招募臨床研究志願者 (大腸癌研究) / Recruiting Clinical Study Volunteers (Colorectal Cancer Study)
香港聯合腫瘤中心正在進行 VVD-133214 大腸癌 臨床研究，招募先前未接受過針對轉移性疾病系統治療的微衛星不穩定（MSI）及/或錯配修復功能缺陷（dMMR）晚期（不可切除及/或轉移性）結直腸腺癌 (CRC) 患者參與，比較 VVD-133214 合併帕博利珠單抗（匹博利組單抗）與帕博利珠單抗（匹博利組單抗）單藥的療效。
研究名稱 / Study Name
一項評估 VVD-133214 合併帕博利珠單抗對比帕博利珠單抗單藥治療 MSI 及/或 dMMR 晚期結直腸腺癌患者的第二期、隨機、開放標籤臨床研究。
Phase 2 Randomized, Open-Label, Multicenter Study of VVD-133214 in Combination with Pembrolizumab Compared to Pembrolizumab Monotherapy in Participants with Advanced Colorectal Adenocarcinoma (CRC) Harboring MSI and/or dMMR.
ClinicalTrials.gov Identifier: 待定（查看詳細研究資料） / Pending
病人申請資格 / Patient Eligibility
患有微衛星不穩定（MSI）及/或錯配修復功能缺陷（dMMR）晚期（不可切除及/或轉移性）結直腸腺癌的患者
Patient with pathologically confirmed MSI and/or dMMR advanced (unresectable and/or metastatic) colorectal adenocarcinoma
年齡 ≥ 18 歲
Age ≥ 18 years
未曾接受針對轉移性疾病的全身性系統治療
No prior systemic treatment for metastatic disease
研究報酬 / Study Compensation
相關治療藥物、研究影像掃描費用及醫生診症費用全免。 All study medications, study required imaging and doctor consultation will be free of charge
研究過程 / Study Process
若您合乎資格參與本研究，您將隨機分配使用：VVD-133214 (口服) + 帕博利珠單抗 (靜脈輸注)
帕博利珠單抗單藥 (靜脈輸注)
備註：VVD-133214 是一種新型口服靶向藥物，旨在藉由阻斷名為「華納症候群解旋酶」（Werner syndrome helicase, WRN）的蛋白質活性，進而導致具有 MSI 及/或 dMMR 特徵的癌細胞中的 DNA 受損。透過此機制，我們期望能在癌細胞內累積 DNA 的損傷程度，從而有助於減緩或停止癌細胞的生長。
English: If you qualify to participate in this study, you will be randomly assigned to receive:
VVD-133214 (oral) + Pembrolizumab (IV)
Pembrolizumab (IV) alone
Note: VVD-133214 is a new drug, which is designed to block the activity of a protein called Werner syndrome helicase (WRN) causing DNA damage in cancer cells. By doing this, we hope to build up the DNA damage which may help slow down or stop the growth of cancer cells.
相關風險 / Related Risks
患者必需了解研究的目的及有機會帶來的潛在風險。在研究期間，您可能會因為接受試驗藥物而有不適。不適和風險程度可能會因人而異。 Participants should be aware of the objectives and potential risks of the trial. During the study, you may experience discomfort and risks associated with the treatments, which may vary from person to person.
聯絡方式 / Contact Us
有意參加者或欲了解初步評估詳情，可經以下方法與我們聯絡： Please contact us if you are interested or need further information:
WhatsApp：5518 2992
微信: hkuoc23868002
相關資源 / Related Resources
查詢更多研究項目：香港聯合腫瘤中心臨床研究頁面
For more clinical studies: HKUOC Clinical Study Page.
了解更多關於大腸癌的資訊：癌症網上資源中心 – 本地癌症 – 香港常見癌症 – 大腸癌
Learn more aboutColorectal Cancer: Cancer Online Resource Hub – Cancers in Hong Kong – Common Cancers in Hong Kong – Colorectal Cancer
研究贊助商 / Sponsor：
Vividion Therapeutics, Inc. (A Bayer Company)
(註：宣傳內容已獲香港腫瘤學研究學會醫學倫理委員會審核並且批准刊登及發佈 / Remarks: This advertisement has been reviewed and approved for publication by the Research Ethics Committee of the Hong Kong Oncology Study Group.)