Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in patients with locally advanced HNSCC. The hypothesis is that the response would be increased with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nimotuzumab Combined With Neoadjuvant Chemotherapy in the Treatment of Resectable LA HNSCC

NCT05351762

Head and Neck Squamous Cell Carcinoma

UNKNOWN PHASE2

A Study of Nimotuzumab Plus Adebrelimab With Chemotherapy in Cisplatin-Ineligible Patients With Head And Neck Squamous Cell Carcinoma

NCT07105592

Head and Neck Squamous Cell Carcinoma

RECRUITING PHASE1/PHASE2

Biweekly TPF Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of Head and Neck

NCT04397341

Locally Advanced Head and Neck Carcinoma

COMPLETED PHASE2

Sintilimab-Nimotuzumab Induction Followed by Chemoradiation-Nimotuzumab in LA-HNSCC: Single-Arm Phase II

NCT07310771

Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN)

NOT_YET_RECRUITING PHASE2

GP Combined With Nimotuzumab and Sintilimab as Induction Therapy for Nasopharyngeal Carcinoma

NCT06490341

Locally Advanced Nasopharyngeal Carcinoma

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Induction chemotherapy followed by radiotherapy is the standard treatment for patients with unresectable HNSCC. However, the role of induction chemotherapy remains uncertain for resectable disease. Therefore, we plan to perform a phase II study to evaluate it, focusing on radiographic and pathologic response after induction chemotherapy. Moreover, a new EGFR monoclonal antibody (nimotuzumab) is incorporated with PF regimen. The hypothesis is the addition of nimotuzumab would improve the response without remarkably increase the toxicity.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

nimotuzumab

nimotuzumab plus PF regimen

Group Type EXPERIMENTAL

nimotuzumab

Intervention Type DRUG

nimotuzumab 400 mg d1

PF regimen (cisplatin and 5-FU)

Intervention Type DRUG

cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nimotuzumab

nimotuzumab 400 mg d1

Intervention Type DRUG

PF regimen (cisplatin and 5-FU)

cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

h-R3 PF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age range 18-70 years old
* ECOG performance status 0-1
* Histologically confirmed and potentially resectable locally advanced (T2-4, N0-3, M0) HNSCC
* Adequate organ function

Exclusion Criteria

* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* Previous serious cardiac disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No