Clinical trial · Interventional
Neoadjuvant Tislelizumab Plus Chemotherapy for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinomas | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Resectable Head and Neck Squamous-cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant therapy of tislelizumab with chemotherapy
- description
- Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles
- interventionNames
- Drug: Tislelizumab
- Drug: Nab-paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Pathological Complete Response (PCR)
- timeFrame
- From neoadjuvant therapy to surgical resection, up to 6 weeks
Secondary outcomes (3)
- measure
- Major Pathological Response (MPR)
- timeFrame
- From neoadjuvant therapy to surgical resection, up to 6 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 .
References
Publications (0)
Data not yet available