NCT04590599已完成2 期
A Randomized, Double-blind, Controlled, Parallel-cohort Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.
- •Aged ≥18 years and ≤75 years.
- •Diagnosed with cervical cancer by histology/cytology.
- •Patients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).
- •The subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue).
排除标准
- •Diagnosis of other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, radically resected carcinoma in situ and/or thyroid papillary carcinoma.
- •Pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage (patients with effusion that does not require drainage or patients with no significant increase in the effusion within 3 days after stopping drainage can be selected).
- •Patients who are planning to undergo or have previously received organ or bone marrow transplantation.
- •Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA> 200 IU/ml or 103 copies/ml; hepatitis C virus (HCV) antibody positive and HCV-RNA level higher than the lower limit of detection. Patients with acute or chronic active hepatitis B or C infection who have received nucleotide antiviral therapy and are below the above standards can be selected.
- •Meningeal metastases or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic brain metastases who do not need treatment with glucocorticoids, anticonvulsants or mannitol after radiotherapy can be enrolled.
研究组 & 干预措施
IBI310+Sintilimab
Experimental
IBI310+Sintilimab
干预措施: IBI310 (Drug)
IBI310+Sintilimab
Experimental
IBI310+Sintilimab
干预措施: Sintilimab (Drug)
Placebo+Sintilimab
Active Comparator
Placebo+Sintilimab
干预措施: Placebo (Drug)
Placebo+Sintilimab
Active Comparator
Placebo+Sintilimab
干预措施: Sintilimab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.
ORR assessed by the investigator according to the RECIST V1.1
次要结局
- Disease Control Rate（DCR）(Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.)
研究者
研究点 (2)
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