Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Gemcitabine/Cisplatin Plus Toripalimab Treatment: a Single Arm, Open Label, Multicenter, Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- progression-free survival(PFS)
研究概览
简要总结
to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab.
详细描述
This study is to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab. Patients received a standard dose of toripalimab combined with gemcitabine/cisplatin every 3 weeks (Q3W) for 4-6 cycles. Efficacy was assessed after 4-6 courses of chemotherapy, and patients with PR/CR were enrolled in the clinical trial for maintenance therapy. During maintenance therapy, capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment（Stage IVb, AJCC/UICC 8th，any T，any N，M1）
- •Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies
- •Age ≥18 years and ≤65 years
- •WBC≥4×10^9/L, platelet ≥ 100×10^9/L, hemoglobin ≥ 90g/L and Albumin≥28 g/L
- •With normal liver function test (TBIL#ALT#AST ≤ 2.5×uln) (patients with liver metastasis≤5×uln)
- •With normal renal function test (creatinine ≤ 1.5×uln or CCR ≥ 60ml/min)
- •ECOG score is 0-1
- •At least one measurable lesion according to RECIST v 1.1 (prior to gemcitabine/cisplatin plus toripalimab)
- •Life expectancy is at least 12 weeks
- •Patients sign informed consent forms
排除标准
- •History of severe anaphylaxis to any component of capecitabine or toripalimab
- •Active or untreated central nervous system metastases
- •Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding
- •Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.
- •Patients with poorly controlled or symptomatic hypercalcemia
- •Pregnancy or lactation
- •Malignancies other than nasopharyngeal carcinoma, with negligible risk of metastasis or death and radical outcome expected after treatment, within the 5 years prior to enrollment.
- •Patients who have previously received allogeneic bone marrow transplants or solid organ transplants.
- •History of autoimmune diseases
- •Received systemic immunostimulant therapy (except toripalimab in palliative chemotherapy, including but not limited to interferon or IL-2) within 4 weeks prior to enrollment or during 5 half-lives of the drug.
- •Receive any active vaccine within 4 weeks prior to enrollment
- •Basic medical conditions that the investigator identified as likely to affect significantly drug administration and protocol adherence of the study
- •Active pneumonia
- •Active infections, including tuberculosis, hepatitis B, hepatitis C or HIV.
- •Presence of severe neurological or psychiatric disorders, including dementia and seizures.
- •Peripheral nerves which was graded as≥ 2 according to NCI-CTCAE
- •Major cardiovascular diseases
研究组 & 干预措施
Capecitabine plus toripalimab maintenance therapy
capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached.
干预措施: Capecitabine plus toripalimab (Drug)
结局指标
主要结局
progression-free survival(PFS)
时间窗: up to 24 month
The time is defined from the enrolment to progression or death from any cause
次要结局
- Disease Control Rate (DCR)(up to 24 month)
- overall survival(OS)(up to 24 month)
- Objective Response Rate(ORR)(up to 24 month)
- Duration of Response (DoR)(up to 24 month)
- Adverse Events (AEs)(up to 24 month)
研究者
Wenjing Yin
attending physician
Affiliated Cancer Hospital & Institute of Guangzhou Medical University