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 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-sen University

Phase

Phase 2

Started

2024-09-11

Last updated

2024-09-26

Condition(s) studied

Laryngeal CancerHypopharynx Cancer

Investigational drug(s) / intervention(s)

SBRT+Toripalimab Plus Docetaxel and Cisplatin

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.

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * Patients with a combination of other malignant tumours * Individuals with contraindications to immunotherapy

Primary outcome measure(s)

objective response rate — two weeks after the last course of neoadjuvant chemotherapy
complete and partial response rate

Trial sites (1)

Facility	City	Region	Status
Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06611137 on ClinicalTrials.gov ↗ ← All trials in China