临床试验和研究是寶康醫院临床研究中心实践循证临床研究的关键组成部分。
临床试验为癌症患者测试新的治疗方式，如新的药物、新的治疗组合、新的手术方式或放射治疗，又或者是全新疗法如基因治疗。这些研究和试验的最终目标，就是要找出更多更好的方式来治疗癌症，帮助癌症患者。
临床研究中心
如果在研究中得以证明一项新的治疗是有效的，它将可能成为可以帮助更多患者的新标准疗法。如今，大多数最有效的标准治疗方法都是基于先前的研究成果，例如乳腺癌，结肠癌，直肠癌和儿童期癌症的治疗结果。
参与临床实验的患者可能会从疗程中获益。参与试验者从癌症专家那里得到最新的护理，他们将接受目前处于测试阶段的新疗法或针对他们的癌症而定制的最佳标准疗法。
由于不能保证所测试的新疗法不会带来风险或产生良好的结果，但是如果新疗法被证明比标准疗法有效或更有效，则临床试验的参与者可能是第一个受益的人。
研究对于提高治疗水平非常重要，但寶康醫院的临床研究中心把参与临床试验参与者的权利，安全和福祉作为优先考量事项。除了我们所有的临床研究均已获得马来西亚卫生部医学和研究伦理委员会的核准外，我们也遵守本地和国际良好临床实践（GCP）标准，以维护试验者的道德利益。
迄今为止，我们的肿瘤科团队已参与了不少临床试验，其中包括比较不同化疗方案的疗效；对抑制剂的抵抗；鼻咽癌的表观遗传变化；以及晚期或转移性胃食管癌的治疗方案等。
肺癌
| No. | Clinical Trial | Status |
|---|---|---|
| 1 | ATORG 001 A prospective, molecular profiling study of mutational genes in Asian patients with Non-Small Cell Lung Cancer. (Non-interventional study). |
进行中 (招募病人) |
| 2 | 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. |
进行中 (招募病人) |
| 3 | ATORG004 Plasma Molecular Profiling in ALK inhibitor resistant non-small cell lung cancer. |
进行中 (招募病人) |
| 4 | InCyte Podium (INCMGA0012-304) 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 (POD1UM 304). |
进行中 (招募病人) |
| 5 | 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. |
进行中 (招募病人) |
| 6 | 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. |
进行中 (招募病人) |
| 7 | MARIPOSA2 A phase 3, Open-Label, Randomised Study of Amivantamab and Lazertinib in Combination with Platinum-Based Chemotherapy Compared with Platinum-Based Chemotherapy in Patients with EGFR-Mutated Advanced or Metastatic NSCLC After Osimertinib Failure. |
进行中 (招募病人) |
| 8 | 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. |
进行中 (招募病人) |
| 9 | Adaura 2 A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete Tumour Resection. |
进行中 (招募病人) |
| 10 | MK7684A-002 A Phase 2, Multi-Center, Randomised study to compare the efficacy and safety of MK-7684-A or MK-7684-A Plus Docetaxel versus Docetaxel Monotherapy in the treatment of participants with Metastatic NSCLC with progressive disease after treatment with a Platinum Doublet Chemo or Immunotherapy. |
进行中 (停止招募病人) |
| 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 (LAURA). |
停止 (停止招募病人) |
| 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. |
进行中 (停止招募病人) |
| 13 | MS200095-0031-INSIGHT 2 A Phase II, two-arm study to investigate tepotinib combined with osimertinib in MET 1amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior Osimertinib therapy. |
进行中 (停止招募病人) |
| 14 | CT-P16 3.1 A double-blind, randomized, active-controlled, parallel-Group, Phase 3 study to compare efficacy and safety of CT-P16 and EU-approved Avastin as first-line treatment for metastatic or recurrent non-squamous non-small cell lung cancer. |
进行中 (停止招募病人) |
| 15 | MK7902-007 A Phase III, randomized, double-blind trial of Pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) in participants with treatment-naïve, metastatic non-small cell lung cancer (NSCLC) whose tumors have a tumor proportion score (TPS) greater than or equal to 1% (LEAP-007). |
进行中 (停止招募病人) |
| 16 | KontRASt-02 Study of JDQ443 in Comparison With Docetaxel in Participants with Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer |
全新 (即将推出) |
| 17 | PALOMA 3 A Phase 3, Open-label, Randomized Study of Lazertinib with Subcutaneous Amivantamab Administered via Manual Injection Compared with Intravenous Amivantamab or Amivantamab Subcutaneous On Body Delivery System in Patients with EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy |
全新 (即将推出) |
| 18 | PALOMA 2 A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients with Advanced or Metastatic Solid Tumors including EGFR-mutated Non-Small Cell Lung Cancer. |
全新 (即将推出) |
| 19 | MK3475-D46 An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator-Controlled Clinical Study of Pembrolizumab (MK‑3475) in Combination with Sacituzumab Govitecan Versus MK‑3475 Monotherapy as First-line Treatment in Participants With PD-L1 Positive Advanced Non-small Cell Lung Cancer (KEYNOTE-D46/EVOKE-03). |
全新 (即将推出) |
| 20 | MK3475-042 A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) versus Platinum Based Chemotherapy in Treatment Naive Subjects with PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042). |
完成 |
| 21 | EMR200095-006 Phase Ib/II Multicentre, Randomized Open Label Trial to Compare (MSC2156119J) Combined Gefitinib Versus Chemotherapy as Second Line Treatment in Subject with MET (+), Locally Advanced / Metastatic Non-Small Lung Cancer (NSCLC) Harbouring EGFR Mutation and Having Acquired Resistance to Prior EGFR-Tyrosine Kinase Inhibitor. |
完成 |
| 22 | A Multiple Center, Open-Label, Randomized Phase III Study To Evaluate The Efficacy And Safety Of Erlotinib (Tarceva®) Versus Gemcitabine / Cisplatin As The First-Line Treatment For Stage IIIB / IV Non-Small Cell Lung Cancer (NSCLC) Patients With Mutations In The Tyrosine Kinase Domain Of Epidermal Growth Factor Receptor (EGFR) In Their Tumors. | 完成 |
乳癌
| No. | Clinical Trial | Status |
|---|---|---|
| 1 | EPIK-B3 A Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess safety and efficacy of alpelisib (BYL719) in combination with nab-paclitaxel in patients with advanced triple negative breast cancer (TNBC) with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation. |
进行中 (招募病人) |
| 2 | 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 trastuzumab and pertuzumab as maintenance therapy in patients with HER2-positive advanced breast cancer with a PIK3CA mutation. |
进行中 (招募病人) |
| 3 | 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. |
进行中 (招募病人) |
| 4 | CAPITELLO-292 A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer. |
全新 (即将推出) |
| 5 | TROIKA A randomised, double-blind, parallel group, equivalence, multicentre phase III trial to compare the efficacy, safety, and pharmacokinetics of HD201 to Herceptin® in patients with HER2+ early breast cancer. |
完成 |
| 6 | CLEE011A2404 An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribocliclib (LEE11) in combination with letrozole for the treatment of men and postmenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC) with no prior hormonal therapy for advanced disease. |
完成 |
| 7 | Healthcare Performance Measurement and Reporting For Breast Cancer Services In Malaysia | 完成 |
结直肠癌
| No. | Clinical Trial | Status |
|---|---|---|
| 1 | Krystal 10 Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation. |
进行中 (招募病人) |
| 2 | 61186372GIC2002 A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer. |
进行中 (招募病人) |
| 3 | MK-4280A-007 A Phase 3 study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PDL1 positive Colorectal Cancer metastatic colorectal adenocarcinoma whose tumors are positive for PD-L1 CPS≥1, have pMMR status based on IHC testing at screening have progressed on or could not tolerate prior line(s) of therapy. |
进行中 (停止招募病人) |
其他
| No. | Clinical Trial | Status |
|---|---|---|
| 1 | MO42541- IMBRAVE251 A Phase III, open-label, randomised study of Atezolizumab with Lenvatinib or Sorafenib versus Lenvatinib or Sorafenib alone in hepatocellular carcinoma previously treated with atezolizumab and bevacizumab. |
进行中 (招募病人) |
| 2 | MK3475-394 A Phase III Randomized Double-Blind study of pembrolizumab plus best supportive care as second-line therapy in Asian subjects with previously systematically treated advanced hepatocellular carcinoma. |
进行中 (停止招募病人) |
| 3 | Invitrocue PDO for drug screening Validating the use of patient-derived organoids for predicting drug response to chemotherapy in patients with advanced solid cancers. |
进行中 (招募病人) |
| 4 | BTM ASEAN Bone turnover markers reference database in five South East Asia Countries. |
完成 |
| 5 | Keynote-590 A randomized, double-blind, placebo-controlled phase III clinical trial of pembrolizumab (MK-3475) in combination of cisplatin and 5FU versus placebo in combination with cisplatin and 5FU as first-line treatment in subjects with advanced/metastatic esophageal carcinoma. |
完成 |
| 6 | Tessa FF01 A Multicentre, Randomised, Open-label, Phase III Clinical Trial of Gemcitabine and Carboplatin followed by Epstein-Barr virus-specific Autologous Cytotoxic T Lymphocytes vs Gemcitabine andCarboplatin as first line treatment for Advanced NPC. |
完成 |
| 7 | Hyperthermia – REMISSION 1C Hyperthermia in Treating Patients with Unresectable Abdominal, Pelvic tumours and Cutaneous and Peritoneal Metastases. |
完成 |
| 8 | Studies On Epigenetic Changes in Nasopharyngeal Cancer. |
完成 |
| 9 | Healthcare Performance Measurement and Reporting System (HPMRS) For Cancer Care. | 完成 |
| 10 | A Randomized, Phase II, Placebo Controlled Study of Lacebo Controlled Study Of GDC-0068, An Inhibitor To AKT, In Combination With Fluoropyrimidine Plus Oxaliplatin In Patients With Locally Advanced Or Metastatic Gastric Or Gastroesophageal Junction Adenocarcinoma. | 完成 |
| 11 | An Open-Label, Randomized Phase 3 Study Of The Efficacy And Tolerability Of Linifanib (ABT-869) Versus Sorafenib In Subjects With Advanced Hepatocellular Carcinoma (HCC). |
完成 |
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）：
|
No. |
Publication Title |
Name of Consultant |
Type of Presentation |
|
1 |
Healthcare Performance Measurement and Reporting System (HPMRS) for Cancer Care |
–
|
–
|
|
2 |
Healthcare Performance Measurement and Reporting for Breast Cancer Services in Malaysia |
–
|
–
|
|
3 |
Does A Picture Really Paint a Thousand Words? A Study on The Technical Qualities Of Online Aesthetic Oculofacial Clinical Photographs |
Dr Ong Chin Tuan |
|
|
4 |
Breast cancer survivorship in an Asian specialist centre from Malaysia: A retrospective analysis |
Dato Ibrahim |
|
|
5 |
Presenting complaints of patients and palliative care referral patterns |
Dr Felicia Chang |
–
|
|
6 |
KASRP |
Dr Koon Sim Lan |
–
|
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 2854与我们联系，或者您可以给我们发邮件 clinicalresearch@beaconhospital.com.my.
