一分钟看懂
这是一项关于胆道癌的II 期研究，登记的药物或干预包括Sacituzumab Tirumotecan (SKB264)；Pembrolizumab，当前状态为招募中。登记地点显示中国北京有研究中心记录。是否仍有名额以及是否值得进一步询问，需要向研究中心确认。
药物或干预
Sacituzumab Tirumotecan (SKB264)；Pembrolizumab · II 期
登记条件中文摘要
年龄范围：18岁至75岁
登记的基本范围为不限性别，年龄18岁至75岁；以下仅摘录8项专业入选条件，需结合英文原文并由研究团队确认。
登记记录列出8项主要排除条件，具体医学含义需结合英文原文并由研究团队确认。
中国哪些地方有记录
以下地点来自登记信息，不代表此刻仍有名额；请向研究中心确认最新情况。
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College · 北京
入选条件原文摘录
以下为摘录，请打开原始登记查看完整入排标准。
- 1. Subjects must voluntarily participate in the study, sign a written informed consent form (ICF), demonstrate good compliance, and cooperate with follow-up visits. Subjects must be $\\ge$ 18 and \< 75 years of age at the time of signing the ICF, with no gender restrictions.
- 2. Histologically and radiologically confirmed advanced biliary tract cancer (BTC) that is unresectable, recurrent, locally advanced, or metastatic, defined as Stage IIIA or higher according to the AJCC 8th edition staging system, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.
- 3. Disease progression after one or more prior lines of standard therapy.
- 4. Ineligible for radical surgery/local therapy for at least 4 weeks prior to baseline assessment, or experienced disease progression thereafter. The aforementioned treatments include lesion resection, ablation, transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiotherapy, etc. All acute toxicities from local therapy must have resolved to ≤ Grade 1 per CTCAE v5.0.
- 5. Presence of at least one measurable lesion (according to RECIST v1.1, the measurable lesion must have a longest diameter ≥ 10 mm by spiral CT scan, or a short axis ≥ 15 mm for enlarged lymph nodes).
- 6. ECOG performance status of 0 or 1 within 1 week prior to enrollment. Estimated life expectancy of ≥ 3 months as assessed by the investigator.
- 7. Adequate hematological and organ function, based on the following laboratory results obtained within 14 days prior to the initiation of study treatment (unless otherwise specified):
- Hematology: (No blood transfusion, no G-CSF administration, and no pharmacological correction within 14 days prior to screening) Hemoglobin (Hb) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5 \* 10\^9/L; Platelets (PLT) ≥100 \* 10\^9/L.
联系前需要确认
请继续确认中心是否启动、疾病分型、既往治疗、检查费用和知情同意安排。
查看登记信息
登记号：NCT07850791；登记信息更新于 2026-10-05；本站同步于 2026-10-08，中国中心当前名额未经人工确认。