Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a Pre-Chemo drug shield bone marrow in head and neck cancer?

NCT ID NCT07679997

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Head & neck squamous cell carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

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.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.