Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma
Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma: A Prospective Single-center Phase II Study
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名:Xiayun He, MD
- 电话号码:+86021-64175590-81412
- 邮箱:hexiayun1962@163.com
研究联系人备份
- 姓名:Fen Xue, MD
- 电话号码:+8618916882304
- 邮箱:dr_fenxue@163.com
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200032
- 招聘中
- Fudan Universtiy Shanghai Cancer Center
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接触:
- Xiayun He, MD
- 电话号码:+86021-64175590-81412
- 邮箱:hexiayun1962@163.com
-
接触:
- Fen Xue, MD
- 邮箱:dr_fenxue@163.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age: 18 - 65 years old
- Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing squamous cell carcinoma.
- AJCC/UICC 9th edition stage II - III; excluding patients with T3N0M0 (only posterior pharyngeal lymph node metastasis) and T3N1M0.
- Baseline plasma EBV-DNA > 0, and able to complete dynamic monitoring according to the protocol.
- ECOG 0 - 1.
- Main organ functions meet the requirements: neutrophils ≥ 2.0×10^9/L, platelets ≥ 100×10^9/L, hemoglobin ≥ 90 g/L; ALT/AST ≤ 1.5×ULN, total bilirubin ≤ 1.5×ULN; creatinine clearance rate ≥ 60 mL/min.
- Signed informed consent form, willing to complete the study according to the protocol.
Exclusion Criteria:
- Clinical or imaging examinations have confirmed distant metastasis.
- Before the diagnosis of nasopharyngeal carcinoma, the patient had received chemotherapy, targeted therapy, or immunotherapy, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies).
- Has an active autoimmune disease, but the following conditions are excluded: type 1 diabetes, hypothyroidism receiving replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia).
- Active hepatitis B with poor control of HBV DNA, active hepatitis C, HIV infection or uncontrolled infection.
- Within 4 weeks before signing the informed consent form, the patient had used systemic glucocorticoids (equivalent to prednisone dose > 10mg/day) or other immunosuppressive treatments; if the patient's systemic glucocorticoid dose is equivalent to prednisone ≤ 10mg/day or only uses inhaled or topical glucocorticoids, participation is allowed.
- Has a history of active tuberculosis (Mycobacterium tuberculosis infection) in the past year; if active tuberculosis has been fully treated and has been over one year ago, participation is allowed.
- Has a history of interstitial lung disease.
- Has received live vaccines within 4 weeks before signing the informed consent form, or is about to receive live vaccines in the near future.
- Pregnant or lactating women, or reproductive-aged subjects who do not agree to take effective contraceptive measures.
- Has a history of other malignant tumors within the past 5 years, but the following situations are excluded: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc.
- Cannot take oral medications or have a known severe allergy to capecitabine, tislelizumab, or cisplatin/gemcitabine.
- Has any other conditions, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illness or family/social factors, which the investigator believes may affect the patient's ability to sign the informed consent form, cooperate and participate in the study, or interfere with the interpretation of the study results.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:Low-risk group
Patient treated with induction chemotherapy(Gemcitabine 1000 mg/m², administered intravenously on days 1 and 8; Cisplatin 80 mg/m², administered intravenously on day 1 or in 3 divided doses; 1 cycle every 21 days, for a total of 2 cycles), followed by IMRT. Then received risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI results at the end of radiotherapy. Clinical follow-up and surveillance only for low-risk group |
Clinical follow-up and surveillance only.
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实验性的:Medium-risk group
Capecitabine for medium-risk group after IMRT
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Capecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks.
Treatment duration: 8 cycles
Tislelizumab and Capecitabine for high-risk group. Tislelizumab: 200 mg ivgtt on day 1, every 3 weeks and capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks. Treatment duration: 8 cycles(Maintenance of tislelizumab could be used in some high-risk patients after 8 cycles) |
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实验性的:High-risk group
Tislelizumab and Capecitabine for high-risk group after IMRT
|
Capecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks.
Treatment duration: 8 cycles
Tislelizumab and Capecitabine for high-risk group. Tislelizumab: 200 mg ivgtt on day 1, every 3 weeks and capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks. Treatment duration: 8 cycles(Maintenance of tislelizumab could be used in some high-risk patients after 8 cycles) |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
2-year Failure Free Survival, 2-y FFS
大体时间:2 years
|
calculated from the date of diagnosis of NPC to the date of tumor recurrence, progression, distant metastasis or death due to any cause,whichever comes earlier.
|
2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overal Survival,OS
大体时间:2 years
|
calculated from the date of diagnosis of NPC to the date of death from any cause
|
2 years
|
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Locoregionally Failure Free Survival,LRFFS
大体时间:2 years
|
calculated from the date of diagnosis of NPC to the date of locoregional failure or date of death from any cause, whichever comes earlier.
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2 years
|
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Distant failure free survival, DFFS
大体时间:2 years
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calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier.
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2 years
|
|
Adverse effects (AE)
大体时间:during and after treatment (up to 2 years)
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during and after treatment (up to 2 years)
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Objective Response Rate
大体时间:at the end of, 3 months and 6 months after IMRT
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at the end of, 3 months and 6 months after IMRT
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合作者和调查者
调查人员
- 首席研究员:Xiayun He、Fudan University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ADAPT-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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