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
Qualifiers
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
Treatments tested in this trial
- Trilaciclib + Cisplatin
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov