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

NCT06009861 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-06-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Peking University Hospital of Stomatology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-27
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06009861 on ClinicalTrials.gov