Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma: A Prospective Single-center Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- 2-year Failure Free Survival, 2-y FFS
研究概览
简要总结
This study aims to explore the efficacy and safety of risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI in nasopharyngeal carcinoma patients.
详细描述
This study aims to evaluate whether the 2-year failure-free survival of NPC patients treated with GP induction chemotherapy, IMRT and risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI results at the end of radiotherapy, is superior to that of a historical control cohort receiving standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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: 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 T3N1M
- •Baseline plasma EBV-DNA > 0, and able to complete dynamic monitoring according to the protocol.
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Observation (Other)
Medium-risk group
Capecitabine for medium-risk group after IMRT
干预措施: Adjuvant therapy (Drug)
High-risk group
Tislelizumab and Capecitabine for high-risk group after IMRT
干预措施: Adjuvant therapy (Drug)
结局指标
主要结局
2-year Failure Free Survival, 2-y FFS
时间窗: 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.
次要结局
- Overal Survival，OS(2 years)
- Locoregionally Failure Free Survival，LRFFS(2 years)
- Distant failure free survival, DFFS(2 years)
- Adverse effects (AE)(during and after treatment （up to 2 years）)
- Objective Response Rate(at the end of, 3 months and 6 months after IMRT)
研究者
Chaosu Hu
Principal Investigator
Fudan University