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Trilaciclib Combined With Immunochemotherapy for R/M HNSCC

28. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of grade ≥3 neutropenia during first-line treatment.
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tidsramme
Incidence of grade 4 neutropenia during chemotherapy
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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).
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juni 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SYSKY-2025-955-01

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