This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC),
This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC), The study aims to evaluate the efficacy and safety of radiotherapy combined with nimotuzumab in platinum-ineligible patients with (LA-HNSCC).Around 70 study sites were involved in the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
335
Treatment regimen: Nimotuzumab(Experimental Group): nimotuzumab injection 200 mg IV once weekly (QW) for 7 weeks (concurrent with radiotherapy).
Treatment regimen: Radiotherapy (both groups): intensity-modulated technique (photon IMRT or proton IMPT); total dose 70 Gy (2.0 Gy per fraction, 35 fractions), 5 fractions per week.
Shandong First Medical University Affiliated Cancer Hospital
Shandong, Province, China
RECRUITINGProgression-Free Survival (PFS)
the proportion of patients in a clinical study who remain free of disease progression (including local recurrence, regional lymph node metastasis, distant metastasis, or second primary malignancy) and have not died from any cause within 2 years from the start of treatment (or randomization in randomized controlled trials).
Time frame: 24 months after treatment initiation
2-year locoregional control (LRC) rate.
the proportion of patients in a clinical study who remain free of disease progression within 2 years from the start of treatment (or randomization in randomized controlled trials).
Time frame: 24 months after treatment initiation
2-year distant metastasis rate.
the prproportion of participants with distant metastatic progression within 24 months,
Time frame: 24 months after treatment initiation
Overall Survival (OS)
the prproportion of participants surviving at 2 years after enrolling,regardless of disease status.
Time frame: 24 months after treatment initiation
Objective Response Rate (ORR; CR+PR by RECIST 1.1).
the proportion of patients with measurable malignant tumors who achieve a complete response (CR) or partial response (PR)
Time frame: 24 months after treatment initiation
Quality of Life (QoL)
Time frame: 24 months after treatment initiation
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