Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07679997

PHASE2

Trilaciclib Combined With Immunochemotherapy for R/M HNSCC

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

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-01

Completion Date

2027-09-30

Last Updated

2026-07-01

Healthy Volunteers

Conditions

Head & Neck Squamous Cell Carcinoma

Interventions

DRUG

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.

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.