A Phase II Pilot Study of yttriuM-90 in Combination With capEcitabine and aTezolizumab for oligomEtastatic cOlorectal Cancer With unResectable lIver MeTastasEs (METEORITE)

BrUOG-430 is a prospective, single-arm, phase 2 trial evaluating yttrium-90 radioembolization in combination with capecitabine and atezolizumab for the treatment of unresectable colorectal cancer liver metastases in individuals who have been treated with two or more lines of systemic therapy.

开始日期2025-04-07

申办/合作机构

Brown University

[+2]

NCT05655949

/ Recruiting临床2期IIT

A Single Arm Phase 2 Study of Y-90 SIRT in Combination With Durvalumab (MEDI 4736) and Gemcitabine/Cisplatin in Locally Advanced, Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

This trial is designed to study a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for bile duct cancer that cannot be removed with surgery.
The specific names of the interventions that will be used are:
* Y-90 (a type of radiation microsphere bead)
* Durvalumab (a type of immunotherapy)
* Gemcitabine (a type of chemotherapy)
* Cisplatin (a type of chemotherapy)

开始日期2024-02-13

申办/合作机构

Beth Israel Deaconess Medical Center, Inc.

[+3]

100 项与 Sirtex Medical Pty Ltd. 相关的临床结果

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项与 Sirtex Medical Pty Ltd. 相关的文献（医药）

2024-12-01·QUALITY OF LIFE RESEARCH

Association of adverse events and quality of life in patients with unresectable hepatocellular carcinoma

Article

作者: Chatellier, Gilles ; Pereira, Helena ; Pollock, Richard F. ; Brennan, Victoria K. ; Agirrezabal, Ion ; Vilgrain, Valérie ; Carion, Phuong Lien ; Brennan, Victoria K ; Shergill, Suki ; Pollock, Richard F

PURPOSE:

Hepatocellular carcinoma (HCC) is the third-leading cause of cancer-related deaths globally. Patients are often diagnosed with advanced disease, in which systemic and locoregional therapies are commonly used as first-line treatment. Such treatments can cause adverse events (AEs) that negatively affect quality of life (QoL), which is particularly undesirable where prognosis is poor. The aim of the present study was to evaluate the impact of common AEs on QoL in patients with HCC.

METHODS:

Data from the SARAH randomized controlled trial (RCT) were analyzed. Given the large number of distinct AEs that occurred in the trial, AEs were grouped as in the SARAH trial and prioritized using principal component analysis (PCA). Linear mixed-effects models were then applied with age, ECOG status, and AEs as predictors of the QoL change as measured with the EORTC Core Quality of Life Questionnaire (QLQ-C30).

RESULTS:

The PCA resulted in the selection of 28 AEs for inclusion in the linear mixed-effects models. Of the 28 AEs, diarrhea, decreased appetite, abdominal pain, and palmar-plantar erythrodysesthesia syndrome (hand-foot syndrome) were significant drivers of reductions in QoL as measured using the QLQ-C30 global health status scale. Diarrhea, abdominal pain, and hand-foot syndrome were also significant drivers of reduced QoL outcomes.

CONCLUSION:

The present analysis showed that diarrhea, decreased appetite, abdominal pain, and palmar-plantar erythrodysesthesia were significantly associated with reduced QoL in patients with unresectable HCC. Reducing the incidence and/or severity of these AEs should therefore be a key focus when selecting the optimal treatments for these patients.

2024-04-01·Advances in therapy

Selective Internal Radiation Therapy Using Y-90 Resin Microspheres for Metastatic Colorectal Cancer: An Updated Systematic Review and Network Meta-Analysis

Review

作者: Carion, Phuong L ; Shergill, Suki ; Zanotto, Bruna S ; Amoury, Nathalie ; de Jesus, Victor Hugo F ; Ziegelmann, Patricia K ; Vetromilla, Bruna M ; Azeredo-da-Silva, André L F ; Agirrezabal, Ion ; Brennan, Victoria K

INTRODUCTION:

This literature review and exploratory network meta-analysis (NMA) aimed to compare the clinical effectiveness and tolerability of selective internal radiation therapy (SIRT) using yttrium-90 (Y-90) resin microspheres, regorafenib (REG), trifluridine-tipiracil (TFD/TPI), and best supportive care (BSC) in adult patients with chemotherapy-refractory or chemotherapy-intolerant metastatic colorectal cancer (mCRC).

METHODS:

In light of recently published data, the literature was searched to complement and update a review published in 2018. Studies up to December 2022 comparing two or more of the treatments and reporting overall survival (OS), progression-free survival (PFS), or incidence of adverse events (AE) were included. The NMA compared hazard ratios (HRs) for OS and PFS using Markov chain Monte Carlo techniques.

RESULTS:

Fifteen studies were included, with eight studies added (none addressing SIRT). All active treatments improved OS in relation to BSC. SIRT had the longest OS among all treatments, although without statistically significant differences (HR [95% credible interval] for SIRT, 0.48 [0.27, 0.87]; TFD/TPI, 0.62 [0.46, 0.83]; REG, 0.78 [0.57, 1.05]) in a fixed effects model. Information regarding SIRT was insufficient for PFS analysis, and TFD/TPI was the best intervention (HR 2.26 [1.6, 3.18]). One SIRT study reported radioembolization-induced liver disease in > 10% of the sample; this was symptomatically managed. Non-haematological AEs (hand-foot skin reaction, fatigue, diarrhoea, hypertension, rash or desquamation) were more common with REG, while haematological events (neutropoenia, leukopenia, and anaemia) were more common with TFD/TPI.

CONCLUSION:

Current evidence supports SIRT treatment in patients with chemotherapy-refractory or chemotherapy-intolerant mCRC compared to newer oral agents, with comparable OS and low incidence of AEs.

2024-01-01·European journal of cancer (Oxford, England : 1990)

Efficacy of transarterial radioembolization using Y-90 resin microspheres versus atezolizumab-bevacizumab in unresectable hepatocellular carcinoma: A matching-adjusted indirect comparison

Article

作者: Vilgrain, Valérie ; Agirrezabal, Ion ; Amoury, Nathalie ; Pinato, David J ; Carion, Phuong Lien ; Brennan, Victoria K ; D'Alessio, Antonio ; Shergill, Suki ; Bouattour, Mohamed

INTRODUCTION:

No head-to-head trials compared the efficacy of transarterial radioembolization (TARE, also known as selective internal radiation therapy) to combination immunotherapy in hepatocellular carcinoma (HCC). The analysis objective was to compare effectiveness outcomes of TARE using Y-90 resin microspheres and atezolizumab-bevacizumab (AB) in advanced unresectable HCC.

METHODS:

Patient-level data from SARAH randomized controlled trial for TARE and aggregate real-world data from AB-real study were used in an unanchored matching-adjusted indirect comparison. The basecase analysis used per-protocol data from SARAH; intention-to-treat data were used in sensitivity analyses. The following prognostic variables and effect modifiers were identified from literature: cause of disease, macrovascular invasion, Eastern Cooperative Oncology Group Performance Status, alpha-fetoprotein level and albumin-bilirubin score. Weights were assigned to patients from SARAH to balance baseline characteristics across studies and reflect characteristics of AB-real patients. Overall survival (OS), progression-free survival (PFS) and response rates (overall response rates [ORR]) were calculated and compared.

RESULTS:

The analysis of OS and PFS included 140 patients receiving TARE and 131 for the analysis of response rates, compared to 202 receiving AB. Median OS was 15.0 and 14.9 months for TARE and AB, respectively (HR=0.980; 95% confidence interval [CI]: 0.658-1.461; p-value=0.922). Median PFS was 4.4 and 6.8 months for TARE and AB, respectively (HR=0.745; 95%CI: 0.544-1.022; p-value=0.068). ORR were 19.8% and 25% with TARE and AB, respectively (OR for AB=1.386, 95%CI: 0.746-2.668; p-value=0.306). Sensitivity analyses generated similar results.

CONCLUSION:

In HCC patients receiving treatment, TARE using Y-90 resin microspheres may achieve comparable effectiveness outcomes compared with AB.

项与 Sirtex Medical Pty Ltd. 相关的新闻（医药）

2025-12-02

·艾瑞网

远大医药“Go Global”战略：向世界展示中国药企坚实的研发实力

近日,远大医药集团受邀出席在英国伦敦举办的Jefferies全球医疗健康大会,这一盛会作为全球医疗行业最具影响力的投资交流平台,汇聚了来自世界各地的顶尖医药企业与投资机构。会上,远大医药系统展示了其“Go Global”全球化创新发展战略,彰显出从中国领先药企向大型跨国药企转型的决心与实力,获得与会投资者及行业专家的高度关注。在全球医药产业面临变革与机遇的当下,远大医药凭借其在核药抗肿瘤诊疗领域的深度布局,展现出强劲的国际竞争力。经过多年深耕,公司已在核药领域实现了研发、生产、配送、销售的全产业链闭环布局,全球员工超过900人,构建了以波士顿、成都为核心的研发基地,以及覆盖波士顿、法兰克福、新加坡、成都的全球生产基地网络,产品销售网络遍及全球50多个国家和地区。在创新研发方面,远大医药通过与国际领先企业Sirtex Medical Pty Ltd、Telix Pharmaceutical Limited及ITM Isotope Technologies Munich SE的深度合作,搭建了具有国际一流水平的肿瘤介入研发平台和放射性核素偶联药物(RDC)研发平台。截至目前,公司在研发注册阶段已储备15款创新核药产品,涵盖5种放射性核素、7大癌种;早期研发阶段以RDC药物为主,产品储备达12款,成为国内III期临床阶段诊断与治疗类RDC储备最丰富的企业。值得关注的是,远大医药的创新产品在全球范围内取得显著进展。其核心产品易甘泰?钇[90Y]微球注射液继2022年在中国获批用于结直肠癌肝转移后,于2025年7月在美国提前获批用于不可切除肝细胞癌(HCC)的新适应症,成为全球首个且唯一获得FDA批准用于不可切除HCC和结直肠癌肝转移双重适应症的选择性内放射治疗产品。随后在9月,该产品又获得欧洲CE标志认证,新增多种肝癌适应症,实现了市场空间的战略性扩容。在研发管线推进方面,公司已有五款创新RDC药物进入注册性临床研究阶段,其中四款已进入III期临床,包括诊断和治疗前列腺癌的TLX591-CDx和TLX591、诊断透明细胞肾细胞癌的TLX250-CDx以及治疗胃肠胰腺神经内分泌瘤的ITM-11。此外,全球创新的GPC-3靶向诊断药物GPN02006在临床研究中展现出卓越的安全性和显像效能,有望成为全球首个针对该靶点的肝细胞癌诊断类RDC产品。作为“Go Global”战略的重要支撑,远大医药位于成都的放射性药物研发及生产基地于2025年6月正式投入运营。该基地作为全球首个核药全产业链闭环平台,覆盖从同位素制备到商业化的全链条,配备14条高标准GMP生产线,实现了核药生产的自主可控,为创新产品的快速落地提供了坚实基础。除了核药领域的突破性进展,远大医药在其他业务板块也展现出强劲增长势头。截至2025年中期,公司累计在研项目达133个,其中创新项目42个,分布于临床前到新药上市申请的不同阶段。过去五年,公司营收年均复合增长率约12.1%,创新和壁垒产品营收占比提升至51.0%,易甘泰?、Lava?等一系列创新产品实现快速放量。在全球医药创新格局重塑的关键时期,远大医药正以坚实的研发实力和清晰的全球化战略,向世界展示中国药企的创新力量,为全球患者提供更多优质的诊疗选择。凭借在研发、生产及商业化方面的全产业链优势,远大医药将持续提升产品的国际市场竞争力和影响力,加速推进创新成果的全球转化与落地。

临床3期放射疗法上市批准

2025-12-01

·搜狐新闻

远大医药亮相Jefferies全球医疗健康大会，“Go Global”战略引领核药创新出海

近日,远大医药集团受邀出席在英国伦敦举办的Jefferies全球医疗健康大会,这一盛会作为全球医疗行业最具影响力的投资交流平台,汇聚了来自世界各地的顶尖医药企业与投资机构。会上,远大医药系统展示了其“Go Global”全球化创新发展战略,彰显出从中国领先药企向大型跨国药企转型的决心与实力,获得与会投资者及行业专家的高度关注。在全球医药产业面临变革与机遇的当下,远大医药凭借其在核药抗肿瘤诊疗领域的深度布局,展现出强劲的国际竞争力。经过多年深耕,公司已在核药领域实现了研发、生产、配送、销售的全产业链闭环布局,全球员工超过900人,构建了以波士顿、成都为核心的研发基地,以及覆盖波士顿、法兰克福、新加坡、成都的全球生产基地网络,产品销售网络遍及全球50多个国家和地区。在创新研发方面,远大医药通过与国际领先企业Sirtex Medical Pty Ltd、Telix Pharmaceutical Limited及ITM Isotope Technologies Munich SE的深度合作,搭建了具有国际一流水平的肿瘤介入研发平台和放射性核素偶联药物(RDC)研发平台。截至目前,公司在研发注册阶段已储备15款创新核药产品,涵盖5种放射性核素、7大癌种;早期研发阶段以RDC药物为主,产品储备达12款,成为国内III期临床阶段诊断与治疗类RDC储备最丰富的企业。值得关注的是,远大医药的创新产品在全球范围内取得显著进展。其核心产品易甘泰®钇[90Y]微球注射液继2022年在中国获批用于结直肠癌肝转移后,于2025年7月在美国提前获批用于不可切除肝细胞癌(HCC)的新适应症,成为全球首个且唯一获得FDA批准用于不可切除HCC和结直肠癌肝转移双重适应症的选择性内放射治疗产品。随后在9月,该产品又获得欧洲CE标志认证,新增多种肝癌适应症,实现了市场空间的战略性扩容。在研发管线推进方面,公司已有五款创新RDC药物进入注册性临床研究阶段,其中四款已进入III期临床,包括诊断和治疗前列腺癌的TLX591-CDx和TLX591、诊断透明细胞肾细胞癌的TLX250-CDx以及治疗胃肠胰腺神经内分泌瘤的ITM-11。此外,全球创新的GPC-3靶向诊断药物GPN02006在临床研究中展现出卓越的安全性和显像效能,有望成为全球首个针对该靶点的肝细胞癌诊断类RDC产品。作为“Go Global”战略的重要支撑,远大医药位于成都的放射性药物研发及生产基地于2025年6月正式投入运营。该基地作为全球首个核药全产业链闭环平台,覆盖从同位素制备到商业化的全链条,配备14条高标准GMP生产线,实现了核药生产的自主可控,为创新产品的快速落地提供了坚实基础。除了核药领域的突破性进展,远大医药在其他业务板块也展现出强劲增长势头。截至2025年中期,公司累计在研项目达133个,其中创新项目42个,分布于临床前到新药上市申请的不同阶段。过去五年,公司营收年均复合增长率约12.1%,创新和壁垒产品营收占比提升至51.0%,易甘泰®、Lava™等一系列创新产品实现快速放量。在全球医药创新格局重塑的关键时期,远大医药正以坚实的研发实力和清晰的全球化战略,向世界展示中国药企的创新力量,为全球患者提供更多优质的诊疗选择。凭借在研发、生产及商业化方面的全产业链优势,远大医药将持续提升产品的国际市场竞争力和影响力,加速推进创新成果的全球转化与落地。返回搜狐，查看更多

临床3期上市批准放射疗法

2025-12-01

·百度百家

汇聚全球医疗领域领军者，远大医药亮相Jefferies全球医疗健康大会

近日,远大医药集团受邀出席在英国伦敦举办的Jefferies全球医疗健康大会,这一盛会作为全球医疗行业最具影响力的投资交流平台,汇聚了来自世界各地的顶尖医药企业与投资机构。会上,远大医药系统展示了其“Go Global”全球化创新发展战略,彰显出从中国领先药企向大型跨国药企转型的决心与实力,获得与会投资者及行业专家的高度关注。在全球医药产业面临变革与机遇的当下,远大医药凭借其在核药抗肿瘤诊疗领域的深度布局,展现出强劲的国际竞争力。经过多年深耕,公司已在核药领域实现了研发、生产、配送、销售的全产业链闭环布局,全球员工超过900人,构建了以波士顿、成都为核心的研发基地,以及覆盖波士顿、法兰克福、新加坡、成都的全球生产基地网络,产品销售网络遍及全球50多个国家和地区。在创新研发方面,远大医药通过与国际领先企业Sirtex Medical Pty Ltd、Telix Pharmaceutical Limited及ITM Isotope Technologies Munich SE的深度合作,搭建了具有国际一流水平的肿瘤介入研发平台和放射性核素偶联药物(RDC)研发平台。截至目前,公司在研发注册阶段已储备15款创新核药产品,涵盖5种放射性核素、7大癌种;早期研发阶段以RDC药物为主,产品储备达12款,成为国内III期临床阶段诊断与治疗类RDC储备最丰富的企业。值得关注的是,远大医药的创新产品在全球范围内取得显著进展。其核心产品易甘泰®钇[90Y]微球注射液继2022年在中国获批用于结直肠癌肝转移后,于2025年7月在美国提前获批用于不可切除肝细胞癌(HCC)的新适应症,成为全球首个且唯一获得FDA批准用于不可切除HCC和结直肠癌肝转移双重适应症的选择性内放射治疗产品。随后在9月,该产品又获得欧洲CE标志认证,新增多种肝癌适应症,实现了市场空间的战略性扩容。在研发管线推进方面,公司已有五款创新RDC药物进入注册性临床研究阶段,其中四款已进入III期临床,包括诊断和治疗前列腺癌的TLX591-CDx和TLX591、诊断透明细胞肾细胞癌的TLX250-CDx以及治疗胃肠胰腺神经内分泌瘤的ITM-11。此外,全球创新的GPC-3靶向诊断药物GPN02006在临床研究中展现出卓越的安全性和显像效能,有望成为全球首个针对该靶点的肝细胞癌诊断类RDC产品。作为“Go Global”战略的重要支撑,远大医药位于成都的放射性药物研发及生产基地于2025年6月正式投入运营。该基地作为全球首个核药全产业链闭环平台,覆盖从同位素制备到商业化的全链条,配备14条高标准GMP生产线,实现了核药生产的自主可控,为创新产品的快速落地提供了坚实基础。除了核药领域的突破性进展,远大医药在其他业务板块也展现出强劲增长势头。截至2025年中期,公司累计在研项目达133个,其中创新项目42个,分布于临床前到新药上市申请的不同阶段。过去五年,公司营收年均复合增长率约12.1%,创新和壁垒产品营收占比提升至51.0%,易甘泰®、Lava™等一系列创新产品实现快速放量。在全球医药创新格局重塑的关键时期,远大医药正以坚实的研发实力和清晰的全球化战略,向世界展示中国药企的创新力量,为全球患者提供更多优质的诊疗选择。凭借在研发、生产及商业化方面的全产业链优势,远大医药将持续提升产品的国际市场竞争力和影响力,加速推进创新成果的全球转化与落地。

临床3期放射疗法上市批准

100 项与 Sirtex Medical Pty Ltd. 相关的药物交易

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100 项与 Sirtex Medical Pty Ltd. 相关的转化医学

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