NCT06235918RecruitingPhase 2
Neoadjuvant Tislelizumab (BGB-A317, Anti-PD-1 Antibody) Plus Nab-Paclitaxel and Carboplatin for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma : A Single-arm, Phase II Trial
Xiang Lu1 site in 1 country30 target enrollmentStarted: January 1, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pathological Complete Response (PCR)
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who voluntarily participate in the project and sign the informed consent.
- •Be 18 years of age on day of signing informed consent.
- •The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-
- •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.
- •Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis.
- •Demonstrate adequate organ function.
Exclusion Criteria
- •The patient has abnormal blood indicators, abnormal liver and kidney function.
- •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.
- •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.
- •The entire clinical research process cannot be completed due to personal, social and economic reasons.
- •Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs .
Arms & Interventions
Neoadjuvant therapy of tislelizumab with chemotherapy
Experimental
Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles
Intervention: Tislelizumab (Drug)
Neoadjuvant therapy of tislelizumab with chemotherapy
Experimental
Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles
Intervention: Nab-paclitaxel (Drug)
Neoadjuvant therapy of tislelizumab with chemotherapy
Experimental
Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles
Intervention: Carboplatin (Drug)
Outcomes
Primary Outcomes
Pathological Complete Response (PCR)
Time Frame: From neoadjuvant therapy to surgical resection, up to 6 weeks
Secondary Outcomes
- 3-year overall survival（OS）rate(3-years after surgery)
- Major Pathological Response (MPR)(From neoadjuvant therapy to surgical resection, up to 6 weeks)
- 3-year Disease-free survival (DFS) rate(3-years after surgery)
Investigators
Xiang Lu
Professor
Tongji Hospital
Study Sites (1)
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