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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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),
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
Radiotherapy alone in LA-HNSCC
干预措施: intensity-modulated technique（IMRT） (Radiation)
Radiotherapy plus nimotuzumab
radiotherapy plus nimotuzumab
干预措施: Nimotuzumab (Drug)
Radiotherapy plus nimotuzumab
radiotherapy plus nimotuzumab
干预措施: intensity-modulated technique（IMRT） (Radiation)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 24 months after treatment initiation
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).
次要结局
- 2-year locoregional control (LRC) rate.(24 months after treatment initiation)
- Overall Survival (OS)(24 months after treatment initiation)
- Objective Response Rate (ORR; CR+PR by RECIST 1.1).(24 months after treatment initiation)
- 2-year distant metastasis rate.(24 months after treatment initiation)
- Quality of Life (QoL)(24 months after treatment initiation)
研究者
Man Hu
Shandong First Medical University Affiliated Cancer Hospital
Shandong Cancer Hospital and Institute