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 | Recruiting Phase 2

• 1 other identifier: B2024-373-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Laryngeal Cancer; Hypopharynx Cancer

Keywords

SBRT; immunotherapy; larynx preservation; laryngeal cancer; hypopharynx cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate

  complete and partial response rate

  two weeks after the last course of neoadjuvant chemotherapy

Study Arms (1)

SBRT+Toripalimab Plus Docetaxel and Cisplatin

EXPERIMENTAL

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

Combination Product: SBRT+Toripalimab Plus Docetaxel and Cisplatin

Interventions

SBRT+Toripalimab Plus Docetaxel and Cisplatin COMBINATION_PRODUCT

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.

SBRT+Toripalimab Plus Docetaxel and Cisplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms; Hypopharyngeal Neoplasms

Interventions

Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Fang-Yun Xie

CONTACT

+8613902205880; xiefy@sysucc.org.cn

Dian OuYang

CONTACT

ouyd@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 24, 2024
• Study Start: September 11, 2024
• Primary Completion: September 11, 2025
• Study Completion (Estimated): September 11, 2027
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

CN (1)