Neoadjuvant Tislelizumab Plus Chemotherapy for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma

Phase 2

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinomas; Resectable Head and Neck Squamous-cell Carcinoma
• Interventions: Drug: Tislelizumab; Drug: Nab-paclitaxel; Drug: Carboplatin

• Registration Number: NCT06235918
• Lead Sponsor: Xiang Lu

Brief Summary

For resectable squamous cell carcinoma of the head and neck , novel therapeutic approaches are still needed to improve outcomes. Neoadjuvant immunochemotherapy is considered as a potentially effective strategy. The purpose of this study is to evaluate the safety and efficacy of neoadjuvant of tislelizumab combined with platinum doublet for resectable locally-advanced head and neck squamous-cell carcinoma .

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients who voluntarily participate in the project and sign the informed consent.
2. Be 18 years of age on day of signing informed consent.
3. The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1.
4. According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVA tumors confirmed by pathology as head and neck squamous cell carcinoma.
5. Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis.
6. Demonstrate adequate organ function.

Exclusion Criteria

1. The patient has abnormal blood indicators, abnormal liver and kidney function.
2. The patient has received prior systemic anti-cancer therapy for head and neck squamous cell carcinoma including investigational agents within 3 months of first dose of study treatment.
3. The patient has previously suffered from other tumors , or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy within the past 5 years.
4. The entire clinical research process cannot be completed due to personal, social and economic reasons.
5. Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant therapy of tislelizumab with chemotherapy	Nab-paclitaxel	Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles
Neoadjuvant therapy of tislelizumab with chemotherapy	Tislelizumab	Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles
Neoadjuvant therapy of tislelizumab with chemotherapy	Carboplatin	Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response (PCR)	From neoadjuvant therapy to surgical resection, up to 6 weeks

Secondary Outcome Measures

Name	Time	Method
3-year overall survival（OS）rate	3-years after surgery	The proportion of all study cases in which no death from any cause occurred within 3 years after surgery
Major Pathological Response (MPR)	From neoadjuvant therapy to surgical resection, up to 6 weeks	In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.
3-year Disease-free survival (DFS) rate	3-years after surgery	Time from randomization to disease recurrence or death of any cause

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China