This prospective, single-arm, exploratory, phase II study was designed to evaluate the efficacy and safety of Trilaciclib in reducing chemotherapy-induced neutropenia in patients with recurrent or metastatic head and neck squamous cell carcinoma. Eligible subjects screened by the inclusion and exclusion criteria will receive chemotherapy alone or combined with immune/targeted therapy and Trilaciclib for 4-6 cycles of continuous treatment. If the efficacy is not progressive after 4-6 cycles of treatment, the investigators can combine with Trilaciclib during immune and/or targeted maintenance therapy according to the specific conditions of the subjects until disease progression or intolerance. The efficacy of Trilaciclib will be evaluated by the incidence of grade ≥3 neutropenia during chemotherapy as the primary endpoint.
After the progression of treatment, if the subjects were treated with chemotherapy for subsequent treatment and were considered to be able to use Trilaciclib according to the evaluation of the investigator, the use of treaclib could be considered until the subjects had disease progression again or were intolerant to treatment.
1. Written informed consent was obtained before enrollment.
2. Age ≥18 years old, both male and female;
3. Recurrent or metastatic head and neck squamous cell carcinoma without prior systemic therapy;
4. the presence of at least one measurable lesion;
1. Patients with known allergies to any of the drugs in the study;
2. Participated in other drug clinical trials within 4 weeks before the study;
3. a history of major bleeding, with any bleeding event of CTCAE4.0 grade 3 or above within 4 weeks before screening;
4. patients with hypertension that is not well controlled by single antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 8. Clinically significant (e.g., active) cardiovascular disease - e.g., cerebrovascular accident (≤ 6 months before randomization), myocardial infarction (≤ 6 months before randomization), unstable angina, congestive heart failure of New York Heart Association (NYHA) class II or higher, or severe arrhythmias that could not be controlled with medications or that could potentially affect trial treatment;
Single group
Trilaciclib
DrugTrilaciclib 240mg/m2, intravenous infusion for 30 minutes, completed within 4 hours before daily chemotherapy; Chemotherapy regimen: FP regimen (cisplatin/carboplatin +5-FU regimen: cisplatin 75mg/m2 D1, D2, D3 or carboplatin AUC 5, intravenous infusion D1; 5-FU 1000 mg/m2, intravenous infusion, D1-4; Q3W); TP regimen (cisplatin/carboplatin +5-FU regimen: cisplatin 75mg/m2 D1, D2, D3 or carboplatin AUC 5, intravenous infusion D1; Docetaxel 75mg/m2 or albumin paclitaxel 200mg, IV infusion, D1, 8; Q3W). The specific dose can be adjusted according to the situation. Immunotherapy: Pembrolizumab 200mg q2w Targeted therapy: cetuximab (400mg/m2 qw 250mg/m2 qw) Some patients can be treated with maintenance therapy, and the treatment regimen is immunotherapy or targeted therapy combined with Trilaciclib
Grade ≥3 neutropenia during chemotherapy alone or combined with immune/targeted therapy
The incidence of grade 4 neutropenia during treatment
Objective response rate (ORR)
The incidence of adverse events
Safety and tolerability
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