NCT07064902尚未招募2 期
Ivonescimab Combined With Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II, Multicenter, Single-Arm Clinical Trial
Sun Yat-sen University3 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年8月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Complete response rate (CRR)
研究概览
简要总结
This trial aims to study the role of Ivonescimab combined with chemoradiotherapy in high-Risk locoregionally advanced nasopharyngeal carcinoma.
详细描述
The trial plans to enroll patients with T3N2M0+ Stage III (AJCC 9th) locoregionally advanced nasopharyngeal carcinoma (LANPC). Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin combined with ivonescimab, followed by concurrent chemoradiotherapy with cisplatin, and then 9 cycles of adjuvant ivonescimab. Ivonescimab will be administered every 3 weeks starting from day 1 of induction therapy and continued through the adjuvant phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years.
- •Histologically confirmed non-keratinizing carcinoma (according to WHO classification).
- •ECOG performance status of 0 or
- •Previously untreated nasopharyngeal carcinoma staged as T3N2M0 or Stage III according to the AJCC 9th edition.
- •Adequate bone marrow function, defined as white blood cell count > 4×10⁹/L, hemoglobin > 90 g/L, and platelet count > 100×10⁹/L.
- •Adequate liver and renal function, defined as total bilirubin ≤ 1.5 × ULN; AST and/or ALT ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; and creatinine clearance ≥ 60 mL/min.
- •Normal thyroid function, amylase, lipase, pituitary function, inflammatory markers, myocardial enzymes, and ECG. For patients over 50 years old with a smoking history, pulmonary function test results must be normal. For patients with ECG abnormalities or a cardiovascular history not meeting
排除标准
- •#8, echocardiography and cardiac function tests must be normal.
- •Signed informed consent and willingness to comply with all scheduled visits, treatment procedures, laboratory tests, and other study-related requirements.
- •Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use reliable contraception from screening until 1 year after completion of treatment.
- •Exclusion Criteria:
- •Tumor invasion of major blood vessels or significant recent (within 1 month) nasopharyngeal or nasal bleeding (>5 mL).
- •HBsAg positive with HBV DNA > 1×10³ copies/mL, or anti-HCV antibody positive.
- •HIV antibody positive or diagnosed with AIDS.
- •Active tuberculosis or history of active tuberculosis within the past year, unless adequately treated.
- •Active, known, or suspected autoimmune disease, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, or asthma requiring bronchodilator therapy; exceptions include type 1 diabetes, hypothyroidism requiring hormone replacement, and localized skin conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia).
- •History of interstitial lung disease or pneumonitis requiring corticosteroid treatment within the past year.
- •Chronic systemic corticosteroid therapy (≥10 mg/day prednisone or equivalent) or use of other immunosuppressive therapy; inhaled or topical corticosteroids are allowed.
- •Uncontrolled cardiovascular disease, including NYHA Class ≥ 2 heart failure, unstable angina, myocardial infarction within 1 year, or supraventricular/ventricular arrhythmias requiring intervention.
- •Pregnant or breastfeeding women; pregnancy testing is required for women of childbearing potential.
- •History or presence of other malignancies, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma.
- •Known hypersensitivity to monoclonal antibodies or any component of ivonescimab.
- •Active systemic infection requiring treatment within 1 week before study treatment.
- •Receipt of live vaccine within 30 days prior to the first dose of ivonescimab.
- •History of organ transplantation.
- •History of psychiatric illness, substance abuse, alcohol or drug dependence.
- •Any other condition which, in the opinion of the investigator, could compromise patient safety or compliance with the study protocol, including severe uncontrolled comorbidities, serious abnormal lab findings, or psychosocial risk factors.
研究组 & 干预措施
Ivonescimab arm
Experimental
Participants in this arm will receive induction chemotherapy with gemcitabine (1000 mg/m² on Days 1 and 8, Q3W × 3 cycles) and cisplatin (80 mg/m² on Day 1, Q3W × 3 cycles), combined with ivonescimab (10 mg/kg on Day 1, Q3W × 3 cycles). This will be followed by concurrent chemoradiotherapy (IMRT, 70 Gy/33 fractions, with cisplatin 100 mg/m² on Day 1, Q3W × 2 cycles), and then adjuvant ivonescimab monotherapy (10 mg/kg Q3W × 9 cycles).
干预措施: Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） (Drug)
结局指标
主要结局
Complete response rate (CRR)
时间窗: At the end of induction therapy
Disappearance of all target lesions, with all pathological lymph nodes (including both target and non-target nodes) reduced in short axis to less than 10 mm.
次要结局
- Objective response rate (ORR)(At the end of induction therapy)
- Overall survival (OS)(2 years)
- Distant metastasis-free survival (DMFS)(2 years)
- Locoregional recurrence-free survival (LRRFS)(2 years)
- Failure-free survival (FFS)(2 years)
- Adverse events (AEs) and serious adverse events (SAEs)(2 years)
- Quality of life (QoL)(2 years)
研究者
Jun Ma, MD
Principal Investigator
Sun Yat-sen University
研究点 (3)
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