临床试验对于寶康医院的研究中心至关重要，因此该中心在2020年被晋升为卓越中心（COE）。
我们的患者、肿瘤学团队和研究团队在马来西亚的多项临床试验和促进多种肿瘤药物的上市方面做出了重要贡献。
在 2021年，我们被马来西亚临床研究机构认可为马来西亚领先的肿瘤学临床试验中心之一。
临床研究中心
我们的优势 / 为什么选择我们
对齐马来西亚的全球临床研究愿景，我们致力于寻找更好的癌症治疗方法，帮助癌症患者。
我们的研究项目均获得马来西亚卫生部伦理委员会的批准，并遵守良好临床实践标准，优先考虑试验患者的道德考虑。
正在进行的临床试验
迄今为止，我们的肿瘤科团队已参与多项临床试验，包括比较不同化疗的疗效；对抑制剂的抵抗力；鼻咽癌的表观遗传变化；以及治疗晚期或转移性胃食管连接部腺癌等。
临床试验列表
乳腺癌
| No. | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | CAPItello-292 A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in hormone receptor-positive and human epidermal growth factor receptor 2-negative locally advanced, unresectable or metastatic breast cancer |
Active (Recruiting) | Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestran |
| 2 | OPERA-01 A phase 3 randomized, open-label study of OP-1250 monotherapy vs SOC for the treatment of ER+, HER2- advanced or metastatic breast cancer following endocrine and CDK4/6 inhibitor therapy |
Active (Recruiting) | Study of OP-1250 monotherapy vs SOC |
| 3 | Elegant Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence – A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT) |
Active (Recruiting) | Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence |
| 4 | EPIK-B3 CBYL719H12301 (EPIK B3) – A Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab-paclitaxel in patients with advanced triple negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation. |
Closed | Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel |
| 5 | EPIK-B2 CBYL719G12301 (EPIK B2) – A two part, Phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with transtuzumab and pertuzumab as maintenance therapy in patients with HER2-positive advanced breast cancer with a PIK3CA mutation. |
Closed | Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab |
| 6 | lidERA A phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant giredestrant compared with physician’s choice of adjuvant endocrine monotherapy in patients with estrogen receptor-positive, her2-negative early breast cancer |
Closed | Study Evaluating the Efficacy |
| 7 | TENOR Phase II Study to assess the efficacy of Talazoparib in asian mEtastatic breast caNcer patients with a hOmologous Recombinant deficiency (HRD) signature (TENOR) |
Closed | NA |
肺癌
| No | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | SOHO-02 A Phase 3 open-label, randomized, active-controlled, multicenter trial to evaluate the efficacy and safety of orally administered BAY 2927088 compared with standard of care as a first-line therapy in patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with HER2-activating mutations. |
Active (Recruiting) | A Study to Learn More About How Well BAY 2927088 Works |
| 2 | ATORG001 A prospective, molecular profiling study of mutational genes in Asian patients with Non-Small Cell Lung Cancer. (Non-interventional study). |
Active (Recruiting) | Study of mutational genes in Asian patients |
| 3 | ATORG004 Plasma Molecular Profiling in ALK inhibitor resistant non-small cell lung cancer |
Active (Recruiting) | Plasma Molecular Profiling in ALK inhibitor resistant non-small cell lung cancer |
| 4 | PACIFIC-8 A Phase 3, Randomised, Double blind, Placebo controlled, Multicentre, International Study of Durvalumab plus Domvanalimab (AB154) in Participants with Locally Advanced (Stage III), Unresectable Non small Cell Lung Cancer Whose Disease has not Progressed Following Definitive Platinum based Concurrent Chemoradiation Therapy (PACIFIC-8) |
Active (Recruiting) | Study of Durvalumab plus Domvanalimab (AB154) in Participants with Locally Advanced |
| 5 | MK3475-D46 Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% |
Active (Recruiting) | Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan |
| 6 | Paloma-2 A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer |
Active (Recruiting) | Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors |
| 7 | Tropion Lung-15 A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants with EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer whose Disease has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)r |
Active (Recruiting) | Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer |
| 8 | BGB-LC-201 A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer |
Closed | Study of Tislelizumab in Combination With Investigational Agents |
| 9 | Jimmy Lung A randomized, double-blind, parallel-group study to compare efficacy, safety, and immunogenicity of GME751 (proposed pembrolizumab biosimilar) and EU-authorized Keytruda® in adult participants with untreated metastatic non-squamous non-small cell lung cancer (NSCLC) |
Closed | A Study to compare efficacy, safety, and immunogenicity of GME751 |
| 10 | INSIGHT-2A Phase II, two-arm study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapy |
Closed | Study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) |
| 11 | LAURA A Phase III, randomized, double-blind, placebo-controlled, multicenter, international study of osimertinib as maintenance therapy in patients with locally advanced, unresectable EGFR mutation-positive on-Small Cell Lung Cancer (Stage III) whose disease has not progressed following definitive platinum-based chemoradiation therapy. |
Closed | Study of osimertinib as maintenance therapy in patients with locally advanced |
| 12 | MARIPOSA A Randomized Study of JNJ-61186372 and Lazertinib Combination Therapy Versus Single Agent Osimertinib or Lazertinib as First-Line Treatment in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer. |
Closed | Study of JNJ-61186372 and Lazertinib Combination Therapy Versus Single Agent Osimertinib or Lazertinib as First-Line Treatment |
| 13 | ATORG003 A single-arm, open-label, phase 2 study of Dacomitinib with or without dose titration for the first-line treatment of locally advanced or metastatic non-small cell lung cancer in subjects with an epidermal growth factor receptor (egfr) activation mutation |
Closed | Study of Dacomitinib with or without dose titration for the first-line treatment of locally advanced |
| 14 | ML41262 A Prospective, Multicentre, Genomic Profiling Study In Patients With Locally Advanced Or Metastatic Non-small Cell Lung Cancer (NSCLC) In Malaysia Using Foundation Medicine |
Closed | |
| 15 | INCMGA 0012-304 A Randomized, Double Blind, Phase 3 Study of Platinum-based Chemotherapy with or without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer Participants |
Closed | Study of Platinum-based Chemotherapy with or without INCMGA00012 |
| 16 | PFIZER A7471067 Real-world utilization and outcomes with “study drug” first-line treatment for EGFR mutation-positive advanced non-small cell lung cancer among Asian patients – A multi-center chart review |
Closed | Real-world utilization and outcomes with “study drug” first-line treatment |
| 17 | MK7684A-002 A Phase II, multicenter, randomized study to compare the efficacy and safety of MK-7684A or MK-7684A plus Docetaxel versus Docetaxel monotherapy in the treatment of participants with metastatic non-small cell lung cancer with progressive disease after treatment with a platinum doublet chemotherapy and immunotherapy |
Closed | Study to compare the efficacy and safety of MK-7684A or MK-7684A plus Docetaxel |
| 18 | MARIPOSA2 A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure |
Closed | A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy |
| 19 | ADAURA-2 D516FC00001 – A Phase III, Double-blind, Randomized, Placebo-Controlled, International Study to assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Patients with EGFR mutation-positive, Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete Tumor Resection |
Closed | Study to assess the Efficacy and Safety of Adjuvant Osimertinib |
| 20 | kontRASt-02 CJDQ443B12301 : A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer |
Closed | A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 |
肝细胞癌
| No | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | MO42541
A phase III, open-label, randomized study of atezolizumab with lenvatinib or sorafenib versus lenvatinib or sorafenib alone in HCC previously treated with atezolizumab and bevacizumab |
Closed | Study of atezolizumab with lenvatinib or sorafenib |
结直肠癌
| No | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | Origami-1
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer |
Closed | Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy |
| 2 | MK4280A-007
A Phase 3 study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 positive Colorectal Cancer |
Closed | Study of atezolizumab with lenvatinib or sorafenib |
| 3 | Krystal-10
A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy |
Closed | Study of MRTX849 in Combination with Cetuximab |
实体肿瘤
| No | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | PRL3-Zumab
An Open Label, Multicenter, Safety and Efficacy Phase II/III Study of PRL3-Zumab in Solid Tumors Patients |
Closed | NA |
血液学
| No | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | GCT3014-01
An Open-Label, Multicenter, Phase 1/2 Study of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies |
Closed | Study of GEN3014 (HexaBody®-CD38) |
| 2 | IMR Bortezomib
Genetic Variation Associated with Bortezomib Induced Peripheral Neuropathy in Adult Multiple Myeloma Patients (Investigator initiated study) |
Closed | NA |
前列腺癌
| No | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | CAAA617D12302
An International, Prospective, Open-label, Multi-center, Randomized Phase III Study comparing lutetium (177Lu) vipivotide tetraxetan (AAA617) versus Observation to delay castration or disease recurrence in adult male patients with prostate-specific membrane antigen (PSMA) positive Oligometastatic Prostate Cancer (OMPC) |
Active (Recruiting) | An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC |
研究发表列表
除了肿瘤学临床试验，来自其他卓越中心的顾问也通过发表研究论文为临床专业做出了重大贡献。以下是我们的顾问发表的研究成果（摘要、研究论文、海报等）:
研究发表标题
| No | Publication Title | Name of Consultant | Type of Presentation |
|---|---|---|---|
| 1 | Effectiveness of adjunctive ultrasound after mammography in improving breast cancer screening findings from a study in Malaysian women | Mohamed Ibrahim Wahid, Nurul Alia Azmi, Pei Yun Tan, Bao Jing Chen, |
Original Article |
| 2 | Topical nonsteroidal anti‐inflammatory drugs for management of osteoarthritis pain: A consensus recommendation | Joon-Kiong Lee, Azlina A.Abbas, Tien-Eang Cheah, Ruslan Nazaruddin Simanjuntak, Sargunan Sockalingam, Sharifah Roohi |
Original Article |
| 3 | Retrospective Analysis of Clinical Outcomes of Stereotactic Body Radiation Therapy for Localized Prostate Cancer at an Asian Cancer Specialist Centre | Jasmin Loh Pei Yuin, Jessica Tan Jia Shin, Chen Bao Jing, Tho Lye Mun, Manivanna Arkonam Balasubramaniam, Dato Mohamed Ibrahim Wahid |
Original Article |
| 4 | KASRP
Impact of a digital educational program on nurses’ knowledge and attitudes toward pain assessment and management in a Malaysian hospital. |
Dr Koon Sim Lan Jessica Tan Jia Shin, Ph.D ( Clinical Informatics Specialist) |
|
| 5 | Presenting complaints of patients and palliative care referral patterns | Dr Felicia Chang Dr Azura Jessica Tan Jia Shin, Ph.D (Clinical Informatics Specialist) |
|
| 6 | Breast cancer survivorship in an Asian specialist centre from Malaysia: A retrospective analysis | Dato Ibrahim Dr Azura Arkonam Balasubramaniam Manivannan (Consultant Oncologists) Jessica Tan Jia Shin. Ph. D (Clinical Informatics Specialist) |
Original Article |
| 7 | Does A Picture Really Paint A Thousand Words? A Study On The Technical Qualities Of Online Aesthetic Oculofacial Clinical Photographs | Dr Ong Chin Tuan (Consultant Ophthalmologist) | Poster |
| 8 | Healthcare Performance Measurement And Reporting For Breast Cancer Services in Malaysia | ||
| 9 | Healthcare Performance Measurement And Reporting System (HPMRS) For Cancer Care |
如果您有兴趣并想了解更多关于这些正在进行的试验，请通过+603-7787 2830 与我们联系，或者您可以给我们发邮件 clinicalresearch@beaconhospital.com.my.
Beacon Hospital Independent Ethics Committee
关于 寶康医院独立伦理委员会 (BH-IEC)
寶康医院独立伦理委员会（BH-IEC）是一个独立机构，由接受过医学培训的专业人士、非医学科学家、非科学成员和社会人士组成，负责确保参与试验的受试者的权利、安全和福祉。
委员会通过审查、批准和持续评估试验方案与其修正、任何用于记录受试者同意书的方式与素材，确保参与试验的受试者的权利、安全与福祉受到保护。
BH-IEC 严格遵守当地和国际道德标准，并根据国家指南接受监管检查。
所有临床试验都会遵循《赫尔辛基宣言》伦理原则，并且遵守良好临床实践标准（GCP）和相关国家法规的要求。
BH-IEC 的权威
BH-IEC 的职责包括：
审查研究方案
- 在合理时间内对临床试验进行评估，确保符合伦理标准和指南，并书面记录审查结果，包括试验的基本信息、审核过的文件，以及批准、修改或否决的日期。
知情同意
- 审核知情同意书及相关流程，确保内容完整清晰，便于参与者理解。
研究监督
- 每年至少一次，或依据对受试者风险评估在合适的阶段对正在进行的研究定期进行审查。
保护参与者
- 确保研究参与者的权益、安全和福祉在整个试验过程中得到保障，尤其是涉及弱势群体的试验。
独立评估
- 对研究活动中的伦理问题提供独立、客观和公正的意见。
受试者补偿
- 审查补偿金额、支付方式和时间安排，确保不会对受试者造成胁迫或不当影响。
BH-IEC Committee Member 2024-2026
| Member (Title and Name) | Occupation (Designation) | Male/Female (M/F) |
|---|---|---|
| Chairperson: Dr. Tho Lye Mun | Consultant Clinical Oncologist, Beacon Hospital | Male |
| Deputy Chairman: Dato’ Dr Lee Joon Kiong | Deputy Medical Director, Consultant Orthopaedic Surgeon, Beacon Hospital | Male |
| Secretary (non-voting): R Suntari Ramachandran | Assistant Manager, Clinical Research, Beacon Hospital | Female |
| Secretary (non-voting): Lynette Tan Pei Yun | Clinical Research Analyst, Beacon Hospital | Female |
| (Scientific / Medical) Dato’ Dr Anuar Zaini Md Zain | Professor of Internal Medicine at Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Consultant Endocrinologist, Beacon Hospital | Male |
| (Scientific / Medical) Dr. Leong Kok Weng | Consultant Anaesthesiologist, Beacon Hospital | Male |
| (Scientific / Medical) Dr. Tengku Ahmad Hidayat | Consultant Hematologist, Beacon Hospital | Male |
| (Scientific / Medical) Dr. Koon Sim Lan | Consultant Palliative Medicine, Beacon Hospital | Female |
| (Non-Scientific / Medical) Wong Mei Teng | Manager of Medical Services Development Department | Female |
| (Non-Scientific / Non-Medical) Helen Wong | Legal Representative | Female |
| (Scientific / Non-Medical) Quah Sean I | Representative of Head, Department of Pharmacy | Female |
| (Non-Scientific / Non-Medical) Yong Lee Lee | Public Representative | Female |
Comment: The duration of membership will be two (2) years
BH-IEC 标准操作程序（SOP）
表格
*表格模板可向 BH-IEC 秘书处获取。
BH-IEC 截止日期和会议安排
2024
| 月份 | 会议日期 （可能变更） |
提交截止日期 |
|---|---|---|
| 12 月 | 2024 年 12 月 27 日 | 2024 年 12 月 10 日 |
2025
| 月份 | 会议日期（可能变更） | 提交截止日期 |
|---|---|---|
| 1 月 | 2025 年 1 月 24 日 | 2025 年 1 月 10 日 |
| 2 月 | 2025 年 2 月 21 日 | 2025 年 2 月 7 日 |
| 3 月 | 2025 年 3 月 21 日 | 2025 年 3 月 7 日 |
| 4 月 | 2025 年 4 月 25 日 | 2025 年 4 月 10 日 |
| 5 月 | 2025 年 5 月 23 日 | 2025 年 5 月 9 日 |
| 6 月 | 2025 年 6 月 20 日 | 2025 年 6 月 6 日 |
| 7 月 | 2025 年 7 月 25 日 | 2025 年 7 月 10 日 |
| 8 月 | 2025 年 8 月 22 日 | 2025 年 8 月 8 日 |
| 9 月 | 2025 年 9 月 26 日 | 2025 年 9 月 10 日 |
| 10 月 | 2025 年 10 月 24 日 | 2025 年 10 月 10 日 |
| 11 月 | 2025 年 11 月 21 日 | 2025 年 11 月 7 日 |
| 12 月 | 2025 年 12 月 26 日 | 2025 年 12 月 10 日 |
注意事项
- BH-IEC 的会议日期可能会有所变动。
- 新研究的审查大约需要 60 天，从秘书处收到申请到委员会的首次决定。请提前规划提交时间。
- 建议申请人联系BH-IEC秘书处，以确认会议日期和申请截止日期。
BH-IEC Secretariat
1, Jalan 215, Seksyen 51, Off Jalan Templer, 46050 Petaling Jaya, Selangor
+603-7787 2830
secretariat.bhiec@beaconhospital.com.my
