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

ConditionsLaryngeal Cancer Hypopharynx Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorSun Yat-sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with a combination of other malignant tumours

Individuals with contraindications to immunotherapy

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

35 Participants

are divided into 1 treatment group

Group A: SBRT+Toripalimab Plus Docetaxel and CisplatinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

objective response rate

complete and partial response rate

Time frame

two weeks after the last course of neoadjuvant chemotherapy

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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