NCT07679997尚未招募2 期
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
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Incidence of grade ≥3 neutropenia during first-line treatment.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Hemoglobin ≥ 100 g/L (female) / 110 g/L (male)
- •Absolute neutrophil count ≥ 2.0 × 10⁹/L
- •Platelet count ≥ 100 × 10⁹/L
- •Serum creatinine ≤ 15 mg/L or creatinine clearance (CrCl) ≥ 60 mL/min (calculated by Cockcroft-Gault formula)
- •Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, or ≤ 5 × ULN in patients with liver metastases
- •Albumin ≥ 30 g/L 6.ECOG Performance Status score of 0 or
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of grade ≥3 neutropenia during first-line treatment.
时间窗: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
次要结局
- Incidence of grade 4 neutropenia during chemotherapy(From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.)
- Incidence of grade 3/4 thrombocytopenia.(From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.)
- Incidence of grade 3/4 anemia during chemotherapy(From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.)
- Incidence of febrile neutropenia.(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).(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(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).(From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.)
- overall response rate(ORR)(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)(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)(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)(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(From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.)
- Quality of life assessment (EORTC QLQ-C30 questionnaire).(From start of first-line treatment to completion of first-line treatment, assessed every 3 weeks, up to18 weeks.)
研究者
相似试验
招募中
2 期
Phase 2 Proof-of-Concept Study of LAD328 in Adults with Hidradenitis Suppurativamoderate-to-severe hidradenitis suppurativa2025-521865-29-00Almirall S.A.4,999,995
尚未招募
2 期
A Single-arm, Phase II, Multi-center Clinical Trial of Sintilimab During the Perioperative Period in Patients With Resectable Locally Advanced Head and Neck Squamous Cell CarcinomaNCT07379424chen chao Professor37
尚未招募
不适用
A Study of SHR-A1811 Combined With Adebelimumab as Neoadjuvant Therapy for Resectable HER2-Altered Non-Small Cell Lung CancerNSCLCNCT07281209Shanghai Chest Hospital40
尚未招募
2 期
SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLCNon-Small Cell Lung CancerNCT07489703Sun Yat-sen University30
招募中
2 期
Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without DiabetesObesityNCT07521631Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.372