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Trilaciclib Combined With Immunochemotherapy for R/M HNSCC

28. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

32

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Incidence of grade ≥3 neutropenia during first-line treatment.
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Incidence of grade 4 neutropenia during chemotherapy
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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).
Zeitfenster: 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
Zeitfenster: 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).
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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).
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

30. September 2027

Studienabschluss (Geschätzt)

30. September 2027

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Juni 2026

Zuerst gepostet (Tatsächlich)

1. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Juni 2026

Zuletzt verifiziert

1. Januar 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SYSKY-2025-955-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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