Toripalimab Combined With Nimotuzumab Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma：A Single-arm, Phase II Clinical Tria
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 2-year progression-free survival
研究概览
简要总结
Investigators target recurrent nasopharyngeal carcinoma that can be resected surgically: rT1, rT2 (tumor confined to the surface of the parapharyngeal space, greater than 0.5cm from the internal carotid artery), rT3 (confined to the floor of the sphenoid sinus, greater than 0.5cm from the internal carotid artery/cavernous sinus) (AJCC 8th stage), A single-arm, phase II clinical trial was designed to investigate the efficacy and safety of triplizumab combined with nituzumab in induction and adjuvant treatment of operable local recurrent nasopharyngeal carcinoma.
详细描述
Investigators target recurrent nasopharyngeal carcinoma that can be resected surgically: rT1, rT2 (tumor confined to the surface of the parapharyngeal space, greater than 0.5cm from the internal carotid artery), rT3 (confined to the floor of the sphenoid sinus, greater than 0.5cm from the internal carotid artery/cavernous sinus) (AJCC 8th stage), A single-arm, phase II clinical trial was designed to investigate the efficacy and safety of triplizumab combined with nituzumab in induction and adjuvant treatment of operable local recurrent nasopharyngeal carcinoma. The investigators focus on the 2-year PFS as the primary outcome.
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
- •Voluntarily participate in and sign the informed consent in person.
- •Aged 18-65 years, male or non-pregnant female.
- •Histologically and/or cytologically confirmed recurrent nasopharyngeal carcinoma (keratinized or non-keratinized carcinoma; Differentiated or undifferentiated)
- •Patients with recurrence time more than 6 months from the end of radiotherapy;
- •Recurrent nasopharyngeal carcinoma that can be resectable: rT1, rT2 (the tumor is confined to the surface of the parapharyngeal space, and the distance from the internal carotid artery is greater than that from the internal carotid artery 0.5cm), rT3 (confined to the floor wall of the sphenoid sinus, greater than 0.5cm from the internal carotid artery/cavernous sinus) (AJCC 8th stage).
- •If the tumor invades the internal carotid artery, or is less than 0.5cm away from the internal carotid artery, but the invasion scope does not exceed the external edge of the internal carotid artery, it can be advanced Internal carotid artery preconditioning (including internal carotid artery embolization or stent implantation) was followed.
- •ECOG score 0-1, no serious dysfunction of heart, lung, liver, kidney and other vital organs.
- •Hemoglobin (HGB) ≥90 g/L, white blood cells (WBC) ≥4.0×109 /L, platelets (PLT) ≥100×109 /L.
- •Liver function: ALT and AST< 2.5 times the upper limit of normal (ULN), total bilirubin <2.0×ULN.
- •Renal function: serum creatinine <1.5×ULN.
排除标准
- •The pathological findings were keratinized squamous cell carcinoma (WHO type I).
- •Received systemic or local glucocorticoid therapy within 4 weeks before enrollment.
- •Patients who have participated in other drug clinical trials within 3 months before treatment.
- •Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Idiopathic pulmonary fibrosis, drug-induced pneumonia, institutional pneumonia (i.e., bronchiolitis obliterans), clinical symptoms or Radiation pneumonia, active pneumonia, or other moderate to severe lung disease requiring steroid treatment
- •Have a comorbiditis that requires prolonged treatment with immunosuppressive drugs or systemic or local use of immunosuppressive doses of corticosteroids.
- •The subject has any active autoimmune disease or history of autoimmune disease (including, but not limited to, interstitial disease) Pneumonia, uveitis, enteritis, hepatitis, pituitaritis, nephritis, hyperthyroidism, hypothyroidism; Suffer from Patients with vitiligo or asthma that had completely resolved in childhood and did not require any intervention in adulthood were included; Need bronchus Dilators for medical intervention in asthma were not included).
- •Positive HBV DNA copy number was detected in both HIV-positive and HBsAg positive patients (quantitative detection ≥ 1000cps/ml); Chronic hepatitis C blood screening positive (HCV antibody positive) with HCV RNA positive detection.
- •Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment.
- •Pregnancy test positive women of childbearing age and breastfeeding women.
- •Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
研究组 & 干预措施
Experimental group
Toripalimab Combined With Nimotuzumab Induction therapy then surgery and Toripalimab Combined With Nimotuzumab adjuvant Therapy
干预措施: Toripalimab (Drug)
Experimental group
Toripalimab Combined With Nimotuzumab Induction therapy then surgery and Toripalimab Combined With Nimotuzumab adjuvant Therapy
干预措施: Nimotuzumab (Drug)
Experimental group
Toripalimab Combined With Nimotuzumab Induction therapy then surgery and Toripalimab Combined With Nimotuzumab adjuvant Therapy
干预措施: surgery (Procedure)
结局指标
主要结局
2-year progression-free survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
2-year progression-free survival
次要结局
未报告次要终点
研究者
YiJun Hua
Chief Physician
Sun Yat-sen University