RecruitingPhase 2NCT06611137

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

Sponsor

Sun Yat-sen University

Enrollment

35 participants

Start Date

Sep 11, 2024

Study Type

INTERVENTIONAL

Conditions

Laryngeal Cancer Hypopharynx Cancer

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new treatment approach for laryngeal and hypopharyngeal cancers (cancers of the voice box and the area around it) that aims to preserve the larynx — allowing patients to keep their ability to speak and swallow. The approach combines radiation delivered in a focused way (SBRT) followed by a combination of immunotherapy (toripalimab) and chemotherapy. **You may be eligible if...** - You have locally advanced cancer of the larynx (voice box, T3-4) or hypopharynx (T2-4) - You are between 18 and 70 years old - You are in good general health (performance status 0–1) - Your organs can tolerate chemotherapy, immunotherapy, and radiation **You may NOT be eligible if...** - You have another active malignant tumor - You have a medical condition that makes immunotherapy unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.