NCT07679997Not yet recruitingPhase 2
Trilaciclib Combined With Immunochemotherapy for R/M HNSCC
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 13 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Head and neck cancer
- NCT number
- NCT07679997
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 32
- From 1 Jun 2026 to the primary completion date, 30 Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.