[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-intrahepatic-cholangiocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-intrahepatic-cholangiocarcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100520599","phase-1-radioembolization-with-tremelimumab-and-durvalumab-for-locally-advanced-unresectable-or-oligo-metastatic-intrahepatic-cholangiocarcinoma-100520599",false,"NCT06058663","Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma","Phase 1 Trial of Safety and Preliminary Efficacy of Segmental Ablative Radioembolization in Combination With Tremelimumab Plus Durvalumab (MEDI4736) in Patients With Unresectable, or Oligo-Metastatic Cholangiocarcinoma Who Are Not Candidates for Curative Therapy (RAIDEN Trial)","Inclusion Criteria:\n\n* Age \\>= 18 years with body weight \\> 30 kg\n* Histologically or cytologically confirmed, locally advanced intrahepatic cholangiocarcinoma that is not amenable to resection, transplantation, or thermal ablation. Oligometastatic intrahepatic cholangiocarcinoma is also eligible. Specifically, such patients must have EITHER =\\\u003C 3 malignant extrahepatic lymph nodes (short axis diameter \\>= 3cm) OR metastatic lesions in one organ other than liver (if only single lesion is present diameter MUST be \\\u003C 3cm, if up to 3 lesions in one organ each lesion MUST be =\\\u003C 1cm)\n* Measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Hemoglobin \\>= 9.0 g\u002FdL (=\\\u003C 14 days prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (=\\\u003C 14 days prior to registration)\n* Platelet count \\>= 75,000\u002Fmm\\^3 (=\\\u003C 14 days prior to registration)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (patients with known Gilbert disease who have serum bilirubin level 3 x ULN may be enrolled) (=\\\u003C 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 5 x ULN (=\\\u003C 14 days prior to registration)\n* Calculated creatinine clearance \\>= 40 ml\u002Fmin using the Cockcroft- Gault formula or measured creatinine clearance \\> 40 ml\u002Fmin (=\\\u003C 14 days prior to registration)\n* International normalized ratio (INR) =\\\u003C 1.6. Note: INR prolongation due\n\n  * Anticoagulation (INR \\>= 2.0 but =\\\u003C 3.0)) for prophylaxis in patients without liver cirrhosis could be exception\n* Adequate hepatic function Child Pugh A and albumin-bilirubin (ALBI) 1 or 2\n* Patients with concurrent hepatitis B (HBV) or hepatitis C virus (HCV) infection should meet the following criteria:\n\n  * Patient with HBV or should be monitored for viral levels during study participation\n  * Patient with detectable hepatitis B surface antigen (HBsAg) or detectable HBV DNA should have HBV DNA \\\u003C 100 IU\u002Fml and should be managed per local guidelines\n  * Controlled hepatitis B subjects will be allowed if they have started treatment prior to or by the time point of enrollment into the study and treatment is continued during study participation and for \\>= 6 months after end of study treatment\n  * Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Negative urine pregnancy test done prior =\\\u003C 7 days registration, for persons of childbearing potential only\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n\nExclusion Criteria:\n\n* Concurrent enrollment in another clinical study, unless it is an observational clinical study or during the follow up period of an interventional study\n* Surgery =\\\u003C 28 days prior to registration\n* Chemotherapy =\\\u003C 4 weeks prior to registration\n* History of \\> 1 prior systemic therapy for cholangiocarcinoma not including that in the adjuvant setting. Patients who progressed during or =\\\u003C 6 months from completion of adjuvant therapy are excluded\n* Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (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 study physician\n  * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician\n  * History of previous locoregional therapy\n  * Previous use of therapeutic cancer vaccines\n* Unstable liver function and\u002F or a change in Child Pugh score during screening\n\n  * Child Pugh B or greater\n  * ALBI grade \\> 2\n  * Model for End-Stage Liver Disease (MELD) \\> 10\n* Patient is unable to undergo mapping angiography or mapping angiography demonstrates tumor blood supply that does not lend itself to transarterial therapy\n* A lung shunt fraction greater than 30 Gy within a single session, or cumulative does greater than 50Gy\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Active or uncontrolled autoimmune or inflammatory disorders (including Inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, granulomatosis with polyangiitis, sarcoidosis, Grave's disease)\n* History of another primary malignancy except for:\n\n  * Malignancy treated with curative intent and with no known active disease \\>= 5 years prior to registration and of low potential of 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\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing uncontrolled infections including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice), human immunodeficiency virus (HIV), hepatitis B and hepatitis C\n  * Serious chronic gastrointestinal condition associated with diarrhea\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris, cardiac arrhythmia and uncontrolled hypertension\n  * Chronic pulmonary disease including interstitial lung disease requiring oxygen\n  * Psychiatric illness\u002Fsocial situations limiting compliance that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent\n  * Uncontrolled hypertension\n* History of leptomeningeal carcinomatosis\n* History of allogeneic transplantation\n* Current or prior use of immunosuppressive medication \\\u003C 14 days before registration. The following are exceptions to this criterion:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections\n  * Systemic corticosteroids at physiologic doses not to exceed 10mg\u002Fday of\n  * Prednisone or its equivalent\n* Known allergy or hypersensitivity to durvalumab and tremelimumab or any of the constituents of the products\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Pregnant or lactating female\n* Life expectancy \\\u003C 3 months\n* Intolerance to contrast agents that is refractory to medical management\n* Any other condition which the investigator believes would make participation in the study not acceptable\n* History of primary immunodeficiency\n* Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts\n* Receipt of live attenuated vaccine \\\u003C 30 days prior to registration and without need to receive any live attenuated vaccines during study conduct and for up to 30 days after end of durvalumab treatment or 90 days after end of tremelimumab treatment respectively\n* Prior immunotherapy such as durvalumab or pembrolizumab is allowed as long as patient does not have progressive disease on it","ALL","18 Years",{"count":19,"type":20},16,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety and side effects of yttrium-90 (Y90) radioembolization combined with immunotherapy drugs tremelimumab and durvalumab in treating patients with intrahepatic cholangiocarcinoma (cancer of the bile ducts in the liver) that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable) who are not candidates for curative therapy or that has spread from where it first started (primary side) to multiple other places in the body (oligo-metastatic). Cholangiocarcinoma is a rare but aggressive cancer with limited curative options outside of surgery. Immunotherapy has shown modest benefit in hepatobiliary (liver, bile ducts, and gallbladder) cancers including cholangiocarcinoma. Radioembolization is a type of radiation therapy used to treat liver cancer that is advanced or has come back where tiny beads that hold the radioactive substance (radioisotope) yttrium Y90 are injected into or near the hepatic artery (the main blood vessel that carries blood to the liver). The beads collect in the tumor and the Y90 gives off radiation. This destroys the blood vessels that the tumor needs to grow and kills the tumor cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving Y90 radioembolization in combination with tremelimumab and durvalumab immunotherapy may be safe and beneficial in treating patients with locally advanced, unresectable or oligo-metastatic intrahepatic cholangiocarcinoma who are not candidates for curative therapy.",[26,27,28,29,30],"Locally Advanced Intrahepatic Cholangiocarcinoma","Oligometastatic Intrahepatic Cholangiocarcinoma","Stage III Intrahepatic Cholangiocarcinoma AJCC v8","Stage IV Intrahepatic Cholangiocarcinoma AJCC v8","Unresectable Intrahepatic Cholangiocarcinoma","RECRUITING","2026-05-11",{"date":34,"type":35},"2026-05-13","ACTUAL",{"date":37,"type":35},"2024-06-06",{"date":39,"type":20},"2028-11-30",{"name":41,"class":42},"Mayo Clinic","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100358074","phase-1-modified-immune-cells-autologous-dendritic-cells-and-a-vaccine-prevnar-combined-with-immune-checkpoint-inhibition-after-high-dose-external-beam-radiation-therapy-in-treating-patients-with-unresectable-liver-cancer-100358074","NCT03942328","Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer","MC1641 Phase II Study Of Intratumoral Injection Of Autologous Dendritic Cells Combined With Immune Checkpoint Inhibition After High-Dose Conformal External Beam Radiotherapy In Patients With Unresectable Primary Liver Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Pilot study (group 1): Histologic confirmation of intrahepatic CCA (Closed as of amendment 3)\n* Phase II study (group 2): Histologic and\u002For radiologic confirmation of hepatocellular carcinoma (HCC)\n* Phase II study (group 3): Histologic confirmation of intrahepatic cholangiocarcinoma (iCCA)\n* The following tumor characteristics must be met\n\n  * Unresectable disease: HCC (group 2) or intrahepatic CCA (group 3)\n  * Measurable or evaluable disease\n  * All lesions should be treatable by EBRT while meeting normal tissue constraints\n  * Tumor lesions should be accessible using an ultrasound (US)-guided approach for intratumoral DC injection\n  * No evidence of extrahepatic tumor (excluding tumor thrombus) by computed tomography (CT) or magnetic resonance imaging (MRI) scan\n\n    * NOTE: Patients who are not candidates for surgical treatment or for ablation with curative intent are allowed\n* Good candidate for standard of care high-dose conformal EBRT in the view of the investigator\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* GROUP 2 HCC ONLY: Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Absolute lymphocyte count (ALC) \\>= 500\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Absolute monocyte count (AMC) \\>= 300\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Platelet count \\>= 50,000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Hemoglobin \\>= 9.0 g\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Total bilirubin \\\u003C 1.5 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 5 x upper limit of normal (ULN) (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Creatinine =\\\u003C 2 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Absence of proteinuria at screening as demonstrated by one of the following:\n\n  * Urine protein\u002Fcreatinine (UPC) ratio \\\u003C 1.0 at screening OR\n  * Urine dipstick for proteinuria \\\u003C 2+ (patients discovered to have \\>= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate =\\\u003C1g of protein in 24 hours to be eligible)\n* GROUP 3 iCCA ONLY: Absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Absolute lymphocyte count ≥ 500\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Absolute monocyte count ≥ 300\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Platelet count ≥ 50,000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Hemoglobin ≥ 9.0 g\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Total bilirubin \\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Creatinine ≤ 2 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: PT\u002FINR\u002FaPTT ≤ 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n\n  * NOTE: If patient is receiving therapeutic anticoagulation, patient must be on a stable anticoagulant regimen\n* Ability to provide written consent\n* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willingness to provide blood and tissue samples for correlative research purposes\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ highly effective contraception during heterosexual intercourse while on this study and for 5 months after the last dose of study medication\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Immunocompromised patients and patients known to be HIV positive.\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial if they are stable on anti-retroviral therapy, have a CD4+ T cell count ≥ 200\u002FuL, and have an undetectable viral load\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring systemic treatment or that could impact patient safety\n  * Severe infection ≤ 4 weeks prior to registration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n  * Significant cardiovascular disease (New York Heart Association \\[NYHA\\] class II), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia\n  * Or, psychiatric illness\u002Fsocial situations (e.g., substance abuse) that would limit compliance with study requirements\n* Receiving any other investigational agent that would be considered a treatment for the primary neoplasm\n* Other active malignancy =\\\u003C 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes\n* Major surgery =\\\u003C 4 weeks prior to enrollment (other than diagnostic surgery or surgical spacer placement in preparation for radiation treatment), or anticipation of need for a major surgical procedure during the study\n* History of hypersensitivity or anaphylactoid reactions to pneumococcal vaccine or any component of the formulation, including diphtheria toxoid\n* Active or history of autoimmune disease or immune deficiency, including but not limited to,myasthenia gravis, myositis, autoimmune hepatitis, Crohn's disease, inflammatory bowel disease, antiphospholipid antibody syndrome, rheumatoid arthritis, Sjogren syndrome, systemic lupus erythematosus, Guillain-Barre syndrome, multiple sclerosis, Wegener granulomatosis, or similar conditions\n\n  * NOTE: Exceptions are allowed for:\n\n    * Patients with hypothyroidism on thyroid replacement therapy\n    * Patients with type 1 diabetes mellitus on insulin regimen\n    * Patients with eczema, psoriasis lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of the following conditions are met:\n\n      * Rash must cover \\\u003C 10% of body surface area\n      * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n      * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids ≤ 12 months prior to registration\n* Requires anticoagulant treatment (INR \\> 1.5 x ULN) or use of anti-platelet agents that cannot be discontinued for the intratumoral injection procedure\n\n  * NOTE: Heparin for line patency without detectable lab abnormalities in coagulation will be allowed\n* Corticosteroids =\\\u003C 2 weeks prior to registration, including oral, intravenous (IV), subcutaneous, or inhaled routes of administration\n\n  * NOTE: Patients on chronic corticosteroids for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg\u002Fday of prednisone (or equivalent)\n  * NOTE: Exception allowed for patients who need prophylactic steroids prior to imaging for contrast allergies\n\n    * Exception: Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study\n    * Exception: Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study\n* History of myocardial infarction =\\\u003C 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Child Pugh class B or C cirrhosis of the liver\n* Previously received immune modulating therapies including but not limited to immune checkpoint inhibitors targeting PD-1 PDL-1 CTLA4, etc.; or prior dendritic cell therapy\n* Prior liver radiation, including radioembolization\n* GROUP 2 ONLY: Barcelona Clinic Liver Cancer (BCLC) stage D disease\n* GROUP 2 ONLY: History of untreated high-risk gastroesophageal varices\n* Active tuberculosis\n* Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to registration\n\n  * NOTE: Exception for patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study\n* Prior allogeneic stem cell or solid organ transplantation\n* Treatment with a live, attenuated vaccine ≤ 4 weeks prior to registration",{"count":52,"type":20},85,[23,54],"PHASE2","This early phase I trial studies the side effects of autologous dendritic cells and a vaccine called Prevnar in combination with immune checkpoint inhibition (with bevacizumab and atezolizumab or druvalumab) in treating patients liver cancer that cannot be removed by surgery (unresectable) after undergoing standard high-dose external beam radiotherapy. Autologous dendritic cells are immune cells generated from patients' own white blood cells that are grown in a special lab and trained to stimulate the immune system to destroy tumor cells. A pneumonia vaccine called Prevnar may also help stimulate the immune system. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab and durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving autologous dendritic cells and Prevnar in combination with immune checkpoint inhibition after radiotherapy may be safe, and tolerable and may stimulate the body's own immune system to fight against the tumor in patients with unresectable liver cancer.",[57,28,58,29,59,30],"Stage III Hepatocellular Carcinoma AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Unresectable Hepatocellular Carcinoma","2026-04-16",{"date":62,"type":35},"2026-04-20",{"date":64,"type":35},"2019-09-19",{"date":66,"type":20},"2029-08-31",{"name":41,"class":42}]