (except for curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection). 2.Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA Class III or IV). 3.History of stroke or major cerebrovascular event within 6 months prior to enrollment. 4.QTcF interval \>480 msec at screening, or \>500 msec for patients with a ventricular pacemaker. 5.Prior hematopoietic stem cell or bone marrow transplantation. 6.Known hypersensitivity to the study drug or any of its components. 7.Any other condition for which the investigator deems the subject unsuitable for participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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