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

NCT06714266 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SDZLEC2024-264-02
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Head and neck squamous cell carcinoma; Chemotherapy induced myelosuppression; Trilaciclib

Outcome Measures

Primary Outcomes (1)

• Grade ≥3 neutropenia during chemotherapy alone or combined with immune/targeted therapy

  2year

Secondary Outcomes (3)

• The incidence of grade 4 neutropenia during treatment

  2year

• Objective response rate (ORR)

  2year

• The incidence of adverse events

  2year

Study Arms (1)

Patients were treated with Trilaciclib + chemotherapy ± immune/targeted therapy

EXPERIMENTAL

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 could be treated with maintenance therapy, and the treatment regimen was immunotherapy or targeted therapy combined with treaclib.

Drug: Trilaciclib

Interventions

Trilaciclib DRUG

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

Also known as: chemotherapy, immune/targeted therapy

Patients were treated with Trilaciclib + chemotherapy ± immune/targeted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Written informed consent was obtained before enrollment.
• \. Age ≥18 years old, both male and female;
• \. Recurrent or metastatic head and neck squamous cell carcinoma without prior systemic therapy;
• \. the presence of at least one measurable lesion;
• \. ECOG PS = 0-1;
• \. Expected survival time ≥ 3 months
• \. Laboratory tests meet the following standards: Hemoglobin ≥ 100 g/L (female), 110g/L (male) Neutrophil count ≥ 2×109/L Platelet count ≥100×109/L; Creatinine ≤ 15mg/L or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); Total bilirubin ≤ 1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or ≤5× ULN (in patients with liver metastases); Albumin ≥ 30 g/L;
• \. Women: all women of childbearing potential must have a negative serum pregnancy test during the screening period and must be using a reliable contraceptive method from the time of informed consent until 3 months after the last dose;

You may not qualify if:

• \. Patients with known allergies to any of the drugs in the study;
• \. Participated in other drug clinical trials within 4 weeks before the study;
• \. a history of major bleeding, with any bleeding event of CTCAE4.0 grade 3 or above within 4 weeks before screening;
• \. 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;
• \. Previous arterial/venous thrombosis events occurred within 6 months before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization due to previous chemotherapy, which was judged by the investigator to be cured), and pulmonary embolism;
• \. Renal insufficiency: urine routine proteinuria \> 2+ and confirmed 24-hour urinary protein quantitation \> 1.0 g;
• \. Symptomatic brain metastases (proven or suspected);
• \. Presence of severe or uncontrolled infection;
• \. Those who have a history of psychotropic drug abuse and cannot be abstinent or have a history of mental disorder;
• \. A history of immunodeficiency, including testing positive for HIV, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation; He had a history of autoimmune diseases.
• \. Use of high-dose glucocorticoids for 4 weeks.
• \. Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of pulmonary function, etc.;
• \. Concomitant medical conditions that, in the investigator's judgment, seriously compromise patient safety or interfere with patient completion of the study. He had received a previous hematopoietic stem-cell or bone marrow transplant
• \. Allergy to the study drug or its components;
• \. Those who were deemed unsuitable for the study by the investigator.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

trilaciclib; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Man Hu, doctor

CONTACT

+86 0531-67626152; wszt111@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician/Professor

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 3, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share