Evaluate Efficacy and Safety of Serplulimab（HLX10）in Patients With Advanced, Recurrent and Metastatic Cervical Cancer：A Prospective, Multicenter, Non-interventive Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is a Prospective, Multicenter, non-interventive Real-world Study to evaluate the efficacy and safety of the treatment of Serplulimab in patients with Advanced,Recurrent and Metastatic Cervical Cancer. Approximately 118 eligible subjects are planned to be enrolled across all sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Age ≥ 18 years at time of study entry.
- •Histologically or cytologically confirmed advanced, recurrent or metastatic cervical cancer.
- •Received at least 1 prior systemic therapies in the recurrent or metastatic setting. Tumor progression or recurrence after treatment with therapy.
- •ECOG performance status of 0 or
- •Patient must have at least one measurable disease as defined by RECIST 1.
- •Ability to provide written and signed informed consent.
排除标准
- •Pregnant or lactating women.
- •Life expectancy < 3 months
- •Ongoing participation in another clinical study, or planned initiation of treatment in this study less than 14 days from the end of treatment in the previous clinical study.
- •Known history of serious allergy to any active ingredie or any excipients list in monoclonal antibody.
- •The patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study.
研究组 & 干预措施
Cohort 1
The medication plan is determined by gynecological oncology or oncology physician. Select the treatment plan containing serplulimab (single drug and/or combination), the other anti-tumor treatment schemes without intervention.
The recommended dose of serplulimab is 300 mg IV, Day1 of each cycle. Apply the drug on the first day of each cycle until the disease progresses or intolerable toxicity occurs.The combined drugs is decided by the doctor.
In this non-interventive study, do not change or interfere with the current medical treatment of the recruited patients.
干预措施: Serplulimab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 24 months
Objective Response Rate is defined as the percentage of patients with Complete Response or Partial Response, as assessed by Response Evaluation Criteria in Solid Tumors v.1.1 criteria or immune Response Evaluation Criteria in Solid Tumors v.1.1 criteria by investigators.
次要结局
- Duration of response (DOR)(Up to approximately 24 months)
- 1-year and 2-year Overall Survival Rate(Baseline up to approximately 24 months)
- Overall Survival (OS)(Baseline up to approximately 36 months)
- 1-year and 2-year Disease Control Rate(Baseline up to approximately 24 months)
- Progression free survival (PFS)(Up to approximately 24 months)
- 1-year and 2-year Progression free survival Rate(Baseline up to approximately 24 months)
- Time to the first disease progression(Up to approximately 24 months)
研究者
Beihua Kong
professor
Shandong University