NCT06235918

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

January 22, 2024

Last Update Submit

January 30, 2024

Conditions

Head and Neck Squamous Cell CarcinomasResectable Head and Neck Squamous-cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Pathological Complete Response (PCR)

    From neoadjuvant therapy to surgical resection, up to 6 weeks

Secondary Outcomes (3)

  • 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

  • 3-year overall survival（OS）rate

    3-years after surgery

Study Arms (1)

Neoadjuvant therapy of tislelizumab with chemotherapy

EXPERIMENTAL

Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles

Drug: TislelizumabDrug: Nab-paclitaxelDrug: Carboplatin

Interventions

TislelizumabDRUG

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

Also known as: BGB-A317
Neoadjuvant therapy of tislelizumab with chemotherapy
Nab-paclitaxelDRUG

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

Neoadjuvant therapy of tislelizumab with chemotherapy
CarboplatinDRUG

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

Neoadjuvant therapy of tislelizumab with chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 0-1.
  • 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.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

tislelizumab130-nm albumin-bound paclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Guangyuan Hu, professor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Lu, professor

CONTACT

027-83662691luxiangent@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2024

First Posted

February 1, 2024

Study Start

January 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)