NCT05869227进行中（未招募）3 期
The Efficacy and Safety of Maintenance Therapy With Toripalimab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma:Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study
XIANG YANQUN1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2023年4月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 166
- 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 investigate the efficacy and safety of the "capecitabine combined with toripalimab maintenance regimen" in improving the first-line treatment of recurrent and metastatic nasopharyngeal carcinoma after receiving remission through chemotherapy combined with anti PD-1 monoclonal antibody standard regimen.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age at the time of diagnosis is 18-75 years old, regardless of gender;
- •Histologically confirmed nasopharyngeal carcinoma;
- •Confirm the presence of distant metastasis in advanced nasopharyngeal carcinoma patients or recurrent nasopharyngeal carcinoma patients who cannot receive local treatment. ;
- •After receiving standard treatment for 4-6 cycles, the disease is control;
- •ECOG score 0-1;
- •Expected survival time of at least 12 weeks;
- •Patients who have not received systemic chemotherapy within 6 months prior to diagnosis ;
- •According to RECIST 1.1 standard, at least 1 measurable lesion;
- •Enough organ function;
- •Sign an informed consent form;
- •Female participants with fertility and male participants with fertility partners must agree to use reliable contraceptive measures within 6 months after screening and the last treatment.
排除标准
- •Patients who are known to be intolerant to capecitabine or allergic to any therapeutic drug, or who are participating in clinical studies of other new drugs;
- •Diseases that may interfere with oral medication treatment, including but not limited to swallowing difficulties, chronic diarrhea, or intestinal obstruction;
- •Previous or current history of other tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, and thyroid papillary carcinoma;
- •Sever heart disease;
- •Central nervous system metastasis with clinical symptoms;
- •Serious infections ;
- •Within 4 weeks of signing the informed consent form, receive systemic hormone or other immunosuppressive therapy with an equivalent dose greater than 10mg prednisone per day. Subjects with a systemic hormone dose ≤ 10mg prednisone per day or inhaled/topical corticosteroids can be enrolled in the study;
- •Patients with active chronic hepatitis B or active hepatitis C.
- •A history of interstitial pneumonia or other autoimmune diseases.
- •HIV infection;
- •Individuals with significant organ dysfunction or uncontrollable comorbidities, including but not limited to uncontrollable hypertension, decompensated liver cirrhosis, active peptic ulcer, or hemorrhagic disease;
- •Less than 6 weeks after major organ surgery;
- •Pregnant or breast feeding;
- •Patients with mental illness, those with a history of alcohol or drug abuse, or those who are unable to obtain informed consent;
- •Other researchers have determined that it is not suitable to participate in this trial.
- •Those who refuse or are unable to sign the informed consent form.
研究组 & 干预措施
Capecitabine combined with toripalimab maintenance group
Experimental
Capecitabine, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle toripalimab, 240mg, intravenously, day 1 and 21 days/cycle
干预措施: Capecitabine/Placebo combined with toripalimab (Drug)
Placebo combined with toripalimab maintenance group
Placebo Comparator
Placebo, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle toripalimab, 240mg, intravenously, day 1 and 21 days/cycle
干预措施: Capecitabine/Placebo combined with toripalimab (Drug)
结局指标
主要结局
Progression free survival
时间窗: 2 years
Progression free survival is defined as the time interval between randomization and the first recording of tumor progression (evaluated according to RECIST 1.1 criteria, regardless of continued treatment) or death from any cause
次要结局
未报告次要终点
研究者
XIANG YANQUN
Professor
Sun Yat-sen University
研究点 (1)
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