Actively Recruiting
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
Led by Sun Yat-sen University · Updated on 2024-09-26
35
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and efficiency of stereotactic body radiotherapy (SBRT) followed by chemoimmunotherapy using Toripalimab combined with Docetaxel and Cisplatin. This study focuses on patients with locally regionally advanced squamous cell carcinoma of the larynx and hypopharynx, aiming to preserve the larynx in these individuals. The trial is a Phase 2 interventional study sponsored by Sun Yat-sen University. All participants will first receive SBRT targeting the gross tumor and metastatic lymph nodes with a total dose of 18 Gy delivered in 3 fractions every other day. This is followed by three cycles of neoadjuvant chemoimmunotherapy consisting of Toripalimab (240 mg), Docetaxel (75 mg/m2 every 3 weeks), and Cisplatin (75 mg/m2 every 3 weeks). After two weeks from the last chemotherapy course, tumor response will be assessed. If there is complete or partial response, participants will receive intensity-modulated radiotherapy with 54 Gy over 27 fractions. If the tumor is stable or progressing, radical surgery will be considered, potentially followed by postoperative radiotherapy. Participants will be monitored by evaluating the objective response rate two weeks after the last neoadjuvant chemotherapy cycle. The study includes assessments of physical status, tumor response, and tolerability of combined treatments. The total study duration extends to the completion of treatment and response assessment, with follow-up for safety and outcomes. The trial includes adults aged 18 to 70 years with good performance status and normal organ function to tolerate the treatments being studied.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with laryngeal cancer (T3-4N0-3M0) or hypopharyngeal cancer (T2-4N0-3M0) staged by AJCC 8th edition
- Aged between 18 and 70 years
- Performance status score of 0 to 1
- Normal organ functions to tolerate chemotherapy, immunotherapy, and radiotherapy
You will not qualify if you...
- Presence of other malignant tumors besides laryngeal or hypopharyngeal cancer
- Known contraindications to immunotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive stereotactic body radiotherapy (SBRT) to the tumor and lymph nodes, followed by three cycles of combined chemoimmunotherapy with Toripalimab, Docetaxel, and Cisplatin.
SBRT delivered in 3 fractions every other day, followed by chemoimmunotherapy every 3 weeks for 3 cycles
Duration - Varies depending on treatment response and surgery timing
Participants who show complete or partial tumor response after neoadjuvant chemotherapy receive intensity modulated radiotherapy (54Gy over 27 fractions). Participants with stable or progressive tumor receive radical surgery with or without postoperative radiotherapy as needed.
Radiotherapy visits for up to 27 fractions or surgery plus approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
F
Fang-Yun Xie
D
Dian OuYang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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