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NOT YET RECRUITING
NCT06554028
PHASE2

Tislelizumab and Induction Chemotherapy for Larynx Preservation in Resectable Advanced Laryngeal/Hypopharyngeal Cancer

Sponsor: Henan Cancer Hospital

View on ClinicalTrials.gov

Summary

This study is a prospective, single-arm, single-center, phase II study. The goal of this clinical trial is to explore the therapeutic value of the treatment model of "tislelizumab combined with chemotherapy followed by radiotherapy/adaptive surgery" on larynx Preservation of locally advanced hypopharyngeal cancer and laryngeal cancer.

Official title: Tislelizumab and Induction Chemotherapy Followed by Radiotherapy or Adaptive Surgery for Larynx Preservation in Resectable Locally Advanced Laryngeal or Hypopharyngeal Cancer: A Single-Arm Phase II Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2024-08

Completion Date

2027-12

Last Updated

2024-08-14

Healthy Volunteers

No

Interventions

DRUG

chemotherapy TP regimen combined with Tislelizumab

Induction chemotherapy TP regimen combined with Tislelizumab for 3 cycles: Cisplatin 37.5mg/m2 d1-2 q3w, Docetaxel 37.5mg/m2 d1and d3 q3w,Tislelizumab 200mg d3 q3w. •Response rate of primary tumor or lymph nodes is evaluated using laryngoscopy and head and neck MRI after 3 cycles of induction therapy. If the primary lesion reaches CR/PR and the lymph nodes reach CR, chemoradiotherapy based on cisplatin is conducted. If the primary lesion reaches CR/PR and lymph node PR/PD, cervical lymph node dissection will be performed, followed by radiotherapy/concurrent chemoradiotherapy. If the primary lesion is SD/PD, regardless of the condition of the lymph nodes, primary lesion resection and lymph node dissection should be performed, followed by adjuvant radiation/chemoradiation. Other Names: Docetaxel Cisplatin Paclitaxel

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China