[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658236":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":44,"studyPopulation":44,"armGroups":51,"interventions":58,"overallOfficials":44,"centralContacts":68,"locations":74,"responsibleParty":91,"collaborators":44,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":44,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":44,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":77,"whyStopped":44,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Objective response rate","Proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1, as assessed by investigators. Tumor assessments will be performed approximately every 6 weeks during the first year, and every 8-12 weeks thereafter.","From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months.",[14,17,21,25,29,32,36,40],{"measure":15,"description":16,"timeFrame":12},"Disease control rate","Proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1, as assessed by investigators. Tumor assessments will be performed approximately every 6 weeks during the first year, and every 8-12 weeks thereafter.",{"measure":18,"description":19,"timeFrame":20},"Progression-Free Survival","Progression-Free Survival is defined as the time from the date of first study drug administration to the first occurrence of disease progression according to RECIST version 1.1, as assessed by investigators, or death from any cause.","From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months.",{"measure":22,"description":23,"timeFrame":24},"Overall Survival","Overall survival is defined as the time from the date of first study drug administration to death from any cause.","From the date of first study drug administration until the date of death from any cause or the date of last valid follow-up, whichever came first, assessed up to approximately 24 months.",{"measure":26,"description":27,"timeFrame":28},"Duration of Response","Duration of response is defined as the time from the date of the first documented CR or PR to the date of the first documented disease progression according to RECIST version 1.1 or death from any cause.","From the date of first documented CR or PR until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months.",{"measure":30,"description":31,"timeFrame":12},"Clinical Benefit Rate","Proportion of participants who achieve CR, PR, or durable stable disease (SD) lasting for a predefined duration (e.g., ≥24 weeks) according to RECIST version 1.1.",{"measure":33,"description":34,"timeFrame":35},"Progression-Free Survival rate at 3 and 6 months","The proportion of participants who remain alive and progression-free at 3 months and 6 months after the first study drug administration, according to RECIST version 1.1.","At 3 months and 6 months after the first study drug administration.",{"measure":37,"description":38,"timeFrame":39},"Mortality rate at 6 and 12 months","The proportion of participants who have died from any cause at 6 months and 12 months after the first study drug administration.","At 6 months and 12 months after the first study drug administration.",{"measure":41,"description":42,"timeFrame":43},"Incidence of Adverse Events","Safety and tolerability will be evaluated by assessing the incidence, type, and severity of adverse events, treatment-related adverse events, serious adverse events, and clinically significant abnormalities in laboratory test results and vital signs. Adverse events will be graded according to NCI CTCAE version 5.0.","From the date of first study drug administration until 90 days after the date of last study drug administration, with all adverse events monitored and documented continuously.",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"NA","SINGLE_GROUP","TREATMENT",{"masking":50,"maskingDescription":44,"whoMasked":44},"NONE",[52],{"label":53,"type":54,"description":44,"interventionNames":55},"sacituzumab tirumotecan combined with pembrolizumab","EXPERIMENTAL",[56,57],"Drug: Sacituzumab Tirumotecan (SKB264)","Drug: Pembrolizumab",[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":44},"DRUG","Sacituzumab Tirumotecan (SKB264)","Sacituzumab tirumotecan will be administered at a dose of 4 mg\u002Fkg via intravenous infusion every 2 weeks. The treatment will continue until documented disease progression, occurrence of unacceptable toxicity, withdrawal of consent, or other protocol-specified criteria for discontinuation are met.",[53],{"type":60,"name":65,"description":66,"armGroupLabels":67,"otherNames":44},"Pembrolizumab","Pembrolizumab will be administered at a fixed dose of 200 mg via intravenous infusion every 3 weeks. The treatment will continue until documented disease progression, occurrence of unacceptable toxicity, withdrawal of consent, or other protocol-specified criteria for discontinuation are met.",[53],[69],{"name":70,"role":71,"phone":72,"phoneExt":44,"email":73},"Haitao Zhao, DR","CONTACT","+86-10-69156042","zhaoht@pumch.cn",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College","RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":84,"coordinates":85},"Point",[86,87],116.39723,39.9075,{"lat":87,"lon":86},[90],{"name":70,"role":71,"phone":72,"phoneExt":44,"email":73},{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"SPONSOR_INVESTIGATOR","Haitao Zhao, MD","Deputy Director, Department of Liver Surgery","100658236","phase-2-a-prospective-study-of-sacituzumab-tirumotecan-plus-pembrolizumab-for-advanced-biliary-tract-cancer-100658236",false,"NCT07850791","A Prospective Study of Sacituzumab Tirumotecan Plus Pembrolizumab for Advanced Biliary Tract Cancer","A Prospective, Multicenter, Single-Arm, Phase II Clinical Study of Sacituzumab Tirumotecan Plus Pembrolizumab as Second-Line Treatment for Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n1. 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 \\\u003C 75 years of age at the time of signing the ICF, with no gender restrictions.\n2. 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.\n3. Disease progression after one or more prior lines of standard therapy.\n4. Ineligible for radical surgery\u002Flocal 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.\n5. 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).\n6. ECOG performance status of 0 or 1 within 1 week prior to enrollment. Estimated life expectancy of ≥ 3 months as assessed by the investigator.\n7. 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):\n\n   Hematology: (No blood transfusion, no G-CSF administration, and no pharmacological correction within 14 days prior to screening) Hemoglobin (Hb) ≥ 90 g\u002FL; Absolute Neutrophil Count (ANC) ≥ 1.5 \\* 10\\^9\u002FL; Platelets (PLT) ≥100 \\* 10\\^9\u002FL.\n\n   Biochemistry: (No albumin transfusion within 14 days) Adequate liver function: ALT and AST ≤ 2.5 $\\\\times$ Upper Limit of Normal (ULN); for patients with liver metastases, ALT and AST ≤ 5 \\* ULN.\n\n   Serum bilirubin ≤ 2.0 \\* ULN; these criteria do not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction must be relieved prior to enrollment.\n8. Adequate renal function: Serum creatinine ≤ 1.5 \\* ULN, or creatinine clearance (CrCl) \\> 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula):\n\n   Female: CrCl = ((140 - Age) \\* Weight (kg) \\* 0.85) \u002F (72 \\* Serum Creatinine (mg\u002FdL)); Male: CrCl = ((140 - Age) \\* Weight (kg) \\* 1.00) \u002F (72 \\* Serum Creatinine (mg\u002FdL)).\n9. Women of childbearing potential: Must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with an annual failure rate of \\\u003C 1% during the treatment period and for at least 6 months after the last dose of study medication.\n10. Males: Must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree not to donate sperm.\n\nExclusion Criteria:\n\n1. Prior treatment with TROP2-targeted therapy and\u002For topoisomerase I inhibitors.\n2. Patients currently receiving approved or investigational systemic anti-cancer therapies, including chemotherapy, biological immunotherapy, targeted therapy, or traditional Chinese medicine with specific anti-cancer indications. (Such treatments are permitted if completed at least 4 weeks prior to enrollment).\n3. Histopathological findings indicating mixed hepatocellular cholangiocarcinoma, the presence of squamous cell carcinoma or sarcomatoid components, or ampullary carcinoma.\n4. Presence of other uncured malignancies within the past 5 years (excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ).\n5. Clinically significant gastrointestinal diseases.\n6. Clinically significant cardiovascular or cerebrovascular diseases.\n7. Hepatic or renal insufficiency:\n\n   Hepatic insufficiency: e.g., presence of jaundice, ascites, and\u002For bilirubin \\> 3 \\* ULN.\n\n   Renal insufficiency: Urine protein-to-creatinine ratio \\> 3.5 g\u002F24 hours, routine urinalysis showing proteinuria ≥ ++, confirmed 24-hour urine protein \\> 1.0 g, or renal failure requiring hemodialysis or peritoneal dialysis.\n\n   Received strong CYP3A4 inhibitors within 7 days prior to study entry, or strong CYP3A4 inducers within 12 days prior to study entry.\n8. Active autoimmune disease, a history of autoimmune disease, or risk of immune-mediated diseases:\n\n   Active Hepatitis B \\[Hepatitis B surface antigen (HBsAg) positive, requiring HBV-DNA testing; HBV-DNA ≥ 500 IU\u002FmL or above the lower limit of detection (LLOD), whichever is higher\\] or Hepatitis C (HCV antibody positive, and HCV-RNA above the LLOD). Note: Subjects who are HBsAg positive are required to receive anti-HBV therapy during the study treatment period.\n9. Neurological diseases:\n\n   Patients with epilepsy requiring pharmacological treatment. Known active central nervous system metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases who have stable brain metastatic disease (no evidence of progression on imaging for at least 4 weeks prior to the first study treatment, and any neurological symptoms have returned to baseline) are eligible to participate, provided there is no evidence of new or enlarging brain metastases, and they have not used steroids for at least 7 days prior to study treatment. However, patients with carcinomatous meningitis are excluded regardless of clinical stability.\n10. Presence of an ongoing or active infection.\n11. Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or a history of corneal diseases that may interfere with or delay corneal healing.\n12. Pregnant or lactating women.\n13. Any condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug, subject safety, or the interpretation of study results, or any other condition rendering the subject unsuitable for participation in the study.","ALL","18 Years","75 Years",{"count":106,"type":107},38,"ESTIMATED","INTERVENTIONAL",[110],"PHASE2","The purpose of this study is to explore the effects of sacituzumab tirumotecan combined with pembrolizumab on survival, disease progression, and safety in patients with advanced biliary tract malignancies in the second-line and later settings. This is a multicenter, phase II, interventional single-arm clinical study. A total of 38 participants will be enrolled. Participants will receive the combination therapy until disease progression or unacceptable toxicity.",[113],"Biliary Tract Cancer (BTC)",[115,65,116,117],"Sacituzumab Tirumotecan","Second-line","TROP-2","2026-09-30",{"date":120,"type":121},"2026-10-05","ACTUAL",{"date":123,"type":107},"2026-10",{"date":125,"type":107},"2029-12",{"name":93,"class":6},1]