Trilaciclib Combined With Immunochemotherapy for R/M HNSCC

June 28, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

A Prospective, Single-Arm, Phase II Trial of Trilaciclib Combined With Immunotherapy and Chemotherapy as First-Line Treatment for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

This study is a prospective, single-arm, phase II clinical trial involving patients with advanced HNSCC receiving immunotherapy plus platinum-based dual-drug chemotherapy. It aims to evaluate the myeloprotective efficacy of administering trilaciclib prior to immunotherapy and platinum-based chemotherapy. The objective is to reduce the incidence of chemotherapy-induced myelosuppression (CIM) through pre-chemotherapy myeloprotection, thereby enabling patients to receive chemotherapy on schedule and at full dose. This approach is intended to ensure the efficacy of the chemotherapy regimen and ultimately achieve survival benefits for the patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trilaciclib

Trilaciclib: 240 mg/m², administered via intravenous infusion over 30 minutes, to be completed within 4 hours prior to chemotherapy.

Chemotherapy Regimen: The recommended regimen is albumin-bound paclitaxel (260 mg/m²) in combination with cisplatin (75 mg/m²) or carboplatin (AUC 5).

Immunotherapy Agent: Investigators will select an immune checkpoint inhibitor based on the subject's condition. The dosage and administration should follow the respective drug's prescribing information.
Drug: Trilaciclib

Trilaciclib: 240 mg/m², administered via intravenous infusion over 30 minutes, to be completed within 4 hours prior to chemotherapy.

Chemotherapy Regimen: The recommended regimen is albumin-bound paclitaxel (260 mg/m²) in combination with cisplatin (75 mg/m²) or carboplatin (AUC 5).

Immunotherapy Agent: Investigators will select an immune checkpoint inhibitor based on the subject's condition. The dosage and administration should follow the respective drug's prescribing information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of grade ≥3 neutropenia during first-line treatment.
Time Frame: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of grade 4 neutropenia during chemotherapy
Time Frame: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
Incidence of grade 3/4 thrombocytopenia.
Time Frame: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
Incidence of grade 3/4 anemia during chemotherapy
Time Frame: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
Incidence of febrile neutropenia.
Time Frame: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
Incidence of granulocyte colony-stimulating factor (G-CSF) administration (non-prophylactic).
Time Frame: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
Incidence of recombinant human interleukin-11 (rhIL-11) and/or thrombopoietin (TPO) administration
Time Frame: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
Incidence of treatment without delay (chemotherapy cycle delay <7 days).
Time Frame: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
overall response rate(ORR)
Time Frame: From date of first dose until disease progression, assessed every 6 weeks (each cycle is 21 days), up to 24 months.
From date of first dose until disease progression, assessed every 6 weeks (each cycle is 21 days), up to 24 months.
disease control rate(DCR)
Time Frame: From date of first dose until disease progression, assessed every 6 weeks (each cycle is 21 days), up to 24 months.
From date of first dose until disease progression, assessed every 6 weeks (each cycle is 21 days), up to 24 months.
duration of response(DOR)
Time Frame: From date of first dose until disease progression, assessed every 6 weeks (each cycle is 21 days), up to 24 months.
From date of first dose until disease progression, assessed every 6 weeks (each cycle is 21 days), up to 24 months.
progression free survival(PFS)
Time Frame: From date of first dose until disease progression, assessed every 6 weeks (each cycle is 21 days), up to 24 months.
From date of first dose until disease progression, assessed every 6 weeks (each cycle is 21 days), up to 24 months.
Incidence of adverse events
Time Frame: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
Quality of life assessment (EORTC QLQ-C30 questionnaire).
Time Frame: From start of first-line treatment to completion of first-line treatment, assessed every 3 weeks, up to18 weeks.
From start of first-line treatment to completion of first-line treatment, assessed every 3 weeks, up to18 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

June 28, 2026

First Posted (Actual)

July 1, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2025-955-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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