JPRN-jRCT2061230037招募中3 期
A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination with Chemotherapy for the First Line Treatment for Patients with Advanced Biliary Tract Cancers - TOURMALINE
Sasaki Hidefumi0 个研究点目标入组 35 人开始时间: 2023年7月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 130age old（—）
- 性别
- All
入选标准
- •Histologically confirmed, unresectable advanced or metastatic biliary tract carcinoma (BTC) including cholangiocarcinoma (intrahepatic or extrahepatic), gallbladder carcinoma, and ampulla of Vater (AoV) carcinoma
- •- Participants with unresectable or metastatic BTC
- •-A World Health Organisation Eastern Cooperative Oncology Group Performance Status (WHO/ECOG PS) of 0 to 2
- •-At least one lesion that qualifies as a Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) target lesion at baseline
- •- Adequate organ and bone marrow function
- •- Body weight of > 30 kg
- •- Negative pregnancy test (serum) for women of childbearing potential
- •- Female participants must be one year post-menopausal (amenorrhoeic for 12 months without an alternative medical cause)
- •- Male and female participants and their partners must be surgically sterile or on their chosen method of birth control as per the protocol.
排除标准
- •-Any evidence of diseases such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diseases, active infection, active interstitial lung disease/pneumonitis, serious chronic gastrointestinal conditions associated with diarrhoea, psychiatric illness/social situations, history of uncontrolled or symptomatic cardiac disease, and history of allogenic organ transplant
- •-Active or prior documented autoimmune or inflammatory disorders
- •-History of another primary malignancy, except for malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study intervention
- •-History of leptomeningeal carcinomatosis
- •-History of active primary immunodeficiency
- •-Known to have tested positive for human immunodeficiency virus [HIV] (positive HIV 1/2 antibodies) or active tuberculosis infection
- •-Participants co-infected with Hepatitis B virus (HBV) and Hepatitis C virus (HCV) or co-infected with HBV and Hepatitis D virus (HDV)
- •-Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAE] Grade > 2) caused by previous anticancer therapy
- •-History of, or current, brain metastases or spinal cord compression
- •-Known allergy or hypersensitivity to any of the study intervention or any of the study intervention excipients.
- •-Any concurrent chemotherapy, other than the one allowed in the study, investigational medicinal product (IMP), biologic, or hormonal therapy for cancer treatment
- •-Palliative radiotherapy with a limited field of radiation within 2 weeks of the first dose of study intervention, or radiotherapy with a wide field of radiation or radiotherapy affecting more than 30% of the bone marrow within 4 weeks before the first dose of study intervention
- •-Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention
- •-Major surgical procedure within 28 days prior to the first dose of IMP
- •-Prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines
- •-Receipt of the last dose of anticancer therapy within 28 days prior to the first dose of IMP
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