Safety and Immunogenicity of a Recombinant Subunit Herpes Zoster Vaccine in Patients With Rheumatic Diseases Undergoing Immunosuppressive or Biologic/Targeted DMARD Therapies: a Double-blind Randomized Placebo-controlled Trial

A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases undergoing immunosuppressive or biologic/targeted DMARD therapies

开始日期2025-01-01

申办/合作机构

Tuen Mun Hospital

NCT06472050 / Recruiting临床4期IIT

Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis: a 2-year Extension Study of a Randomized Controlled Trial

The investigators conducted an open-label randomized controlled trial (RCT) in chronic glucocorticoid (GC) users with moderate/high risk of fracture to compare the efficacy and tolerability of romosozumab (ROMO) for 12 months followed by denosumab (DEN) for 12 more months vs DEN for 24 months throughout. Superiority of ROMO/DEN to DEN/DEN in raising the spine bone mineral density (BMD) was demonstrated at month 12 and month 24. The present study was to report the further BMD changes at 48 months (2 year extension) for those participants who were maintained on DEN treatment.

开始日期2024-08-20

申办/合作机构

Tuen Mun Hospital

NCT05731349 / CompletedN/A

Early Sepsis Care With the National Early Warning Score 2-guided Sepsis Hour-1 Bundle in the Emergency Department: A Hybrid Type 1 Effectiveness-Implementation Pilot Stepped Wedge Randomised Controlled Trial (NEWS-1 Trial Pilot Study)

The goal of this pilot clinical trial is to determine the feasibility of conducting a fully powered type 1 hybrid effectiveness-implementation trial on early sepsis care that is guided by early warning score in adult emergency department (ED) patients who have infection. The main questions it aims to answer are:
* Is it feasible to execute the trial procedure and fulfill the progression criteria to a full-scale trial?
* Does the Surviving Sepsis Campaign (SSC) Hour-1 Bundle care reduce the mortality of adult ED patients with a clinical diagnosis of infection and a National Early Warning Score 2 (NEWS2) equal to or greater than 5?
* What are the barriers to and facilitators of the implementation of the SSC Hour-1 Bundle in the ED settings?
Participants will receive the following SSC Hour-1 Bundle care during the intervention period:
* Blood lactate level measurement
* Blood cultures collection before administering antibiotics
* Broad-spectrum antibiotics
* Intravenous fluid
* Vasopressors if the blood pressure remains low during or after fluid replacement to maintain the mean arterial blood pressure equal to or greater than 65 mmHg
Researchers will compare patients who receive SSC Hour-1 Bundle triggered by a NEWS2 equal to or greater than 5 and patients who receive standard treatment based on clinical judgement to see if the SSC Hour-1 that is triggered by a high NEWS2 score could reduce mortality of adult ED patients with infection.

开始日期2023-04-01

申办/合作机构

香港大学

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0 项与 Tuen Mun Hospital 相关的专利（医药）

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项与 Tuen Mun Hospital 相关的文献（医药）

2025-01-01·Journal of Stroke & Cerebrovascular Diseases

Outcomes of endovascular thrombectomy for acute ischaemic stroke in patients aged ≥80 years: A Hong Kong stroke center experience

Article

作者: Lee, Yat Sing ; Chan, Wai Tat ; Lau, Hin Yue ; Sin, Long Hin ; Tan, Chong Boon ; Siu, Chi Wai

BACKGROUND:

Elderly patients contribute to the large proportion of ischaemic stroke worldwide. Currently, treatment for elderly stroke remains aggressive, as the exact age cutoff for endovascular thrombectomy (EVT) has not been well established due to a lack of large-scale randomized control trials. In this study we investigate the difference in outcome after EVT in the octogenarian and above, compared to their younger counterparts.

METHODS:

EVT patients were divided into two groups, the octogenarian group and younger group (below age of 80). Primary outcome were the 90-days post-thrombectomy functional independence (modified Rankin scale), and Barthel index. Secondary and safety outcomes of post-thrombectomy were also analyzed, including reperfusion status (modified Thrombolysis in Cerebral Infarction (TICI) score), National Institutes of Health Stroke Scale (NIHSS), major complications and mortality rate.

RESULTS:

A total 340 patients were included from 2020 to 29 Feb 2024, and patients' demographics were obtained. Poorer neurological outcome and functional independence were noted in octogenarian group compared with younger counterpart (OR 0.33; 95 % CI 0.14-0.51; p < 0.001). A slightly higher trend of overall post-procedural death was also identified in elder group compared with the younger group (OR 1.48; 95 % CI 0.85-2.60, p = 0.08). Subgroup analysis with more advanced age cutoff at 90 took a step further and proposed that advanced age resulting in more devastating neurological outcome.

CONCLUSION:

Outcomes after endovascular thrombectomy in the elder group were significantly worse than their younger counterparts. More than 80 % of elder group who were treated with EVT required moderate functional dependence, and one in four were dead within 90-days post-EVT.

2025-01-01·CLINICAL ONCOLOGY

Early Outcomes of Preoperative Short Course Radiotherapy With Simultaneous Integrated Boost and Response-adapted Chemotherapy for Advanced Rectal Cancer

Article

作者: Lee, Francis Ann Shing ; Chan, Brian ; Wong, N.S.M. ; Chan, Serena Oi Ling ; Chan, B ; Chan, B. ; Wo, Barry Bar Wai ; Chan, O.L. ; Lee, A S ; Wo, B.B.W. ; Lee, A.S. ; Wong, N S M ; Wo, B B W ; Wong, Natalie Sean-Man ; Chan, O L

BACKGROUND AND PURPOSE:

Limited evidence exists for dose escalation in neoadjuvant short course radiotherapy (SCRT) for rectal cancer. With enhanced imaging and radiotherapy techniques over the past decades along with the valuable endpoint of pathological complete response (pCR), we believe SCRT with simultaneous integrated boost could potentially provide deeper pathological responses and improve local control.

METHODS AND MATERIALS:

Between January 2020 and December 2022, locoregional-advanced rectal cancer patients that were treated with neoadjuvant SCRT with simultaneous integrated boost up to 5.5-6Gy per fraction with five daily fractions followed by response-adapted chemotherapy was retrospectively reviewed. The pCR rates, R0 resection rates, tumor downstaging, toxicities, and early pattern of recurrence are reported.

RESULTS:

Among the 76 patients, 67 (88%) were able to undergo curative intent surgery. R0 resection was achieved in 99% (n = 66) of patients with pCR rates of 28% (n = 19). Forty-six percent (n = 31) of patients had significant pathological downstaging (ypT2N0) and 55% (n = 37) of patients had both T and N downstaging. Most common grade 3 or above radiotherapy-related side-effects were proctitis, rectal pain, and dermatitis found in 5% (n = 4), 3% (n = 2) and 3% (n = 2) of patients, respectively. Grade 3 or above surgical complications were observed in 15% (n = 10) of patients. There were no treatment-related deaths. With a median follow-up of 27 months, only 6% (n = 4) had local recurrence after surgery.

CONCLUSIONS:

Neoadjuvant short course radiotherapy with simultaneous boost for rectal cancer is feasible with no added toxicities. Patients who underwent surgery achieve a high R0 resection and pCR rates. Early data suggest low rates of locoregional recurrence. Further follow-up and research is needed to validate and optimize the dose, method, and schedule of dose escalation.

2024-12-01·EUROPEAN JOURNAL OF RADIOLOGY

Training the next generation of onco-radiologists: The Hong Kong experience

Review

作者: Kwok, Kai-Yan ; Lun Poon, Wai ; Tak Alta Lai, Yee ; Kwok, Kai-yan ; Ling Chan, Oi ; Hang Keith Chiu, Wan ; Fai Cheng, Lik

Oncologic Radiology (OR) is a new higher subspecialty training programme developed by the Hong Kong College of Radiologists. Instead of the traditional organ-centric approach, the curriculum ensures exposure in a wide spectrum of cancers to trainees who wish to pursue a career in cancer imaging and interventions. The OR training is hands-on and trainees will learn to interpret and report many imaging modalities including ultrasound, mammography, computed tomography and magnetic resonance. Aside from diagnostic training, trainees will also acquire basic knowledge and skills in Interventional Oncology. Specific emphasis is put on inter-disciplinary collaboration with input from Medical Physicists and Clinical Oncologists during their training. The curriculum aims to provide comprehensive knowledge and necessary skills in radiological findings, clinical aspects, pathology, treatment options of oncologic diseases in different organ systems to meet the demand of modern Oncology.

项与 Tuen Mun Hospital 相关的新闻（医药）

2023-01-20

·生物谷

《柳叶刀》子刊：肝癌治疗重大突破！港大团队新方案使过半无法根治的局部晚期肝癌患者有了根治机会

该研究首次报告了TACE、SBRT和Avelumab组成的START-FIT方案，用于局部晚期不可切除HCC患者的转化率和完全缓解率高、且安全性好，有望为局部晚期不可手术HCC患者带来根治机会介入治疗中的经动脉化疗栓塞术（TACE），是广泛用于局部晚期不可切除肝细胞癌（HCC）患者的治疗方式，然而对大肝癌（>5cm）或多结节肝癌患者的缓解率偏低（约30%）[1]；对于存在血管侵犯的患者，系统性药物治疗则是标准治疗方案，但治疗缓解率也不高（5-40%）[2]。而且不管是TACE还是系统性药物治疗，在转化降期、争取根治性手术机会方面的效果都比较有限，因此目前对局部晚期不可切除的HCC患者，还没有统一的转化治疗方案。既往研究表明，立体定向放疗（SBRT）与TACE联合使用时，可提高局部缓解率，比重复TACE具有更好的抗肿瘤反应和生存获益，且不增加毒性[3]。另外，局部治疗还可以调节肿瘤微环境，增强对免疫检查点抑制剂的反应[4]， SBRT联合PD-1抑制剂可在放射野外实现持久控制，完全缓解率达50%[5]。那么将TACE、SBRT及免疫治疗有机结合，设计更优的联合治疗方案，是否能取得更大的战果呢？针对不适合根治性手术的局部晚期HCC患者，由香港大学玛丽医院陈智仁教授领衔的研究团队牵头，联合屯门医院、香港大学深圳医院，开展了一项名为START-FIT的单臂II期临床研究，评估TACE、SBRT及PD-L1抑制剂Avelumab序贯治疗方案（以下简称START-FIT方案）的有效性和安全性，该研究结果近期发表在国际胃肠肝病学顶级期刊《柳叶刀·胃肠病和肝病学》（The Lancet Gastroenterology & Hepatology）上[6]。研究显示，33例局部晚期不可切除HCC患者经START-FIT方案治疗后，在中位随访时间为17.2个月时，有18例（55%）可行根治性治疗，其中14例（42%）达影像学完全缓解而选择密切监测，4例（12%）接受了根治性治疗。而相对于单独使用TACE、SBRT或Avelumab，START-FIT方案未出现任何新的安全性问题。该研究是第一个使用免疫疗法和局部治疗相结合，作为局部晚期不可切除HCC转化疗法的前瞻性试验，初步结果非常可喜，有望为局部晚期不可切除HCC患者的转化治疗提供新的选择。论文首页截图下面我们一起来看看这个研究是如何开展的。 START-FIT是一项单臂、多中心、研究者发起的II期临床试验，2019年3月18日至2021年1月27日，研究人员对68例患者进行资格筛选，最终33例患者被纳入研究，均为≥18岁且患有不可切除的、无淋巴结或肝外转移的HCC患者，其中21例（64%）为巴塞罗那肝癌分期（BCLC）C期并伴有大血管浸润，8例为BCLC-B期且超出up-to-7标准（即肿瘤个数与最大肿瘤直径之和不超过7），患者病灶最大直径的中位数总和为15.1cm，患者其他基线特征如下图所示。患者基线特征患者入组研究后在第1天接受TACE治疗，然后在第28天接受SBRT治疗（27.5-40.0Gy，分5次分割），在SBRT后14天使用Avelumab治疗（10mg/kg，每2周一次，最多12周期）。研究主要终点为转化治疗后适合根治性治疗的患者百分比，定义为持续完全缓解或部分缓解至少2个月，且可以进行根治性治疗（即肿瘤切除、射频消融或肝移植）的患者。截至2021年12月31日，33例患者均已完成研究规定方案治疗，患者接受Avelumab的中位周期数为8个周期，SBRT的中位剂量为30.0Gy（5次分割）。在接受START-FIT方案后，18例（55%）患者可行根治性治疗，其中14例（42%）获得完全缓解并选择主动监测，4例（12%）接受根治性治疗；其余15例（45%）患者被认定为不适合根治性治疗，具体如下图所示。研究患者流程图缓解率方面，经研究者评估证实的客观缓解率为67%，完全缓解率为42%，部分缓解率为24%，疾病控制率为70%；独立盲法审查委员会评估的客观缓解率为67%，疾病控制率为73%，94%（31/33）的靶病灶出现消退；从治疗起始到实现缓解的中位时间为3.8个月，患者的中位缓解持续时间（DoR）长达20.2个月。而生存结局方面，14例获得完全缓解的患者在获得完全缓解后，都停止使用Avelumab，Avelumab的中位用药周期为9个，而在中位随访时间为17.2个月时，79%（11/14）的患者没有出现疾病进展，没有患者在放射野内复发。整个队列中位随访时间为17.2个月时，患者的中位无进展生存期（PFS）为20.7个月，中位总生存期（OS）为30.3个月，12个月和24个月的局部病灶控制率均为92%，患者PFS率分别为52%和38%，OS率分别为72%和69%；18例适合根治患者的24个月OS率为94%，其中14例完全缓解并选择密切监测的患者的24个月OS率为92%，4例接受根治性治疗的患者的24个月OS率则为100%。生存结局和局部控制：A为无进展生存率；B为总生存率；C为55个病灶的局部控制率安全性方面，研究期间所有患者均发生了治疗相关的不良事件，但生活质量评分没有显著下降。33例患者中有11例（33%）出现了3级或更严重的治疗相关不良事件，其中最常见的是TACE后ALT/AST的一过性升高（5/33，15%）；5例（5/33，15%）患者发生了3级或更严重的免疫相关不良事件，3例为肝炎，2例为皮炎；在放疗反应方面，未观察到放疗引起的肝病或放疗相关的死亡。治疗相关不良事件情况汇总总之，该研究首次报告了TACE、SBRT和Avelumab组成的START-FIT方案，用于局部晚期不可切除HCC患者的转化率和完全缓解率高、且安全性好，有望为局部晚期不可手术HCC患者带来根治机会，争取更多生机。但这项研究仍有一些不足，如仅为单臂II期研究，患者中超过70%患有慢性乙型肝炎，女性患者参与比例低等，这些因素可能影响研究结果的普适性。期待后续随机对照试验的开展，推动START-FIT方案在HCC患者中广泛应用。参考文献： [1].Kudo M, Han KH, Ye SL, et al. A Changing Paradigm for the Treatment of Intermediate-Stage Hepatocellular Carcinoma: Asia-Pacific Primary Liver Cancer Expert Consensus Statements. Liver Cancer. 2020;9(3):245-260. doi:10.1159/000507370 [2].Finn RS, Ryoo BY, Merle P, et al. Pembrolizumab As Second-Line Therapy in Patients With Advanced Hepatocellular Carcinoma in KEYNOTE-240: A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2020;38(3):193-202. doi:10.1200/JCO.19.01307 [3].Wong TC, Chiang CL, Lee AS, et al. Better survival after stereotactic body radiation therapy following transarterial chemoembolization in nonresectable hepatocellular carcinoma: A propensity score matched analysis. Surg Oncol. 2019;28:228-235. doi:10.1016/j.suronc.2019.01.006 [4].Sharabi AB, Lim M, DeWeese TL, Drake CG. Radiation and checkpoint blockade immunotherapy: radiosensitisation and potential mechanisms of synergy. Lancet Oncol. 2015;16(13):e498-e509. doi:10.1016/S1470-2045(15)00007-8 [5].Chiang CL, Chiu KW, Lee FA, Kong FS, Chan AC. Combined Stereotactic Body Radiotherapy and Immunotherapy Versus Transarterial Chemoembolization in Locally Advanced Hepatocellular Carcinoma: A Propensity Score Matching Analysis. Front Oncol. 2021;11:798832. Published 2021 Dec 7. doi:10.3389/fonc.2021.798832 [6].Chiang CL, Chiu KWH, Chan KSK, et al. Sequential transarterial chemoembolisation and stereotactic body radiotherapy followed by immunotherapy as conversion therapy for patients with locally advanced, unresectable hepatocellular carcinoma (START-FIT): a single-arm, phase 2 trial [published online ahead of print, 2022 Dec 15]. Lancet Gastroenterol Hepatol. 2022;S2468-1253(22)00339-9. doi:10.1016/S2468-1253(22)00339-9