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Nimotuzumab Plus Radiotherapy in Elderly Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

ConditionsHead & Neck CancerRadiotherapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorKe Hu

About this trial

This is a prospective, single-center, open-label, single-arm phase II study. The purpose of this study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent intensity-modulated radiotherapy (IMRT) in elderly patients (≥65 years old) with locally advanced unresectable head-and-neck squamous cell carcinoma (HNSCC) who are unfit for standard concurrent cisplatin-based chemoradiotherapy. Eligible patients will receive standard-dose intensity-modulated radiotherapy together with weekly nimotuzumab. The primary endpoint is 1-year overall survival rate. Secondary endpoints include progression-free survival, objective tumor response rate, locoregional control rate, distant metastasis rate, and treatment-related adverse events. Patients will be followed up for survival, tumor status and safety assessments after treatment completion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 65 years old.

Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx).

Positive EGFR test result in tumor tissue.

Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available.

Disqualifiers

Age ≥ 65 years old.

Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx).

Positive EGFR test result in tumor tissue.

Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available.

Trial design

Design model

Single group

Treatments tested in this trial

  • Nimotuzumab

    Drug

    Humanized anti-EGFR monoclonal antibody, administered by intravenous infusion once weekly during the whole radiotherapy period.

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Experimental: Nimotuzumab Combined with RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate

Percentage of patients achieving complete response (CR) or partial response (PR), assessed according to RECIST version 1.1. Only evaluable patients for tumor response will be included in analysis.

Time frame
At 4-week, 12-week after radiotherapy completion, then every 3 months up to 2-year follow-up or until disease progression/withdrawal

Secondary outcomes

1

2-year progression-free survival rate

Progression-free survival (PFS) is defined as the time from initiation of study treatment to documented disease progression (locoregional recurrence or distant metastasis) or death from any cause, whichever occurs first. The 2-year PFS rate is estimated by the Kaplan-Meier method. Imaging assessments are performed at 4 weeks and 12 weeks after radiotherapy completion, then every 3-months until disease progression, subject intolerance, withdrawal, or completion of 2-year follow-up.

Time frame
From start of study treatment up to 24 months
2

2-year locoregional control rate

Locoregional control (LRC) is defined as the time from the start of study treatment until clinical or imaging-confirmed locoregional tumor recurrence (primary site or regional lymph nodes). Distant metastasis alone is not regarded as a locoregional control event. The 2-year locoregional control rate will be estimated using the Kaplan-Meier method. Tumor imaging assessments are performed at 4 weeks and 12 weeks after radiotherapy completion, then every 3 months until disease progression, subject intolerance, withdrawal, or completion of 2-year follow-up.

Time frame
From start of study treatment through 2-year follow-up
3

Overall survival

Overall survival (OS) is defined as the time from initiation of study treatment to death from any cause. Patients who are alive will be censored at the end of 2-year follow-up. Survival status will be collected during regular follow-up visits.

Time frame
From start of study treatment through 2-year follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ke Hu

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: