NCT04955886Unknown2 期
Efficacy and Safety of Surufatinib Combined With Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma : a Prospective, Single Arm and Multicenter Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
A prospective, single-arm,mutil-center study to assess the efficacy and safety of Surufatinib combined with Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma.
详细描述
This study adopt Simon's two-stage Optimal designs method based on the primary endpoint of objective response rates. 4 patients were planned for the first stage. If one or more responses were observed, an additional 8 patients were to be accrued for a total of 12 patients. If 4 or more of the 12 patients achieved an objective response, then this study was designated worthy of additional investigation.Considering a 10% abscission rate, a total of 14 patients were included.
Surufatinib（250mg) will be orally administered within 1 hour after breakfast once a day (QD) , Toripalimab was administered intravenously at a fixed dose of 240 mg, and the infusion time was 60 ± 5 min, once every 21 days. The cumulative longest medication period is 2 years. Until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met .
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
- •Male and Female aged between 18 and 75 years are eligible;
- •Histologically or cytologically confirmed that Recurrent or Metastatic Nasopharyngeal Carcinoma.
- •Patients must have received at least one standard platinum-based systemic chemotherapy regimen for the treatment of recurrent or metastatic NPC;Or the insensitivity or intolerance to platinum when the patient has previously received radical therapy;
- •Not suitable for local treatment (no radiotherapy or surgery);
- •Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- •Screening laboratory values must meet the following criteria (within past 14 days):
- •neutrophils ≥1.5×109/L ;
- •platelets ≥100×109/L；
- •hemoglobin ≥ 10 g/dL;
- •total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1.5╳ULN;
- •Ability to follow the program;
- •Toxic side effects of any previous chemotherapy have returned to less than or equal to NCI CTCAE1 level or baseline;
- •Predicted survival >3 months;
- •Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 6 months after the last dose of study drug.
排除标准
- •The pathological type was neuroendocrine or small cell carcinoma;
- •Evidence with active CNS disease or previous brain metastases;
- •Prior received anti-tumor monoclonal antibodies or other investigational drugs within the first 4 weeks of enrollment;Previous treatment with other anti-PD-1 antibodies or other treatments targeting PD-1 / PD-L
- •Prior treatment with Surufatinib,or other antiangiogenic drugs were used ;
- •Patients were on immunosuppressive or systemic hormone therapy (doses greater than 10mg/day prednisone or other equivalent hormone) for immunosuppressive purposes and were still on it within 2 weeks prior to enrolment;
- •The patient has any active autoimmune disease or a history of autoimmune disease;
- •Have clinical cardiac symptoms or diseases that are not well controlled;
- •Patients with congenital or acquired immune deficiency;
- •Chemotherapy, targeted therapy and radiotherapy were received within 2 weeks before enrollment;
- •Patients who had a history of gastrointestinal perforation or had undergone major surgery 4 weeks before enrollment;
- •During the first 6 months of enrollment, there were arterial/venous thrombosis events, such as non-cardiovascular and cerebrovascular (including temporary ischemic attack), deep vein thrombosis (except for venous thrombosis caused by intravenous catheterization during pre-chemotherapy, which was determined by the investigators to be cured), and pulmonary embolism;
- •Patients with abnormal coagulation function (International normalized ratio (INR) >1.5 or partially activated prothrombin time (APTT) >1.5×ULN), bleeding tendency (such as active ulcer lesions in the stomach, occlusive blood in the stool (++), melenia and/or hematemesis and hemoptysis within 3 months) or lesions close to large vessels.The lesions involved in the skin or mucosal cavity are at risk of rupture;
- •Hypertension that cannot be controlled by medication;
- •Routine urine indicated more than 2+ urine protein or 24 hours urine protein >150mg/L;
- •Calibration of QT interval > 470MSEC;If the patient has an extended QT interval, but the investigator's study evaluates the prolonged period as due to a pacemaker (and no other cardiac abnormality), it is up to the investigator to determine whether the patient is eligible for the study;
- •Had other malignant tumors in the past 5 years (except for basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ that have been effectively controlled);
- •Known to be allergic to drug ingredients;
- •Patients at risk of massive bleeding in the nasopharynx or deep ulcers in the nasopharynx.
研究组 & 干预措施
Recurrent or Metastatic Nasopharyngeal Carcinoma.
Experimental
Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma were given Surufatinib Combined With Toripalimab.
干预措施: Surufatinib(HMPL-012) (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: up to 12 months
CR + PR rate according to the RECIST version 1.1 guidelines.
次要结局
- Overall survival time(up to 36 months)
- Progression Free Survival (PFS)(up to 12 months)
- Assess the anti-tumor activity:DCR(up to 12 months)
- Duration of relief (DOR)(through study completion, an average of 1 year)
研究者
研究点 (2)
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