NCT04341883已完成2 期
A Open-label, Single-arm, Multicentre, Phase Ⅱ Study of Evaluate Efficacy and Safety of Anti-PD-1 Combined With Albumin-Bound Paclitaxel in Patients With Recurrent Cervical Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年1月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
This is an open-label, single-arm, phase II, multi-center clinical trial. Subjects can only enter this study after they meet the inclusion and exclusion criteria. All enrolled patients will receive the treatment with anti-PD-1 combined with albumin-bound paclitaxel, every 3 weeks, until progressive disease, initiation of new anti-tumour therapy, death, intolerable toxicity. Albumin-bound paclitaxel may be used for up to 6 cycles and anti-PD-1 for up to 2 years.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate and have signed the informed consent form (ICF);
- •Patients histologically diagnosed with cervical cancer ;
- •Patients with advanced cervical cancer who have experienced progressive disease or relapse after receiving standard treatment (first-line chemotherapy must be included) or who are intolerant to first-line chemotherapy.
- •The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1;
- •An Eastern Cooperative Oncology Group(ECOG) score of 0 or 1;
- •Life expectancy ≥ 3 months;
- •Adequate hepatic, renal, heart, and hematologic functions. Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 70×109/L, Hemoglobin(HGB) ≥ 80 g/L, total bilirubin within 1.5×the upper limit of normal (ULN), and serum transaminase≤2.5×Upper Limit Of Normal(ULN), serum creatine ≤ 1.5 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥50ml/min, International Normalized Ratio<1.5 x Upper Limit Of Normal(ULN), Urinary protein≤（+）and Thyroid stimulating hormone≤ 1.5 x Upper Limit Of Normal(ULN).
排除标准
- •Pathology confirmed with sarcoma components (including malignant mixed mullerian tumors, endometrial leiomyosarcoma, and endometrial stromal sarcoma);
- •Patients who have previously received albumin-bound paclitaxel or exposures to any anti-PD-1 antibody drugs;
- •Exposures to any anti-tumor drugs within 4 weeks;
- •Current or prior use of any immunosuppressive medication or systemic hormone therapy（which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid Prednisone>10mg/d）within 14 days before the first dose of anti-PD-1 antibody;
- •Any primary malignancy within 5 years (except for fully treated in situ malignant such as breast cancer, bladder cancer, cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cell carcinoma);
- •History of psychiatric drugs abuse and not be abstinent, or dysphrenia；
- •Central nervous system diseases, including uncontrollable epilepsy and symptomatic brain metastases;
- •Severe cardiovascular disease: unstable angina pectoris, myocardial infarction, grade III-IV cardiac insufficiency (NYHA standard), and peripheral vascular disease above 2 degrees within 6 months prior to enrollment;
- •Severe arrhythmia requiring drug control, QT interval >470ms；
- •Active infections such as HIV/AIDS or other serious infectious diseases;
- •Any active autoimmune disease or history of autoimmune disease (including but not limit to autoimmune hepatitis, interstitial pneumonia, hepatitis, enteritis, nephritis, hyperthyroidism, pituitary inflammation, vasculitis, uveitis) . Patients need receiving systemic hormonal therapy and/or immunosuppressive therapy (eg asthma requiring bronchodilators);
- •Receipt of live attenuated vaccination within 30 days prior to study entry;
- •Other conditions regimented at investigators' discretion.
研究组 & 干预措施
anti-PD-1
Experimental
PD-1+albumin-bound paclitaxel
干预措施: anti-PD-1+Albumin-Bound Paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: up to 2 years
Objective tumor response was defined as the proportion of patients whose tumor volume has been reduced to a predetermined value and can be maintained for more than 4 weeks, ie ORR=CR+PR.
次要结局
- Disease Control Rate(DCR)(up to 2 years)
- Progression Free Survival(PFS)(up to 2 years)
- Overall Survival(OS)(up to 2 years)
- Duration of Response(DoR)(up to 2 years)
研究者
Xin Huang
Hospital Chief Physician，Professor
Sun Yat-sen University
研究点 (1)
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