NCT05174156Unknown2 期
Study on the Biomarker of First-line Immunotherapy Combined With Chemotherapy in Advanced Esophageal Cancer
Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study intends to explore the predictive biomarkers by Next-generation sequencing (NGS) and multiple immunohistochemistry (mIHC) for the treatment of SHR-1210 in combination with paclitaxel and platinum in advanced esophageal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable locally advanced/ recurrent or distant metastatic esophageal squamous cell carcinoma confirmed by histology or cytology;
- •Not received any previous systematic antitumor therapy.
- •Eastern Cooperative Oncology Group (ECOG) fitness status score was 0 or 1 within 3 days before the first administration of the intervention.
- •8-10 tumor tissue samples can be provided.
- •Demonstrate good organ and bone marrow function.
- •Consent to participate in the contraceptive methods related to clinical research.
排除标准
- •Have a history of allergy to monoclonal antibodies, any component of SHR-1210, albumin-paclitaxel, carboplatin, and other platinum drugs;
- •Weight loss > 20% in the past 3 months.
- •Major surgery within 28 days prior to enrollment.
- •Have received systemic chemotherapy or radiation therapy for esophageal cancer.
- •Had a myocardial infarction within the past 6 months.
- •Have any medical history or current evidence, treatment, or laboratory abnormalities that prevent the subject from participating fully in the study with the investigator's opinion.
- •Prior treatment with immunotherapy drugs.
- •Received live vaccine within 30 days prior to initial administration of the investigational drug.
- •Have been diagnosed with immunodeficiency or are receiving immunosuppressive treatment.
- •Another malignancy is known to exist.
- •Have active infections that require systemic treatment.
- •Pregnant or lactating, or planning to become pregnant or become a father during the study period (180 days for lactating subjects receiving carboplatin) from the beginning of the screening visit until 120 days after the last dose of the study intervention.
研究组 & 干预措施
biomarker study and treatment study
Experimental
All enrolled patients undergo biomarker study and treatment study.
- Biomarker study: the baseline tumor tissue will be collected and analyzed via NGS and mIHC
- Treatment study: SHR-1210 plus albumin-bound paclitaxel and platinum-based chemotherapy
干预措施: Combination therapy (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to approximately 1 year
ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
次要结局
- Progression-Free Survival (PFS)(up to approximately 1 year)
- Disease Control Rate (DCR)(up to approximately 1 year)
- Overall Survival (OS)(up to approximately 1 year)
- Adverse events (AEs)(up to approximately 1 year)
研究者
研究点 (1)
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