Hypopharynx Cancer, Laryngeal Cancer
Conditions
Keywords
SBRT, immunotherapy, larynx preservation, laryngeal cancer, hypopharynx cancer
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
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | two weeks after the last course of neoadjuvant chemotherapy | complete and partial response rate |
Countries
China
Contacts
Primary ContactFang-Yun Xie
Backup ContactDian OuYang
Outcome results
None listed