[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cholangiocarcinoma-non-resectable\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cholangiocarcinoma-non-resectable":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,55,84,131,161,185,213,239,266],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":37,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":5},"100574188","phase-1-ct-95-in-advanced-cancers-associated-with-mesothelin-expression-100574188",false,"NCT06756035","CT-95 in Advanced Cancers Associated With Mesothelin Expression","Phase 1a\u002F1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression","Inclusion Criteria:\n\n* ECOG 0 or 1\n* Subjects with evaluable disease per RECIST 1.1 or mRECIST\n* Subjects with adequate organ function.\n* Subjects with advanced cancers associated with mesothelin expression\n\nExclusion Criteria:\n\n* Uncontrolled significant active infection or any medical or other condition that in opinion of the investigator would preclude the subject's participation in the study.\n* Prior treatment with MSLN-targeted CD3 or chimeric antigen receptor T cell (CAR-T) therapy\n* Concurrent participation in another investigational clinical trial.\n* Evidence of leptomeningeal disease","ALL","18 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1a\u002F1b, first-in-human (FIH), open-label, multi-center dose escalation and expansion study of the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of single-agent CT-95 in subjects with advanced (recurrent, unresectable, or metastatic) cancers associated with MSLN expression.",[26,27,28,29,30,31,32,33,34,35,36],"Mesothelin-Expressing Tumors","Epithelial Ovarian Cancer","Malignant Pleural Mesothelioma, Advanced","Malignant Peritoneal Mesothelioma, Advanced","Pancreatic Adenocarcinoma Advanced or Metastatic","Lung Adenocarcinoma Metastatic","Cholangiocarcinoma Advanced","Cholangiocarcinoma Non-resectable","Mesothelin-expressing Advanced Cancers","Mesothelin-positive Advanced Malignant Solid Tumors","Colorectal Cancer",[38,39,40,41,42],"Phase 1 Dose Escalation Study","CT-95","Advanced, recurrent cancers","Unresectable, metastatic cancers","Cancers associated with mesothelin expression","RECRUITING","2026-06-10",{"date":46,"type":47},"2026-06-12","ACTUAL",{"date":49,"type":47},"2025-03-31",{"date":51,"type":20},"2028-12",{"name":53,"class":54},"Context Therapeutics Inc.","INDUSTRY",{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":66,"conditions":67,"keywords":72,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100489655","phase-2-y-90-with-durvalumabgemcis-in-intrahepatic-cholangio-100489655","NCT05655949","Y-90 With Durvalumab\u002FGem\u002FCis in Intrahepatic Cholangio","A Single Arm Phase 2 Study of Y-90 SIRT in Combination With Durvalumab (MEDI 4736) and Gemcitabine\u002FCisplatin in Locally Advanced, Unresectable or Metastatic Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study\n* Male and female participants at least 18 years of age at the time of signing the ICF\n* Histologically or cytologically confirmed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma; at least one intrahepatic lesion must be present\n* Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria\n* ECOG performance status ≤1\n* Body weight \\>30 kg\n* Must have a life expectancy of at least 12 weeks\n* Participants must have adequate marrow function as defined below:\n\n  * Hemoglobin ≥9.0 g\u002FdL\n  * Absolute neutrophil count (ANC) ≥1.0 × 109 \u002FL\n  * Platelet count ≥75 × 109\u002FL\n* Participants must have adequate renal function as defined below:\n\n  * Serum creatinine ≤ 1.5 mg\u002FdL OR\n  * Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance\n* Participants must have adequate hepatic function as defined below:\n\n  * Bilirubin ≤1.5 x ULN\n  * ALT ≤ 2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN\n  * AST ≤ 2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN\n  * 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 their physician\n  * No known history of active HBV or HCV infection.\n\n    * Note: Participants with Hepatitis C who have been clinically cured, defined as persistent absence of Hepatitis C RNA detected by polymerase chain reaction (PCR) test in serum 12 weeks after completing antiviral treatment, are eligible for this study\n    * Note: Participants with a history of Hepatitis B infection that are currently on viral suppressive therapy are eligible for enrollment\n* Adequate coagulation studies as demonstrated by prothrombin (PT) and partial thromboplastin (PTT) time within normal limits (\\\u003C\u002F= 1.5 x ULN) in the absence of anticoagulation medication. Participants receiving anticoagulation may be approved by sponsor\n* Participants with known human immunodeficiency virus (HIV) on effective highly-active antiretroviral therapy (HAART) with undetectable viral load within 6 months are eligible for this trial, so long as the following criteria are met:\n\n  * HAART does not interact with or have overlapping toxicities with study medication, per discretion of the treating provider\n  * CD4 count is ≥350 cells\u002FuL, viral load is undetectable, and not taking prohibited cytochrome (CYP)-interacting medications\n  * Probable long-term survival with HIV if cancer were not present\n  * Stable on a HAART regimen for ≥4 weeks and willing to adhere to their HAART regimen with minimal overlapping toxicity and drug-drug interactions with the experimental agents in this study\n  * HIV is not multi-drug resistant\n  * Taking medication and\u002For receiving antiretroviral therapy that does not interact or have overlapping toxicities with the study medication\n\nExclusion Criteria:\n\n* Surgically resectable disease at enrollment\n* Histologically or cytologically confirmed diagnosis of primary hepatocellular carcinoma or mixed adenocarcinoma\u002Fhepatocellular carcinoma\n* Received prior systemic chemotherapy and\u002For radiotherapy for intrahepatic cholangiocarcinoma. Prior surgical resection and adjuvant chemotherapy or chemoradiotherapy is allowed if more than 6 months have elapsed since last dose of treatment, and if the tumor is amenable to Y-90 SIRT\n* Prior treatment with anti-PD-1, anti-PD-L, including durvalumab antibody, or any other drug treatment specifically targeting T-cell co-stimulation or checkpoint pathways\n* Any of the following within 6 months of screening:\n\n  * New York Heart Association (NYHA) Class III or IV heart failure\n  * Myocardial infarction, unstable angina pectoris, or symptomatic coronary artery disease\n  * Unstable arrhythmia\n  * Stroke to transient ischemic attack\n* Previous malignancies, except for adequately treated non-melanoma skin cancer, in-situ cancer, or any other cancer from which the subject has been disease-free for at least 3 years\n* Severe chronic obstructive or other pulmonary disease with chronic baseline hypoxemia due to potential for gemcitabine-induced bronchospasm and\u002For durvalumab-induced pneumonitis\n* Major surgery (other than diagnostic) within 4 weeks of study treatment day 1\n* Active, uncontrolled or untreated bacterial, viral, or fungal infection that requires systemic therapy\n* Active, untreated HIV, HBV, or HCV\n* Subjects who have participated in another investigational drug or device study within 4 weeks prior to study registration.\n\nPregnant women are excluded from this study because cisplatin is a class D agent with the potential for teratogenic or abortifacient effects. Because cisplatin is present in breast milk and there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cisplatin, breastfeeding should be discontinued prior to entry into the study. Subjects and their sexual partners entered into the study must agree to contraception. The following restrictions apply while the patient is receiving study treatment and for the specified times before and after:\n\n* Female patients of child-bearing potential Female patients of childbearing potential who are not abstinent and intend to be sexually active with a non sterilized male partner must use at least 1 highly effective method of contraception (Table 2) from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after the last dose of durvalumab monotherapy). Non-sterilised male partners of a female patient of childbearing potential must use male condom plus spermicide throughout this period. Cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Female patients should also refrain from breastfeeding throughout this period.\n* Male patients with a female partner of childbearing potential Non-sterilized male patients who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom plus spermicide from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after the last dose of durvalumab monotherapy). However, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Male patients should refrain from sperm donation throughout this period.\n\nFemale partners (of childbearing potential) of male patients must also use a highly effective method of contraception throughout this period (Table 2).\n\nFemales of childbearing potential are defined as those who are not surgically sterile (ie, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal.\n\nWomen will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n* Women \\\u003C50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution.\n* Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago.\n\nHighly effective methods of contraception, defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly are described in Table 2. Note that some contraception methods are not considered highly effective (e.g. male or female condom with or without spermicide; female cap, diaphragm, or sponge with or without spermicide; non-copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation is not the primary mode of action \\[excluding Cerazette\u002Fdesogestrel which is considered highly effective\\]; and triphasic combined oral contraceptive pills).\n\n* Copper T intrauterine device\n* Levonorgestrel-releasing intrauterine system (e.g., Mirena®)a\n* Implants: Etonogestrel-releasing implants: e.g. Implanon® or Norplant®\n* Intravaginal: Ethinylestradiol\u002Fetonogestrel-releasing intravaginal devices: e.g. NuvaRing®\n* Injection: Medroxyprogesterone injection: e.g. Depo-Provera®\n* Combined Pill: Normal and low dose combined oral contraceptive pill\n* Patch: Norelgestromin\u002Fethinylestradiol-releasing transdermal system: e.g. Ortho Evra® Minipillc: Progesterone based oral contraceptive pill using desogestrel: Cerazette® is currently the only highly effective progesterone-based\n\n  * Any concomitant disease or condition that could interfere with the conduct of the study, or that would in the option of the investigator pose an unacceptable risk to the subject in the study\n  * Contraindications to Y-90 SIRT per assessment by treating Interventional Radiologist (eg significant vascular drainage of the tumor to the lung that increases the potential for pulmonary toxicity)\n  * Unwillingness or inability to comply with the study protocol\n  * History of allogenic organ transplantation.\n  * 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 study physician\n    * Patients with celiac disease controlled by diet alone\n  * 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\n  * History of active primary immunodeficiency\n  * Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice\n  * 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 \\\u003C\\\u003C10 mg\u002Fday\\>\\> of prednisone or its equivalent\n    * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n  * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n  * Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n  * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.",{"count":63,"type":20},30,[65],"PHASE2","This trial is designed to study a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for bile duct cancer that cannot be removed with surgery.\n\nThe specific names of the interventions that will be used are:\n\n* Y-90 (a type of radiation microsphere bead)\n* Durvalumab (a type of immunotherapy)\n* Gemcitabine (a type of chemotherapy)\n* Cisplatin (a type of chemotherapy)",[68,69,33,70,71],"Bile Duct Cancer","Cholangiocarcinoma","Cholangiocarcinoma Metastatic","Metastatic Intrahepatic Cholangiocarcinoma",[68,69,33,70,71],"2026-04-17",{"date":75,"type":47},"2026-04-22",{"date":77,"type":47},"2024-02-13",{"date":79,"type":20},"2027-12-01",{"name":81,"class":82},"Beth Israel Deaconess Medical Center","OTHER",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":93,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":108,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":83},"100627888","trace-btc-relation-of-biomarkers-and-patients-reported-quality-of-life-to-outcomes-in-patients-with-biliary-tract-cancer-a-real--world-cohort-100627888","NCT07454486","TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort","TRACE-BTC","Inclusion Criteria:\n\n* Histopathologically verified biliary tract cancer (BTC) and\u002For Multidisciplinary Team (MDT) conference decision to define the patient as suffering from BTC.\n* Eligible for curative, adjuvant, or palliative oncological treatment.\n* Age ≥ 18 years.\n* Written and oral consent.\n\nExclusion Criteria:\n\n* Other malignant diseases within 5 years of BTC diagnosis, excluding early-stage non-melanoma skin cancer and carcinoma in situ of the cervix.\n* Conditions that prohibit blood sampling.\n* Known or suspected non-compliance.",{"count":92,"type":20},300,"5 Years","OBSERVATIONAL","Purpose of the Study:\n\nBile duct cancers are rare and aggressive. About 250 new cases are diagnosed each year in Denmark. These cancers are difficult to detect early, so only about 20% of patients can have surgery when diagnosed. Even after surgery, the cancer often returns, and chemotherapy only slightly reduces the risk of relapse.\n\nFor patients who cannot have surgery, treatments such as chemotherapy (sometimes combined with immunotherapy) can relieve symptoms and extend life, but their effect is limited. A small number of patients have specific genetic changes in their cancer that can be treated with targeted medicines.\n\nCurrently, doctors cannot predict which patients will benefit from treatment. Standard monitoring methods like CT scans are expensive, inconvenient, and sometimes unreliable because bile ducts are hard to see clearly on scans.\n\nBlood tests that detect cancer DNA in the blood (called circulating tumor DNA or ctDNA) and other biological markers may be a better way to monitor the disease and adjust treatment. These tests could help detect cancer recurrence earlier and determine whether treatment is working. Measuring patients' quality of life and symptoms over time may also help predict treatment benefit and evaluate effectiveness.\n\nThe goal of this study is to:\n\n* Investigate how biomarkers, including ctDNA, can predict disease course, detect relapse, and monitor treatment response.\n* Identify the best way to measure ctDNA in patients with bile duct cancer.\n* Examine whether patients' own reports of quality of life and symptoms can help assess treatment effect and prognosis.\n\nStudy Design and Procedures:\n\nThis is a prospective cohort study focusing on blood biomarkers and patient-reported symptoms and quality of life.\n\nParticipants agree to provide blood samples:\n\n* Before treatment\n* During treatment\n* During follow-up\n\nEach sample involves up to 40 ml of blood, with a maximum of 20 samples per patient.\n\nThe blood will be analyzed for:\n\n* ctDNA and genetic changes\n* Cancer-related markers\n* Inflammation markers\n* Immune system markers\n\nTumor tissue samples will also be examined to compare blood and tissue results. Full genome or exome sequencing will not be performed. Samples will be stored in a research biobank.\n\nFor patients with incurable disease, quality of life and symptom burden will be monitored repeatedly using Danish questionnaires.\n\nParticipants:\n\nThe study will include:\n\n* Up to 100 patients with potentially curable disease\n* Up to 200 patients with incurable disease\n\nTo participate, patients must:\n\n* Have confirmed bile duct cancer\n* Be eligible for curative, additional (adjuvant), or palliative treatment\n* Be over 18 years old\n* Provide written and verbal consent\n\nPatients cannot participate if they:\n\n* Had another cancer within the past 5 years (except early skin cancer or very early cervical cancer)\n* Cannot safely provide blood samples\n* Are unable to cooperate with study procedures\n\nRisks and Inconveniences:\n\nParticipants will have extra blood samples taken, usually during regular hospital visits. Possible side effects include mild soreness or small bruises at the needle site. The extra blood amount (40 ml per sample) is considered medically insignificant.\n\nParticipants will also spend time filling out questionnaires. The number and frequency of questions have been kept as low as possible while still providing meaningful data.\n\nFinancial Information:\n\nExtra costs for blood sampling, laboratory analysis, and data collection will be covered by external research funding managed by Aarhus University Hospital.\n\nThe researchers have no financial interest in the project. Patients will not receive financial compensation for participating.\n\nRecruitment and Consent:\n\nPotential participants are identified during routine clinical care. During a planned meeting with a doctor, patients receive written and verbal information about the study, including its purpose, risks, advantages, and disadvantages.\n\nThe conversation takes place in a calm and private setting. Patients may bring a support person. They have time to ask questions and at least 24 hours to consider participation.\n\nPatients can withdraw their consent at any time without affecting their treatment. Consent must be given before any study-related procedures begin.\n\nPublication of Results:\n\nThe results - whether positive or negative - will be presented at national and international conferences and submitted to peer-reviewed scientific journals.\n\nEthical Considerations:\n\nAll participants receive standard medical treatment. The risks and disadvantages are limited, and participants are unlikely to benefit directly from the study. However, the research may improve how biomarkers and patient-reported outcomes are used to predict prognosis and treatment response, potentially leading to better treatment for future patients with bile duct cancer.",[97,98,99,100,69,33,101,70,102,103,104,105,106,107],"Biliary Tract Cancer (BTC)","Biliary Tract Cancer (CCA)","Gall Bladder Cancer","Biliary Tract Cancers (BTC)","Cholangiocarcinoma Resectable","Cholangiocarcinoma of the Bile Duct","Cholangiocarcinoma, Extrahepatic","Cholangiocarcinoma, Hilar","Cholangiocarcinoma, Intrahepatic","Cholangiocarcinoma, Perihilar","Cholangiocarcinoma; Liver",[109,69,110,111,112,113,114,115,116,117,118,119,120],"Biliary Tract Neoplasms","Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Gallbladder Neoplasms","Circulating Tumor DNA","Liquid Biopsy","Minimal Residual Disease","Biomarkers, Tumor","Observational Study","Biobanking","DNA Methylation","Precision Oncology","NOT_YET_RECRUITING","2026-03-02",{"date":124,"type":47},"2026-03-06",{"date":126,"type":20},"2026-03-15",{"date":128,"type":20},"2031-12-30",{"name":130,"class":82},"Aarhus University Hospital",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100618020","preoperative-right-hepatic-artery-embolization-for-locally-advanced-bismuth-iiib-and-iv-perihilar-cholangiocarcinoma-100618020","NCT07326189","Preoperative Right Hepatic Artery Embolization for Locally Advanced Bismuth IIIb and IV Perihilar Cholangiocarcinoma","A Prospective, Multicenter, Single-Arm Study on the Efficacy and Safety of Preoperative Right Hepatic Artery Embolization Combined With Surgical Resection for Locally Advanced Bismuth IIIb and IV Perihilar Cholangiocarcinoma","PHAE-PHCC","Inclusion Criteria:\n\n* Signed informed consent.\n* Age 18-80 years.\n* Clinical diagnosis of Bismuth IIIb or IV perihilar cholangiocarcinoma, deemed suitable for radical resection via left hepatectomy or left trisectionectomy.\n* Imaging (CTA\u002FMRA) confirms tumor invasion of the right hepatic artery (RHA) that is assessed as \"unable to be safely reconstructed after resection\" (e.g., involvement of RHA branches or requiring vascular graft for reconstruction).\n* Portal vein on the side of the future liver remnant is not invaded or is reconstructable.\n* ECOG performance status 0-1.\n* Child-Pugh score ≤ 7 (Class A or B).\n* Adequate organ function (bone marrow, liver, kidney) as per protocol-defined laboratory values.\n* Expected survival ≥ 12 weeks.\n\nExclusion Criteria:\n\n* Evidence of distant metastasis (M1).\n* History of other malignancies within the past 5 years (except cured basal cell carcinoma or cervical carcinoma in situ).\n* Severe cardiac, pulmonary, renal, or cerebrovascular disease as specified in the protocol (e.g., recent myocardial infarction, severe COPD, chronic renal failure stage ≥ III).\n* Uncontrolled active infection or diabetes.\n* Pregnancy or lactation.\n* Allergy to iodinated contrast media.\n* Postoperative pathology confirms non-cholangiocarcinoma.","80 Years",{"count":141,"type":20},33,[143],"NA","This is a prospective, multicenter, single-arm study investigating the efficacy and safety of preoperative right hepatic artery embolization (PHAE) followed by surgical resection in patients with locally advanced Bismuth IIIb or IV perihilar cholangiocarcinoma (PHCC) involving the right hepatic artery. The standard treatment for such cases is often considered unresectable due to the high risk of hepatic ischemia after arterial resection without reconstruction. This study proposes a strategy: preoperative embolization of the tumor-involved right hepatic artery to stimulate the development of collateral arterial circulation (e.g., from the right inferior phrenic artery), enabling subsequent radical resection of the right hepatic artery without reconstruction. The primary objective is to evaluate the 1-year overall survival rate. Secondary objectives include surgical conversion rate, R0 resection rate, 1-year\u002F3-year recurrence-free survival, 3-year overall survival rate and safety assessment. A total of 33 participants will be enrolled across multiple centers in China.",[33],[147,148,149,150,151],"Perihilar cholangiocarcinoma","Hepatic artery embolization","Vascular invasion","Surgical conversion","Radical resection","2026-01-14",{"date":154,"type":47},"2026-01-16",{"date":156,"type":20},"2026-04-01",{"date":158,"type":20},"2029-03-31",{"name":160,"class":82},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100313750","phase-2-hepatic-arterial-infusion-of-gemcitabine-oxaliplatin-for-second-line-therapy-in-non-metastatic-unresectable-intra-hepatic-cholangiocarcinoma-100313750","NCT03364530","Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma","Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma: a Multicentric Single-arm Phase II Study","GEMOXIA-02","Inclusion Criteria:\n\n* Histologically-proven intrahepatic cholangiocarcinoma previously treated by first-line systemic therapy\n* Absence of extra-hepatic metastasis or peritoneal carcinomatosis (as demonstrated by CT-scan)\n* General health status : World Health Organization Performance Status = 0, 1\n* Estimated life expectancy \\> 3 months\n* Disease that is not suitable for resection with a curative intent, as validated by a multidisciplinary committee with at least one senior hepatic surgeon\n* At least one measurable lesion according to RECIST 1.1 criteria\n* Platelets ≥100,000\u002Fmm3, polynuclear neutrophils ≥ 2000\u002Fmm3 , hemoglobin 9g\u002FdL (even transfused patients can be included)\n* Creatininemia \\\u003C 1.5 mol\u002FL\n* Creatinine clearance \\> 30 mL\u002Fmin\n* Bilirubinemia ≤2 N (after biliary drainage if necessary)\n* Aspartate and Alanine Transaminase ≤ 5 mol\u002FL\n* Reference hepatic MRI (according to the foreseen protocol) done during the 30 days preceding the 1st cycle of treatment\n* Written informed consent\n* National health insurance cover\n\nExclusion Criteria:\n\n* Patients with cholangiocarcinoma of the gallbladder or common bile duct or those with hepatocholangiocarcinoma or a Klatskin tumor\n* Patients who are eligible for surgical resection or liver transplantation\n* Extra-hepatic metastases (Pulmonary micronodules \\\u003C7mm without uptake on positron emission tomography are not a contra-indication)\n* Presence of clinical ascites\n* History of intra-arterial therapy or more than one line of systemic treatment\n* Contra-indication or grade 3-4 allergy to any of the treatment drugs Gemcitabine, Oxaliplatin (notably myelosuppression developped before the beginning of the first cycle of therapy, peripheral sensory neuropathy before the first cycle of therapy, severe renal failure)\n* Grade 2 peripheral neuropathy\n* Ongoing participation or participation within the 21 days prior to inclusion in the study in another therapeutic trial with an experimental drug\n* Concomitant systemic treatment with immunotherapy, chemotherapy or hormone therapy\n* Serious non-stabilized disease, active uncontrolled infection or other serious underlying disorder likely to prevent the patient from receiving the treatment\n* Pregnancy (beta-human chorionic gonadotropin positive), breast-feeding or the absence of effective contraception for women of child-bearing age\n* Another cancer in the 5 years preceding or at the time of inclusion in the trial (except for in situ cervical cancer or basal cell carcinoma of the skin)\n* Allergy or contra-indication to iodine contrast agents (thyrotoxicosis, allergy to the active substance or excipients)\n* Treatment with anticoagulants (heparin or AVK) that cannot be interrupted for 12 hours\n* Treatment with anti-platelets that cannot be interrupted for 5 days for aspirin or Plavix.\n* Contra-indication for use of an intra-arterial approach (severe arteriopathy)\n* Legal incapacity (persons in custody or under guardianship)\n* Deprived of liberty Subject (by judicial or administrative decision)\n* Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social or psychological reasons\n* Contraindication for the MRI : Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreign body similar to the nervous structure.",{"count":170,"type":20},40,[65],"We hypothesized that intra-arterial gemcitabine\u002Foxaliplatin administered as second-line treatment could strongly improve objective response rate at 4 months after inclusion in patient with non-metastatic unresectable intra-hepatic cholangiocarcinoma.",[33,174],"Non-metastatic","2025-12-31",{"date":177,"type":47},"2026-01-05",{"date":179,"type":47},"2018-06-11",{"date":181,"type":20},"2026-10-21",{"name":183,"class":82},"University Hospital, Montpellier",7,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":197,"conditions":198,"keywords":201,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":83},"100581472","en-bloc-resection-of-the-liver-and-pancreas-with-a-non-touch-technique-followed-by-liver-transplantation-to-improve-the-overall-survival-in-patients-with-non-resectable-hilar-cholangiocarcinoma-beyond-the-mayo-clinic-transplant-criteria-100581472","NCT06850753","En Bloc Resection of the Liver and Pancreas With a \"Non-touch\" Technique Followed by Liver Transplantation to Improve the Overall Survival in Patients With Non-resectable Hilar Cholangiocarcinoma Beyond the Mayo Clinic Transplant Criteria","Superior Right Abdominal Excentration and Liver Transplantation (SURE-LT) for Perihilar Cholangiocarcinoma","SURE-LT","Inclusion Criteria:\n\n* Histologically verified or strong suspicion of cholangiocarcinoma based on radiology and endoscopy and elevated Ca 19-9 \\> 100U\u002FL\n* Perihilar cholangiocarcinoma that is deemed unresectable based on tumor location or severity of the underlying liver disease. Perihilar recurrence in PSC patients more than 24 months following the previous resection (N0, R0, no macrovascular involvement) is accepted.\n* Patients should not be eligible for liver transplantation according to the Mayo protocol criteria.\n* Tumor involvement of the hepatic artery distal to the gastroduodenal artery or the portal vein without tumor thrombus is accepted.\n* No evidence of distant metastasis or metastatic lymph node (M1) involvement (para-aortic, coeliac or para-colic)\n* Good performance status Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1\n* At least 6 months of observation time during which the patient should be treated by chemotherapy and radiation (hyperfractioned 30-50 Gy) with response or stable disease before listing for LT. Patients with PSC and significant liver dysfunction that restricts the tolerability of chemoradiotherapy may be considered on an individual basis\n\nExclusion Criteria:\n\n* Radiological signs of tumor invasion along intended resection borders\n* Direct tumor invasion of the pancreatic head\n* Signs of spread to the para-aortic, superior mesenteric, or coeliac lymph nodes\n* Perforation of the visceral peritoneum\n* Weight loss \\>10% in the last six months\n* Patient BMI \\> 30 kg\u002Fm2\n* Other malignancies, except curatively treated basal cell carcinoma or other tumors with disease-free interval \\> five years without relapse. The final decision on acceptable previous cancer diagnoses is at the principal investigator's discretion.\n* Known history of human immunodeficiency virus (HIV) infection\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n* Known hypersensitivity to rapamycin\n* Prior metastatic disease\n* Women who are pregnant or breastfeeding\n* Any reason why, in the opinion of the investigator, the patient should not participate","70 Years",{"count":195,"type":20},15,[143],"Surgery for hilar cholangiocarcinoma (phCCA) remains a significant challenge. The minority of patients who are eligible for resection are exposed to high procedure-related morbidity and mortality, and despite apparent R0 resection, cancer recurrence is common. The benefit of R1 resection compared to the best palliative chemotherapy has been questioned. The concept of extended surgery to achieve better radicality is controversial and in many instances, associated with higher procedure-related risk and unclarified oncological benefit. For unresectable patients, liver transplantation, per the Mayo protocol, remains the only alternative for a few patients.\n\nOptimal staging pre- and intraoperatively is problematic since only the local biliary ductal involvement and, to a certain extent, lymph node dissemination can be reasonably correctly assessed. The reliability and validity of the intraoperative frozen section have been questioned. Furthermore, microscopic tumor cell affection leading to recurrent disease has been found in 16% of presumed N0 lymph nodes when analyzed by immunohistochemistry, and patients with nodal micrometastasis showed the same dismal survival as those with positive nodes on regular pathology (pN1).\n\nTaken together, there is a lack of good surgical options for patients with marginally or unresectable phCCA that do not satisfy current criteria for liver transplantation.\n\nThe practical problem in the current surgical techniques for hilar cholangiocarcinoma, particularly in locally advanced disease, is that the hepatoduodenal ligament, in most instances, represents an incompletely staged operative field, making the probability of obtaining true free margins uncertain.\n\nAn alternative procedure must, therefore, consider the anatomical and multidimensional pattern of dissemination and the limitations in the accurate staging of phCCA, and this suggests that a wider surgical margin is needed to obtain radical resection in locally advanced phCCA.\n\nThe aim of the current study is tho these the following hypothesis:\n\nLocally advanced hilar cholangiocarcinoma without M1 lymph node metastatic disease can be radically resected by extending the surgical margin to include the complete hepatobiliary axis and the main anatomical trajectories of local and regional dissemination through an \"en-bloc\" surgical approach.\n\nM1 metastatic disease is defined as positive nodes in the following locations at staging:\n\n* Station 9: lymph nodes around the celiac axis.\n* Station 14: lymph nodes along the superior mesenteric artery or vein.\n* Station 15: lymph nodes along the middle colic vein.\n* Station 16: para-aortic lymph nodes.\n\nPatients will be treated by chemotherapy and radiation therapy with an observation period of at least 6 months showing response or stable disease before final inclusion.\n\nThe operative procedure consists of a superior right abdominal exenteration, including the liver, pancreas, spleen, and vena cava + liver transplantation. If islets are available from the same donor, this will be administered postoperatively according to the institutional protocol.\n\nMain enpoint is overall survival at 1, 3 and 5 years",[33,199,200],"Cholangiocarcinoma Recurrent","Liver Transplantation",[202,203],"hilar cholangiocarcinoma","Liver transplantation","2025-08-15",{"date":206,"type":47},"2025-08-21",{"date":208,"type":47},"2025-01-01",{"date":210,"type":20},"2030-12-31",{"name":212,"class":82},"Oslo University Hospital",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":226,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":83},"100530900","phase-2-combined-haic-lenvatinib-and-pucotenlimab-as-conversion-therapy-for-unresectable-intrahepatic-cholangiocarcinoma-100530900","NCT06192797","Combined HAIC, Lenvatinib and Pucotenlimab As Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma","A Phase 2, Open-label, Single Arm Study of Combined HAIC, Lenvatinib and Pucotenlimab As Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma","CCGLC-013","Inclusion Criteria:\n\n* Histologically confirmed intrahepatic cholangiocarcinoma.\n* Age ≥18 years.\n* ECOG performance status score of 0 or 1.\n* Not suitable for radical surgery (including radical hepatic resection, liver transplantation or ablation) after evaluation by the MDT expert group of treating hepatobiliary cancer. Specifically, any of the following conditions are met：\n\n  1. R0 resection is not feasible.\n  2. in subjects without cirrhosis, the volume of normal liver parenchyma is less than 30% of the total volume, or in patients with cirrhosis, the volume of normal liver parenchyma is less than 40% of the total volume, or ICG-R15\\>15%.\n  3. Number of lesions \\>1.\n* No prior systemic anti-tumor treatment for intrahepatic cholangiocarcinoma before the first dose.\n* According to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1), at least 1 measurable lesion, or a measurable lesion that has clearly progressed (based on RECIST V1.1 criteria) after local treatment.\n* Subjects with portal vein tumor thrombus (PVTT):\n\n  1. Chen's group A and B, or Cheng's type I-III can be enrolled.\n  2. Chen's group C, or Cheng's type IV (superior vena cava tumor thrombus) cannot be enrolled.\n* Subjects with hepatic vein tumor thrombus:\n\n  1. VV1 and VV2 types can be enrolled.\n  2. VV3 type, or Sakamoto type I (inferior vena cava tumor thrombus) can also be enrolled.\n  3. Sakamoto type II (inferior vena cava tumor thrombus extending above the diaphragm), or Sakamoto type III (inferior vena cava tumor thrombus reaching the right atrium) cannot be enrolled.\n* Subjects with oligometastases outside the liver can be enrolled: Oligometastases outside the liver are defined as up to three metastatic lesions in a maximum of two organs, with the largest diameter being 3cm.\n* Child-Pugh score less than or equal to 7.\n* Adequate organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to inclusion (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous corrective treatment drugs are allowed within 14 days prior to obtaining laboratory tests):\n\n  1. Complete blood count: Absolute Neutrophil Count (ANC) ≥1.5×10\\^9\u002FL; Platelet count (PLT) ≥75×10\\^9\u002FL; Hemoglobin (HGB) ≥9.0 g\u002FdL.\n  2. Liver function: Total Bilirubin (TBIL) ≤2×Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤5×ULN; Serum albumin ≥28 g\u002FL; Alkaline Phosphatase (ALP) ≤5×ULN.\n  3. Kidney function: Serum Creatinine (Cr) ≤ 1.5×ULN or Clearance of Creatinine (CCr) ≥50mL\u002Fmin (Cockcroft-Gault formula); Urinalysis shows proteinuria \\\u003C2+; For subjects with baseline urinalysis showing proteinuria ≥2+, a 24-hour urine collection should be performed and 24-hour urinary protein quantification \\\u003C1g.\n  4. Coagulation function: International Normalized Ratio (INR) ≤2.3 or Prothrombin Time (PT) extension ≤6 seconds.\n* Estimated life expectancy of ≥12 weeks.\n* Female subjects of childbearing age or male subjects whose sexual partners are of childbearing age need to take effective contraceptive measures during the entire treatment period and for 6 months after the last medication.\n* Signed written informed consent, and able to comply with the visit and related procedures stipulated in the protocol.\n\nExclusion Criteria:\n\n* Histologically\u002Fcytologically confirmed sarcomatoid intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, etc.\n* History of hepatic encephalopathy or liver transplantation.\n* Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage. Patients with only radiologically detected minimal pleural effusion, ascites, or pericardial effusion without symptoms can be included.\n* Acute or chronic active hepatitis B or C infection, with hepatitis B virus (HBV) DNA \\>2000IU\u002Fml or 10\\^4 copies\u002Fml; hepatitis C virus (HCV) RNA \\>10\\^3 copies\u002Fml; co-positive for hepatitis B surface antigen (HbsAg) and anti-HCV antibody. Patients who meet the above criteria after antiviral treatment with nucleoside analogs can be included.\n* Presence of central nervous system metastases.\n* History of esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months. Patients assessed by the investigator to be at high risk of bleeding.\n* Any life-threatening bleeding event within the past 3 months, including those requiring blood transfusion, surgery or local treatment, or continuous drug treatment.\n* History of arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other serious thromboembolic events. Exceptions are made for thrombosis formation related to implanted venous infusion ports or catheters, or superficial vein thrombosis that has stabilized after routine anticoagulation treatment. Preventive use of low-dose low molecular weight heparin (such as enoxaparin 40 mg\u002Fday) is allowed.\n* Continuous use of aspirin (\\>325 mg\u002Fday) or other known platelet function inhibitors such as clopidogrel or ticlopidine for 10 days within 2 weeks prior to the first dose.\n* Uncontrolled hypertension, with systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy.\n* Presence of any toxicity caused by previous treatment that has not recovered to grade 0 or 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0) before the first dose of study treatment (excluding alopecia, non-clinically significant and asymptomatic laboratory abnormalities).\n* Symptomatic congestive heart failure (New York Heart Association class II-IV), left ventricular ejection fraction (LVEF) \\\u003C50% as indicated by echocardiography.\n* Symptomatic or poorly controlled arrhythmia. History of congenital long QT syndrome or corrected QTc \\>500 ms (calculated using the Fridericia formula) at screening.\n* Severe bleeding tendency or coagulation disorder, or currently receiving thrombolytic therapy.\n* History of gastrointestinal perforation and\u002For fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive intestinal resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within the past 6 months.\n* Received radiotherapy within 3 weeks prior to the first dose of study treatment. For patients who received radiotherapy more than 3 weeks prior to the first dose of study treatment, all of the following conditions must be met for inclusion: no current radiation-related toxicities, no need for corticosteroids, and exclusion of radiation pneumonitis, radiation hepatitis, radiation enteritis, etc.\n* History or current diagnosis of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function, and other lung diseases.\n* Active pulmonary tuberculosis, currently receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to the first dose.\n* Infection with human immunodeficiency virus (HIV) (HIV 1\u002F2 antibody positive), known syphilis infection requiring treatment.\n* Active or clinically uncontrolled severe infection. Severe infection within 4 weeks prior to the first dose, including but not limited to hospitalization for complications of infection, sepsis, or severe pneumonia.\n* Active autoimmune disease requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is allowed. History of primary immunodeficiency. Patients with only autoantibody positivity need to be confirmed by the investigator whether there is an autoimmune disease.\n* Use of immunosuppressive drugs within 4 weeks prior to the first dose, excluding intranasal, inhaled, or other local corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10mg\u002Fday prednisone or equivalent doses of other corticosteroids). Temporary use of corticosteroids for the treatment of dyspnea symptoms due to allergies or diseases such as asthma, chronic obstructive pulmonary disease, etc., is allowed.\n* Received a live attenuated vaccine within 4 weeks prior to the first dose or planned to receive one during the study period.\n* Major surgery (craniotomy, thoracotomy, or laparotomy) or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose. Minor surgical procedures or tissue biopsy within 7 days prior to the first dose, excluding venous puncture for the purpose of intravenous infusion, are excluded.\n* Local treatment for hepatocellular carcinoma within 4 weeks prior to the first dose.\n* Use of traditional Chinese medicine with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, etc., except for local use to control pleural effusion or ascites, etc.) within 2 weeks prior to the first dose.\n* Uncontrolled\u002Funcorrectable metabolic disorders or other non-malignant neoplastic organ diseases or systemic diseases or secondary reactions to cancer that could result in higher medical risk and\u002For uncertainty in survival evaluation, or the presence of other conditions that, in the judgment of the investigator, make enrollment inappropriate.\n* Diagnosis of other malignancy within 5 years prior to first dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For radically resected carcinoma in situ. If other malignancy was diagnosed more than 5 years prior to dosing, even if the liver lesion meets the EASL-ILCA clinical diagnostic criteria for intrahepatic cholangiocarcinoma, the liver lesion must still be diagnosed pathologically or cytologically and those who are definitively intrahepatic cholangiocarcinoma may be enrolled.\n* Previous treatment with any anti-PD-1 antibody, anti-PD-L1\u002FL2 antibody, anti-CTLA-4 antibody, or other immunotherapy. Previous treatment with targeted therapy against VEGF and\u002For VEGFR, RAF, MEK, PDGFR, FGFR, etc.\n* Known allergy to any component of oxaliplatin, 5-fluorouracil, calcium folinate, lenvatinib, or pucotenlimab; or severe allergic reaction to other monoclonal antibodies in the past.\n* Patients diagnosed with aortic dissection aneurysm, celiac trunk and superior mesenteric artery dissection aneurysm.\n* Received treatment in other clinical trials within 4 weeks prior to the first dose.\n* Pregnant or breastfeeding women.\n* Patients with systemic multiple metastases, portal vein tumor thrombus involving the superior mesenteric vein, inferior vena cava tumor thrombus extending above the diaphragm or reaching the right atrium.\n* Other acute or chronic diseases, mental illnesses, or laboratory test abnormalities that may result in the following outcomes: increased risk associated with study participation or study drug administration, or interference with the interpretation of study results, and other conditions that, in the investigator's judgment, make the patient ineligible to participate in the study.",{"count":222,"type":20},36,[65],"This is an open-label, single-arm, phase 2 study. The purpose of study is to evaluate the feasibility and safety of hepatic artery infusion chemotherapy combined with lenvatinib and pucotenlimab as conversion therapy for unresectable intrahepatic cholangiocarcinoma.",[33],[110,227,228,229],"Pucotenlimab","Lenvatinib","HAIC","2024-11-01",{"date":232,"type":47},"2024-11-05",{"date":234,"type":47},"2024-06-11",{"date":236,"type":20},"2028-06-30",{"name":238,"class":82},"Tongji Hospital",{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":247,"enrollmentInfo":248,"targetDuration":4,"studyType":21,"phases":249,"briefSummary":250,"conditions":251,"keywords":255,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":83},"100553559","tace-combined-with-immune-checkpoint-inhibitors-for-liver-malignant-tumors-100553559","NCT06487663","TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors","Transcatheter Hepatic Artery Chemoembolization Combined With Immune Checkpoint Inhibitors for Liver Tumors","TIKET","Inclusion Criteria:\n\n* Confirmed diagnosis of HCC by histology\u002F cytology or clinical criteria\n* Sign informed consent\n* When screening for age, the age should be ≥ 18 years old\n* Eligible for TACE treatment\n* ECOG physical condition score is 0 or 1\n* No prior systemic therapy for HCC, especially immunotherapy\n* According to the following mRECIST criteria, at least one measurable intrahepatic lesion is suitable for repeated evaluation\n\nExclusion Criteria:\n\n* Have any history of kidney disease or nephrotic syndrome\n* Evidence of extrahepatic spread (EHS)\n* Cardiovascular diseases with clinical significance (such as activity), including unstable angina, ≥ grade 2 congestive heart failure, and arrhythmia with poor drug treatment control\n* Any condition representing a contraindication to TACE as determined by the investigators\n* Known genetic factors for bleeding or thrombosis; Any previous or current evidence indicating a tendency for bleeding\n* Individuals who have received immunotherapy (anti PD-1, anti PD-L1, or anti CTLA-4 treatment)\n* Previously received HAIC (hepatic artery infusion chemotherapy), TACE (hepatic artery chemoembolization), TAE (hepatic artery embolization), or TARE (hepatic artery radiation embolization)\n* Previously received systemic anti-cancer treatment for HCC ,ICC or liver metastasis.","75 Years",{"count":170,"type":20},[143],"This study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma.",[252,33,253,254],"Hepatocellular Carcinoma Non-resectable","Liver Metastases","Liver Malignant Tumors",[256,69,253,254],"Hepatocellular Carcinoma","2024-06-27",{"date":259,"type":47},"2024-07-05",{"date":261,"type":47},"2020-10-27",{"date":263,"type":20},"2026-10-27",{"name":265,"class":82},"Tianjin Medical University Cancer Institute and Hospital",{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":247,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":83},"100514446","phase-2-cadonilimab-with-chemotherapy-in-treating-advanced-biliary-cancer-100514446","NCT05978609","Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer","Efficacy and Safety of Cadonilimab Combined With Gemcitabine and Cisplatin in the First-line Treatment of Unresectable Locally Advanced or Metastatic Biliary Malignancies","Inclusion Criteria:\n\n1. Obtain written informed consent before implementing any experimental procedures.\n2. Age between 18 and 75 years (any gender).\n3. Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tumors (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma).\n4. No prior systemic treatment, curative surgery, or adjuvant therapy allowed within the past 6 months.\n5. Expected survival time \\> 3 months.\n6. Presence of at least one measurable lesion according to RECIST 1.1 criteria.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1.\n8. Adequate organ function, with the following laboratory criteria:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5x10\\^9\u002FL, without the use of granulocyte-colony stimulating factor in the past 14 days.\n   2. Platelet count ≥ 90x10\\^9\u002FL, without transfusion in the past 14 days.\n   3. Hemoglobin \\> 9 g\u002FdL, without transfusion or use of erythropoietin-stimulating agents in the past 14 days.\n   4. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN).\n   5. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN (ALT or AST ≤ 5 times ULN for patients with liver metastases).\n   6. Serum creatinine ≤ 1.5 times ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 ml\u002Fmin.\n   7. Coagulation function within normal limits, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.\n   8. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total triiodothyronine (T3) (or free T3) and free thyroxine (FT4) within the normal range can still be included.\n   9. Normal cardiac enzymes (clinically insignificant isolated laboratory abnormalities are allowed, as determined by the investigator).\n9. For premenopausal female subjects, a negative pregnancy test result (urine or serum) should be obtained within 3 days before the first dose of study drug (Day 1 of Cycle 1). If urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required. Postmenopausal female is defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.\n10. If there is a risk of pregnancy, all subjects (both male and female) must use contraception with a failure rate of less than 1% per year throughout the entire treatment period and for 120 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Diagnosis of malignant diseases other than extrahepatic bile duct cancer, excluding completely resected basal cell carcinoma, squamous cell carcinoma of the skin, and\u002For in situ carcinoma within the past 5 years.\n2. Tumors located in the ampulla of Vater.\n3. Currently participating in an interventional clinical study or received other investigational drugs or investigational device treatment within 4 weeks prior to the first dose of study drug.\n4. Previously received therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting another T-cell receptor with inhibitory or co-stimulatory function (e.g., CTLA-4, OX-40, CD137).\n5. Previously received palliative radiotherapy for biliary tumors, excluding postoperative adjuvant radiotherapy.\n6. Received traditional Chinese medicine or immune modulatory drugs with anti-tumor indications within 2 weeks prior to the first dose of study drug (including thymosin, interferon, interleukins), except for local use to control pleural effusion.\n7. Active autoimmune diseases requiring systemic treatment within 2 years prior to the first dose of study drug, or known history of primary immunodeficiency diseases. Patients with positive autoimmune antibodies alone will be evaluated by the investigator to determine if they have autoimmune diseases.\n8. Currently receiving systemic corticosteroid therapy (excluding intranasal, inhaled, or topical corticosteroids) or any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug. Physiological doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) are permitted.\n9. Uncontrolled pleural effusion or ascites that requires drainage or has not shown a significant increase in the past 3 days in patients who do not require drainage or whose drainage has been stopped.\n10. Prior solid organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n11. Known hypersensitivity to the study drug, Candonilimab active substance, or excipients.\n12. Insufficient recovery from any toxicities and\u002For complications related to previous interventions before starting treatment (i.e., ≤ Grade 1 or returning to baseline, excluding fatigue or alopecia).\n13. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1\u002F2 antibodies).\n14. Untreated active hepatitis B defined as positive HBsAg and detectable HBV-DNA levels above the upper limit of normal at the study center. Note: The following HBV-infected patients may be included:\n\n    HBV viral load \\\u003C2.5 × 10\\^3 copies\u002FmL (500 IU\u002FmL) prior to the first dose of study drug, and patients should receive anti-HBV therapy throughout the study treatment.\n\n    For patients who are anti-HBc positive, HBsAg negative, anti-HBs negative, and HBV DNA negative, no prophylactic anti-HBV therapy is required, but viral reactivation needs to be closely monitored.\n15. Active hepatitis C infection (positive for hepatitis C virus (HCV) antibodies and HCV-RNA levels above the lower limit of detection).\n16. Vaccination with live attenuated vaccines within 4 weeks prior to the first dose of study drug.\n17. Pregnant or lactating women.\n18. Presence of any severe or uncontrolled systemic diseases, including:\n\n    Resting electrocardiogram with significant and symptomatic abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, grade II or higher cardiac conduction block, ventricular arrhythmia, or atrial fibrillation.\n\n    Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification ≥ Grade 2.\n\n    Any arterial thrombosis, embolism, or ischemia event within the past 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.\n\n    Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study drug or unhealed wounds, ulcers, or fractures. Minor surgical procedures, including venous puncture for intravenous infusion, within 7 days prior to the first dose of study drug are excluded.\n\n    Poor blood pressure control (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg).\n\n    Active pulmonary tuberculosis. Active or uncontrolled infections requiring systemic treatment. Clinical active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n\n    Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis.\n\n    Poorly controlled diabetes (fasting blood glucose \\>10 mmol\u002FL). Urine analysis showing urinary protein ≥++ and confirmed 24-hour urinary protein \\>1.0 g.\n\n    Presence of psychiatric disorders that would hinder compliance with treatment.\n19. Any medical history, evidence of disease, or abnormal laboratory values that could interfere with the study results, hinder the subject's full participation in the study, or pose other potential risks as determined by the investigator.",{"count":274,"type":20},65,[65],"The goal of this single-arm, Phase II interventional clinical trial is to test the safety and effectiveness of a combination treatment using the Cadonilimab with Gemcitabine and Cisplatin in patients with unresectable, locally advanced or metastatic biliary tract malignancies. The main questions it aims to answer are:\n\n* Is this combined treatment protocol safe for these patients?\n* Is this combined treatment protocol effective in treating these patients?\n\nParticipants will be given a combination treatment of Cadonilimab, Gemcitabine, and Cisplatin. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.",[33],"2023-08-04",{"date":280,"type":47},"2023-08-07",{"date":282,"type":47},"2023-07-01",{"date":284,"type":20},"2026-07-01",{"name":286,"class":82},"West China Hospital"]