Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHunan Cancer Hospital
About this trial
To evaluate the efficacy and safety of trilaciclib combined with standard treatment project as an adjuvant treatment for Head and neck cancer after surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically or histologically confirmed locally advanced squamous cell carcinoma of the head and neck (this study includes cancers of the oral cavity, oropharynx, hypopharynx, and larynx, excluding cancers of the lip and nasopharynx).
(1) Staging of T1-4N0-3M0, having undergone radical surgery;
(2) At least one of the following factors: positive surgical margin, tumor close to the surgical margin, postoperative pathological staging pT3-4 or pN2-3, positive lymph nodes in neck level IV or V, tumor invasion of nerves/blood vessels/lymphatic vessels.
ECOG performance status score of 0-1.
Disqualifiers
Pathologically confirmed non-squamous cell carcinoma.
Patients with recurrence or distant metastasis (M1).
Previous chemotherapy for any reason, or prior surgery, radiotherapy, molecular targeted therapy, or immune checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, anti-PD-L2, etc.) in the head and neck region.
Pregnant or breastfeeding women.
Trial design
Design model
Single group
Treatments tested in this trial
Trilaciclib + Cisplatin
DrugTrilaciclib: 240 mg/m², intravenous infusion over 30 minutes, administered within 4 hours prior to each chemotherapy session. Cisplatin: 40 mg/m², intravenous infusion over 2-3 hours, once a week, for a total of 6-7 times.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Trilaciclib + CisplatinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Grade 3/4 Neutropenia
Neutrophils ≤ 1.0\*109/L
Time frame
From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.Secondary outcomes
1
Incidence of Grade 3/4 Thrombocytopenia during Chemotherapy
Platelets≤ 50\*109/L
Time frame
From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.2
Incidence of Grade 3/4 Anemia during Chemotherapy
hemoglobin\<80g/L
Time frame
From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.3
Incidence of Febrile Neutropenia
ANC \<0.5×10\^9/L or ANC between 0.5 and 1×10\^9/L (Grade 3) but expected to drop to \<0.5×10\^9/L within the next 48 hours;temperature ≥38.3°C or ≥38.0°C for more than 1 hour.
Time frame
From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.4
Incidence of Platelet Transfusion
Incidence of Platelet Transfusion
Time frame
From the date of enrollment to the 15th day after the completion of postoperative concurrent chemoradiotherapy.Other outcomes
1
Survival Data-Related Endpoints
1-Year Disease-Free Survival (DFS) Rate
Time frame
1-YearSponsors and contacts
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Source ClinicalTrials.gov