[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intrahepatic-cholangiocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intrahepatic-cholangiocarcinoma":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,40,0,25,[9,52,88,115,151,175,197,225,245,273,304,334,356,380,406,429,450,471,492,515,542,574,596,615,632],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100605991","phase-1-a-study-to-investigate-alep03-as-monotherapy-in-adult-patients-with-selected-advanced-or-metastatic-cldn1-solid-tumors-100605991",false,"NCT07169734","A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","A Phase I\u002FII, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","Inclusion Criteria:\n\n* Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.\n* Have documented radiological disease progression at study entry.\n* Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.\n\nPhase I Dose Escalation:\n\n\\- Received and being refractory\u002Fintolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.\n\nPhase I RDE and Phase II:\n\n* Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.\n* Patients with actionable oncogenic drivers: received feasible targeted therapy.\n\nApplicable for Phase I Dose Escalation, Phase I RDE and Phase II:\n\n* Measurable disease per RECIST 1.1, as determined by the site.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.\n* Demonstrate adequate bone marrow and organ function as per the protocol.\n\nExclusion Criteria:\n\n* SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.\n* Has received antineoplastic therapies prior to study intervention within specified time frame.\n* Has rapidly progressing disease.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has a history of (non-infectious) interstitial lung disease\u002Fpneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and\u002For immunosuppressive therapies.\n* Has clinically significant gastrointestinal bleeding.\n* Has an active infection requiring systemic treatment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.","ALL","18 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P03 monotherapy in adult patients with selected squamous solid tumors.",[28,29,30,31,32],"Cervical Squamous Cell Carcinoma","Squamous Non-small-cell Lung Cancer","Colorectal Cancer","Intrahepatic Cholangiocarcinoma","Urothelial Carcinoma",[34,35,36,37,38],"Claudin-1 Targeted Antibody-Drug Conjugate","Monotherapy","First-in-Human","Recommended Phase 2 dose","Recommended dose for expansion","RECRUITING","2026-07-01",{"date":42,"type":43},"2026-07-02","ACTUAL",{"date":45,"type":43},"2025-08-26",{"date":47,"type":21},"2029-10-04",{"name":49,"class":50},"Alentis Therapeutics AG","INDUSTRY",41,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100592225","outpatient-versus-inpatient-care-pathway-for-intra-arterial-treatment-of-primary-liver-cancer-choc-100592225","NCT06990659","Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC)","CHOC - Implementation and Evaluation of an Ambulatory Care Pathway for Intra-arterial Treatment of Primary Liver Cancer: Study Protocol for a Multicentre Randomised Controlled Hybrid Type 1 Trial Implémentation et évaluation d'un Parcours de Soin Ambulatoire Pour Les Patients traités Par Voie Intra-artérielle d'un Cancer Primitif du Foie : Essai Multicentrique contrôlé randomisé","CHOC","Inclusion Criteria:\n\n* Age ≥ 18 years\n* HCC or iCCA diagnosed according to the criteria of the European Association for the Study of the Liver (2024) or histologically proven.\n* Patient with HCC or iCCA eligible for intra-arterial treatment (transarterial chemoembolization \\[TACE\\] or transarterial radioembolization \\[TARE\\]), with no prior intra-arterial treatment of the same type as the one planned in the trial:\n\n  * no prior TACE for patients included for TACE;\n  * no prior TARE for patients included for TARE. Prior intra-arterial treatment of the other type is allowed (prior TACE before TARE, or prior TARE before TACE). Prior non-intra-arterial treatments are allowed.\n* If TACE is proposed at the multidisciplinary tumour board (RCP):\n\n  * Patient Child-Pugh \\\u003C B8\n  * Single or multiple HCC\n  * Absence of lobar or truncal portal obstruction\n  * Absence of bile duct dilatation\n* If treatment by TARE proposed in RCP:\n\n  * Absence of truncal portal tumor invasion\n  * Uni-lobar tumor invasion (except for centrohepatic iCCA)\n  * Total bilirubin \\\u003C 20 mg\u002Fl (or 35 µmol\u002FL)\n* Patient affiliated to or benefiting from a social security scheme\n* Patient having signed an informed consent form\n\nExclusion Criteria:\n\n* Technical contraindication or morphological elements of predictable technical difficulty\n* Planned combined same-day therapeutic strategies at the index procedure (e.g., TACE combined with percutaneous ablation) are not allowed; sequential (non-same-day) treatments are allowed.\n* Chronic renal insufficiency (Clairance \\\u003C 30 ml\u002Fmin)\n* Known allergy to a contrast agent or chemotherapy agent\n* inability to participate in ambulatory care (inability to understand and follow discharge instructions, lack of reliable telephone access, absence of a responsible accompanying adult for the first night after discharge, or inability to access urgent care in a timely manner if symptoms occur)\n* Patient previously included in the study\n* Patient who, for psychological, social, family or geographical reasons, could not be regularly monitored, patient who, for psychological, social, family or geographical reasons, could not be followed regularly\n* Concomitant disease or severe uncontrolled clinical situation\n* Severe uncontrolled infection\n* Pregnant, breast-feeding or parturient woman\n* Person deprived of liberty by judicial or administrative decision\n* Person under compulsory psychiatric care\n* Person under a legal protection measure\n* Person unable to give consent",{"count":61,"type":21},206,[63],"NA","Randomized multicentre trial comparing two care organisations (ambulatory vs conventional inpatient) for patients undergoing transarterial chemoembolization (TACE) or radioembolization (TARE) for primary liver cancer (Hepato Cellular Carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA)). Patients are followed for 7 months to assess patient satisfaction, safety and clinical outcomes. A qualitative implementation study and a medico-economic evaluation (cost analysis and 5-years budget impact analysis) are embedded to assess acceptability, adoption, feasability, and sustainability and to inform scaling.",[66,31],"Hepato Cellular Carcinoma (HCC)",[68,69,70,71,72,73,74,75,76,77],"ambulatory care","hospitalization","Hepato cellular carcinoma","Patient satisfaction","randomized trial","chemoembolization","radioembolization","Intrahepatic","Cholangiocarcinoma","Primary liver cancer","2026-06-30",{"date":42,"type":43},{"date":81,"type":43},"2025-12-18",{"date":83,"type":21},"2028-12-17",{"name":85,"class":86},"University Hospital, Angers","OTHER_GOV",19,{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100523866","locally-ablative-therapy-for-oligo-progressive-gastrointestinal-malignancies-livelong-100523866","NCT06101277","Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)","LIVELONG","Inclusion Criteria:\n\n1. Must have one of the following histologically and\u002For biochemically confirmed cancers:\n\n   1. Cohort A: (Cohort removed in protocol version 4.0)\n   2. Cohort B: Small bowel\n   3. Cohort C: Pancreatic and ampullary, colorectal, and appendiceal\n   4. Cohort D: (Cohort removed in protocol version 4.0)\n2. Provision of signed and dated informed consent form.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Age ≥18 years at time of consent.\n5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.\n6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \\[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\\]\n7. ≤ 5 progressing or new metastatic lesions.\n8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and\u002F interventional radiologist.\n\nExclusion Criteria:\n\n1. Medical comorbidities precluding locally ablative therapies.\n2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.\n3. Progressing intracranial lesions.",{"count":96,"type":21},300,[63],"This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.",[100,30,101,102,103,31,104,105],"Small Bowel Cancer","Appendiceal Cancer","Biliary Cancer","Gall Bladder Cancer","Extrahepatic Cholangiocarcinoma","Oligoprogressive",{"date":42,"type":43},{"date":108,"type":43},"2023-10-05",{"date":110,"type":21},"2039-09-15",{"name":112,"class":113},"University of California, Davis","OTHER",1,{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":114},"100642684","phase-1-dual-target-her2cea-car-nk-cells-in-advanced-biliary-tract-cancer-100642684","NCT07641036","Dual-Target HER2\u002FCEA CAR-NK Cells in Advanced Biliary Tract Cancer","A Phase 1\u002F2, Open-Label, Biomarker-Selected Study of Allogeneic Dual-Target HER2\u002FCEACAM5 Chimeric Antigen Receptor Natural Killer Cells (EB-HC01) in Participants With Unresectable or Metastatic Cholangiocarcinoma and Other Biliary Tract Cancers","DUET-BTC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable, recurrent, or metastatic intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma.\n* Disease progression after at least 1 prior gemcitabine\u002Fplatinum-containing regimen in the advanced setting; prior durvalumab and prior HER2-targeted therapy are allowed.\n* Central biomarker confirmation of HER2 positivity (IHC 3+ or IHC 2+\u002FISH+ or ERBB2 amplification) and CEACAM5\u002FCEA positivity (membranous expression in \\>=20% of viable tumor cells by IHC).\n* At least 1 measurable lesion according to RECIST 1.1.\n* ECOG performance status 0-1.\n* Adequate marrow, renal, hepatic, and cardiac function as defined by the protocol.\n* Resolved biliary obstruction or stable internal\u002Fexternal drainage for \\>=7 days before lymphodepletion, with no active cholangitis.\n* Life expectancy \\>=12 weeks.\n* Willingness to provide archival or fresh tumor tissue and serial blood samples for central biomarker testing and correlative studies.\n* Agreement to use protocol-specified contraception\n\nExclusion Criteria:\n\n* Prior HER2-directed or CEA-directed gene-modified cell therapy.\n* Untreated or unstable CNS metastases or leptomeningeal disease.\n* Active uncontrolled infection, including uncontrolled cholangitis, sepsis, or clinically significant uncontrolled hepatitis or HIV infection.\n* Ongoing systemic immunosuppression greater than 10 mg\u002Fday prednisone equivalent within 7 days before lymphodepletion.\n* Clinically significant interstitial lung disease, uncontrolled heart failure, unstable arrhythmia, or recent myocardial infarction.\n* Child-Pugh B or C liver disease, hepatic encephalopathy, or clinically significant refractory ascites.\n* Prior allogeneic solid organ transplant or allogeneic stemcell transplant.\n* Active autoimmune disease requiring systemic therapy within the previous 2 years.\n* Pregnancy or breastfeeding.\n* Any condition that, in the investigator's judgment, would make lymphodepletion or EB-HC01 infusion unsafe or would interfere with protocol compliance.",{"count":124,"type":21},30,[24,25],"This example phase 1\u002F2, open-label, biomarker-selected study evaluates EB-HC01, an allogeneic dual-target CARNK product composed of a 1:1 mixture of HER2-CAR-NK and CEACAM5-CAR-NK cells, in adults with unresectable or metastatic cholangiocarcinoma or other biliary tract cancers after standard therapy. Part A determines safety, dose-limiting toxicities (DLTs), and the recommended phase 2 dose (RP2D) after reduced-intensity lymphodepletion. Part B evaluates preliminary anti-tumor activity, CAR-NK persistence, and biomarker-response associations.",[76,31,104,128,129],"Gallbladder Carcinoma","Biliary Tract Cancer",[131,132,133,134,135,136,137,138,139,140,141],"CAR-NK","dual-target cell therapy","HER2","ERBB2","CEA","CEACAM5","cholangiocarcinoma","biliary tract cancer","allogeneic","off-the-shelf","adoptive cell therapy","2026-06-06",{"date":144,"type":43},"2026-06-11",{"date":146,"type":43},"2026-03-02",{"date":148,"type":21},"2028-10-17",{"name":150,"class":50},"Beijing Biotech",{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100572064","phase-2-a-phase-ii-study-of-pemigatinib-plus-durvalumab-in-previously-treated-advanced-intrahepatic-cholangiocarcinoma-patients-with-fgfr-2-fusion-or-rearrangement-100572064","NCT06728410","A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement","A Phase II Study of Pemigatinib Plus Durvalumab (MEDI4736) in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of 0 or 1.\n4. Body weight of \\> 30 kg.\n5. Histologically diagnosed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma with FGFR-2 fusion or rearrangement detected by Clinical Laboratory Improvement Act (CLIA)-certified assays including commercial tests (Foundation Medicine, Caris, Tempus, Guardant 360 or other platforms of next generation sequencing will be allowed). AJCC, 8th edition. Subjects with gallbladder cancer or ampulla of Vater carcinoma are not eligible.\n6. Measurable disease according to RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n7. Have received gemcitabine cisplatin and durvalumab or another anti-PD-1 Ab for unresectable locally advanced or metastatic cholangiocarcinoma with either disease progression, intolerance to cytotoxic chemotherapy, or have received at least 6 months of therapy with stable disease or partial response. Prior neoadjuvant or adjuvant therapy is permitted if documented disease recurrence occurred ≥ 6 months after the last date of neoadjuvant or adjuvant therapy.\n8. Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.\n\n   * Absolute Neutrophil Count (ANC): ≥1500\u002FµL\n   * Hemoglobin (Hgb): ≥ 9 g\u002FdL; Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n   * Platelet (PLT): ≥ 100 000\u002FµL\n   * Calculated creatinine clearance: \\>40 mL\u002Fmin\n   * Bilirubin: ≤ 1.5 × upper limit of normal (ULN) This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with the sponsor-investigator.\n   * Aspartate aminotransferase (AST): ≤ 2.5 × institutional upper limit of normal unless liver metastases are present, in which case it must be ≤ 5x ULN\n   * Alanine aminotransferase (ALT): ≤ 2.5 × institutional upper limit of normal unless liver metastases are present, in which case it must be ≤ 5x ULN\n   * International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT): ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n9. Females of childbearing potential must have a negative serum pregnancy test at screening.\n10. Females of childbearing potential who are sexually active with a male able to father a child must be willing to use an effective method(s) of contraception. Males able to father a child who are sexually active with female of childbearing potential must be willing to use an effective method(s) of contraception.\n11. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n12. Must have a life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n1. Prior therapy with a FGFR inhibitor.\n2. Current evidence of clinically significant corneal (including but not limited to bullous\u002Fband keratopathy, corneal abrasion, inflammation\u002Fulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to macular\u002Fretinal degeneration, diabetic retinopathy, and retinal detachment) as confirmed by ophthalmologic examination\n3. History of calcium and phosphate homeostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues (exception: commonly observed calcifications in soft tissues such as the skin, kidney tendon, or vessels due to injury, disease, or aging in the absence of systemic mineral imbalance)\n4. Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Moderate CYP3A4 inhibitors are not prohibited but should be avoided.\n5. History of hypovitaminosis D requiring supraphysiologic doses (eg, 50,000 UI\u002Fweekly) to replenish the deficiency. Vitamin D supplements are allowed.\n6. Participation in another clinical study with an investigational product during the last 3 months\n7. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n8. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤ 28 days prior to the first dose of study regimen. If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by sponsor-investigator.\n9. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n\n   * Patients with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the sponsor-investigator.\n   * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with the study regimen may be included only after consultation with the sponsor-investigator.\n10. Any concurrent chemotherapy, study drug, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n11. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study regimen.\n12. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study regimen. NOTE: Local surgery of isolated lesions for palliative intent is acceptable.\n13. History of allogenic organ transplantation.\n14. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n    * Patients with vitiligo or alopecia\n    * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n    * Any chronic skin condition that does not require systemic therapy\n    * Patients without active disease in the last 5 years may be included but only after consultation with the sponsor-investigator\n    * Patients with celiac disease controlled by diet alone\n15. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n16. History of another primary malignancy except for\n\n    * Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of the study regimen and of low potential risk for recurrence\n    * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    * Adequately treated carcinoma in situ without evidence of disease\n17. History of leptomeningeal carcinomatosis\n18. Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry. Has untreated central nervous system (CNS) metastases and\u002For carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period or identified prior to signing the ICF. Patients whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of ≤ 10mg\u002Fday of prednisone or its equivalent and anticonvulsants for at least 14 days prior to the start of treatment. Brain metastases will not be recorded as RECIST Target Lesions at baseline.\n19. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).\n20. History of active primary immunodeficiency\n21. Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc). Participants with a past or resolved HBV infection (defined as the presence of antiHBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n\n    * Participants co-infected with HBV and HCV, or co-infected with HBV and HDV, namely: HBV positive (presence of HBsAg and\u002For anti HBcAb with detectable HBV DNA); AND\n    * HCV positive (presence of anti-HCV antibodies); OR\n    * HDV positive (presence of anti-HDV antibodies).\n22. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies).\n23. Known active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n24. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n25. Receipt of live vaccines or live attenuated vaccines within 30 days prior to the first dose of study regimen. NOTE: Patients, if enrolled, should not receive live vaccine whilst receiving study regimen and up to 90 days after the last dose of study regimen.\n26. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control.\n27. Known allergy or hypersensitivity to any of the study regimen medications or any of the study regimen medication excipients.\n28. Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n29. Patients who have received prior anti-PD-1, anti PD-L1:\n\n    * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n    * All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n    * Must not have experienced a ≥ Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤ Grade 2 are permitted to enrol if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n    * Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.\n30. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.",{"count":159,"type":21},38,[25],"This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks. Pemigatinib is administered at 13.5 mg orally daily 2 weeks on and 1 week off. Durvalumab is administered at 1500 mg intravenously once every 3 weeks. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur every 9 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject\u002Fphysician decision. A maximum of 24 months (about 35 cycles) of pemigatinib and durvalumab treatment from Cycle 1 Day 1 is allowed.",[31,163,164],"FGFR2 Gene Rearrangement","FGFR2 Gene Mutation","2026-05-07",{"date":167,"type":43},"2026-05-08",{"date":169,"type":43},"2026-01-27",{"date":171,"type":21},"2027-07",{"name":173,"class":113},"Mehmet Akce",2,{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":114},"100636835","phase-2-chidamide-combined-with-chemotherapy-and-immunotherapy-as-first-line-treatment-for-advanced-intrahepatic-cholangiocarcinoma-100636835","NCT07570849","Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma","Open-label, Phase II Clinical Study of Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF), fully understand the study, and be willing to comply with and capable of completing all trial procedures.\n2. Male or female, aged 18 to 75 years.\n3. Patients with histologically or pathologically confirmed unresectable or metastatic intrahepatic cholangiocarcinoma (ICC). Patients with extrahepatic cholangiocarcinoma (EHCC) or gallbladder cancer (GBC) are excluded.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Laboratory test values within 7 days prior to the start of treatment must meet the following criteria:\n\n   1. Neutrophils ≥ 1.5 × 10⁹\u002FL;\n   2. Platelets ≥ 50 × 10⁹\u002FL;\n   3. Hemoglobin ≥ 90 g\u002FL (without packed red blood cell transfusion within the past 2 weeks);\n   4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) and creatinine clearance ≥ 50 mL\u002Fmin;\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;\n   6. Serum albumin ≥ 30 g\u002FL;\n   7. For patients not receiving anticoagulation therapy: INR or aPTT ≤ 1.5 × ULN. Patients receiving prophylactic anticoagulation are eligible if INR ≤ 2 × ULN and aPTT is within the normal range within 14 days prior to the start of study treatment;\n   8. Serum bilirubin ≤ 1.25 × ULN.\n6. Life expectancy ≥ 12 weeks.\n7. Presence of at least one measurable lesion as confirmed by RECIST version 1.1.\n8. Patients with controlled hepatitis B are eligible if they meet the following criteria: HBV antiviral therapy must have been administered for at least 4 weeks, and HBV viral load must be less than 100 IU\u002FmL prior to the first dose of study drug. Patients receiving anti-HBV treatment with a viral load below 100 IU\u002FmL should maintain the same treatment throughout the study period. Patients who are positive for hepatitis B core antibody (HBcAb), negative for hepatitis B surface antigen (HBsAg), negative or positive for hepatitis B surface antibody (HBsAb), and have an HBV viral load below 100 IU\u002FmL do not require prophylactic anti-HBV treatment.\n9. Patients must have good compliance.\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with a histone deacetylase (HDAC) inhibitor. 2. Has an active autoimmune disease (with the exception of psoriasis) that has required systemic treatment within the past 2 years (i.e., use of corticosteroids or immunosuppressive medications). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n\n  3\\. Anticipated major surgery during the study period, including the 28-day screening period (diagnostic surgical procedures are excluded). Major surgery is defined as a procedure requiring at least 3 weeks of recovery time before study treatment can be administered.\n\n  4\\. Known history of interstitial lung disease or has non-infectious pneumonitis requiring corticosteroid treatment.\n\n  5\\. Known history of human immunodeficiency virus (HIV) infection, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation or stem cell transplantation.\n\n  6\\. Known clinically significant liver disease, including active viral hepatitis, alcoholic hepatitis, or other hepatitis; severe cirrhosis, fatty liver, hereditary liver disease, liver atrophy, portal hypertension, uncontrolled major seizure disorder, or superior vena cava syndrome.\n\n  7\\. Known history of allergy to macromolecular protein preparations\u002Fmonoclonal antibodies or to the chemotherapeutic agents used in this trial.\n\n  8\\. Participation in another clinical trial of an investigational drug within 4 weeks prior to the first dose of study drug (calculated from the last use of the investigational drug).\n\n  9\\. Receipt of a live vaccine within 30 days prior to the first dose of study drug. Inactivated virus vaccines for seasonal influenza are permitted; however, intranasally administered live attenuated influenza vaccines are not permitted.\n\n  10\\. Received prior local therapy to the liver (transcatheter chemoembolization, transcatheter embolization, hepatic arterial infusion, radiotherapy, radioembolization, or ablation) within 4 weeks prior to the first dose of study drug. Note: Patients must have evidence of disease progression after local therapy to be eligible.\n\n  11\\. Received prior radiotherapy to non-hepatic regions within 2 weeks prior to the first dose of study drug. Patients must have recovered from all radiotherapy-related toxicities, not require corticosteroids, and have no history of radiation pneumonitis. A 2-week washout period is permitted for palliative radiotherapy for non-central nervous system (CNS) disease (≤ 2 weeks of radiotherapy).\n\n  12\\. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical carcinoma in situ) that have undergone potentially curative therapy are permitted.\n\n  13\\. History of alcohol dependence, or history of drug abuse or substance abuse within the past 1 year.\n\n  14\\. Is pregnant or breastfeeding, or plans to become pregnant or father a child during the study period, from the screening visit through 120 days after the last dose of study treatment.\n\n  15\\. Has any condition (e.g., disease history or evidence, treatment, laboratory abnormality) that, in the investigator's judgment, could interfere with the trial results, preclude the patient's full participation in the study, or for which participation in the study is not in the patient's best interest.\n\n  16\\. Patients deemed by the investigator to be unsuitable for participation in this trial for any other reason.","75 Years",{"count":184,"type":21},35,[25],"This is a single-center, open-label, phase II clinical trial designed to evaluate the efficacy and safety of chidamide in combination with chemotherapy and immunotherapy as a first-line treatment for patients with advanced intrahepatic cholangiocarcinoma (ICC), a type of liver cancer.\n\nThe study will enroll approximately 35 patients with histologically or pathologically confirmed unresectable or metastatic ICC who have not received prior systemic therapy. All participants will receive chidamide, an oral HDAC inhibitor, in combination with gemcitabine, cisplatin, and an immune checkpoint inhibitor. Treatment will be administered in 21-day cycles until disease progression, unacceptable toxicity, or other withdrawal criteria are met.\n\nThe primary study endpoints are objective response rate (ORR), and safety, evaluated by the frequency and severity of adverse events. Secondary endpoints include progression-free survival (PFS), duration of response (DOR), overall survival (OS), and exploratory biomarker analyses.\n\nThe study aims to assess whether the addition of chidamide to standard chemotherapy and immunotherapy can improve treatment outcomes in this patient population.",[31],"2026-05-01",{"date":190,"type":43},"2026-05-06",{"date":192,"type":43},"2026-03-01",{"date":194,"type":21},"2029-01-01",{"name":196,"class":113},"Shanghai Zhongshan Hospital",{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100430915","phase-2-gemcitabine-and-oxaliplatin-chemotherapy-with-or-without-a-floxuridine-and-dexamethasone-pump-in-people-with-cholangiocarcinoma-that-cannot-be-removed-with-surgery-100430915","NCT04891289","Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery","A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR\u002FDexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Age ≥18 years\n* ECOG 0-1\n* Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (IHC). Confirmation of the diagnosis at MSKCC or at the enrolling institution must be obtained prior to randomization.\n* Clinical or radiographic evidence of metastatic disease confined to the liver. Note: presence of regional (porta hepatis) lymph node metastases will be allowed, provided they are amenable to resection. (Note: If peritoneal or other extrahepatic disease is found at time of pump placement, the pump will not be implanted. The patient will be removed from study, deemed nonevaluable and will not count toward the overall study accrual.)\n* Radiographically measurable disease. Measurable disease is defined as disease that can be assessed with 2-dimensional measurements on a cross-sectional imaging. Minimum lesion size is 2 cm in greatest diameter as per RECIST criteria.\n* Disease must be considered unresectable at the time of preoperative evaluation.\\*\n* Considered candidate for general anesthesia, abdominal exploration and hepatic artery pump placement.\n* Patients with chronic hepatitis and\u002For cirrhosis are eligible, but must be Child-Pugh class A.\n* WBC ≥ 2,000\u002FmcL , ANC ≥ 1000\u002FmcL\n* Platelet count ≥ 75,000\u002FmcL\n* Creatinine ≤ 1.8 mg\u002FdL\n* Total bilirubin \\\u003C 1.5 mg\u002FdL\n* Hgb \\> 7 g\u002FdL The % involvement of the liver will be determined by radiologists after review of imaging\n\nExclusion Criteria:\n\n* Presence of distant metastatic disease. Patients will undergo radiographic evaluation to exclude the possibility of distant metastatic disease. For patients who have undergone pre- or post-operative biopsies that definitively diagnose IHC, the diagnostic studies may be modified at the discretion of the MSKCC Principal Investigator. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.\n* Patients previously treated with systemic chemotherapy for IHC will be non-eligible.\n* Prior treatment with FUDR.\n* Prior external beam radiation therapy to the liver.\n* Prior ablative therapy to the liver.\n* Diagnosis of sclerosing cholangitis.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis; surgically related ascites does not exclude the patient).\n* Active infection within one week prior to HAI placement.\n* Pregnant or lactating women.\n* History of other malignancy within the past 3 years except with early stage\u002Flocalized cancer that was surgically resected or radiation treatment that would yield the same result as surgery within the past 3 years.\n* Life expectancy \\\u003C12 weeks.\n* Inability to comply with study and\u002For follow-up procedures.\n* History of peripheral neuropathy. There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population.",{"count":205,"type":21},164,[25],"This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.",[31],[210,211,212,213,214],"Gemcitabine","Oxaliplatin","Floxuridine","Dexamethasone Pump","20-348","2026-04-21",{"date":217,"type":43},"2026-04-22",{"date":219,"type":43},"2021-05-07",{"date":221,"type":21},"2027-05",{"name":223,"class":113},"Memorial Sloan Kettering Cancer Center",11,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":182,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":236,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":241,"leadSponsor":243,"locationsCount":114},"100633114","phase-2-a-clinical-study-to-evaluate-the-efficacy-and-safety-of-vg2025-in-intrahepatic-cholangiocarcinoma-100633114","NCT07522476","A Clinical Study to Evaluate the Efficacy and Safety of VG2025 in Intrahepatic Cholangiocarcinoma","An Open-label Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of VG2025 in the Treatment of Advanced Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n1. Signed written informed consent form.\n2. Age 18 to 75 years (inclusive), male or female.\n3. Histologically or cytologically confirmed advanced intrahepatic cholangiocarcinoma.\n4. Eligible participants of childbearing participants(male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment.\n\nExclusion Criteria:\n\n1. Participants who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.\n2. Participants who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.\n3. In the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.\n4. Other active uncontrolled infection.\n5. Known alcohol or drug dependence.\n6. Participants with mental disorders or poor compliance.\n7. Women who are pregnant or breastfeeding.\n8. Participants in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.",{"count":124,"type":21},[25],"VG2025 is a Recombinant Human IL12\u002F15 Dual-Regulated Oncolytic HSV-1 Injection. Currently, one phase I dose escalation safety study has been completed in China and the United States respectively, both demonstrating excellent safety profiles with no dose-limiting toxicities (DLTs) observed and no maximum tolerated dose (MTD) identified. Moreover, it has shown preliminary efficacy in treating advanced tumors. Considering the actual clinical needs and the volume of intratumoral administration, a more appropriate recommended phase 2 dose (RP2D) level has been selected for the phase II clinical trial.",[31],"NOT_YET_RECRUITING","2026-04-07",{"date":239,"type":43},"2026-04-13",{"date":40,"type":21},{"date":242,"type":21},"2028-11-13",{"name":244,"class":50},"Virogin Biotech Ltd.",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":260,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":114},"100586080","liver-transplantation-for-locally-advanced-intrahepatic-cholangiocarcinoma-after-sirt-and-chemotherapy-100586080","NCT06910722","Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy","Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After Selective Internal Radiotherapy With Labeled Yttrium and Chemotherapy: a Phase 2 Study","RIS-TH","Inclusion Criteria:\n\n* Patient aged 18 to 65\n* With histologically documented intrahepatic cholangiocarcinoma (primary diagnosis):\n\n  * Uni or pauci nodular (≤ 5 lesions (all lesions are counted, even those less than 1 cm))\n  * Without extrahepatic or lymph node involvement\n  * Technically unresectable R0 according to an expert panel\n* Tumor target \\> 2 cm\n* WHO 0-1\n* free and informed consent signed\n* highly effective contraception for men and women of childbearing age during study participation up to 2 years post TH\n\nExclusion Criteria:\n\n* Extrahepatic, vesicular or perihilar cholangiocarcinoma\n* Tumor infiltration of more than 50% of the liver\n* Mixed cholangiocarcinoma, hepatocellular carcinoma, fibrolamellar carcinoma\n* Previous treatment for CCI\n* Cirrhosis ≥ Child B7\n* Chronic alcoholism\n* Uncontrolled chronic active infections (patients with HBV, HCV or HDV infections may be included if infections are controlled)\n* Stage III A, IIIB, IV and V chronic renal failure (glomerular filtration rate 59 ml\u002Fmin)\n* Contraindications to liver transplant\n\n  * Severe untreatable conditions\n  * Recent history (less than 5 years) of cancer\n  * severe comorbidities\n  * Psychiatric or psychological disorders\n* Pregnant or breast-feeding women\n* Patient under guardianship\n* Not affiliated to a Health care system\n* Participating in another interventional study or within the exclusion period of a previous study involving the human body","65 Years",{"count":255,"type":21},36,[63],"The study hypothesis is that liver transplantation after selective internal radiation therapy (SIRT) and chemotherapy would improve 3-year overall survival in patients with locally advanced (unresectable but non-metastatic) intrahepatic cholangiocarcinoma.\n\nIt is planned to include 36 patients with locally advanced intrahepatic cholangiocarcinoma, not eligible for initial surgery and without metastases. Participants will be recruited from care facilities in France.",[31,259],"Locally Advanced Intrahepatic Cholangiocarcinoma",[261,262,263],"liver transplantation","locally advanced intrahepatic cholangiocarcinoma","selective internal radiation therapy","2026-04-02",{"date":266,"type":43},"2026-04-06",{"date":268,"type":43},"2025-08-28",{"date":270,"type":21},"2034-10-01",{"name":272,"class":113},"Assistance Publique - Hôpitaux de Paris",{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":282,"phases":4,"briefSummary":283,"conditions":284,"keywords":290,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100542403","an-exosome-based-liquid-biopsy-for-the-differential-diagnosis-of-primary-liver-cancer-100542403","NCT06342414","An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer","ELUCIDATE","Inclusion Criteria:\n\n* A histologically confirmed diagnosis of hepatocellular carcinoma\n* A histologically confirmed diagnosis of intrahepatic cholangiocarcinoma\n* Received standard diagnostic and staging procedures as per local guidelines\n* Availability of at least one blood-derived sample, drawn before receiving any curative-intent treatment\n\nExclusion Criteria:\n\n* Lack of or inability to provide informed consent\n* Synchronous hepatocellular carcinoma and intrahepatic cholangiocarcinoma\n* Primary liver cancer other than hepatocellular carcinoma or intrahepatic cholangiocarcinoma\n* Secondary liver cancer",{"count":281,"type":21},400,"OBSERVATIONAL","It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery.",[285,31,76,286,287,288,289],"Hepatocellular Carcinoma","Primary Liver Cancer","Primary Liver Carcinoma","Hepatic Cancer","Hepatic Carcinoma",[291,292,293],"Exosome","micro RNA","Differential Diagnosis","2026-04-01",{"date":296,"type":43},"2026-04-03",{"date":298,"type":43},"2024-03-15",{"date":300,"type":21},"2026-06-18",{"name":302,"class":113},"City of Hope Medical Center",5,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":311,"enrollmentInfo":312,"targetDuration":313,"studyType":282,"phases":4,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":174},"100526852","liver-transplantation-in-intrahepatic-cholangiocarcinoma-100526852","NCT06140134","Liver Transplantation in Intrahepatic Cholangiocarcinoma","A Single-Arm Nonrandomized Phase II Study of Liver Transplantation in Locally Advanced Unresectable Non-Metastatic Intrahepatic Cholangiocarcinoma Treated With Neoadjuvant Systemic Therapy","Inclusion Criteria:\n\n* Age ≥18 years of age on the day of consenting to the study.\n* Patients must have histologically confirmed diagnosis of locally advanced intrahepatic cholangiocarcinoma\n* Confirmed diagnosis of locally advanced unresectable iCCA with no vascular invasion, lymph node, or extrahepatic disease.\n* Unresectable disease based on tumor location or underlying liver disease\n* Patients must have ≥ 6 months of disease stability or tumor regression on neoadjuvant therapy. In cases in which patients had received second-line therapy, disease must also have been controlled for ≥ 6 months on that regimen.\n* Patients who had previous surgical resection for iCCA are eligible if surgery occurred more than 6 months prior to listing, and patients have had ≥ 6 months of disease stability or response on therapy.\n* ECOG performance status ≤1 (Karnofsky ≥70%, see Appendix A).\n* Patients must have organ and marrow function acceptable for liver transplantation per institutional protocol:\n* If history of chronic hepatitis B virus (HBV) infection, viral load should be undetectable on suppressive therapy.\n* If history of chronic hepatitis C virus (HCV) infection, patients should have undetectable HCV viral load.\n* Women of child-bearing years must have contraception plan in place from the time of study enrollment until at least one year following liver transplant.\n* Ability to understand and the willingness to sign a written informed consent document\n* Meets all other medical and psychosocial criteria for liver transplant\n* Demonstrate ability to comply with study procedures\n\nExclusion Criteria:\n\n* Age \\\u003C18 years of age on the day of consenting to the study.\n* Patients who have extrahepatic metastases, lymph node involvement, invasion or encasement of major hepatic vascular structures, perforation of the visceral peritoneum, invasion of extrahepatic structures, invasion of perihilar fat, periductular invasion, concurrent hepatoma or mixed hepatocellular cholangiocarcinoma.\n* Concurrent severe and\u002For uncontrolled concurrent illness including, but not limited to, ongoing or active infection, acute fulminant liver failure, symptomatic congestive heart failure, unstable angina pectoris, severe uncorrected coronary artery disease, severe cerebrovascular disease, severe pulmonary disease, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements and that would exclude the patient from eligibility for liver transplantation per institutional protocol.\n* Prior solid organ or bone marrow transplant\n* Dependent on ≥2 IV inotropic support to maintain hemodynamics\n* Previous (within the past 5 years) or concurrent presence of other cancer, except non-melanoma skin cancer and in situ carcinomas.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score \\>1 (Karnofsky \\\u003C70%, see Appendix A).\n* Unable to understand and sign a written informed consent document\n* Untreated viral hepatitis\n* Pregnant or breast-feeding women\n* HIV-infected patients","89 Years",{"count":124,"type":21},"5 Years","The aim of the current study is to determine the potential efficacy of liver transplantation in the form of patients' overall survival (OS) after neoadjuvant systemic therapy in patients with biologically responsive locally advanced non-metastatic intrahepatic cholangiocarcinoma (iCCA) in comparison to patients historically treated with chemotherapy alone.",[31,316],"Cholangiocarcinoma, Intrahepatic",[261,318,319,320,321,322,323,324,262],"neoadjuvant systemic therapy","intrahepatic cholangiocarcinoma","iCCA","locally advanced non-metastatic iCCA","non-metastatic intrahepatic cholangiocarcinoma","liver transplant","unresectable intrahepatic cholangiocarcinoma","2026-03-18",{"date":327,"type":43},"2026-03-20",{"date":329,"type":43},"2023-12-15",{"date":331,"type":21},"2029-11",{"name":333,"class":113},"Rutgers, The State University of New Jersey",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":182,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":343,"conditions":344,"keywords":345,"overallStatus":236,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":4},"100626202","phase-2-a-study-of-liposomal-irinotecan-plus-5-fulv-haic-with-lenvatinib-and-a-pd-1-inhibitor-in-advanced-icc-100626202","NCT07432568","A Study of Liposomal Irinotecan Plus 5-FU\u002FLV HAIC With Lenvatinib and a PD-1 Inhibitor in Advanced ICC","A Prospective Study on the Efficacy and Safety of Liposomal Irinotecan, 5-Fluorouracil, and Leucovorin Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Lenvatinib and a PD-1 Inhibitor as First-Line Therapy for Advanced Intrahepatic Cholangiocarcinoma (ICC)","Inclusion Criteria:\n\n1. Aged 18 to 75 years.\n2. Histologically or cytologically confirmed unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (ICC).\n3. Liver function: Child-Pugh class A (score 5-6) or good class B (score ≤7).\n4. At least one measurable lesion as defined by RECIST 1.1 criteria.\n5. ECOG performance status of 0 or 1.\n6. Life expectancy greater than 12 months.\n7. No prior systemic therapy for unresectable locally advanced or metastatic ICC. Prior adjuvant or neoadjuvant chemotherapy is allowed if completed \\>6 months before recurrence.\n8. Adequate bone marrow function: Absolute Neutrophil Count (ANC) ≥1.5×10⁹\u002FL, Hemoglobin ≥90 g\u002FL, Platelet count (PLT) ≥100×10⁹\u002FL, White Blood Cell count (WBC) ≥3.0×10⁹\u002FL.\n9. Adequate renal function: Serum creatinine (Cr) ≤1.5 × ULN or Creatinine Clearance (CCr) ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n10. Adequate coagulation function: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and International Normalized Ratio (INR) ≤1.5 × ULN.\n11. No active or suspected infection.\n12. Not pregnant or lactating. Female and male participants of childbearing potential must use effective contraception during the study and for 6 months after the last dose.\n13. Good compliance, ability to understand the study procedures, and provision of signed informed consent.\n\nExclusion Criteria:\n\n1. History of other malignancies within the past 5 years (except cured carcinoma in situ or basal cell skin cancer).\n2. Significant clinical bleeding symptoms or tendency within 3 months prior to treatment (e.g., \\>30 mL bleeding, hematemesis, melena, hematochezia), hemoptysis (\\>5 mL of fresh blood within 4 weeks). Venous\u002Fthrombotic events within the past 6 months (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism). Requirement for long-term anticoagulation (e.g., warfarin, heparin) or antiplatelet therapy (Aspirin ≥300 mg\u002Fday or Clopidogrel ≥75 mg\u002Fday).\n3. Extensive distant metastasis (e.g., peritoneal metastasis, multiple bone\u002Fbrain metastases).\n4. Use of strong CYP3A4 inducers within 3 weeks prior to first dose, or use of strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 3 weeks prior to first dose.\n5. Major organ surgery within 4 weeks prior to treatment (excluding needle biopsy, central venous catheter placement, port implantation, biliary stenting, percutaneous transhepatic biliary drainage, cholecystostomy) or planned elective surgery.\n6. Active cardiac disease within 6 months prior to treatment, including myocardial infarction, severe\u002Funstable angina. Left ventricular ejection fraction (LVEF) \\\u003C50% by echocardiogram, or poorly controlled arrhythmia.\n7. Congenital or acquired immunodeficiency (e.g., HIV infection), or active hepatitis (abnormal liver enzymes; for Hepatitis B: HBV DNA ≥1000 IU\u002FmL; for Hepatitis C: HCV RNA ≥1000 IU\u002FmL). Chronic HBV carriers with HBV DNA \\\u003C2000 IU\u002Fml can be enrolled if they receive concurrent antiviral therapy during the trial.\n8. Any other disease, metabolic disorder, physical examination finding, or laboratory abnormality that, in the investigator's judgment, contraindicates the use of the study drug, may affect result interpretation, or places the patient at high risk.\n9. Bowel obstruction (except incomplete obstruction manageable with enteral nutrition) or patients at risk of bowel perforation (e.g., acute diverticulitis, abdominal abscess, history of abdominal cancer).\n10. Pregnant or lactating female participants.",{"count":124,"type":21},[25],"This is a prospective, single-center, single-arm clinical study. It aims to evaluate the efficacy and safety of a new combination therapy as a first-line treatment for patients with advanced intrahepatic cholangiocarcinoma (ICC) who cannot be treated with surgery. The combined therapy includes hepatic arterial infusion chemotherapy (HAIC) with Liposomal Irinotecan, 5-Fluorouracil, and Leucovorin, along with the oral targeted drug Lenvatinib and an intravenous PD-1 inhibitor (an immunotherapy). A total of 30 participants will be enrolled. The main goal of the study is to measure the Objective Response Rate (ORR), which is the percentage of patients whose cancer shrinks or disappears after treatment.",[31],[346],"Hepatic Arterial Infusion Chemotherapy(HAIC), Liposomal Irinotecan, 5-Fluorouracil, Leucovorin, Lenvatinib, PD-1 Inhibitor, Immunotherapy, Targeted Therapy","2026-02-23",{"date":349,"type":43},"2026-02-25",{"date":351,"type":21},"2026-03-09",{"date":353,"type":21},"2032-08-09",{"name":355,"class":113},"Tianjin Medical University Cancer Institute and Hospital",{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":114},"100610109","phase-2-regulus-mri-guided-adaptive-sabr-for-liver-cancers-100610109","NCT07223307","REGULUS: MRI-guided Adaptive SABR for Liver Cancers","Phase II Trial of REal Time MRI GUided Adaptive Stereotactic Ablative Radiotherapy for Liver Cancers Using a Single Session, Simulation Free Workflow","Inclusion Criteria:\n\n* Histologically confirmed HCC, intrahepatic cholangiocarcinoma, or metastatic cancer. In the case of suspected HCC in patients with known cirrhosis, noninvasive criteria recommended by the European Association for the Study of Liver Diseases (lesion \\> 1 cm with arterial phase hyperenhancement and venous phase washout) or LI-RADS score of 5 may be used\n* ≥ 18 years old at time of study enrollment\n* Child-Pugh A status\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\n* Life Expectancy \\> 6 months\n* For women of childbearing potential or who are not postmenopausal (see Appendix F for Definition of Menopausal Status), a negative urine or serum pregnancy test must be done.\n* Ability to understand and the willingness to provide written informed consent.\n* Patients treated with prior liver-directed therapies with the exception of radioembolization are eligible for this study if they otherwise meet eligibility criteria\n\nExclusion Criteria:\n\n* Prior treatment with radioembolization\n* Cytotoxic chemotherapy or investigational agent within 1 week of SABR\n* Prior radiotherapy overlapping with study treatment site\n* Female patients who are pregnant\n* Contraindication to having an MRI scan or inability to tolerate MRI\n* Presence of a pacemaker or other implanted cardiac device\n* Direct tumor extension into the stomach, duodenum, small bowel or large bowel\n* Patient unable to breath hold \\> 15 seconds",{"count":364,"type":21},62,[25],"Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers",[368,31,369,370],"Liver Cancer","Liver Metastases","HCC","2026-02-05",{"date":373,"type":43},"2026-02-09",{"date":375,"type":43},"2026-01-23",{"date":377,"type":21},"2030-01",{"name":379,"class":113},"Stanford University",{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":387,"enrollmentInfo":388,"targetDuration":4,"studyType":22,"phases":390,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":402,"leadSponsor":404,"locationsCount":114},"100608435","phase-2-study-of-safetyfeasibility-of-a-hybrid-model-of-tertiary-and-community-delivery-of-hepatic-artery-infusion-chemotherapy-100608435","NCT07201519","Study of Safety\u002FFeasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy","Phase IIa Study of Safety\u002FFeasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy","Inclusion Criteria:\n\n* Colorectal adenocarcinoma metastatic to the liver which is either Unresectable (group A) or Resectable (group B; ie, will be completely resected), AND with no definitive clinical or radiographic evidence of extrahepatic disease other than: metastatic disease to resectable peri-hepatic lymph nodes; up to 5 proven or suspected lung metastases, provided they are stable or responding in number and size for a minimum of 2-months of systemic chemotherapy and are amenable to SBRT or resection. or\n* Histologically confirmed unresectable intrahepatic cholangiocarcinoma (group C), with presence of less than 70% liver involvement with no definitive clinical or radiographic evidence of extrahepatic metastatic disease other than resectable perihepatic lymph nodes.\n* Patients \\> or equal 18 years of age\n* ECOG Performance Status of 0 - 1 (APPENDIX C)\n* Lab Values \\\u003C or equal 14 days prior to study enrollment: absolute neutrophil count \\> or equal 1,500\u002FmcL Total Bilirubin \\\u003C or equal 1.5 mg\u002FdL AST\u002FALT \\\u003C 5 x institutional upper limit of normal (ULN) Platelets \\> or equal 100,000\u002FmcL Creatinine \\\u003C 1.5 mg\u002FdL HGB \\> 8 g\u002FdL INR \\\u003C or equal 1.5\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Prior chemotherapy is acceptable if last dose given \\> or equal 3 weeks prior to study enrollment\n* Any investigational agent is acceptable if last dose administered \\> or equal 3 months before study enrollment\n* In order for patients to select treatment in the CO arm, they must have the ability to do telehealth visits, either via a home computer, tablet, or smartphone, either via home internet access or cellphone network.\n\nExclusion Criteria:\n\n* Presence of distant non-liver metastatic disease confirmed by radiographic evaluation. Clinical or radiographic evidence of metastatic disease to regional peri-hepatic lymph nodes will be allowed, provided it is amenable to resection. For the colorectal carcinoma only: Up to 5 lung metastases are allowable, provided they are stable (or responding) in number and size for minimum of 2-mos of systemic chemo and are amenable to SBRT.\n* Microsatellite instability (MSI) or Mismatch repair deficiency (MMR-D)\n* Prior radiation to the liver, including external beam, SBRT, Y90. Prior radiation therapy to the pelvis is acceptable\n* Bevacizumab (Avastin®) cannot be given concurrently with HAI FUDR. Patients can previously have received it with a minimum 6-week washout period\n* Active infection, hepatic encephalopathy\n* Clinical evidence of portal hypertension (ascites, gastroesophageal varices or portal vein thrombosis) are exclusions. Note: surgically-related ascites does not exclude the patient.\n* Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of childbearing potential must have negative pregnancy test prior to surgery)\n* If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment\n* Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy; Patients with a history of stroke within 3 months or with substantial residual deficit, based on investigator discretion\n* Serious or non-healing active wound, ulcer, or bone fracture\n* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the HAIP chemotherapy (i.e., investigational regimen)\n* Patients with psychiatric illness or social situations that would limit compliance with study requirements. Examples: active substance abuse, active severe alcohol abuse, etc.\n* Inability to reliably commit to traveling to either Lexington, KY (for patients choosing TO site for HAI administration) or local CO site every 2 weeks for duration of the study treatment (6 months). Patient must have readily identifiable, reliable primary and back-up modes of transportation regardless of weather.\n* Patients with AXIOS™ stents (or similar) used to connect the small intestine to the gastric remnant after a prior gastric bypass for access for ERCP\u002Fstent in the setting of biliary obstruction are eligible at the discretion of the investigator. Considerations regarding eligibility comprise removal of the stent prior to HAIP implantation, or the placement of the HAIP catheter at least 5cm away from the AXIOS stent.","99 Years",{"count":389,"type":21},80,[25],"The goal of this clinical trial is to help learn about the safety and feasibility of hepatic artery infusion chemotherapy for those who have colorectal liver metastases, both resectable and unresectable, or unresectable intrahepatic cholangiocarcinoma. The main questions it aims to answer are:\n\n* safety and feasibility of installing a pump that deliveries chemotherapy to the hepatic artery (the blood vessel that supplies blood to the liver)\n* help learn more about the safety of patients having pump refills at home or a local clinic versus having it routinely done at the hospital\n\nParticipants will have surgery to install a pump which is a standard surgical procedure. After surgery, participants will select to either receive treatment at the hospital facility or with a community oncologist that will provide cancer care to participants close to home, rather than in a large hospital or academic medical center.\n\nThe main treatment on study will last about 3-4 months.",[393,31],"Colorectal Cancer Metastatic",[395,396,397],"hepatic artery infusion","chemotherapy","floxuridine","2026-02-01",{"date":400,"type":43},"2026-02-04",{"date":375,"type":43},{"date":403,"type":21},"2030-02",{"name":405,"class":113},"Michael J Cavnar, MD",{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":22,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":114},"100540158","phase-2-hai-floxuridine-or-sirt-combined-with-gemox-for-patients-with-intra-hepatic-cholangiocarcinoma-not-amenable-to-resection-tomcat-100540158","NCT06313203","HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)","Trans-arterial Treatment of Patients With Intra-hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)","TOMCAT","Inclusion Criteria:\n\n1. Intra-hepatic cholangiocarcinoma. Diagnosis confirmed by biopsy, cytology or previous resection.\n2. Not amenable for upfront resection. Defined as:\n\n   1. A tumour that is technically not resectable with R0 margins (i.e. where resection will not yield an FLR of sufficient size and function) without reconstruction of portal or liver vein, or artery.\n   2. Any multifocality (more than one tumour) irrespective of distance between assumed primary and other lesions\n   3. Recurrent tumour following resection\n   4. Radiologically or cytology-proven malignant regional lymph nodes\n3. Disease confined to the liver or associated with limited, resectable porta hepatis lymph node metastases\n4. Radiologically measurable disease with at least one lesion \\> 2 cm in greatest diameter\n5. Physical performance score WHO\u002FECOG stage 0\u002F1\n6. Age \\> 18 years\n7. Assumed ability to tolerate at least one full cycle of GemOx\n8. For eligibility to HAI-FUDR\u002FDEX treatment, patients must be willing and able to go to Oslo every fortnight\n9. Women of childbearing age and potential must be willing to use highly effective contraception during the study and for a period after the study, as defined in this protocol. Male patients or male patients who have female partners of childbearing age and potential must be willing to use highly effective contraception during the study and for a period after the study, as defined in this protocol. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n\nExclusion Criteria:\n\n1. Any non-liver malignant deposit (except for resectable, hilar lymph nodes)\n2. Serum bilirubin, creatinine or INR outside of normal range\n3. Haemoglobin \\\u003C 7 g\u002FdL and thrombocytes \\\u003C 75 × 109\u002FL\n4. Liver failure (if cirrhosis, Child-Pugh B or C)\n5. Clinical evidence of portal hypertension (non-surgically related ascites, gastro-oesophageal varices, portal vein thrombosis)\n6. History of peripheral neuropathy\n7. More than 70 % of liver consisting of tumour\n8. History of other malignancy past three years except localized\u002Fearly stage cancer that has been adequately resected.\n9. Pregnant or lactating women\n10. Expected life expectancy less than three months.\n11. Inability to comply with study routines or follow-up procedures\n12. Inability to read and comprehend Norwegian\n13. Arterial anatomy unsuited for SIRT or HAI, respectively\n14. Any reason why, in the view of the investigators, the patient should not be included",{"count":415,"type":21},39,[25],"Patients with intrahepatic cholangiocarcinoma (IHC) have relatively aggressive tumors, and the prognosis for most of these patients is dismal. Surgery is the only option that can offer potential cure, but only an estimated 20-25 % are amenable to resection. Down-staging conventional chemotherapy has a relatively low response rate (\\\u003C 50 %). Patients will be included into the respective treatment arms based on their tumour characteristics and disease stage, but also based on their ability\u002Fpreferences, as HAI-FUDR\u002FDEX requires going to Oslo every fortnight for the duration of the treatment and SIRT has some limitations regarding tumour distribution.\n\nData from the MSKCC has suggested a clinically relevant benefit from adding intrahepatic chemotherapy to systemic therapy. HAI-FUDR\u002FDEX is not approved in Norway and can only be evaluated in a protocolized trial. Given the risk of distant disease progression with IHC, the addition of conventional systemic chemotherapy makes good clinical sense, and data from MSKCC supports this approach. SIRT is another modality also applied trans-arterially and directly into the tumour. This treatment is approved in Norway and available in Bergen and in Oslo. It is far less cumbersome to deliver and maintain than HAI-FUDR\u002FDEX. The efficacy and safety of the two treatment groups, HAI-FUDR\u002FDEX and SIRT, will be compared in a parallel cohort (non-randomized) design",[31,419],"Chemotherapy Effect","2026-01-29",{"date":422,"type":43},"2026-02-02",{"date":424,"type":43},"2024-02-13",{"date":426,"type":21},"2034-01",{"name":428,"class":113},"Oslo University Hospital",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":114},"100471731","phase-2-the-purpose-of-this-research-study-is-to-see-if-combining-gemcitabine-cisplatin-and-durvalumab-chemotherapy-treatments-with-a-direct-tumor-therapy-yittrium-90-y-90-will-work-better-together-to-shrink-tumors-and-control-cancer-100471731","NCT05422690","The Purpose of This Research Study is to See if Combining Gemcitabine, Cisplatin and Durvalumab Chemotherapy Treatments With a Direct Tumor Therapy Yittrium-90 (Y-90) Will Work Better Together to Shrink Tumors and Control Cancer","A Phase II Single-center, Open-label, Single Arm Study of Induction Gemcitabine, Cisplatin and Durvalumab Followed by Gemcitabine, Cisplatin and Yttrium-90 (Y-90) Radioembolization for the Treatment of Locally Advanced Unresectable Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Adult males and females at least 18 years of age\n* Histologically and\u002For cytologically confirmed iCCA that is previously untreated or, if systemic therapy has been rendered for prior disease, has been administered at least 6 months before the development of recurrent or de novo new sites of disease.\n* Unresectable disease, as deemed by the Inova multidisciplinary tumor board (i.e. disease that cannot be safely resected with negative margins, leaving 2 adjacent segments of liver with intact portal venous and hepatic arterial inflow and intact biliary and hepatic venous outflow with the future liver remnant of sufficient volume to avoid postoperative liver insufficiency)\n* Measurable disease per RECIST 1.1 at least 2 cm in size\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Noncirrhotic liver - patients should not have a preexisting diagnosis of cirrhosis either diagnosed via biopsy or with features consistent with cirrhosis on imaging (e.g. shrunken liver with nodularity consistent with cirrhosis). Child-Pugh score must be less than 5.\n* No evidence of extrahepatic disease, except for regional adenopathy that would be resected as part of a standard oncologic surgical procedure\n* Adequate organ function as indicated by the following laboratory values (Table 1)\n* Ability to complete testing in the protocol\n* Able and willing to consent to protocol\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breast-feeding\n* History of allogeneic organ transplantation.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  * Patients with controlled type 1 diabetes on an insulin regimen are eligible for the study.\n  * Patients with vitiligo or alopecia.\n  * Any chronic skin condition that does not require systemic therapy.\n  * Patients without an active autoimmune disease in the last 5 years may be included but only after consultation with the study physician.\n  * Patients with diet controlled celiac disease.\n* Current or recent use of immunosuppressive medication within 14 days before durvalumab initiation except if:\n\n  * Intranasal, inhaled, topical or local steroid injections\n  * Systemic corticosteroids at physiologic doses that do not exceed 10 mg\u002Fday of prednisone or its equivalent.\n  * Steroids as premedication for hypersensitivity reactions, (i.e. CT scan premedication).\n* Child-Pugh B7 or greater cirrhosis\n* Extrahepatic or perihilar cholangiocarcinoma\n* Gallbladder cancer\n* Pancreatic or ampullary cancer\n* Portal vein thrombosis involving the main portal vein or first order right or left portal vein branches\n* Extrahepatic disease, other than regional lymph nodes that would be removed at time of surgery as part of a routine oncologic procedure for iCCA\n* Previous treatment with chemotherapy, intra-arterial or radiotherapy for iCCA is exclusionary, with the exception of adjuvant therapy with capecitabine which is allowed.\n* Contraindication to durvalumab, gemcitabine, or cisplatin\n* Active hepatitis B or C for which patients refuse treatment. Patients who are newly diagnosed with active disease as part of protocol screening and are agreeable to initiate on antiviral treatment are allowed to enroll.\n* Contraindication found during work-up angiography, including significant lung shunting (lung dose \\>30 Gy for a single treatment or \\>50 Gy cumulative), or non-manageable extrahepatic deposition of technetium Tc 99m macroaggregated albumin on scintigraphy performed after planning angiography\n* \\> 75% hepatic tumor burden\n* Inability to protect non-target arteries to intestines or solid organs from radioembolization\n* Serum albumin \\\u003C 3 g\u002FdL\n* Serum bilirubin \\> 2 mg\u002FdL, serum aspartate aminotransferase or alanine aminotransferase \\> 5 times upper limit of normal\n* Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.\n* Life-threatening intercurrent illness\n* Anticipated poor compliance\n* Prisoners or subjects who are involuntarily incarcerated\n* Persons with decisional incapacity\u002Fcognitive impairment\n* Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study\n* Subject is enrolled in a separate interventional clinical trial",{"count":437,"type":21},16,[25],"The purpose of this research is to see if combining gemcitabine, cisplatin and Durvalumab chemotherapy treatments with a direct tumor therapy called Yittrium-90, will work better together to shrink the tumor and control cancer.",[31],"2025-07-07",{"date":443,"type":43},"2025-07-10",{"date":445,"type":43},"2024-06-12",{"date":447,"type":21},"2028-09-30",{"name":449,"class":113},"Inova Health Care Services",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":457,"sex":17,"minAge":18,"maxAge":182,"enrollmentInfo":458,"targetDuration":4,"studyType":282,"phases":4,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":114},"100565517","d-tace-haic-combined-with-envafolimab-and-lenvatinib-for-unresectable-icc-100565517","NCT06643208","D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC","Department of Hepatobiliary Pancreatic Surgery, Fujian Provincial Hospital","Inclusion Criteria:\n\n* 1\\. Ages of 18 and 75;\n* 2\\. Child-Pugh liver function grade: A\u002FB;\n* 3\\. ECOG score (see annex for scoring standards) : ≤1 score;\n* 4\\. ICC was confirmed by pathology and evaluated by two senior hepatobiliary surgeons as unresectable for surgery (including multiple intrahepatic lesions, local vascular invasion, local lymph node metastasis, and distant metastasis);\n* 5\\. According to RECIST 1.1 criteria, the patient has at least one measurable lesion (the CT\u002FMRI scan diameter of the lesion can be measured ≥10mm, and the lesion has not received local treatment such as radiotherapy or freezing);\n* 6\\. The expected survival time is greater than 3 months;\n* 7\\. Patients who had not received any tumor-related targeting, immunization, radiotherapy or chemotherapy before enrollment;\n* 8\\. Functional indexes of vital organs met the following requirements: · Routine blood: absolute neutrophil count ≥1.5×109\u002FL, Hb≥9.0g\u002FL, PLT≥75×109\u002FL; · Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN) (≤2.5 times ULN after biliary drainage in patients with obstructive jaundice); Alanine aminotransferase (ALT), aspartate aminotransferase (AST)≤ 5x ULN, albumin ≥30g \u002FL; · Renal function: serum creatinine ≤1.5mg\u002FdL, creatinine clearance ≥60ml \u002Fmin; · Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT)≤1.5 times ULN;\n* 9\\. No history of severe arrhythmia or heart failure; No history of severe ventilation dysfunction or severe pulmonary infection;\n* 10\\. Women of childbearing age should agree to use contraception during the use of medication and for 6 months after the end of medication; Patients who had a negative serum or urine pregnancy test in the 7 days prior to study enrollment and must be non-lactating patients, men should consent to use contraception during the study period and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* 1\\. Patients who have previously received other local anti-tumor treatments (such as radiotherapy, radiofrequency ablation, etc.), who are allowed to relapse 6 months after previous surgery, and who are allowed to undergo biliary drainage (including PTCD and biliary stent implantation);\n* 2\\. History of allergy to gemcitabine, oxaliplatin, Envolizumab, Renvastinib and its components;\n* 3\\. A history of other malignant tumors within the past 5 years or at the same time, except cured basal cell carcinoma of the skin, cervical carcinoma in situ and thyroid papillary carcinoma;\n* 4\\. Patients who have previously received an organ transplant or are planning to receive an organ transplant;\n* 5\\. The presence of any active autoimmune disease or patients with autoimmune disease and expected recurrence (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes);\n* 6\\. History of immune deficiency; The patient is taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes and continues to use it within 2 weeks prior to signing the informed consent;\n* 7\\. Known hereditary or acquired bleeding (e.g. coagulation disorders) or thrombotic tendencies, e.g. in hemophiliacs; Is currently or recently (within 10 days prior to the start of study therapy) used full dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin, low-molecular weight heparin permitted);\n* 8\\. Serious infections, such as severe pneumonia, bacteremia, and comorbiditis requiring hospitalization, occurred within 4 weeks prior to the first use of the study drug; Baseline chest imaging findings indicate active lung inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use);\n* 9\\. Patients with mental illness; Have a history of psychotropic substance abuse, alcoholism and drug use;\n* 10\\. Pregnant or lactating women;\n* 11\\. Those who, according to the judgment of the researcher, should not participate in this experiment for other reasons;",true,{"count":459,"type":21},37,"This is a prospective, single-arm, multicenter, phase II trial to evaluate the efficacy and safety of D-TACE-HAIC (GEMOX protocol) in combination with Envafolimab and Lenvatinib for unresectable intrahepatic cholangiocarcinoma.",[31],"2025-06-21",{"date":464,"type":43},"2025-06-26",{"date":466,"type":43},"2024-07-01",{"date":468,"type":21},"2027-03-01",{"name":470,"class":113},"Fujian Provincial Hospital",{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":182,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":479,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":114},"100547349","early-phase-1-neoantigen-vaccine-plus-capecitabine-as-adjuvant-therapy-for-intrahepatic-cholangiocarcinoma-after-radical-resection-100547349","NCT06406816","Neoantigen Vaccine Plus Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma After Radical Resection","Inclusion Criteria:\n\n1. Sign a written informed consent form and be able to comply with the scheduled visits and related procedures as per the protocol;\n2. Age ≥18 years and ≤75 years, any gender;\n3. Confirmed pathologically as a patient with intrahepatic cholangiocarcinoma;\n4. Not receiving neoadjuvant therapy, underwent surgical resection, and pathology confirmed high-risk factors for recurrence: positive margins, lymph node metastasis, vascular invasion, nerve invasion, diameter \\>5cm, classified as stage IB-IIIB according to AJCC TNM (8th edition, 2017), and have not yet received systemic adjuvant therapy;\n5. Child-Pugh score grade A;\n6. ECOG score of 0-1;\n7. If infected with hepatitis B virus (HBV), such as HBsAg positive, HBV-DNA must be tested and HBV-DNA should be \\\u003C2000 IU\u002FmL (if the research center uses copy\u002FmL as the detection unit, then it must be \\\u003C104 copy\u002FmL), and must have received at least 1 week of anti-HBV treatment before the start of the study and willing to undergo antiviral treatment throughout the study period; HCV RNA positive patients must receive antiviral treatment according to the treatment guidelines;\n8. The subjects are required to provide fresh or archived tumor tissue samples as requested in the post-operative protocol for use in gene sequencing and peptide gel vaccine preparation;\n9. Expected survival period ≥12 weeks;\n10. Has sufficient organ and bone marrow function, has not received blood transfusion or hematopoietic growth factor within 14 days before screening. Laboratory test values meet the following requirements, as follows: a. Hematology: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Platelet count (PLT) ≥50×10\\^9\u002FL; Hemoglobin (HGB) ≥90g\u002FL b. Liver function: Total bilirubin (TBIL) ≤3×upper limit of normal value (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤5×ULN; Serum albumin ≥30g\u002FL c. Renal function: Serum creatinine (Cr) ≤1.5×ULN, or for subjects with creatinine \\>1.5×ULN, creatinine clearance rate (CCr) ≥45 mL\u002Fmin (Cockcroft-Gault formula); Urine routine results show urine protein \\\u003C2+; For subjects with urine protein ≥2+ on baseline urine routine testing, 24-hour urine collection should be performed and 24-hour urine protein quantification \\\u003C1 g d. Coagulation function: International normalized ratio (INR) or APTT ≤1.5×ULN;\n11. Fertile women: Must agree to abstain from sexual intercourse (avoid heterosexual intercourse) or use a reliable and effective method of contraception from the start of signing the informed consent form until at least 120 days after the last dose of study drug. Serum HCG test must be negative in the week before treatment; and must be non-lactating. If female patients have menstruated and have not reached postmenopausal status (consecutive absence of menstruation for ≥12 months, no other reason except for menopause), and have not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), they are considered fertile;\n12. For male subjects with fertile female partners, must agree to abstain from sexual intercourse or use a reliable and effective method of contraception from the start of signing the informed consent form until at least 120 days after the last dose of study drug. Male subjects must also agree not to donate sperm during the same period. Male subjects whose partners are pregnant must use condoms, and no other contraceptive method is necessary\n\nExclusion Criteria:\n\n1. Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, hilar cholangiocarcinoma, and gallbladder cancer;\n2. Patients with other active malignant tumors other than intrahepatic cholangiocarcinoma within 5 years or simultaneously. Patients with localized tumors that have been cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostatic carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included;\n3. Currently with interstitial pneumonia or interstitial lung disease, or with a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment in the past, or other possible interferences with the judgment and treatment of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with active pneumonia or severe lung function impairment shown by chest CT during screening; active tuberculosis;\n4. Presence of active autoimmune diseases or a history of autoimmune diseases that may relapse \\[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients controlled only by hormone replacement therapy can be included)\\]; patients with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type 1 diabetes mellitus treated with insulin, or patients with asthma who have completely resolved in childhood and require no intervention as adults can be included; patients with asthma requiring bronchodilators for medical intervention cannot be included;\n5. Within 2 weeks before the start of the study, use of immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose \\>10mg\u002Fday prednisone or other equivalent glucocorticoids);\n6. Patients with active infections, with unexplained fever ≥38.5°C within 1 week before the start of the study, or with a baseline white blood cell count \\>15×10\\^9\u002FL;\n7. Patients with congenital or acquired immune deficiency (e.g., HIV infection);\n8. Within 4 weeks before the first dose, received or planned to receive live or attenuated live vaccines during the study;\n9. Within 6 months before the start of the study, significant clinical bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, etc. If positive for occult blood in stool at baseline, it can be retested; if still positive after retesting, endoscopy is required;\n10. Known existing hereditary or acquired bleeding disorders (e.g., hemophilia patients), coagulation disorders, thrombocytopenia, etc.); currently receiving full-dose oral or injected anticoagulants or thrombolytics for therapeutic purposes (prophylactic use of low-dose aspirin is allowed, etc.);\n11. Within 6 months before the start of the study, arterial thromboembolic events, such as cerebrovascular accidents (including transient ischemic attacks, intracerebral hemorrhage, cerebral infarction), CTCAE grade 3 or higher deep vein thrombosis, pulmonary embolism, etc;\n12. Uncontrolled heart clinical symptoms or diseases, such as: (1) New York Heart Association (NYHA) standard II or higher heart failure or echocardiography: LVEF (left ventricular ejection fraction) \\\u003C50%; (2) unstable angina pectoris; (3) myocardial infarction within 1 year before treatment; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc \\>450ms (men); QTc \\>470ms (women) (QTc interval calculated using the Fridericia formula: if QTc is abnormal, it can be continuously measured for 3 times at intervals of 2 minutes and the average value is taken);\n13. Hypertension that cannot be well controlled with antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (based on the average of blood pressure readings from ≥2 measurements); previous history of hypertensive emergencies or hypertensive encephalopathy is allowed;\n14. Within 6 months before the start of the study, the occurrence of major vascular diseases (e.g., aortic aneurysms requiring surgical repair or recent peripheral arterial thrombosis);\n15. Severe, unhealed, or open wounds, as well as active ulcerations or untreated fractures;\n16. Within 4 weeks before the start of the study, received major surgery treatment (excluding diagnostic procedures) or expect to undergo major surgery during the study period;\n17. Unable to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption;\n18. Within 6 months before the start of the study, experienced intestinal obstruction and\u002For had clinical signs or symptoms of gastrointestinal obstruction, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding. If patients with incomplete obstruction\u002Fobstruction syndrome\u002Fintestinal obstruction signs\u002Fsymptoms at the time of initial diagnosis received definitive (surgical) treatment to resolve symptoms, they may be eligible for inclusion in the study;\n19. Within 2 weeks before the start of the study, the use of strong CYP3A4\u002FCYP2C1 inducers including rifampicin (and its analogues) and St. John's wort, or strong CYP3A4\u002FCYP2C19 inhibitors;\n20. Subjects who have received other neoantigen vaccines, or are allergic to any chemotherapy drugs, anti-angiogenic targeted drugs, or excipients",{"count":478,"type":21},10,[480],"EARLY_PHASE1","This study is a single-arm, open-label, exploratory clinical trial, with the primary objective to evaluate the efficacy and safety of the Neoantigen Vaccine plus capecitabine for the treatment of high-intermediate risk recurrent intrahepatic cholangiocarcinoma",[31],"2025-05-12",{"date":485,"type":43},"2025-05-15",{"date":487,"type":43},"2024-05-06",{"date":489,"type":21},"2026-05",{"name":491,"class":113},"Yongyi Zeng",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":22,"phases":501,"briefSummary":502,"conditions":503,"keywords":504,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":114},"100560964","early-phase-1-a-clinical-trial-evaluating-the-safety-and-efficacy-of-intravenous-hnf4-srrna-in-treating-advanced-icc-patients-100560964","NCT06583993","A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α srRNA in Treating Advanced ICC Patients","A Clinical Trial Assessing the Safety and Efficacy of Intravenous HNF4α srRNA for the Treatment of Patients With Advanced Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n1. Males or females, aged 18 years or older.\n2. Histologically or cytologically confirmed intrahepatic cholangiocarcinoma patients.\n3. Patients with intrahepatic cholangiocarcinoma not suitable for surgical resection, liver transplantation, or ablation therapy, or those with post-surgical recurrence and\u002For metastasis.\n4. Patients not suitable for local or systemic treatment, or those who have progressed after at least one chemotherapy regimen containing gemcitabine\u002Ffluoropyrimidine\u002Fplatinum, etc..\n5. Life expectancy of 12 weeks or more.\n6. Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.\n7. Males with fertility and females of childbearing potential are willing to use a highly effective method of contraception for the entire study period and for 6 months after study drug discontinuation. Females of childbearing age, including premenopausal females and within 2 years after menopause, must have a negative serum pregnancy test result within 7 days prior to the first dose of study treatment.\n8. Subjects who had a voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria were excluded from participation in this study\n\n  1. Inadequate liver function：Albumin (ALB) \\\u003C 25 g\u002FL, or total bilirubin \\> 5 × the upper limit of normal (ULN), or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) \\>10 × ULN.\n  2. Inadequate renal function defined as creatinine \\>1.5 × ULN or calculated creatinine clearance \\\u003C 40 mL\u002Fmin.\n  3. Absolute neutrophil count (ANC) \\\u003C 1.0×109\u002FL, or Platelets \\\u003C 30×109\u002FL, or Hemoglobin \\\u003C 8.5 g\u002FdL.\n  4. International normalized ratio (INR) \\> 2.3.\n  5. Poorly controlled hypertension, diabetes or other serious heart or lung diseases, or with serious dysfunction.\n  6. Patients who have received local or systemic anti-tumor treatments such as ablation, Transhepatic Arterial Chemotherapy and Embolization (TACE), local radiotherapy of the liver, immunotherapy, targeted therapy, etc., within 4 weeks, or chemotherapy, other trial drugs, or radiotherapy of metastatic lesions within 2 weeks, except for treatment regimens assessed as disease progression according to RECIST v1.1.\n  7. Patients with incurable brain metastasis.\n  8. All toxicities related to prior locoregional or systemic anti-tumor treatments are still grade 2 or more (except for hair loss and other events that have been judged tolerable by researchers).\n  9. Complication histories of liver cirrhosis or HCC such as gastrointestinal hemorrhage, overt hepatic encephalopathy, or refractory ascites within 2 weeks prior to the first dose of study treatment.\n  10. Uncontrolled active infection (eg, lung infections, or abdominal infections).\n  11. History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival rate \\> 90%), such as adequately treated early gastric carcinoma, carcinoma in situ of the cervix, non-melanoma skin carcinoma, or localized prostate cancer.\n  12. Hepatitis B virus DNA greater than 500 copies\u002FmL, or hepatitis C virus RNA greater than 15 U\u002FmL.\n  13. Positive for human immunodeficiency virus (HIV).\n  14. Allergic to contrast agents.\n  15. Pregnant\u002Flactating women, or women with the possibility of pregnancy.\n  16. Any medical conditions which, in the opinion of the investigator, would preclude participation in this clinical trial.",{"count":500,"type":21},9,[480],"The goal of this investigator-initiated, a single-arm, open-label, pilot study is to investigate the safety, tolerability, and efficacy of intravenous HNF4α srRNA treatment in subjects with advanced Intrahepatic Cholangiocarcinoma (ICC).\n\nCondition of disease: advanced intrahepatic cholangiocarcinoma Intervention： HNF4α srRNA will be administered intravenously for the treatment of ICC. The dosing regimen is planned for a second dose 14 ± 3 days post-initial treatment, followed by subsequent treatments every 28 ± 7 days, with adjustments made based on patient tolerance and therapeutic response. This is a dose escalation assay employing a i3+3 design to assess escalating HNF4α srRNA dosages: 25 μg, 50 μg, and 100 μg. Post-initial dose, a 14-day dose-limiting toxicities (DLT) observation will evaluate tolerability and safety, guiding dose adjustments or selection of the Recommended Dose (RD) for the expansion phase. Cohorts may include up to 9 participants, adjusted for safety.\n\nDrug: HNF4α srRNA, a drug specifically designed to target liver cancer cells and facilitate the expression of HNF4α.\n\nAccording to Amendment 1, patients who have received at least 4 cycles of HNF4α srRNA therapy and have a tumor assessment of SD (stable disease) or PD (progressive disease) per RECIST v1.1 criteria may, after a comprehensive evaluation by the investigator considering the patient's treatment history and the current safety and efficacy data of HNF4α srRNA, continue HNF4α srRNA at the same dose, or have their dose adjusted, in combination with immunotherapy, targeted therapy, or chemotherapy.",[31],[31,505],"Hepatocyte nuclear factor 4α","2025-04-21",{"date":508,"type":43},"2025-04-24",{"date":510,"type":43},"2024-11-07",{"date":512,"type":21},"2026-07",{"name":514,"class":113},"Shanghai Changzheng Hospital",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":182,"enrollmentInfo":522,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":526,"conditions":527,"keywords":528,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":114},"100465551","phase-3-toripalimab-plus-lenvatinib-and-gemcitabine-based-chemotherapy-in-1l-treatment-of-advanced-icc-a-phase-iii-study-100465551","NCT05342194","Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study","A Phase III, Randomized, Three-arm, Double-blind, Placebo-controlled, International Multi-center Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Lenvatinib and Gemcitabine-based Chemotherapy Compared With Gemcitabine-based Chemotherapy as First-line Treatment in Patients With Unresectable Advanced Intrahepatic Cholangiocarcinoma (ICC)","Inclusion Criteria:\n\n1. Age of 18-75 years (inclusive), male or female;\n2. Volunteer to participate in the study by signing the informed consent form and the ability to comply with the study protocol;\n3. Advanced ICC with diagnosis confirmed by histology or cytology;\n4. Stage II, III, or IV per TNM staging for ICC of the American Joint Committee on Cancer (AJCC) (8th edition, 2017). Those with Stage II or III should be determined to be unresectable by the investigator;\n5. Patients with no prior systemic chemotherapy or targeted therapy or loco-regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization) for ICC. Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible;\n6. Measurable lesion per RECIST v1.1;\n7. Child-Pugh class A with no history of hepatic encephalopathy;\n8. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1;\n9. Life expectancy ≥12 weeks;\n\nExclusion Criteria:\n\n1. Diagnosis of hepatocellular carcinoma (HCC), mixed cholangiocarcinoma and HCC, sarcomatoid hepatocellular carcinoma, or hepatic fibrolamellar carcinoma by histology or cytology;\n2. History of malignancy other than ICC within 5 years prior to screening, with the exception of localized malignancies that have been cured, including non-melanoma skin cancers, cervical carcinoma in situ, breast carcinoma in situ, and papillary thyroid carcinoma;\n3. Prior radiotherapy for ICC within 4 weeks prior to randomization;\n4. Major surgical procedures within 4 weeks prior to randomization;\n5. Side effects from prior therapy (except alopecia and pigmentation) that has not recovered to ≤ grade 1 (per NCI-CTCAE v5.0) or levels specified in the inclusion\u002Fexclusion criteria;\n6. Uncontrolled pericardial effusion, pleural effusion, or clinically significant moderate or severe ascites that is symptomatic or requires thoracentesis or paracentesis during the screening phase for control of symptoms;\n7. Gastrointestinal (GI) hemorrhage within 6 months prior to randomization and\u002For gastrointestinal varices that have not been assessed and treated, if appropriate, within 6 months prior to randomization.\n8. Gastrointestinal or non-gastrointestinal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to randomization;\n9. Ongoing or a history of recurrent intestinal obstruction. Patients with a single episode of intestinal obstruction that has fully resolved following treatment are eligible allowed;\n10. History of serious cardiovascular and cerebrovascular diseases:\n11. Significant bleeding and coagulopathy or other evidence of bleeding diathesis, to include:\n12. Pre-existing CNS metastases and\u002For meningeal metastases (including dural metastases and leptomeningeal metastases);\n13. Serious non-healing wound, active ulcer, or untreated bone fracture;\n14. Vaccination with live virus or bacteria within 30 days prior to randomization;\n15. Active autoimmune disease or history of autoimmune disease",{"count":523,"type":21},480,[525],"PHASE3","This is a Phase III, prospective, randomized, three-arm, double-blind, placebo-controlled, international multicenter study to evaluate the efficacy and safety of toripalimab in combination with lenvatinib and gemcitabine-based chemotherapy compared with gemcitabine-based chemotherapy as first-line treatment for unresectable advanced ICC.\n\nThis study will enroll approximately 480 patients with unresectable advanced ICC who have received no prior systemic therapy. Patients who meet the requirements will be randomly assigned to Treatment Arm A: Toripalimab, lenvatinib, and gemcitabine-based chemotherapy or Treatment Arm B: Toripalimab, oral placebo, and gemcitabine-based chemotherapy or Treatment Arm C: Intravenous placebo, oral placebo, and gemcitabine-based chemotherapy.\n\nAll patients will receive standard chemotherapy (GEMOX or GC per Investigator decision) for a maximum of 8 cycles. After the completion of standard chemotherapy, all patients continue to receive maintenance therapy with toripalimab injection or its placebo in combination with lenvatinib mesylate capsule or its placebo until unacceptable toxicity, confirmed disease progression and loss of clinical benefit as determined by the investigators, start of new anti-cancer therapy, death, other conditions requiring termination of study treatment, or the patient meets the criteria for study withdrawal, whichever occurs first.\n\nIn the absence of unacceptable toxicity, patients who meet criteria for unconfirmed disease progression per RECIST v1.1 while receiving toripalimab, lenvatinib, or their placebos will be permitted to continue treatment if their clinical status or symptoms are stable or improved (as determined by the investigators) or until loss of clinical benefit. Patients with confirmed disease progression should discontinue toripalimab, lenvatinib, or their placebos.\n\nTumor assessments will be performed at screening and during the study treatment per protocol. In the absence of progression, tumor assessments will continue as scheduled, regardless of whether study treatment ends, until confirmed disease progression or other criteria for study withdrawal are met, whichever occurs first. Patients who meet RECIST v1.1 criteria for progression should undergo tumor assessments as scheduled if clinical benefits of continuing study treatment are determined by investigators until progression is confirmed per iRECIST (iCPD), or the criteria for study withdrawal are met, whichever occurs first.\n\nComputerized tomography (CT)\u002Fmagnetic resonance imaging (MRI) scans for efficacy evaluation will be performed at baseline, every 6 weeks (Q6W) in the first year (52 weeks), and every 9 weeks (Q9W) in the second year (after week 52).\n\nAll AEs and concomitant medications during the study will be recorded. An end-of-treatment (EOT) visit will be performed within 30 days after the last dose of study treatment or termination of study treatment is confirmed by the investigator. After the EOT visit, follow-up for survival (telephone visit is allowed) will be conducted and AEs and subsequent anti-cancer therapy will be collected.",[31],[529,530,531,532],"Intrahepatic cholangiocarcinoma","Toripalimab","lenvatinib","Chemotherapy","2025-04-17",{"date":535,"type":43},"2025-04-23",{"date":537,"type":43},"2023-06-19",{"date":539,"type":21},"2027-05-31",{"name":541,"class":113},"Shanghai Junshi Bioscience Co., Ltd.",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":22,"phases":551,"briefSummary":552,"conditions":553,"keywords":557,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":114},"100584340","phase-2-additional-chemotherapy-administered-directly-into-the-liver-using-a-chemo-pump-in-patients-with-bile-duct-cancer-inside-the-liver-treatable-by-surgery-100584340","NCT06888063","Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery","Preventing Liver Recurrence After Partial Hepatectomy for Intrahepatic Cholangiocarcinoma Using Adjuvant Hepatic Arterial Infusion Pump Chemotherapy - PUMP IV Trial","PUMP IV","Inclusion Criteria:\n\n* 18 years or older\n* ECOG or WHO performance status 0 or 1\n* Diagnosis of resectable iCCA on imaging. No histological confirmation is needed before surgery, according to standard of care.\n* Patient is able to undergo a laparotomy.\n* Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT-scan with early arterial phase with 1mm cuts. The default site for the catheter insertion is the GDA. Accessory or aberrant hepatic arteries are no contraindication for catheter placement.\n* Adequate bone marrow, liver, and renal function before inclusion (values may be max. 30 days old)\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^ 9\u002FL\n* White blood cell count (WBC) ≥ 2.5 x 10\\^9\u002FL\n* Platelets ≥ 100 x 10\\^9\u002FL\n* Glomerular filtration rate (GFR) ≥ 30 ml\u002Fmin\n* Haemoglobin (Hb) ≥ 5.5 mmol\u002FL\n* Total bilirubin ≤ 25 µmol\u002FL\n* Written informed consent must be given according to ICH\u002Fgood clinical practice (GCP), and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Presence of extrahepatic disease at the time of first presentation. Patients with locoregional lymph node disease or with small (≤ 1 cm) extrahepatic lesions that are too small to characterize or biopsy are eligible.\n* Second primary malignancy, except for adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence or with a life expectancy longer than 5 years.\n* Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency\n* Prior hepatic radiation, ablation, or resection for iCCA.\n* Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Some postoperative ascites is allowed.\n* (Partial) portal vein thrombosis in future liver remnant.\n* Pregnant or lactating women.\n* History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy.\n* Serious concomitant systemic disorders that would compromise the safety of the patient or his\u002Fher ability to complete the study, at the discretion of the investigator.\n* Organ allografts requiring immunosuppressive therapy.\n* Serious infections (uncontrolled or requiring treatment).\n* Participation in another interventional study for iCCA with survival as outcome.\n* Participation in another prospective study with an interventional medical product.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial",{"count":5,"type":21},[25],"The goal of this clinical trial is to learn if additional chemotherapy by means of a chemo pump can prevent return of disease in adult patients with bile duct cancer in the liver that can be treated with surgery. The main questions it aims to answer are:\n\n* Does addition of chemotherapy by means of a chemo pump lead to less return of disease within the liver two years after surgery?\n* Does addition of chemotherapy by means of a chemo pump lead to longer survival of patients?\n* Does addition of chemotherapy by means of a chemo pump lead to an increase in quality of life?\n\nParticipants will receive an implanted chemo pump, through which additional chemotherapy will be given to the liver in addition to surgery.",[554,555,556,31],"Intrahepatic Bile Duct Cancer","Intrahepatic Cholangiocarcinoma (Icc)","Intrahepatic Bile Duct Carcinoma",[558,548,559,560,561,562,529,320,563,564],"PUMP","Hepatic Arterial Infusion Chemotherapy","Hepatic Arterial Infusion Pump chemotherapy","HAIP","HAIC","Floxuridin","Chemopump","2025-03-14",{"date":567,"type":43},"2025-03-21",{"date":569,"type":43},"2024-11-20",{"date":571,"type":21},"2031-09",{"name":573,"class":113},"Erasmus Medical Center",{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":182,"enrollmentInfo":581,"targetDuration":4,"studyType":22,"phases":583,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":595},"100532104","phase-2-neoadjuvant-therapy-of-haicgemox-combined-with-adebrelimab-and-lenvatinib-for-resectable-intrahepatic-cholangiocarcinoma-with-high-risk-recurrence-factors-100532104","NCT06208462","Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors","Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors：NEO-ERA-01 Study","Inclusion Criteria:\n\n1. The patient must sign the informed consent;\n2. Age 18-75 years old, male and female;\n3. ECOG Physical status Score (PS score) 0 or 1;\n4. Patients with ICC who have been pathologically diagnosed (histopathological and\u002For cytological examination) or clinically diagnosed as having high-risk factors;\n\n   Risk factors are defined as follows:\n\n   Stage ≥Ib, single lesion \\> 5cm, multiple tumor lesions in the same lobe, technically resectable;Vascular invasion, regional lymph node metastasis, technically resectable\n5. Patients with untreated and resectable locally advanced ICC who have been assessed by the surgeon as surgically resectable;\n6. The functional indicators of vital organs meet the following requirements\n\n   ① Neutrophils ≥1.5\\*109\u002FL; Platelet ≥80\\*109\u002FL; Hemoglobin ≥9g\u002Fdl; Serum albumin ≥3g\u002Fdl;② Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal, T3, T4 in the normal range;③ Bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤ 2 times the upper limit of normal value;④ Serum creatinine ≤ 1.5 times the upper limit of normal value, creatinine clearance ≥60 ml\u002Fmin;\n7. The subject has at least one measurable lesion (according to RECIST1.1);\n8. Fertile women: must agree to abstain from sex (abstain from heterosexual intercourse) or use a reliable, effective method of contraception for at least 120 days from the signing of the informed consent until the final administration of the study drug. Serum HCG test must be negative within 72 hours before randomization. And must be non-lactating.A woman is considered fertile if she has menstruated, has not yet reached postmenopausal status (no continuous periods for ≥12 months, no cause other than menopause has been found), and has not undergone sterilization (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).\n9. For male subjects whose partner is a fertile woman, they must agree to abstain from sex or use a reliable, effective method of contraception for at least 120 days from the signing of the informed consent until the final administration of the study drug. Male subjects also had to agree not to donate sperm during the same time period. Male subjects with a pregnant partner are required to use condoms and do not need to use other methods of contraception.\n\nExclusion Criteria:\n\n1. Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma and other non-cholangiocarcinoma malignant tumor components;\n2. Prior systemic therapy and tumor-related surgical treatment (biliary drainage allowed);Patients who relapse after surgery, have received PD1 antibody, PDL1 antibody or CTLA4 antibody, Lenvatinib, chemotherapy in the past; participated in other clinical trials 30 days before screening\n3. Previous or co-existing malignancies other than adequately treated non-melanin skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;\n4. Active pulmonary tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment; Had a history of active tuberculosis infection more than 1 year before enrollment, had not received formal anti-tuberculosis therapy or had active tuberculosis;\n5. Have an active, known, or suspected autoimmune disease. Subjects with hypothyroidism requiring hormone replacement therapy and skin conditions that do not require systemic therapy are eligible;\n6. Long-term acceptance of systemic sex hormones (doses equivalent to \\> 10mg prednisone per day) or any other form of immunosuppressive therapy. Participants using inhaled or topical corticosteroids may be enrolled;\n7. Severe cardiopulmonary and renal dysfunction;\n8. Have hypertension that is not well controlled by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);\n9. Abnormal coagulation function (PT\\> 14s), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy;\n10. HBV DNA\\> 2000IU\u002Fml, HCV RNA\\> 1000 IU\u002Fml;\n11. Had clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;\n12. Active infections that require systemic treatment;\n13. Human immunodeficiency virus (HIV, HIV1\u002F2 antibodies) positive;\n14. Have a history of psychotropic substance abuse, alcohol abuse or drug use;\n15. Have a history of drug allergy;\n16. Other factors, as determined by the investigator, that may affect the subject's safety or compliance with the test. Such as a serious illness (including mental illness) requiring co-treatment, serious laboratory abnormalities, or other family or social factors.",{"count":582,"type":21},33,[25],"Clinical Study on the efficacy and safety of HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.",[31],"2025-02-27",{"date":588,"type":43},"2025-03-03",{"date":590,"type":43},"2024-01-19",{"date":592,"type":21},"2027-01",{"name":594,"class":113},"The First Affiliated Hospital with Nanjing Medical University",3,{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":601,"acronym":4,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":22,"phases":604,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":114},"100440083","phase-2-lenvatinib-plus-sintilimab-in-patients-with-immune-checkpoint-inhibitor-previously-treated-advanced-liver-cancer-100440083","NCT05010681","Lenvatinib Plus Sintilimab in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Liver Cancer","A Phase II Study of Lenvatinib Plus Sintilimab in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Liver Cancer","Inclusion Criteria:\n\n* Written informed consent obtained.\n* Age ≥ 18 years at time of study entry.\n* Participants must have unresectable or metastatic histologically or cytologically confirmed hepatocellular carcinoma or intrahepatic cholangiocarcinoma\n* Participants must have disease progression with an anti-PD-1 or anti-PD-L1 based regimen.\n* At least one measurable site of disease as defined by RECIST 1.1 criteria with spiral CT scan or MRI.\n* Performance status (PS) ≤ 2 (ECOG scale).\n* Life expectancy of at least 12 weeks.\n* Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500\u002FL, platelets ≥75 x103\u002FL; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g\u002FdL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (if using the Cockcroft-Gault formula )\n* Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n* History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment\n* Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.\n* Prior treatment with Lenvatinib or other targeted therapy.\n* RFA and resection administered less then 4 weeks prior to study treatment start.\n* Radiotherapy administered less then 4 weeks prior to study treatment start.\n* Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.\n* Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.\n* Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.\n* Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to:\n* history of interstitial lung disease\n* known acute or chronic pancreatitis\n* active tuberculosis\n* any other active infection (viral, fungal or bacterial) requiring systemic therapy\n* history of allogeneic tissue\u002Fsolid organ transplant\n* diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of nivolumab-monotherapy treatment.\n* Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma\u002Fatopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study.\n* Live vaccine within 30 days prior to the first dose of nivolumab-monotherapy treatment or during study treatment.\n* History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of nivolumab-monotherapy treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS\n* Medication that is known to interfere with any of the agents applied in the trial.\n* Any other efficacious cancer treatment except protocol specified treatment at study start.\n* Patient has received any other investigational product within 28 days of study entry.\n* Female subjects who are pregnant, breast-feeding or male\u002Ffemale patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). \\[Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner\\]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.",{"count":7,"type":21},[25],"The objective of this study is to evaluate the efficacy and safety of Lenvatinib plus Sintilimab in patients with advanced liver cancer progressed after treatment with immune checkpoint inhibitors.",[31],"2025-02-25",{"date":586,"type":43},{"date":610,"type":43},"2021-08-24",{"date":612,"type":21},"2025-08-20",{"name":614,"class":113},"Fudan University",{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":22,"phases":623,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":114},"100435788","phase-2-tace-combined-with-tislelizumab-in-patients-with-advanced-intrahepatic-cholangiocarcinoma-100435788","NCT04954781","TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma","A Phase II Study of Transcatheter Arterial Chemoembolization (TACE) Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Written informed consent obtained.\n* Age ≥ 18 years at the time of study entry.\n* Participants must have unresectable or metastatic histologically or cytologically confirmed intrahepatic cholangiocarcinoma\n* Participants must have failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity.\n* At least one measurable site of disease as defined by RECIST1.1 criteria with spiral CT scan or MRI.\n* Performance status (PS) ≤ 2 (ECOG scale).\n* Life expectancy of at least 12 weeks.\n* Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500\u002FL, platelets ≥75 x103\u002FL; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g\u002FdL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\n* History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment.\n* Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.\n* RFA and resection administered less then 4 weeks prior to study treatment start.\n* Radiotherapy administered less then 4 weeks prior to study treatment start.\n* Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.\n* Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.\n* Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.\n* Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to:\n\n  1. history of interstitial lung disease\n  2. Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)\n  3. known acute or chronic pancreatitis\n  4. active tuberculosis\n  5. any other active infection (viral, fungal or bacterial) requiring systemic therapy\n  6. history of allogeneic tissue\u002Fsolid organ transplant\n  7. diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of nivolumab-monotherapy treatment.\n  8. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma\u002Fatopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study.\n  9. Live vaccine within 30 days prior to the first dose of nivolumab-monotherapy treatment or during study treatment.\n  10. History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of nivolumab-monotherapy treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS.\n* Medication that is known to interfere with any of the agents applied in the trial.\n* Any other efficacious cancer treatment except protocol specified treatment at study start.\n* Patient has received any other investigational product within 28 days of study entry.\n* Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n* Female subjects who are pregnant, breast-feeding or male\u002Ffemale patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). \\[Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner\\]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.",{"count":7,"type":21},[25],"The objective of this study is to evaluate the efficacy and safety of TACE combined with Tislelizumab in patients with advanced intrahepatic cholangiocarcinoma after progression on first-line systemic therapy.",[31],{"date":586,"type":43},{"date":628,"type":43},"2021-07-14",{"date":630,"type":21},"2025-07-15",{"name":614,"class":113},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":22,"phases":640,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":114},"100385505","phase-2-cryoablation-combined-with-anti-pd-1-antibody-in-patients-with-advanced-intrahepatic-cholangiocarcinoma-100385505","NCT04299581","Cryoablation Combined with Anti-PD-1 Antibody in Patients with Advanced Intrahepatic Cholangiocarcinoma","A Phase II Study of Cryoablation Combined with Anti-PD-1 Antibody （SHR-1210） in Patients with Advanced Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Written informed consent obtained.\n* Age ≥ 18 years at time of study entry.\n* Participants must have unresectable or metastatic histologically or cytologically confirmed intrahepatic cholangiocarcinoma\n* Participants must have failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity.\n* At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.\n* Performance status (PS) ≤ 2 (ECOG scale).\n* Life expectancy of at least 12 weeks.\n* Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500\u002FL, platelets ≥75 x103\u002FL; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g\u002FdL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (if using the Cockcroft-Gault formula ).\n* Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n* History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment\n* Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.\n* Radiofrequency ablation and resection administered less then 4 weeks prior to study treatment start.\n* Radiotherapy administered less then 4 weeks prior to study treatment start.\n* Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.\n* Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.\n* Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.\n* Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to:\n\n  1. history of interstitial lung disease\n  2. Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)\n  3. known acute or chronic pancreatitis\n  4. active tuberculosis\n  5. any other active infection (viral, fungal or bacterial) requiring systemic therapy\n  6. history of allogeneic tissue\u002Fsolid organ transplant\n  7. diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of nivolumab-monotherapy treatment.\n  8. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma\u002Fatopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study.\n  9. Live vaccine within 30 days prior to the first dose of nivolumab-monotherapy treatment or during study treatment.\n  10. History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of nivolumab-monotherapy treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS.\n* Medication that is known to interfere with any of the agents applied in the trial.\n* Any other efficacious cancer treatment except protocol specified treatment at study start.\n* Patient has received any other investigational product within 28 days of study entry.\n* Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n* Female subjects who are pregnant, breast-feeding or male\u002Ffemale patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). \\[Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner\\]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.",{"count":7,"type":21},[25],"The objective of this study is to evaluate the efficacy and safety of cryoablation combined with anti-pd-1 antibody in patients with advanced hepatocellular carcinoma after progression on first line systemic therapy.",[31],{"date":586,"type":43},{"date":645,"type":43},"2020-07-07",{"date":647,"type":21},"2026-12-30",{"name":614,"class":113}]