NCT07147426

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

A Prospective, Randomized Controlled, Phase II Clinical Study on the Neoadjuvant Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma With Tislelizumab Combined With Chemotherapy for Different Cycles (NeoTempo)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Head &Amp; Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab Combined With Chemotherapy for 4 cycles	Tislelizumab: 200mg, day 1, every 3 weeks for 4 cycles Cisplatin: 75mg/m\^2 Nab-paclitaxel: 260mg/m\^2
DRUG	Tislelizumab Combined With Chemotherapy for 2 cycles	Tislelizumab: 200mg, day 1, every 3 weeks for 2 cycles Cisplatin: 75mg/m\^2 Nab-paclitaxel: 260mg/m\^2

Timeline

• Start date: 2025-09-20
• Primary completion: 2026-10-20
• Completion: 2028-10-20
• First posted: 2025-08-29
• Last updated: 2025-08-29