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Trilaciclib Combined With Immunochemotherapy for R/M HNSCC

ConditionHead & Neck Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Age ≥18 and ≤75 years, male or female. 2.Histologically or cytologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC).

Hemoglobin ≥ 100 g/L (female) / 110 g/L (male)

Absolute neutrophil count ≥ 2.0 × 10⁹/L

Platelet count ≥ 100 × 10⁹/L

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Trilaciclib

    Drug

    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.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: TrilaciclibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.

Secondary outcomes

1

Incidence of grade 4 neutropenia during chemotherapy

Time frame
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
2

Incidence of grade 3/4 thrombocytopenia.

Time frame
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
3

Incidence of grade 3/4 anemia during chemotherapy

Time frame
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
4

Incidence of febrile neutropenia.

Time frame
From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: