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

Xiang Lu

Status and phase: Enrolling; Phase 2

Conditions: Head and Neck Squamous Cell Carcinomas; Resectable Head and Neck Squamous-cell Carcinoma

Treatments: Drug: Tislelizumab; Drug: Nab-paclitaxel; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT06235918

TJ-IRB20220529

Details and patient eligibility

About

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 .

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Neoadjuvant therapy of tislelizumab with chemotherapy

Experimental group

Description:

Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles

Treatment:

Drug: Carboplatin

Drug: Nab-paclitaxel

Drug: Tislelizumab