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Neoadjuvant Immunochemotherapy for LAOSCC

NCT06258811 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-03-13

No results posted yet for this study

Summary

To evaluate the prognostic efficacy of neoadjuvant immunochemotherapy with tislelizumab, albumin paclitaxel and cisplatin followed by radical surgery and adjuvant therapy compared with standard therapy for patients with locally advanced and resectable oral squamous cell carcinoma.

Conditions

  • Oral Squamous Cell Carcinoma
  • Locally Advanced Head and Neck Carcinoma

Interventions

DRUG

albumin paclitaxel, cispatin, tislelizumab

Neoadjuvant immunochemotherapy (2 cycles, and 21 days each cycle, 260mg/m2 albumin paclitaxel intravenously on day 1 and day 22, with 75mg/m2 of cisplatin and 200mg of tislelizumab) + radical surgery + adjuvant therapy (radiation/chemoradiation followed by 200mg of tislelizumab, every 3 weeks for one year)

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Central South University

    collaborator OTHER

  • Fujian Medical University

    collaborator OTHER

  • Lai-ping Zhong

    lead OTHER

Principal Investigators

  • Lai-ping Zhong, MD, PhD · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2026-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

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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 NCT06258811 on ClinicalTrials.gov