Phase II Study of Comparing Toripalimab Combined With GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.
详细描述
About 4-10% of patients with nasopharyngeal carcinoma (NPC) have metastatic disease at diagnosis. The treatment recommendation of primary metastatic NPC is systemic chemotherapy. However, the optimal regimen is yet to determine due to lack of prospective randomized trial for this unique group of patients. Generally, GP regimen is used as the first-line treatment of primary metastatic NPC. The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign an informed consent;
- •Age older than 18 years old and younger than 70 years old;
- •Patients with newly histologically confirmed primary metastatic nasopharyngeal carcinoma;
- •At least one metastatic site that fulfills the criteria of "Evaluable Disease" per RECIST 1.1 Criteria;
- •Anticipated overall survival more than 3 months;
- •Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1;
- •No primary treatment of radiation, surgery, chemotherapy, targeted therapy and immune therapy post diagnosis of NPC;
- •Neutrophil ≥ 1.5×109 /L and PLT ≥100×109 /L and HGB ≥90 g/L;
- •With normal liver function test (ALT、AST ≤ 3×ULN, TBIL≤ 1.5×ULN, Albumin≥2.8g/dL );
- •With normal renal function test (Creatinine ≤ 1.5 ×ULN and creatinine clearance ≥60 ml/min);
- •HBV DNA<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ;
- •Male and no pregnant female, able to adapt birth control methods during treatment.
排除标准
- •Hypersensitivity to Toripalimab, Gemcitabine, Cisplatin and Capecitabine;
- •Symptomatic spinal cord compression, or high-risk to develop pathological fracture that requires urgent surgery or radiation;
- •Necrotic disease, high-risk of massive nasal bleeding;
- •Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
- •Receive vaccine or live vaccine within 30 days prior to signing the informed consent;
- •Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent;
- •Severe, uncontrolled medical conditions and infections;
- •Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy; vitiligo or inactive asthma who don't need systemic therapy can recruit;
- •History of interstitial lung disease;
- •HIV positive;
- •Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA;
- •Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors;
- •Women of child-bearing potential who are pregnant or breastfeeding.
研究组 & 干预措施
GP Arm
Systemic chemotherapy for 6 cycles: Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Capecitabine: Capecitabine 1000mg/m2 bid d1-14, q3w
干预措施: IMRT to the nasopharynx and neck (Radiation)
Toripalimab Combined with GP Arm
Systemic chemotherapy for 6 cycles: Toripalimab 240mg d1+Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Toripalimab with Capecitabine: Toripalimab 240mg d1+Capecitabine 1000mg/m2 bid d1-14, q3w
干预措施: Toripalimab (Drug)
Toripalimab Combined with GP Arm
Systemic chemotherapy for 6 cycles: Toripalimab 240mg d1+Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Toripalimab with Capecitabine: Toripalimab 240mg d1+Capecitabine 1000mg/m2 bid d1-14, q3w
干预措施: IMRT to the nasopharynx and neck (Radiation)
Toripalimab Combined with GP Arm
Systemic chemotherapy for 6 cycles: Toripalimab 240mg d1+Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Toripalimab with Capecitabine: Toripalimab 240mg d1+Capecitabine 1000mg/m2 bid d1-14, q3w
干预措施: Gemcitabine and Cisplatin Chemotherapy (Drug)
Toripalimab Combined with GP Arm
Systemic chemotherapy for 6 cycles: Toripalimab 240mg d1+Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Toripalimab with Capecitabine: Toripalimab 240mg d1+Capecitabine 1000mg/m2 bid d1-14, q3w
干预措施: Adjuvant chemotherapy with Capecitabine (Drug)
GP Arm
Systemic chemotherapy for 6 cycles: Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Capecitabine: Capecitabine 1000mg/m2 bid d1-14, q3w
干预措施: Gemcitabine and Cisplatin Chemotherapy (Drug)
GP Arm
Systemic chemotherapy for 6 cycles: Gemcitabine 1.0g/m2 d1, Cisplatin 80mg/m2 d1, q3w; Followed by Radiotherapy to the nasopharynx and neck; Then maintenance therapy of Capecitabine: Capecitabine 1000mg/m2 bid d1-14, q3w
干预措施: Adjuvant chemotherapy with Capecitabine (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 5 year
PFS, defined as the time from randomization to the first documented objective tumor progression or death from any cause
次要结局
- Objective Response Rate of Systemic chemotherapy(At the end of Cycle 6 of chemotherapy (each cycle is 21 days))
- Disease Control Rate of Systemic chemotherapy(At the end of Cycle 6 of chemotherapy (each cycle is 21days))
- The proportion of patients received radiotherapy to nasopharynx(2 year)
- Overall Survival(5 year)
- Progression-free Survival Rate(1 year, 2 year rates)
- Overall Survival Rate(1 year, 2 year rates)
- the Incidence of Adverse Effect(1 year)
- Changes of Quality of life, according to EORTC QLQ-C30(1 year)
- Changes of Quality of life, according to EORTC QLQ-H&N35(1 year)
研究者
Chaosu Hu
Vice Director of Department of Radiation Oncology, Clinical Professor
Fudan University