A Randomized,Open-label, Multi-Center, Phase II Clinical Trial to Assess the Efficacy and Safety of SHR-1210± SHR-1020 Versus Physician's Choice Chemotherapy in the Treatment of Recurrent or Metastatic Cervical Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) assessed by Blinded Independent Central Review in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
研究概览
简要总结
This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.
详细描述
This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.The primary study hypotheses are that the combination of SHR-1210 plus SHR-1020 is superior to SHR-1210 or physician's choice chemotherapy with respect to: 1) Progression free survival(PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus SHR-1210；2) Overall survival(OS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus Physician's choice 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
- 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
- •Voluntarily agree to participate by giving written informed consent.
- •Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
- •The patients relapsed after a platinum-based treatment regimen for recurrent or metastatic disease.
- •Patients must provide a fresh biopsy. If not, sufficient and adequate tumor tissue sample from the most recent biopsy of a tumor lesion will be required for PD-L1 expression.
- •Has measurable lesion on imaging based on RECIST version 1.
- •Have a life expectancy of at least 3 months.
- •ECOG performance status 0-
- •If childbearing potential, female patients must be willing to use at least 1 adequate barrier methods throughout the study, starting with the screening visit through 6 months after the last dose of study treatment.
排除标准
- •Has any malignancy <5 years prior to study entry. Except for curative skin basal cell carcinoma, carcinoma in situ or breast cancer >3 years.
- •Has received prior therapy with: anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies; Famitinib; patient is allergic to monoclonal antibody.
- •Known to have autoimmune disease.
- •Recived other anticancer therapy 4 weeks before randomization.
- •Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
- •Untreated and/or uncontrolled brain metastases.
- •With high risk of vaginal bleeding or gastrointestinal perforation.
研究组 & 干预措施
Single Arm
SHR-1210
干预措施: SHR-1210 (Drug)
Doublet Arm
SHR-1210+SHR-1020
干预措施: SHR-1210 (Drug)
Doublet Arm
SHR-1210+SHR-1020
干预措施: SHR-1020 (Drug)
Physician's choice chemotherapy
Albumin-bound paclitaxel injection or Pemetrexed disodium for injection or Gemcitabine for injection
干预措施: Physician's choice chemotherapy (Drug)
结局指标
主要结局
Objective Response Rate (ORR) assessed by Blinded Independent Central Review in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
时间窗: Up to approximately 2 years
Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.
次要结局
- Overall survival (OS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)(Up to approximately 2 years)
- Objective Response Rate (ORR) assessed by investigator in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)(Up to approximately 2 years)
- Progression free survival (PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)(Up to approximately 2 years)
- Peak Serum Concentration of SHR-1210(from the first drug administration to within 90 days for the last treatment dose)
- Adverse Events (AEs)(from the first drug administration to within 90 days for the last treatment dose)
- Area under the Serum Concentration versus Time Curve of SHR-1210(from the first drug administration to within 90 days for the last treatment dose)
- Time to response (TTR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.(Up to approximately 2 years)
- Characteristic of Anti drug antibody(from the first drug administration to within 90 days for the last treatment dose)
- Disease control rate (DCR)，recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria(Up to approximately 2 years)
- Duration of response (DoR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.(Up to approximately 2 years)
- Tolerance(from the first drug administration to within 90 days for the last treatment dose)
- Area under the Plasma Concentration versus Time Curve of famitinib(from the first drug administration to within 90 days for the last treatment dose)
- Time to treatment failure (TTF)，in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.(Up to approximately 2 years)
- Peak Plasma Concentration of famitinib(from the first drug administration to within 90 days for the last treatment dose)