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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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.
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.
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.
Incidence of grade 3/4 thrombocytopenia.
Time frame: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
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.
Incidence of febrile neutropenia.
Time frame: 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).
Time frame: 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
Time frame: 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).
Time frame: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
overall response rate(ORR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: From start of first-line treatment to completion of first-line treatment, assessed up to18 weeks.
Quality of life assessment (EORTC QLQ-C30 questionnaire).
Time frame: From start of first-line treatment to completion of first-line treatment, assessed every 3 weeks, up to18 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.