SBRT Followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Larynx Preservation in Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx

NCT06611137 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-09-26

No results posted yet for this study

Summary

This trial aims to evaluate the safety and efficiency of SBRT followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx

Conditions

  • Laryngeal Cancer
  • Hypopharynx Cancer

Interventions

COMBINATION_PRODUCT

SBRT+Toripalimab Plus Docetaxel and Cisplatin

All participants will receive SBRT (18Gy/3 fractions, QOD ) to gross tumor and metastatic lymph nodes, followed by neoadjuvant chemoimmunotherapy of Toripalimab (240mg) Plus Docetaxel (75mg/m2, q3w) and Cisplatin (75mg/m2, q3w) for 3 cycles. If tumor has complete or partial response at 2 weeks after the last course of neoadjuvant chemotherapy, participants will then receive intensity modulated radiotherapy (54Gy/27 fractions). If tumor is stable or progressive, participants will receive radical resection with or without postoperative intensity modulated radiotherapy when necessary.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2025-09-11
Completion
2027-09-11

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 NCT06611137 on ClinicalTrials.gov