Recruiting

NCT Number: NCT06611137

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

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

Recruiting

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Key information

Conditions

Laryngeal Cancer Head and Neck Neoplasms Hypopharyngeal Neoplasms Hypopharynx Cancer Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Dian OuYang

CONTACT

[email protected]

Dian OuYang

CONTACT

Fang-Yun Xie

CONTACT

[email protected]

+8613902205880

Fang-Yun Xie

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

objective response rate

Time frame: two weeks after the last course of neoadjuvant chemotherapy

complete and partial response rate

Study contacts

Contact information is provided by the study sponsor or research team.

Dian OuYang

CONTACT

[email protected]

Fang-Yun Xie

CONTACT

[email protected]

+8613902205880

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2027
First posted: Sep 24, 2024
Registry last updated: Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed