A Prospective Single Arm Trial of Concurrent Chemoradiotherapy (With Albumin-Bound Paclitaxel/Cisplatin) Followed by PD-1 Inhibitor in Locally Advanced Cervical Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- progression disease free survival
研究概览
简要总结
To explore the safety and efficacy of Albumin-Bound Paclitaxel/Platinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancer
详细描述
Patients with pathologically confirmed locally advanced cervical cancer will be treated with concurrent chemoradiotherapy (weekly Albumin-Bound Paclitaxel and cisplatin), followed by Sintilimab 200mg q3w for 8 cycles.
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
- •Age between 18 and 75;
- •Untreated patients with pathologically proven locally advanced cervical cancer;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- •Adequate hematological, renal and hepatic functions:
- •4.1 Hemoglobin > 8.0 g/dl 4.2 Neutrophils > 2000 cells/μl; Leukocytes > 4 × 109/L 4.3 Platelets > 100 × 109/Lg. 4.4 Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) 4.5 Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) 4.6 Serum ALT/AST ≤ 2.5× UNL 4.7 Serum Total bilirubin ≤ 1.5× UNL
- •Life expectancy > 6 months
- •Eligible for concurrent chemoradiotherapy assessed by principle investigator;
- •No obvious active bleeding;
- •Written informed consent must be available before study registration.
排除标准
- •Recurrent or distant metastatic disease;
- •Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
- •Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
- •Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study;
- •Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
- •Previous organ transplantation or HIV patients;
- •Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
- •Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA> 103 copies/ml.
研究组 & 干预措施
treatment arm
with Albumin-Bound Paclitaxel 50-75mg/m2, cisplatin 25-40 mg/m2 weekly for up to 5 cycles during radical radiation (EBRT followed by brachytherapy); followed by Sintilimab 200mg Q3W for 8 cycles.
干预措施: Albumin-Bound Paclitaxel, cisplatin, Sintilimab (Drug)
结局指标
主要结局
progression disease free survival
时间窗: -2 years
the time interval from the date of treatment to disease progression, local or distant recurrence.
safety of Albumin-Bound Paclitaxel/cisplatin based concurrent chemoradiotherapy followed by Sintilimab
时间窗: -1 years
the occurrence and grade of side effect from treatment according to the CTCAE 4.0 and NCCN clinical practice guidelines in the evaluation treatment-related toxicity (through the symptoms, physical examination, and also through blood/image/encoscopy examination, such as blood routine, liver and renal function, TSH/T3/T4/ACTH concentration, myocardial enzymes, and EKG, echocardiography, CT, et al).
次要结局
- Objective Response Rate (ORR)(3 months)
- distant-metastasis free survival(-2 years)