NCT06675214招募中3 期
Under Whole-course of Immunotherapy, Gradient Fractionated Radiotherapy with Concurrent Chemotherapy Versus Standard Fractionated Radiotherapy with Concurrent Chemotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma Who Achieved Partial Response After Induction Chemotherapy: a Randomized, Open-label, Multicenter, Phase III Trial.
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 586 人开始时间: 2024年7月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 586
- 试验地点
- 1
- 主要终点
- Progress-Free Survival (PFS)
研究概览
简要总结
This prospective trial aims to enroll patients with stage III-IVA (AJCC 8th,) locoregionally advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved radiological partial response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1 ratio to receive gradient radiotherapy (reducing the irradiation dose of PET-CT areas without metabolic abnormalities, while maintaining adequate irradiation dose of areas with metabolic abnormalities) or standard dose radiotherapy with concurrent chemotherapy. It is expected to provide a new therapeutic option for locally advanced nasopharyngeal carcinoma at moderate risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- •Tumor staged as III-IVA (AJCC 8th).
- •Patients who achieved partial response according to the RECIST criteria on the basis of MRI, PET-CT and endoscopic biopsy after 3 cycles of induction therapy of platinum-based chemotherapy plus immunotherapy.
- •Eastern Cooperative Oncology Group performance status ≤
- •Age: 18-65 years old.
- •Adequate organ function:
- •Adequate marrow function: neutrocyte count≥4×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
- •Adequate liver and kidney function: Alanine Aminotransferase (ALT)/ Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 2.5×ULN.; creatinine clearance rate ≥ 60 ml/min or creatinine of no more than 1.5 times the upper normal limit.
- •Patients must be informed of the investigational nature of this study and give written informed consent.
排除标准
- •Patients who are evaluated as CR or SD or PD after 3 cycles of induction therapy of platinum-based chemotherapy plus PD-1/PD-L1 blockades.
- •The laboratory examination value does not meet the relevant standards within 7 days before enrollment.
- •The images of PET-CT and enhanced MRI/CT before induction chemotherapy showed necrotic foci in the center of primary tumors or regional lymph nodes.
- •The metabolic changes shown by PET-CT images after induction chemotherapy were inconsistent with the changes in the extent of tumor invasion shown by anatomical images such as enhanced MRI/CT.
- •The primary and/or cervical metastases of patients have received prior chemotherapy, immunotherapy, targeted therapy, or surgery (except diagnostic treatment).
- •Has a known history of hypersensitivity to any components of the PD-1/PD-L1 blockades formulation or other monoclonal antibodies.
- •Has a known or suspected history of autoimmune diseases, including dementia and seizures.
- •Patients with recurrence, distant metastasis and other malignant tumors.
- •Severe heart disease, lung dysfunction, heart function, lung function below grade 3 (including grade 3)
- •Patients who underwent anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway) and anti-angiogenic drugs.
- •Complications requiring long-term use of immunosuppressive drugs or systemic or local use of immunosuppressive-dose corticosteroids.
- •HIV positive; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis C with blood screening positive (HCV antibody positive).
- •Has a known history of allergic reactions to the drugs in the study (gemcitabine, cisplatin, docetaxel, abraxane, paclitaxel ).
- •Has a known history of active TB (bacillus tuberculosis) within 1 year; anti-TB treatment is ongoing or within 1 year prior to screening.
- •Has received a live vaccine; or a systematic glucocorticoid therapy ; or any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) ; any Chinese anti-tumor herbs within 4 weeks prior to enrollment.
- •Pregnancy or breastfeeding.
- •Other patients who were considered unsuitable by the treating physicians.
研究组 & 干预措施
Induction chemotherapy plus gradient fractioned radiotherapy and concurrent chemotherapy
Experimental
干预措施: Cisplatin-based induction chemotherapy (Drug)
Induction chemotherapy plus conventional concurrent chemoradiotherapy
Active Comparator
干预措施: Full course of PD-1/PD-L1 blockades (Drug)
Induction chemotherapy plus conventional concurrent chemoradiotherapy
Active Comparator
干预措施: Cisplatin-based induction chemotherapy (Drug)
Induction chemotherapy plus conventional concurrent chemoradiotherapy
Active Comparator
干预措施: Standard-dose IMRT (Radiation)
Induction chemotherapy plus conventional concurrent chemoradiotherapy
Active Comparator
干预措施: Concurrent Chemotherapy (Drug)
Induction chemotherapy plus gradient fractioned radiotherapy and concurrent chemotherapy
Experimental
干预措施: Full course of PD-1/PD-L1 blockades (Drug)
Induction chemotherapy plus gradient fractioned radiotherapy and concurrent chemotherapy
Experimental
干预措施: Gradient Fractionated IMRT (Radiation)
Induction chemotherapy plus gradient fractioned radiotherapy and concurrent chemotherapy
Experimental
干预措施: Concurrent Chemotherapy (Drug)
结局指标
主要结局
Progress-Free Survival (PFS)
时间窗: 3 years
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
次要结局
- Overall Survival (OS)(3 years)
- Locoregional Relapse-Free Survival (LRRFS)(3 years)
- Distant Metastasis-Free Survival (DMFS)(3 years)
- The proportion of patients with treatment related acute complications(1 year)
- The proportion of patients with treatment related late complications(3 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)(3 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)(3 years)
研究者
Ming-Yuan Chen
Principal Investigator
Sun Yat-sen University
研究点 (1)
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