[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iv-intrahepatic-cholangiocarcinoma-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iv-intrahepatic-cholangiocarcinoma-ajcc-v8":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,54,85,109],{"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":25,"conditions":26,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":4},"100651876","phase-2-testing-the-addition-of-ivonescimab-combined-with-standard-chemotherapy-compared-to-the-usual-chemotherapy-and-immunotherapy-treatment-for-patients-with-advanced-biliary-tract-cancer-100651876",false,"NCT07765433","Testing the Addition of Ivonescimab Combined With Standard Chemotherapy Compared to the Usual Chemotherapy and Immunotherapy Treatment for Patients With Advanced Biliary Tract Cancer","A Phase II\u002FIII Randomized Study of Ivonescimab With Gemcitabine and Cisplatin Versus Standard of Care Chemoimmunotherapy in Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n* Patient must be ≥ 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Patient must have histologically or cytologically confirmed adenocarcinoma of the biliary tract including cholangiocarcinoma (intrahepatic or extrahepatic) or gallbladder carcinoma\n* Patient must not have a diagnosis of ampullary cancer\n* Patient must have documented metastatic or locally advanced unresectable disease on CT or MR imaging\n* Patient must have measurable disease as documented on CT or MRI imaging done within 28 days prior to randomization\n* Patient must not have received prior systemic therapy for current metastatic or locally advanced biliary tract cancer\n\n  * NOTE: Patients who have previously received adjuvant\u002Fneoadjuvant chemotherapy and\u002For radiotherapy for curative intent non-metastatic disease are eligible if they developed recurrent disease \\> 6 months after completion of adjuvant therapy\u002Fradiotherapy\n* Patient must not be on any systemic immunosuppressant therapy other than inhaled steroids, intranasal steroids, topical steroids or systemic steroids up to 10mg prednisone equivalent\n* Patient must not have received a live attenuated vaccine within 30 days prior to randomization. Patients must also not receive a live attenuated vaccine while on protocol treatment or up to 30 days after the last dose of protocol treatment\n* Patient must have no contraindication to VEGF inhibitor therapy\n* Patient must not have significant vascular disease (i.e., aortic aneurysm surgical repair or peripheral arterial thrombosis) within 6 months prior to randomization\n* Patient must not have inadequately controlled arterial hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\[BP\\] \\> 100 mmHg). Anti-hypertensive therapy to achieve these parameters is allowed\n* Patient must not have experienced a clinically significant bleeding event within 6 months prior to randomization\n* Patient must not have experienced gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, or intraabdominal abscess\n* Patient must not have had surgery within 30 days prior to randomization\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Patients of childbearing potential must continue contraceptive measures for 6 months after the last dose of protocol treatment, with the exception of cisplatin requiring 14 months for female patients and 11 months for male patients\n* Patient must not nurse infants for 4 months after the last dose of pembrolizumab, 3 months after the last dose of durvalumab or ivonescimab and for four weeks after the last dose of cisplatin\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Hemoglobin ≥ 9.0 g\u002FdL (must be obtained ≤ 7 days prior to randomization)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3 (must be obtained ≤ 7 days prior to randomization)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (must be obtained ≤ 7 days prior to randomization)\n* Bilirubin ≤ 2.5 x institutional upper limit of normal (ULN) (must be obtained ≤ 7 days prior to randomization). Patients with Gilbert's syndrome must have a direct bilirubin \\\u003C 1.5 mg\u002FdL\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 2.5 × institutional ULN (must be obtained ≤ 7 days prior to randomization). For patients with liver metastases, AST and ALT ≤ 5 x ULN\n* Creatinine clearance (CrCI) \\> 50ml\u002Fmin or calculated CrCI \\> 50ml\u002Fmin as determined by Cockcroft-Gault (using actual body weight) Cockcroft-Gault Formula (must be obtained ≤ 7 days prior to randomization)\n* Urine dipstick for proteinuria \\\u003C 2+ or 24 hour urine protein \\\u003C 1.0 g (within 7 days prior to initiation of study treatment)\n* Prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 X ULN (must be obtained ≤ 7 days prior to randomization). This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation are eligible if on stable dose\n* Patient must not have National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade \\> 2 peripheral neuropathy at the time of randomization\n* Patient must not have a history of allogeneic organ transplantation\n* Patient must not have prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease such as colitis or Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (i.e.: 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 (i.e.: following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without an active disease in the last 5 years\n  * Patients with celiac disease controlled by diet alone\n  * Patients with insulin dependent diabetes\n* Patient must not have uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase the risk of incurring AEs, or compromise the ability of the patient to give written informed consent\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to randomization 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* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better","ALL","18 Years",{"count":19,"type":20},336,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This phase II\u002FIII trial studies how well the addition of ivonescimab to standard chemotherapy (gemcitabine and cisplatin) works when compared to usual chemotherapy and immunotherapy (durvalumab or pembrolizumab) in treating patients with biliary tract cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivonescimab is a bispecific antibody that is directed against both the programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF) protein. By targeting PD-1, ivonescimab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. By targeting VEGF, ivonescimab may help stop the formation of blood vessels that bring oxygen and nutrients to tumor. Adding ivonescimab to standard chemotherapy may work better than usual chemotherapy and immunotherapy in lowering the chance of advanced biliary tract cancer growing or spreading.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Locally Advanced Biliary Tract Adenocarcinoma","Locally Advanced Extrahepatic Cholangiocarcinoma","Locally Advanced Intrahepatic Cholangiocarcinoma","Locally Advanced Unresectable Gallbladder Adenocarcinoma","Metastatic Biliary Tract Adenocarcinoma","Metastatic Extrahepatic Cholangiocarcinoma","Metastatic Gallbladder Adenocarcinoma","Metastatic Intrahepatic Cholangiocarcinoma","Stage III Distal Bile Duct Cancer AJCC v8","Stage III Intrahepatic Cholangiocarcinoma AJCC v8","Stage IV Distal Bile Duct Cancer AJCC v8","Stage IV Intrahepatic Cholangiocarcinoma AJCC v8","Unresectable Biliary Tract Adenocarcinoma","Unresectable Extrahepatic Cholangiocarcinoma","Unresectable Intrahepatic Cholangiocarcinoma","NOT_YET_RECRUITING","2026-08-13",{"date":45,"type":46},"2026-08-14","ACTUAL",{"date":48,"type":20},"2027-01-11",{"date":50,"type":20},"2029-12-31",{"name":52,"class":53},"ECOG-ACRIN Cancer Research Group","NETWORK",{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100461186","phase-1-pressurized-intraperitoneal-aerosolized-nab-paclitaxel-in-combination-with-gemcitabine-and-cisplatin-for-the-treatment-of-biliary-tract-cancer-patients-with-peritoneal-metastases-100461186","NCT05285358","Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases","Safety of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Biliary Tract Cancer Patients With Peritoneal Metastases","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histologically or cytologically confirmed intrahepatic cholangiocarcinoma or extrahepatic cholangiocarcinoma or gallbladder cancer\n* Documented metastatic disease on computed tomography (CT) imaging or magnetic resonance imaging (MRI). CT scan or MRI to assess measurable disease must have been completed within 28 days prior to registration\n* Visible peritoneal metastatic disease on cross-sectional imaging or diagnostic laparoscopy (does not have to be measurable by Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n* Fully recovered from acute toxic effects (except alopecia, hearing loss, or non-clinically significant laboratory abnormalities) =\\\u003C grade 1 of prior anti-cancer therapy\n* Complete medical history and physical exam (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)\n* Platelets \\>= 100,000\u002FmcL (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)\n* Hemoglobin \\>= 8 g\u002FdL (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)\n* Serum albumin \\>= 2.8 g\u002FdL (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)\n* Total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease, then direct bilirubin \\\u003C 1.5 mg\u002FdL) (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)\n* Aspartate aminotransferase (AST) =\\\u003C 5 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)\n* Alanine aminotransferase (ALT) =\\\u003C 5 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)\n* Calculated creatinine clearance of \\>= 45 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)\n* Seronegative for human immunodeficiency virus (HIV) antigen (Ag)\u002Fantibody (Ab) combo (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * If seropositive, patient may be eligible if they are stable on antiretroviral therapy, have a CD4 T cell count \\>= 200\u002FµL, and have an undetectable viral load\n* Documented virology status of hepatitis, confirmed by hepatitis B virus (HBV) and hepatitis C virus (HCV) tests (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * For patients with active HBV, HBV deoxyribonucleic acid (DNA) \\\u003C 500 IU\u002FmL during screening, initiation of anti-HBV treatment at least 14 days prior to day 1 of cycle 1, and willingness to continue anti-HBV treatment during the study (per standard of care)\n  * If seropositive for HCV, nucleic acid quantification must be performed. Viral load must be undetectable\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control (e.g. licensed hormonal\u002Fbarrier methods or surgery intended to prevent pregnancy \\[or with a side effect of pregnancy prevention\\]) or abstain from heterosexual activity for the course of the study through at least 14 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Any prior systemic therapy treatment for advanced cholangiocarcinoma or gallbladder cancer\n* Any prior adjuvant therapy (chemotherapy, radiation therapy, biological therapy, immunotherapy) completed \\\u003C 6 months prior to registration\n* Strong CYP3A4 inducers\u002Finhibitors within 14 days prior to day 1 of protocol therapy\n* Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy, or exclusive total parenteral nutrition\n* Evidence of liver metastases with \\>= 50% liver occupation\n* Any history of, or current, brain or subdural metastases\n* Life expectancy \\\u003C 3 months\n* History of peripheral neuropathy \\>= grade 2 measured by NCI CTCAE version 5.0 (\"moderate symptoms, limiting instrumental activities of daily living\")\n* Treatment with therapeutic oral or IV antibiotics within 14 days prior to day 1 cycle 1 of treatment\n\n  * Patients receiving prophylactic antibiotics are eligible, provided the signs of active infection have resolved\n* Any prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for two years\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents (platinum-based compounds, etc.)\n* Clinically significant uncontrolled illness\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":62,"type":20},12,[64],"PHASE1","This phase I trial studies the side effects of pressurized intraperitoneal aerosolized chemotherapy (PIPAC) nab-paclitaxel in combination with gemcitabine and cisplatin in treating patients with biliary tract cancer that has spread to the peritoneum (peritoneal metastases). PIPAC involves the administration of intraperitoneal chemotherapy (anticancer drugs given directly to the lining of the abdomen). PIPAC uses a nebulizer (a device that turns liquids into a fine mist) which is connected to a high-pressure injector and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and insert a camera and other instruments into the abdominal cavity for diagnosis and\u002For to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen), which results in the drug reaching more of the tissue as well as reaching deeper into the tissue, which reduces the amount of chemotherapy that needs to be used and potentially reduces side effect. Chemotherapy drugs, such as nab-paclitaxel, gemcitabine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nab-paclitaxel via PIPAC in combination with standard of care gemcitabine and cisplatin may reduce side effects and make this chemotherapy regimen more tolerable in patients with biliary tract cancer that has spread to the spread to the peritoneum.",[67,68,69,70,37,71,38,72],"Distal Bile Duct Adenocarcinoma","Gallbladder Carcinoma","Intrahepatic Cholangiocarcinoma","Metastatic Malignant Neoplasm in the Peritoneum","Stage IV Intrahepatic Bile Duct Cancer AJCC v8","Stage IVB Gallbladder Cancer AJCC v8","RECRUITING","2026-07-31",{"date":76,"type":46},"2026-08-03",{"date":78,"type":46},"2022-09-19",{"date":80,"type":20},"2028-10-11",{"name":82,"class":83},"City of Hope Medical Center","OTHER",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":84},"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":93,"type":20},85,[64,23],"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.",[97,36,98,38,99,41],"Stage III Hepatocellular Carcinoma AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Unresectable Hepatocellular Carcinoma","2026-07-09",{"date":102,"type":46},"2026-07-10",{"date":104,"type":46},"2019-09-19",{"date":106,"type":20},"2031-02-28",{"name":108,"class":83},"Mayo Clinic",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":84},"100520599","phase-1-radioembolization-with-tremelimumab-and-durvalumab-for-locally-advanced-unresectable-or-oligo-metastatic-intrahepatic-cholangiocarcinoma-100520599","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",{"count":117,"type":20},16,[64],"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.",[29,121,36,38,41],"Oligometastatic Intrahepatic Cholangiocarcinoma","2026-05-11",{"date":124,"type":46},"2026-05-13",{"date":126,"type":46},"2024-06-06",{"date":128,"type":20},"2028-11-30",{"name":108,"class":83}]