RecruitingPhase 2NCT06611137

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


Sponsor

Sun Yat-sen University

Enrollment

35 participants

Start Date

Sep 11, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • Laryngeal (T3-4N0-3M0 ) and hypopharyngeal ( T2-4N0-3M0) cancers staged by AJCC8th
  • age 18-70
  • PS score 0-1
  • normal functions to tolerate chemotherapy, immunotherapy and radiotherapy

Exclusion Criteria2

  • Patients with a combination of other malignant tumours
  • Individuals with contraindications to immunotherapy

Interventions

COMBINATION_PRODUCTSBRT+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.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06611137


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