EUCTR2015-005298-19-GB进行中（未招募）1 期
Phase 1/2 Study of anti-PD-L1 in Combination with Chemo(radio)therapy for Oesophageal Cancer - LUD2015-005
udwig Institute for Cancer Research Ltd.0 个研究点目标入组 75 人开始时间: 2016年1月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Histological diagnosis of oesophageal or gastrooesophageal cancer. Have not received full dose systemic chemotherapy.
- •- Cohorts A and B - metastatic/locally advanced cancer
- •- Cohorts C and D/D2 - deemed suitable for surgery with curative intent
- •2.Recovered from prior therapy (Grade 1 persistent AEs acceptable)
- •3.Anticipated lifespan greater than 4 months
- •4.ECOG performance status of 0 or 1
- •5.At the time of day 1 of the study, subjects with brain metastases must be asymptomatic and show evidence that their CNS disease is not progressing
- •6.Adequate normal organ and marrow function as defined in detail in the protocol
- •7.Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •8.Age =18 years
- •9.Have been informed of other treatment options
- •10. Willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, examinations, biopsies and follow up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Previous enrollment in the present study.
- •2.Participation in another clinical study with an investigational product within 4 weeks prior to Day 1 of the study; resolution of respective adverse event to Grade 1 or lower should have occurred.
- •3.Mean QT interval corrected for heart rate (QTc) =470 ms
- •4.Active or prior documented autoimmune disease within the past 2 years
- •5.Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
- •6.History of allogeneic organ transplant
- •7.Uncontrolled intercurrent illness
- •8.Known history of previous clinical diagnosis of tuberculosis
- •9.Prior exposure to tremelimumab / durvalumab or checkpoint inhibitors
- •10.History of severe allergic reactions to any unknown allergens or any components of the study drugs.
- •11.Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •12.Treatment with sorivudine or its chemically related analogues, such as brivudine
- •13.Peripheral sensitive neuropathy with functional impairment
- •14.History of sarcoidosis syndrome.
- •15.Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
- •16.History of pneumonitis or interstitial lung disease.
- •17.Major surgical procedure (as defined by the investigator) within 30 days prior to Day 1 or still recovering from prior surgery.
- •18.Women who are breast feeding or pregnant
- •19.Any condition that, in the clinical judgment of the treating physician, is likely to interfere with evaluation of study treatment, interpretation of subject safety or study results, prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
- •20.Subjects should not donate blood while participating in this study
- •21.For oxaliplatin, capecitabine, paclitaxel, carboplatin, 5-fluorouracil, leucovorin, docetaxel: refer to prescribing information for additional information
研究者
相似试验
招募中
2 期
A phase II open-label study with the anti-PD-L1 Atezolizumab monoclonal antibody in combination with Bevacizumab in patients with advanced chemotherapy resistant colorectal cancer and MSI-like molecular signaturebowlecancercolorectal carcinoma10017991NL-OMON49178Vall D'Hebron Institute of Oncology (VHIO)12
进行中（未招募）
1 期
Atezolizumab in combination with Beva in advanced CRC with MSI-like molecular signatureColorectal carcinomaMedDRA version: 20.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002001-19-ESVHIO58
进行中（未招募）
1 期
Atezolizumab in combination with Beva in advanced CRC with MSI-like molecular signatureColorectal carcinomaMedDRA version: 21.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002001-19-ITVALL D'HEBRON INSTITUTE OF ONCOLOGY (VHIO)58
进行中（未招募）
1 期
Atezolizumab in combination with Beva in advanced CRC with MSI-like molecular signatureEUCTR2016-002001-19-BEVHIO58
进行中（未招募）
1 期
Atezolizumab in combination with Beva in advanced CRC with MSI-like molecular signatureColorectal carcinomaMedDRA version: 21.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002001-19-NLVHIO58