이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Trilaciclib Combined With Immunochemotherapy for R/M HNSCC

2026년 6월 28일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

32

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Incidence of grade ≥3 neutropenia during first-line treatment.
기간: 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.

2차 결과 측정

결과 측정
기간
Incidence of grade 4 neutropenia during chemotherapy
기간: 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.
기간: 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
기간: 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.
기간: 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).
기간: 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
기간: 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).
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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).
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2027년 9월 30일

연구 완료 (추정된)

2027년 9월 30일

연구 등록 날짜

최초 제출

2026년 5월 13일

QC 기준을 충족하는 최초 제출

2026년 6월 28일

처음 게시됨 (실제)

2026년 7월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 28일

마지막으로 확인됨

2026년 1월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SYSKY-2025-955-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

두경부 편평 세포 암종에 대한 임상 시험

Trilaciclib에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Switzerland

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다