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Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

NCT06714266 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-03

No results posted yet for this study

Summary

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.

Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

DRUG

Trilaciclib

Trilaciclib 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

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-15
Primary Completion
2026-08-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06714266 on ClinicalTrials.gov