To hear about similar clinical trials, please enter your email below
Trial Title:
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
NCT ID:
NCT06611137
Condition:
Laryngeal Cancer
Hypopharynx Cancer
Conditions: Official terms:
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Laryngeal Neoplasms
Docetaxel
Conditions: Keywords:
SBRT
immunotherapy
larynx preservation
laryngeal cancer
hypopharynx cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
SBRT+Toripalimab Plus Docetaxel and Cisplatin
Description:
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.
Arm group label:
SBRT+Toripalimab Plus Docetaxel and Cisplatin
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Fang-Yun Xie
Phone:
+8613902205880
Email:
xiefy@sysucc.org.cn
Contact backup:
Last name:
Dian OuYang
Email:
ouyd@sysucc.org.cn
Contact backup:
Last name:
Fang-Yun Xie
Contact backup:
Last name:
Dian OuYang
Start date:
September 11, 2024
Completion date:
September 11, 2027
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06611137
