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Clinical Trials List

Protocol NumberNANORAY-312

NCT Number(ClinicalTrials.gov Identfier)NCT04892173

2022-01-31 - 2026-03-31

Phase III

Not yet recruiting1

Recruiting4

A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With LA-HNSCC

Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2025/11/18

Investigators and Locations

Principal Investigator

Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林進清無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsiang-Fong Kao 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉怡君無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Shang-Yin Wu

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Locally Advanced Head and Neck Squamous Cell Carcinoma

Objectives

Nanobiotix S.A. and Shanghai Liantuo Biotechnology Co., Ltd. (the commissioning party) are conducting a research trial to understand whether an investigational product (IP) called NBTXR3 can help treat locally advanced head and neck squamous cell cancer (HNSCC) and its safety in humans.

Test Drug

NBTXR3NBTXR3

Active Ingredient

NBTXR3
NBTXR3

Dosage Form

Suspension for injeciton
Suspension for injeciton

Dosage

64 mg/ml
64 mg/ml

Endpoints

Survival outcomes were assessed in subjects receiving NBTXR3 via intratumoral injection of either radiotherapy (RT) monotherapy (selected by the trial administrator) or RT plus cetuximab activation, compared to those receiving the same therapy alone. This is referred to as NBTXR3/RT±cetuximab versus RT±cetuximab.

Inclution Criteria

Inclusion Criteria:

Age greater than or equal to (>=) 60 years old
Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab
Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
One primary tumor lesion amendable for intratumoral injection
Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):

Estimated creatinine clearance >= 30 and less than (<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation), Grade >= 2 hearing loss or tinnitus, Grade >= 2 peripheral neuropathy, Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or New York Heart Association Class 3
Age 70-74 years old with Geriatric 8 (G8) score less than or equal to (<=) 14
Age >= 75 years old

Exclusion Criteria

Exclusion Criteria:

Carcinoma of the nasopharynx, paranasal sinus(es), salivary gland, thyroid gland, or unknown primary
Non-squamous cell histology
Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
Loco-regionally recurrent head & neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
Prior or concurrent primary malignancy (including second synchronous head & neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent
Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization

The Estimated Number of Participants

Taiwan

15 participants
Global

500 participants