NCT05235516进行中（未招募）3 期
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer
Akeso9 个研究点 分布在 1 个国家目标入组 636 人开始时间: 2022年6月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 636
- 试验地点
- 9
- 主要终点
- Progression-Free Survival(PFS) by investigator(INV)
研究概览
简要总结
This study is to evaluate the efficacy and safety of AK104 plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •signs the written informed consent form
- •Life expectancy ≥ 3 months.
- •The histological types include squamous cell carcinoma,adenocarcinoma, or adenosquamous cell carcinoma;
- •Locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage 3A-4A
- •At least one measurable tumor lesion per RECIST v1.1
- •Adequate organ function as assessed in the laboratory tests
排除标准
- •Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.
- •FIGO 2018 IVB
- •Subjects who had previously undergone total hysterectomy
- •Subjects who cannot receive brachytherapy
- •Subjects with other active malignancies within 2 years prior to randomization
- •Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator
- •Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PDL1 antibody, anti-CTLA-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against ICOS, CD40,CD137, GITR, OX40 targets, etc).
- •Subjects who require systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization;
- •Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study
- •Use of live vaccines within 4 weeks prior to randomization
- •Active or potentially recurrent autoimmune disease
- •Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- •Known history of interstitial lung disease or non-infectious pneumonitis
- •Pregnant or lactating women.
- •Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.
研究组 & 干预措施
placebo arm
Placebo Comparator
干预措施: EBRT (Radiation)
treatment arm
Experimental
干预措施: AK104 (Drug)
treatment arm
Experimental
干预措施: EBRT (Radiation)
treatment arm
Experimental
干预措施: BT (Radiation)
treatment arm
Experimental
干预措施: cisplatin (Drug)
placebo arm
Placebo Comparator
干预措施: BT (Radiation)
placebo arm
Placebo Comparator
干预措施: cisplatin (Drug)
placebo arm
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-Free Survival(PFS) by investigator(INV)
时间窗: 54 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 and/or biopsy
次要结局
- PFS rate at month 36(36 months)
- Overall Survival(OS)(5 years)
研究者
研究点 (9)
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