Tislelizumab Combined With Chemotherapy for Different Cycles of Neoadjuvant Therapy for Locally Advanced Resectable Squamous Cell Carcinoma of the Head and Neck (NeoTempo)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

This study aims to explore the optimal course of neoadjuvant immunotherapy for HNSCC by comparing the efficacy and safety of 4 cycles and 2 cycles of neoadjuvant tislelizumab combined with chemotherapy.

Eligibility criteria

Qualifiers

Histological or pathological diagnosis of head and neck squamous cell carcinoma;

Initially resectable stage III-IVB oral cancer/laryngeal cancer/hypopharyngeal cancer/P16-oropharyngeal cancer, or stage III p16+ oropharyngeal cancer (AJCC 8th), and evaluated by the researcher to achieve R0 resection;

Plan to perform neoadjuvant therapy;

No previous anti-tumor treatment for HNSCC;

Disqualifiers

Previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T-cell co-stimulation or checkpoint pathways);

There is a clear history of allergies, and there may be potential allergies or intolerances to the research drug and its similar biological agents;

Participated in clinical trials of other anti-tumor drugs within 4 weeks before the first administration; Or within 4 weeks before the first administration or planning to receive a live attenuated vaccine during the study period;

Other malignant tumors have occurred within the past five years (except for well-treated squamous cell carcinoma of the skin or controlled basal cell carcinoma of the skin);

Trial design

Treatments tested in this trial

  • Tislelizumab Combined With Chemotherapy for 4 cycles
  • Tislelizumab Combined With Chemotherapy for 2 cycles

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations