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OncoMatch/Clinical Trials/NCT06752798

Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC

Is NCT06752798 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Trilaciclib + Cisplatin for head and neck cancer squamous cell carcinoma.

Phase 2RecruitingHunan Cancer HospitalNCT06752798Data as of May 2026

Treatment: Trilaciclib + CisplatinTo evaluate the efficacy and safety of trilaciclib combined with standard treatment project as an adjuvant treatment for Head and neck cancer after surgery

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage T1-4N0-3M0, PT3-4, PN2-3

Staging of T1-4N0-3M0, having undergone radical surgery; ... postoperative pathological staging pT3-4 or pN2-3

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Previous chemotherapy for any reason

Cannot have received: surgery

Exception: prior surgery in the head and neck region allowed only if radical surgery for current diagnosis

prior surgery ... in the head and neck region

Cannot have received: radiotherapy

Exception: postoperative radiotherapy for current diagnosis allowed

prior ... radiotherapy ... in the head and neck region

Cannot have received: molecular targeted therapy

prior ... molecular targeted therapy ... in the head and neck region

Cannot have received: immune checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, anti-PD-L2)

prior ... immune checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, anti-PD-L2, etc.) in the head and neck region

Cannot have received: hematopoietic stem cell or bone marrow transplant

Previous hematopoietic stem cell or bone marrow transplant

Lab requirements

Blood counts

HB ≥ 90 g/L; Neu ≥ 1.5×10^9/L; PLT ≥ 100×10^9/L; no blood transfusion or blood products within 14 days

Kidney function

Serum Cr ≤ 1.0× ULN or creatinine clearance rate > 60 ml/min

Liver function

TBIL < 1.5× ULN; ALT and AST < 2.5× ULN

Cardiac function

No Grade I or higher myocardial ischemia or myocardial infarction, arrhythmia, or Grade II heart failure; no stroke or cardiovascular events within 6 months prior to enrollment

Normal major organ function, meeting the following criteria: ... Hematology standards ... Biochemical criteria ... Abnormal function of vital organs such as the heart, brain, or lungs: Hypertension that cannot be controlled ... myocardial ischemia or myocardial infarction, arrhythmia, and Grade II heart failure; stroke or cardiovascular events within 6 months prior to enrollment; abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with a tendency to bleed or receiving thrombolytic or anticoagulant therapy; clear tendency to bleed; patients with positive proteinuria (urine protein test 2+ or above, or 24-hour urine protein quantification > 1.0 g).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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