Phase II Study on AK104 in Neoadjuvant Treatment of Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
Phase II open label study to evaluate the safety and efficacy of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) in neoadjuvant treatment of cervical cancer.
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≥18 & ≤
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Histologically or cytologically confirmed diagnosis of primary cervical squamous cell carcinoma.
- •According to the 2018 International Federation of Cervical Cancer Obstetrics and Gynecology (FIGO) staging standard, the patient was diagnosed in stage IB2-IIA
- •Has not received any treatment before.
- •Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
- •Has adequate organ function.
排除标准
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •Active Hepatitis B or Hepatitis C.
- •History of severe bleeding tendency or coagulation disorder.
- •Undergone major surgery within 30 days prior to the first dose of study treatment.
- •Pregnant or lactating female patients.
- •Drug or alcohol abuse.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
研究组 & 干预措施
AK104
Patients will be treated with 1-4 cycles of neoadjuvant AK104. 2-4 weeks after the last cycle of neoadjuvant treatment, patients will undergo radical surgery.
干预措施: AK104 (Drug)
结局指标
主要结局
Adverse Events (AEs)
时间窗: Up to approximately 6 mouths
The number of participants experiencing an AE will be assessed. An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy.
Major pathological response (MPR) rate
时间窗: within 14 working days after operation
MPR rate is defined as the percentage of participants having ≤ 10% viable tumor cells in the pathological examination of resected specimens.
次要结局
- R0 resection rate(within 14 working days after operation)
- Objective response rates (ORR)(4-6 weeks after the first cycle of neoadjuvant treatment)
- Pathological Complete Response (pCR) rate(within 14 working days after operation)