Safety and Efficacy of Anlotinib With Chemoradiation for Patients With Locally Advanced Nasopharyngeal Carcinoma: a Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
anlotinib was added to TP inductive chemotherapy and definitive chemoradiation in nasopharyngeal carcinoma patients with N2-3 disease with necrosis or/and ECM
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed nasopharyngeal carcinoma confirmed by histology/cytology ;
- •N2-3 disease (UICC/AJCC 8th) with necrosis or/and ECM;
- •with sufficient organ and bone marrow function;
- •ECOG (Eastern US Cooperative Oncology Group) score < 3
- •with good compliance and cooperation to treatment and follow-up
- •agree to use effective methods of contraception during the study period and within 180 days of the last study administration.
排除标准
- •patients with other malignant tumors diagnosed within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)]
- •patients with bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers or fracture;
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and HCV RNA higher than the detection limit of the analysis method) or co infection with hepatitis B and C.
- •Active infection (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs) or fever of unknown origin >38.5℃ 1 weeks ago (except for tumor related fever determined by researchers).
- •Abnormal coagulation (INR > 1.5 or APTT > 1.5 × ULN), bleeding tendency or undergoing thrombolysis or anticoagulation. Long term anticoagulation with warfarin or heparin or long-term antiplatelet therapy is required.
- •serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study
- •Allergy to the drugs in the study
研究组 & 干预措施
anlotinib
3 cycles of anlotinib (12mg, d1-14)was given concurrently with docetaxel plus cisplatin chemotherapy as induction , then 2 additional cycles of anlotinib concurrent with definitive chemoradiation (IMRT with conccurent cisplatin)
干预措施: Anlotinib hydrochloride (Drug)
anlotinib
3 cycles of anlotinib (12mg, d1-14)was given concurrently with docetaxel plus cisplatin chemotherapy as induction , then 2 additional cycles of anlotinib concurrent with definitive chemoradiation (IMRT with conccurent cisplatin)
干预措施: induction chemotherapy (Drug)
anlotinib
3 cycles of anlotinib (12mg, d1-14)was given concurrently with docetaxel plus cisplatin chemotherapy as induction , then 2 additional cycles of anlotinib concurrent with definitive chemoradiation (IMRT with conccurent cisplatin)
干预措施: concurrent chemoradiation (Radiation)
结局指标
主要结局
ORR
时间窗: induction phase ; 3 months after chemoradiation
tumor objective response rate
次要结局
- PFS(3year)
- LRR(3 years)
- RRR(3 years)
研究者
Chen Xiaozhong
Director, Head of Radiation department, Principal Investigator, Clinical Professor
Zhejiang Cancer Hospital