[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-intrahepatic-cholangiocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-intrahepatic-cholangiocarcinoma":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"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":64,"conditions":65,"keywords":70,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"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":62,"type":20},30,[23],"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)",[66,67,68,69,34],"Bile Duct Cancer","Cholangiocarcinoma","Cholangiocarcinoma Non-resectable","Cholangiocarcinoma Metastatic",[66,67,68,69,34],"RECRUITING","2026-04-17",{"date":74,"type":46},"2026-04-22",{"date":76,"type":46},"2024-02-13",{"date":78,"type":20},"2027-12-01",{"name":80,"class":81},"Beth Israel Deaconess Medical Center","OTHER",1]