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

January 30, 2024 updated by: Xiang Lu

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant therapy of tislelizumab with chemotherapy
Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles
Drug: Tislelizumab
Tislelizumab: 200mg,administered via Intravenous (IV) injection, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles
Other Names:
  • BGB-A317
Drug: Nab-paclitaxel
260mg/m^2, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathological Complete Response (PCR)
Time Frame: From neoadjuvant therapy to surgical resection, up to 6 weeks
From neoadjuvant therapy to surgical resection, up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Pathological Response (MPR)
Time Frame: 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%.
From neoadjuvant therapy to surgical resection, up to 6 weeks
3-year Disease-free survival (DFS) rate
Time Frame: 3-years after surgery
Time from randomization to disease recurrence or death of any cause
3-years after surgery
3-year overall survival（OS）rate
Time Frame: 3-years after surgery
The proportion of all study cases in which no death from any cause occurred within 3 years after surgery
3-years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiang Lu

Investigators

  • Principal Investigator: Guangyuan Hu, professor, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB20220529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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