NCT05179239终止3 期
A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Incidence and severity of Participants Who Experience a Serious AE (SAE) as per NCI-CTC AE 5.0（Stage I）
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years, female.
- •With Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-
- •With a life expectancy of ≥ 12 weeks.
- •Acute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).
- •With at least one measurable lesion as per RECIST v1.
- •With histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.
- •Persistent, recurrent, or metastatic cervical cancer.
- •Patients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).
- •Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.
- •Patients must agree and have signed the informed consent form.
排除标准
- •With known contraindications to paclitaxel, cisplatin, or carboplatin.
- •With known allergies to any of the study drugs or their excipients; severe allergic reactions to other monoclonal antibodies.
- •With inadequately treated CNS metastasis.
- •With uncontrolled hypertension.
- •With uncontrolled cardiac diseases or symptoms.
- •With major vascular disease.
- •With arterial/venous thrombotic events within 6 months prior to randomization.
- •Have received full-dose anticoagulant or hemolytic therapy within 10 days prior to randomization.
- •With clinically significant hemorrhage or definitive bleeding diathesis within 3 months prior to randomization.
- •With severe, unhealed, or open wounds as well as active ulcers or untreated fractures.
- •With any active autoimmune disease or a history of autoimmune disease that is expected to recur.
- •Had other active malignant tumors within 5 years prior to study enrolment.
- •With congenital or acquired immunodeficiency (such as HIV-infected patients).
研究组 & 干预措施
SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102
Experimental
干预措施: SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102 (Drug)
SHR-1701 + paclitaxel + cisplatin/carboplatin ± BP102
Experimental
干预措施: SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102 (Drug)
Placebo + paclitaxel + cisplatin/carboplatin ± BP102
Placebo Comparator
干预措施: Placebo + paclitaxel + cisplatin/carboplatin ± BP102 (Drug)
结局指标
主要结局
Incidence and severity of Participants Who Experience a Serious AE (SAE) as per NCI-CTC AE 5.0（Stage I）
时间窗: Up to approximately 21 days
Incidence and severity of Participants Who Experience an Immune-related AE (irAE) as per NCI-CTC AE 5.0（Stage I）
时间窗: Up to approximately 21 days
BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II）
时间窗: Up to approximately 10 months
OS is defined as the time from randomization to death due to any cause. （Stage II）
时间窗: Up to approximately 26 months
Incidence and severity of Participants Who Experience an Adverse Event (AE) as per NCI-CTC AE 5.0（Stage I）
时间窗: Up to approximately 21 days
次要结局
- Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator （Stage I）(Up to approximately 26 months)
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator （Stage I）(Up to approximately 26 months)
- Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator （Stage I）(Up to approximately 26 months)
- Overall survival (OS) up to approximately 26 months（Stage I）(up to approximately 26 months)
- Duration of Response (DOR) Per RECIST 1.1 as Assessed by BIRC- and investigator （Stage II）(Up to approximately 26 months)
- Disease Control Rate (DCR)up to approximately 26 months（Stage I）(up to approximately 26 months)
- Time to Progress(TTP) up to approximately 26 months（Stage I）(up to approximately 26 months)
- Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BIRC- and investigator（Stage II）(Up to approximately 26 months)
- Disease Control Rate (DCR)Per RECIST 1.1 as Assessed by BIRC- and investigator（Stage II）(Up to approximately 26 months)
- Incidence and severity of Participants Who Experience an Adverse Event (AE) as per NCI-CTC AE 5.0 （Stage II）(Up to approximately 26 months)
- Incidence and severity of Participants Who Experience a Serious AE (SAE) as per NCI-CTC AE 5.0（Stage II）(Up to approximately 26 months)
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by BIRC- and investigator（Stage II）(Up to approximately 26 months)
- Time to Progress(TTP) up to approximately 26 months （Stage II）(up to approximately 26 months)
- Incidence and severity of Participants Who Experience an Immune-related AE (irAE) as per NCI-CTC AE 5.0（Stage II）(Up to approximately 26 months.)
研究者
研究点 (1)
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