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

Phase 1

Recruiting

• Conditions: Laryngeal Cancer; Hypopharynx Cancer
• Interventions: Combination Product: SBRT+Toripalimab Plus Docetaxel and Cisplatin

• Registration Number: NCT06611137
• Lead Sponsor: Sun Yat-sen University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-11
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Primary Completion: 2025-09-11
• Study Completion: 2027-09-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT+Toripalimab Plus Docetaxel and Cisplatin	SBRT+Toripalimab Plus Docetaxel and Cisplatin	SBRT for gross tumor and metastatic lymph nodes, followed by neoadjuvant chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin

Primary Outcome Measures

Name	Time	Method
objective response rate	two weeks after the last course of neoadjuvant chemotherapy	complete and partial response rate

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China