A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes and Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Progress-free survival
研究概览
简要总结
This is a Phase II trial to study the effectiveness and security of cisplatin concurrent chemoradiotherapy plus TIL versus cisplatin concurrent chemoradiotherapy only with IMRT in treating patients with locoregionally advanced high risk nasopharyngeal carcinoma.
详细描述
Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. For locoregionally advanced NPC,especially for the high risk NPC (EB virus DNA ≥ 4000 copies/ml) ,the incidence of treatment failure is still high. Although concurrent chemoradiotherapy (CCRT) can improve the treatment outcomes of these patients, approximately 25% of locoregionally advanced NPCs relapse. Adjuvant chemotherapy or inducing chemotherapy addition to CCRT did not significantly improve patient survival compared to CCRT alone. Hence, there is an urgent need for novel therapies to improve disease-free survival and reduce treatment-related toxicity in patients.
Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor recognition and greatly expanded in vitro are especially effective for treating cancer patients.The investigations phase I results showed that TILs following CCRT as a novel treatment strategy in locoregionally advanced NPC patients resulted in sustained anti-tumor activity and anti-EBV immune responses, associated with a good tolerance.
This is a Phase II trial to study the effectiveness and security of cisplatin CCRT plus TIL versus cisplatin CCRT only with IMRT in treating patients with locoregionally advanced high risk NPC.
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
- •Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- •Original clinical staged as T3-4N1-3 M0 or any T、N2-3M0（according to the 7th AJCC edition）
- •No evidence of distant metastasis (M0)
- •Plasm EB Virus DNA≥4000copies/ml
- •Male and no pregnant female
- •Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
- •WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
- •With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
- •With normal renal function test (Creatinine ≤ 1.5×ULN)
排除标准
- •Patients have evidence of relapse or distant metastasis
- •Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
- •Receiving radiotherapy or chemotherapy previously
- •The presence of uncontrolled life-threatening illness
- •Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- •Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
- •Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- •Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
- •Concurrent systemic steroid therapy
- •HIV positive
- •Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously
研究组 & 干预措施
Cisplatin+TIL
Cisplatin concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)
干预措施: Cisplatin+TIL (Drug)
Cisplatin
Cisplatin concurrent chemoradiotherapy(CCRT) only
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progress-free survival
时间窗: 3 years
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
次要结局
- Overall Survival (OS)(3 years)
- Distant Metastasis-Free Survival (DMFS)(3 years)
- Locoregional Relapse-Free Survival (LRRF)(3 years)
- Complete Response (CR)(after the completion of the chemoradiotherapy treatment (up to 9 weeks))
- Determine the toxic effects in these patients.(4 weeks)
- Determine the molecular expression of EBV DNA.(12 weeks)
- Determine the quality of life (QoL) of these regimens in these patients.(4 weeks)
研究者
Hai-Qiang Mai,MD,PhD
Deputy Director of the Department of Nasopharyngeal Carcinoma
Sun Yat-sen University