NCT06009861

Neoadjuvant Tislelizumab Plus Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer (NeoSPOT)

Neoadjuvant Chemoimmunotherapy With Tislelizumab, Albumin-bound Paclitaxel, and Cisplatin in Locally Advanced Oral/Oropharyngeal Squamous Cell Carcinoma: A Prospective, Multicenter, Single-arm Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Peking University Hospital of Stomatology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Previous studies confirmed locally advanced oral/oropharyngeal squamous cell carcinoma (LA OSCC or OPSCC) patients with a pathological response had higher probability of survival in neoadjuvant settings. Several ongoing trials of neoadjuvant immunotherapy in head and neck cancer showed promising results. However, the optimal regimen remains unclear. This trial aimed to evaluate the efficacy and safety of neoadjuvant therapy with anti-programmed cell death 1 monoclonal antibody Tislelizumab and chemotherapy, followed by surgery and adjuvant radiotherapy or chemoradiotherapy plus Tislelizumab in LA OSCC or OPSCC.

Conditions

• Oral Squamous Cell Carcinoma
• Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	Dose: 200 mg Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks
DRUG	Albumin-Bound Paclitaxel	Dose: 260 mg/m\^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks
DRUG	Cisplatin	Dose: 60-75 mg/m\^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks

Timeline

• Start date: 2023-06-27
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2023-08-24
• Last updated: 2025-06-06

Locations

13 sites across 1 country: China