Perioperative Finotonlimab Plus Chemotherapy in Untreated Stage II HNSCC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYanjie Zhang, MD
About this trial
This multicenter, randomized, open-label, parallel-controlled clinical trial aims to evaluate the efficacy and safety of surgery combined with postoperative chemoradiotherapy versus finotonlimab plus induction chemotherapy followed by postoperative finotonlimab maintenance therapy in patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
Eligibility criteria
Qualifiers
Age 18-75 years
Pathologically confirmed primary head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)
Clinical stage II (8th edition TNM staging), no distant metastasis, primary tumor resectable
ECOG sccore 0-1
Disqualifiers
Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways
Active severe autoimmune disease. Subjects in stable condition not requiring systemic immunosuppressive therapy are eligible, such as type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)
Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection)
Known hypersensitivity to the study drug or any of its excipients, or history of severe allergic reaction to other monoclonal antibodies
Trial design
Treatments tested in this trial
- Neoadjuvant Finotonlimab Plus Chemotherapy
- Surgery
- Postoperative Finotonlimab Maintenance
Treatment groups
142 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Yanjie Zhang, MD
Lead sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor institution
Source ClinicalTrials.gov