NCT06554028

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Historical studies have shown that induction chemotherapy can provide an opportunity to preserve the larynx in approximately 60-70% of patients with locally advanced laryngeal/hypopharynx carcinoma. Recently, phase I-II clinical studies have shown that induction of PD-1 inhibitors has a good pathological response in locally advanced head and neck cancer, with or without combined chemotherapy. However,the primary lesion and lymph nodes respond asynchronously or even in the opposite way to immune induction therapy. The primary lesion is more likely to achieve CR/PR, while the lymph nodes are more likely to show PR/SD or even PD. Therefore, the surgical or radiotherapy plan should be implemented according to the specific response of the primary lesion and metastatic lymph nodes to induction therapy. This study aimed to determine whether the combination of induction chemotherapy with a PD-1 inhibitor (Tislelizumab) followed by chemoradiotherapy or adaptive surgery can improve the rate of laryngeal preservation in patients with resectable laryngeal/hypopharynx cancer.

Conditions

• Laryngeal Cancer
• Hypopharynx Cancer
• Laryngeal Neoplasms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2027-12-01
• First posted: 2024-08-14
• Last updated: 2024-08-14

Locations

1 site across 1 country: China