[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iv-distal-bile-duct-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iv-distal-bile-duct-cancer-ajcc-v8":37},{"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":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]