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Comparing Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor Versus Neoadjuvant Chemotherapy in Locally Advanced Laryngeal and Hypopharyngeal Carcinoma

NCT06957938 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-05-08

No results posted yet for this study

Summary

Neoadjuvant chemotherapy combined with immunotherapy has achieved promising pathological remission rates in locally advanced head and neck squamous cell carcinoma and has offered new hope for patients with locally advanced laryngeal and hypopharyngeal cancer. In our center's previous phase II study on locally advanced laryngeal and hypopharyngeal cancer, neoadjuvant chemotherapy combined with immunotherapy showed good 1 - year laryngeal preservation rate and 1 - year PFS rate. However, in locally advanced laryngeal and hypopharyngeal cancer, whether neoadjuvant chemotherapy combined with PD-1 inhibitor, compared with neoadjuvant chemotherapy, can improve laryngeal preservation survival, event - free survival and overall survival remains unclear.

Thus, this study aims to explore in locally advanced laryngeal and hypopharyngeal cancer whether neoadjuvant immuno - chemotherapy, compared with neoadjuvant chemotherapy, can improve laryngeal preservation survival and bring benefits in quality of life.

Conditions

  • Laryngeal Carcinoma
  • Hypopharyngeal Carcinoma

Interventions

DRUG

Neoadjuvant Chemotherapy (NACT)

Neoadjuvant Chemotherapy with paclitaxel (or albumin - bound paclitaxel) and cisplatin

DRUG

Neoadjuvant and maintenance Tislelizumab

Neoadjuvant and maintenance Tislelizumab

RADIATION

Concurrent chemo-radiotherapy (CCRT)

Concurrent chemo-radiotherapy (CCRT), with cisplatin-based chemotherapy

PROCEDURE

Surgery and adjuvant (chemo-)radiotherapy

Definitive surgery, with adjuvant (chemo-)radiotherapy, depending on pathologic findings.

Sponsors & Collaborators

  • Sun Yat-sen University Cancer Center (SUSUCC)

    collaborator UNKNOWN

  • Fujian Cancer Hospital

    collaborator OTHER_GOV

  • Fudan University

    lead OTHER

Principal Investigators

  • Yu Wang, M.D., professor, Chief · Department of head and neck surgery, Fudan University Shanghai Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-04-28
Primary Completion
2029-05-01
Completion
2031-05-01

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 NCT06957938 on ClinicalTrials.gov