Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma

Официальное название

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)

Обзор

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),

Подробное описание

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.

Вмешательства

• Препарат Nimotuzumab
  Treatment regimen： Nimotuzumab(Experimental Group): nimotuzumab injection 200 mg IV once weekly (QW) for 7 weeks (concurrent with radiotherapy).
• Лучевая терапия intensity-modulated technique（IMRT）
  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.

Первичные конечные точки

• Progression-Free Survival (PFS) [Срок оценки: 24 months after treatment initiation]

Вторичные конечные точки (5)

• 2-year locoregional control (LRC) rate. [Срок оценки: 24 months after treatment initiation]
• 2-year distant metastasis rate. [Срок оценки: 24 months after treatment initiation]
• Overall Survival (OS) [Срок оценки: 24 months after treatment initiation]
• Objective Response Rate (ORR; CR+PR by RECIST 1.1). [Срок оценки: 24 months after treatment initiation]
• Quality of Life (QoL) [Срок оценки: 24 months after treatment initiation]

Критерии участия

Критерии включения

• Eligible subjects must meet all of the following:

• Age ≥18 years.
• Histologically confirmed stage III-IVB (AJCC 8th edition) head and neck squamous cell carcinoma (including cancers of the oral cavity, oropharynx, hypopharynx, and larynx).
• Unsuitable for surgical treatment (defined as: due to patient condition or tumor factors \[T3-4 N0-3 M0, or T1-2 N2-3 M0\] or medical reasons, surgery is not feasible; or an R0 resection is not achievable).
• Suitable for definitive radiotherapy with curative intent.
• At least one of the following reasons for being unsuitable for cisplatin-based chemotherapy:
• Age ≥65 years and, in the investigator's judgment, unable to tolerate chemotherapy;
• ECOG Performance Status >2 (if this criterion is met, the ECOG criterion listed below may be waived);
• Renal dysfunction: creatinine clearance (CrCl) <50 mL/min (Cockcroft-Gault) (if this criterion is met, the renal function criterion listed below may be waived);
• Severe tinnitus or hearing loss (requires a hearing aid or audiometry shows ≥25 dB loss at two consecutive frequencies);
• Peripheral neuropathy > Grade 1;
• Inability to receive intravenous hydration (e.g., due to cardiac dysfunction) or other comorbidities, per investigator's judgment.

• Provide tumor tissue, whenever possible, for EGFR testing; for oropharyngeal cancer, provide tissue for HPV/p16 testing if feasible (no need to retest if previously tested).
• ECOG Performance Status 0-1 (or Karnofsky Performance Status ≥80).
• At least one measurable lesion per RECIST 1.1.
• Expected survival ≥6 months.
• Adequate hematologic function: WBC ≥4×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L; platelets ≥100×10\^9/L; hemoglobin ≥90 g/L.
• Adequate renal function: serum creatinine ≤1.5×ULN or CrCl ≥60 mL/min (Cockcroft-Gault):
• Female CrCl = (140 - age) × weight (kg) × 0.85 / (72 × S\_cr \[mg/dL\])
• Male CrCl = (140 - age) × weight (kg) × 1.00 / (72 × S\_cr \[mg/dL\])

• Adequate liver function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.
• Voluntary participation: signed written informed consent and ability to comply with visits and procedures.

Критерии исключения

• Any of the following excludes enrollment:

• Receipt of a PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic agent within 4 weeks prior to enrollment.
• Participation in another interventional clinical trial within 30 days prior to screening.
• History of other malignancy (except cured basal cell carcinoma of the skin).
• History of primary immunodeficiency.
• Uncontrolled comorbid conditions (e.g., congestive heart failure, severe pulmonary disease, severe liver disease, psychiatric illness).
• Known HIV infection, or active viral hepatitis or active tuberculosis.
• Major surgery within 90 days before first study treatment, or planned surgery during the study.
• Known allergy to nimotuzumab or its excipients.
• Deemed unsuitable to participate by the investigator.
• Unwilling or unable to sign informed consent.
• Receipt of a live vaccine within 30 days before first dose.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shandong First Medical University Affiliated Cancer Hospital — Shandong

Идентификаторы

NCT: NCT07333274 · IST-Nim-HNSCC-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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