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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-01-01

Brief Summary

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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 .

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Detailed Description

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Conditions

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Head and Neck Squamous Cell Carcinomas Resectable Head and Neck Squamous-cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant therapy of tislelizumab with chemotherapy

Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Tislelizumab: 200mg,administered via Intravenous (IV) injection, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles

Nab-paclitaxel

Intervention Type DRUG

260mg/m\^2, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles

Carboplatin

Intervention Type DRUG

AUC 5 mg/mL/min by IV infusion once every 3 weeks,day 1 of each 21-day cycle,neoadjuvant therapy : 2 cycles

Interventions

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Tislelizumab

Tislelizumab: 200mg,administered via Intravenous (IV) injection, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles

Intervention Type DRUG

Nab-paclitaxel

260mg/m\^2, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles

Intervention Type DRUG

Carboplatin

AUC 5 mg/mL/min by IV infusion once every 3 weeks,day 1 of each 21-day cycle,neoadjuvant therapy : 2 cycles

Intervention Type DRUG

Other Intervention Names

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BGB-A317

Eligibility Criteria

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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 .

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No