[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cholangiocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cholangiocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,104,0,25,[9,42,76,101,123,151,176,206,234,258,288,318,338,369,389,421,443,467,494,533,561,587,609,642,669],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100596279","streamlining-radioembolization-for-ccc-and-metastatic-liver-cancer-100596279",false,"NCT07043387","Streamlining Radioembolization for CCC and Metastatic Liver Cancer","Streamlining Radioembolization for Cholangiocarcinoma or Metastatic Liver Cancer ≤ 7 cm : Multicenter Prospective Registry Study","ISTAR-03","Inclusion Criteria:\n\n* Adult aged 19 and over\n\n  * metastatic liver cancer or cholangiocarcinoma\n\n    * the diameter of the largest tumor ≤ 7cm, tumor number 5 or less\n\n      * FLR volume \\> 30% of total non-tumorous liver volume\n\n        * Dysmorphic intratumoral vessel : absent, if present, 3mm or thinner ⑥ Child-Pugh class A\n\n          * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 ⑧ No major organ dysfunction according to blood test performed within two months of study enrollment A. Leukocytes ≥ 1,000\u002FµL and ≤ 20,000\u002FµL B. Hemoglobin ≥ 6.0 g\u002FdL (transfusion allowed to meet this criterion) C. Total bilirubin ≤ 2.0 mg\u002FdL D. Platelet ≥ 40,000\u002FµL E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants F. Aspartate transaminase (AST) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit) G. Alanine transaminase (ALT) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit) H. Creatinine ≤ 2.5 mg\u002FdL (If patients is undergoing hemodialysis, no limit of creatinine) ⑨ Patients with a life expectancy of more than 3 months ⑩ For women of childbearing age, a negative serum pregnancy test. ⑪ Patients who have adequately understood the clinical trial and consented in writing\n\nExclusion Criteria:\n\n* hepatic vein invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI)\n* Hepatic vein enhancement on arterial phase CT\u002FMRI\n* dysmorphic intratumoral vessel \\> 3mm on arterial phase CT\u002FMRI\n* TIPS is present\n* Lobar portal vein enhancement on arterial phase CT\u002FMRI due to AP shunt\n* main portal vein tumor thrombosis\n* Cases where the operator judges that the occurrence of even mild radiation pneumonitis could be fatal, based on marked emphysema or interstitial lung disease findings on chest CT\n* biliary stent or bilioenteric anastomosis\n* History of severe allergy of intolerance to contrast agents\n* Contraindication to angiography or selective visceral catheterization","ALL","19 Years",{"count":21,"type":22},60,"ESTIMATED","OBSERVATIONAL","TARE uses radioactive microspheres (20-60 μm), which are trapped in tumors due to abnormal vasculature, while normal liver sinusoids (≤15 μm) prevent their passage. However, some microspheres may drain into hepatic veins and reach the lungs, risking radiation pneumonitis. Pre-procedural evaluation with angiography and nuclear imaging (MAA scan with SPECT\u002FCT) is required to calculate lung shunt fraction (LSF). TARE is contraindicated if LSF \\>20%, and may be used with caution if LSF is 10-20%.\n\nFindings associated with high LSF include large tumors, hepatic vein invasion, TIPS, and dysmorphic intratumoral vessels. In contrast, small or medium sized (\\\u003C7 cm) cholangiocarcinoma or metastatic liver cancers without hepatic vein invasion or dysmorphic vessels show consistently low LSF (\\\u003C5%). Over 10 years at SNUH, no cases of radiation pneumonitis have been observed in such patients. Therefore, \"streamlining TARE\" omits pre-procedural nuclear imaging for this group to reduce procedural delays, reserving nuclear imaging for patients who need it most.\n\nSIR-Spheres (SIRTEX) facilitate single-session TARE as they are provided in a bulk vial, unlike TheraSphere which requires advance preparation based on dosimetry.\n\nProtocol Overview :\n\nProcedure: Same-day angiography, cone-beam CT, and TARE using SIR-Spheres.\n\nDosimetry: Lung shunt fraction is assumed as 5%, estimated lung dose is capped at 10 Gy.\n\nTumor dose goal: 80\\~400 Gy (around 250Gy)(single-compartment MIRD), or 300 \\~ 1000 Gy (multi-compartment MIRD). minimal tumor dose by partition dosimetry : 100Gy\n\nSoftware: Simplicit90Y for planning, Y90 PET\u002FCT the next day for post-treatment dosimetry.\n\nFollow-up: 1 year; additional treatments follow institutional guidelines.\n\nThis streamlined approach maximizes efficiency while maintaining safety in selected patients.",[26,27,28],"Metastatic Colorectal Carcinoma (mCRC)","Metastatic Liver Cancer","Cholangiocarcinoma","RECRUITING","2026-08-16",{"date":32,"type":33},"2026-08-18","ACTUAL",{"date":35,"type":33},"2025-06-22",{"date":37,"type":22},"2029-06-30",{"name":39,"class":40},"Seoul National University Hospital","OTHER",4,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100412023","phase-1-evaluating-efficacy-of-tivozanib-av-951-in-biliary-tract-cancers-100412023","NCT04645160","Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers","Phase II Study Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers","* INCLUSION CRITERIA:\n\n  1. Participants with histologically or cytologically confirmed biliary tract cancer (BTC) (cholangiocarcinoma or gallbladder cancer). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required.\n  2. Participants must have disease that is not amenable to resection.\n  3. Participants must have had prior treatment with 1st line chemotherapy.\n  4. Disease must be measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.\n  5. Age \\>=18 years.\n\n     NOTE: Because no dosing or adverse event data are currently available on the use of tivozanib in participants \\\u003C 18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.\n  6. ECOG performance status \\\u003C= 2\n  7. Adequate organ and marrow function as defined below:\n\n     * Hemoglobin \\>= 8.0 g\u002FdL\n     * Absolute Neutrophil Count \\>= 1,000\u002FmcL\n     * Platelets \\>= 75,000\u002FmcL\n     * Total Bilirubin \\\u003C= 2.5 X institutional upper limit of normal (ULN)\n     * AST(SGOT)\u002FALT(SGPT) \\\u003C= 5 X institutional ULN\n     * Creatinine Clearance \\> 30\n     * Serum Albumin (g\u002FL) \\> 28\n  8. Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP), excepting identified false-positive pregnancy test results as permitted in the note below.\n\n     NOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. IOCBP must have a negative pregnancy test (HCG blood or urine) during screening.\n\n     NOTE: Advanced biliary tract disease may secrete hormones that produce false-positive pregnancy test results. A false-positive result will be explicitly determined in this protocol at screening via a series of serial blood tests (i.e., serum HCG measurements) over a 5-day period (i.e., a minimum of a blood test on the first and fifth day of the 5-day period), in which a false-positive result not compatible with pregnancy will be defined as results indicating a consecutive, clinically low, constant level (i.e., no more than a 15% rate of increase) of HCG over the testing period. An ultrasound may be performed for clarification purposes as necessary.\n  9. All participants (regardless of childbearing potential) must (all) agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 1 month after completion of treatment.\n  10. Ability of participant to understand and the willingness to sign a written informed consent document.\n  11. Ability and willingness to co-enroll on the tissue collection protocol 13C0176, \"Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors\".\n\nEXCLUSION CRITERIA:\n\n1. Chemotherapy, small molecule or radiation therapy within 2 weeks prior to administration of first dose of study drug.\n2. Prior treatment with Tivozanib.\n3. History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy (e.g., no lactulose, rifaximin, etc. if used for purposes of hepatic encephalopathy).\n4. Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.\n5. Previous malignant disease other than the target malignancy within the last 3 years with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, chronic lymphocytic leukemia, or thyroid carcinoma.\n6. Current active second primary malignancy, other than skin carcinoma (basal or squamous cell carcinoma), chronic lymphocytic leukemia not requiring active treatment, or differentiated thyroid carcinoma.\n7. History of allergic reactions or known or suspected hypersensitivity attributed to compounds of similar chemical or biologic composition to tivozanib.\n8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy (see exceptions below), or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n\n   * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n   * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable and on suppressive therapy, if indicated. For participants with HBV infection who are currently on treatment, they are eligible if they have an undetectable HBV viral load.\n   * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n9. Significant cardiovascular disease, including: Active clinically symptomatic left ventricular failure, uncontrolled hypertension, myocardial infarction, severe angina, or unstable angina within 3 months prior to administration of first dose of study drug, history of serious ventricular arrhythmia, cardiac arrhythmias requiring anti-arrhythmic medications.\n10. Uncontrolled hypertension, i.e., blood pressure (BP) of \\>= 150\u002F90 mmHg; participants who have a history of hypertension controlled by medication must be on a stable dose of antihypertensive therapy such that there has been no increase in hypertensive medications or dosage (for at least -14 days) and meet all other inclusion criteria.\n11. Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders.\n12. GI Bleeding (e.g., esophageal varices or ulcer bleeding) within 3 months. (Note: For participants with a history of GI bleeding for more than 12 months or assessed as high risk for esophageal variceal by the Investigator, adequate endoscopic therapy according to institutional standards is required.)\n13. Complex biliary obstruction requiring bile duct stents at more than one level of the biliary tree or external biliary drainage.\n14. Recurrent episodes of cholangitis (\\>1) in the preceding 3 months prior to enrollment.\n15. Therapeutic anti-coagulation or anti-platelet therapy with the exception of low molecular weight heparin, aspirin, or factor Xa inhibitors.\n16. Pregnant or lactating individuals. Pregnant individuals are excluded from this study because based on findings in animals and its mechanism of action, tivozanib can cause fetal harm when administered to a pregnant individual. In animal reproduction studies, administration of tivozanib to pregnant rats caused adverse developmental outcomes including embryo- fetal mortality. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the individual with tivozanib, nursing (such as breastfeeding) should be discontinued if the individual is treated with tivozanib. These potential risks may also apply to other agents used in this study.","18 Years",{"count":51,"type":22},31,"INTERVENTIONAL",[54,55],"PHASE1","PHASE2","Background:\n\nCholangiocarcinoma (CCA) is an aggressive cancer of the bile ducts. People with CCA have few treatment options and poor survival. Researchers want to see if a new drug can stop or slow CCA growth.\n\nObjective:\n\nTo find the safest and most effective dose of tivozanib to treat CCA and learn its overall response rate.\n\nEligibility:\n\nAdults ages 18 and older with CCA not removable with surgery and have been treated with at least one type of chemotherapy.\n\nDesign:\n\nParticipants will be screened with the following:\n\n* Medical history\n* Physical exam\n* Assessment of their ability to do daily activities\n* Medicine review\n* Blood tests, including thyroid function tests\n* Urine tests\n* Electrocardiogram, to check heart function\n* Pregnancy test, if needed\n* Tumor biopsy, if needed\n* Computed tomography scans\n* Magnetic resonance imaging, if needed\n\nSome screening tests may be repeated during the study.\n\nParticipants will be asked to enroll in protocol #13C0176. This will allow any remaining tumor or blood samples to be used in future research.\n\nParticipants will take tivozanib by mouth, once a day for 21 days per cycle or every other day per cycle. Each cycle is 28 days. They can take the drug until they have bad side effects, their CCA gets worse, or if they become pregnant. They will record their blood pressure twice daily at home. They will also keep a medication diary of each dose of tivozanib they take and any side effects.\n\nParticipants will have study visits before starting each new cycle and every 8 weeks. They will also have a follow-up visit 30 days after treatment ends at NIH, or if they are unable to come to NIH by phone, videocall, or other NIH-approved platform. Then they will be contacted 6 and 12 months later, and then once a year.",[28,58,59],"Bile Duct Neoplasm","Biliary Tract Malignancy",[61,62,63,64,65],"CCA","FOTIVDA","pan-vascular endothelial growth factor receptor (VEGFR) inhibitor","XPO7","Ste-20 like kinase (SLK)","2026-08-15",{"date":32,"type":33},{"date":69,"type":33},"2022-03-04",{"date":71,"type":22},"2029-12-31",{"name":73,"class":74},"National Cancer Institute (NCI)","NIH",1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":4,"leadSponsor":100,"locationsCount":75},"100202701","obtaining-solid-tumor-tissue-from-people-having-biopsy-or-surgery-for-certain-types-of-cancer-100202701","NCT01915225","Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer","Tumor, Normal Tissue and Specimens From Patients Undergoing Evaluation or Surgical Resection of Solid Tumors","* INCLUSION CRITERIA:\n* Participants must be 2 years of age or older. Note: Participants greater than or equal to 2 and \\\u003C 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the biospecimen sampling (e.g., blood, urine, ascites, bile, or \\[clinically indicated\\] resected tumor tissue) does not add risk to the clinically indicated procedures.\n* Participants who have premalignant, primary, or metastatic solid tumors based upon either radiographic or clinical suspicion, biochemical testing, a genetic predisposition, or histological\u002Fcytological analysis that requires surgery or biopsy as part of the diagnosis, prevention, treatment, and\u002For follow-up.\n* Participants without solid tumors in whom a diagnostic, preventative, or therapeutic intervention is being performed, but for whom surgical quality and safety outcomes data are generated.\n* Participants should have laboratory and physical examination parameters within acceptable limits prior to biopsy or surgery.\n* Participants must be planning to undergo surgery or biopsy as part of their normal treatment plan.\n* Ability of participant, parent\u002Fguardian or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nNone.","2 Years",{"count":85,"type":22},1800,"Background:\n\n\\- Recent advances in cancer research have led to new therapies to treat the disease. It is important to continue these advances and discover new ones. To do that, researchers need tissue samples from solid tumors. This study will collect such samples from people already scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).\n\nObjectives:\n\n\\- To collect tissue samples for use in studying new ways to treat tumors.\n\nEligibility:\n\n* Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled to have surgery or a biopsy at the NIHCC.\n* Children under the age of 18 but who are older than 2 years of age are eligible to be enrolled on the research sample collection portion of this study if they will have a biopsy or surgery as part of their medical care.\n\nDesign:\n\n* Before their procedure, participants will have a small blood sample taken.\n* Some participants will undergo leukapheresis. In this procedure, blood is removed through a tube in one arm and circulated through a machine that removes white blood cells. The blood, minus the white blood cells, is returned through a tube in the other arm. The procedure takes 3-4 hours.\n* For all participants, during the surgery or biopsy, pieces of the tumor and pieces of normal tissue near it will be removed for this study. The rest of the tumor or precancerous growth will be sent to a lab for analysis.\n* Participants will return to the clinic about 6 weeks after the operation for a routine checkup. Some may have to return for additional follow-up.",[88,89,28,90,91],"Colorectal Neoplasms","Gastric Neoplasms","Bile Duct Cancer","Pancreas Cancer",[93,94,95,96],"Tissue Procurement","Surgery","Metastasectomy","Natural History",{"date":32,"type":33},{"date":99,"type":33},"2013-07-21",{"name":73,"class":74},{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":52,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":75},"100644764","phase-2-18fftt-positron-emission-tomographycomputed-tomography-to-predict-treatment-response-in-patients-scheduled-to-receive-gemcitabine-cisplatin-and-durvalumab-for-newly-diagnosed-cholangiocarcinoma-100644764","NCT07673341","[18F]FTT Positron Emission Tomography\u002FComputed Tomography to Predict Treatment Response in Patients Scheduled to Receive Gemcitabine, Cisplatin, and Durvalumab for Newly Diagnosed Cholangiocarcinoma","Imaging PARP Expression in Cholangiocarcinoma","Inclusion Criteria:\n\n* Patient must have histologically confirmed cholangiocarcinoma\n* Patient must be newly diagnosed and have not yet been treated\n* Patient planned to receive GCD per standard-of-care\n* Patient must have evaluable disease or at least one measurable lesion that can be assessed at baseline by CT (or MRI) per RECIST 1.1\n* Age ≥ 18 years\n* For women of childbearing potential, a negative serum pregnancy test is required within 7 days prior to \\[18F\\]FTT PET imaging\n* Men and women of reproductive potential need to agree to employ acceptable forms of contraception throughout their participation in the study that meet requirements for GCD treatment per standard of care\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing all study procedures\n* Ability to understand and the willingness to sign a written informed consent document. Informed consent must be provided prior to any study specific procedures\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":109,"type":22},22,[55],"This phase II trial studies whether \\[18F\\]FTT can be used with positron emission tomography (PET)\u002Fcomputed tomography (CT) imaging to predict treatment response in patients scheduled to receive gemcitabine, cisplatin, and durvalumab (GCD) for newly diagnosed cholangiocarcinoma. PET\u002FCT is an imaging technique that utilizes PET and CT in a single machine. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this trial, \\[18F\\]FTT, to make detailed, computerized pictures of areas inside the body where the tracer is used. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the patient's body. \\[18F\\]FTT targets and binds to poly (ADP-ribose) polymerase 1 (PARP1). Some cholangiocarcinoma tumor cells may express PARP1 which may make it easier to see them on PET\u002FCT. Research has shown that tumor cells that express PARP1 may not respond well to GCD treatment. Researchers hope that by using \\[18F\\]FTT with PET\u002FCT imaging they will be able to detect which patients have tumor cells that express PARP1, which may help predict treatment response in patients scheduled to receive GCD for newly diagnosed cholangiocarcinoma.",[28],"NOT_YET_RECRUITING","2026-08-12",{"date":116,"type":33},"2026-08-14",{"date":118,"type":22},"2026-11-01",{"date":120,"type":22},"2028-12-31",{"name":122,"class":40},"University of Washington",{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":52,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100612945","phase-2-phase-ii-study-evaluating-ivosidenib-maintenance-after-soc-adjuvant-chemotherapy-in-curative-midh1-cholangiocarcinoma-100612945","NCT07260175","Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma","adIVO - A Phase II Trial of Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma","adIVO","Inclusion Criteria:\n\n1. Patient\\* provides signed informed consent.\n2. Patient is ≥ 18 years at the time of given informed consent.\n3. Patient has histologically documented curatively resected intrahepatic cholangiocarcinoma, without metastatic spread, in the adjuvant situation (R0-resected)\n4. Patient has proven IDH1 mutation (IDH1-variant status evaluated locally by certified test on formalin-fixed paraffin-embedded tumor tissue specimen. If local testing for screening is not possible per local standard, tumor tissue samples will be subject to pre-screening via central IDH1 dPCR)\n5. Patient finished adjuvant systemic SOC chemotherapy (with regimens allowed per the protocol) directly prior to trial inclusion.\n6. Radiologic imaging available that shows that patient is tumor free at the timepoint of enrollment (not older than 6 weeks from the day of inclusion).\n7. Patient has ECOG Performance status ≤ 1\n8. Hematological, hepatic and renal function parameters adequate to allow targeted therapy with ivosidenib at investigator´s discretion and IB.\n9. Patient has adequate coagulability to allow targeted therapy with ivosidenib at investigator´s discretion and IB. Patients receiving warfarin \u002F Phenprocoumon must be switched to low molecular weight heparin and before starting trial-specific.\n10. Patient must be willingly to provide liquid biopsy samples, archival tumor tissue samples (if available), and in the event of disease recurrence, re-biopsy samples (if re-biopsy is considered safe for the patient) for the translational research program.\n11. Female patients of childbearing potential or male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C1% per year during the treatment period and for at least 6 months after the last dose of trial treatment. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy. Female patients of child-bearing potential must have a negative pregnancy test within the last 7 days prior to the start of trial therapy.\n12. Patient is willing and able to comply with the protocol (including contraceptive measures) for the duration of the trial including undergoing treatment and scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n1. Patient has a metastatic or R+ resected biliary tract cancer.\n2. Patient received previous therapy with an IDH1 inhibitor.\n3. Patient has known presence of tumors other than intrahepatic cholangiocarcinoma or a secondary tumor other than squamous or basal cell carcinomas of the skin or in situ carcinomas of the cervix which have been effectively treated. The sponsor decides to include patients who have received curative treatment and have been disease-free for at least 5 years.\n4. Simultaneous, ongoing systemic immunotherapy, chemotherapy, or hormone therapy not described in the trial protocol.\n5. Patient receives simultaneous treatment with a different anti-cancer therapy other than that provided for in the trial (excluding palliative radiotherapy only for symptom control).\n6. Patient has a stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or clinically significant ascites resulting from cirrhosis. Clinically significant ascites is defined as ascites resulting from cirrhosis requiring diuretics or paracentesis.\n7. Patient has known allergic \u002F hypersensitive reactions to at least one of the treatment components.\n8. Patient has other serious illnesses or medical ailments within the last 12 months prior to the start of the trial.\n9. Patient has a known presence of an active, uncontrollable infection.\n10. Patient has QTc \\> 480ms or other factors that, in the discretion of the investigator increase significantly the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT syndrome). NOTE: Medications that prolong the QT interval should be avoided, unless they can be transferred to other medication within ≥ 5 half-lives to dosing or unless the medications can be properly monitored during the study. (If equivalent medication is not available, QTc should be closely monitored).\n11. Patient has active disseminated intravascular coagulation.\n12. Patient has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n13. Patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial drug.\n14. Patient has any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect. NOTE: strong CYP3A4 inducers or sensitive CYP3A4 substrates with narrow therapeutic window should be avoided, unless they can be transferred to alternative medication within at least 5-half lives prior to dosing.\n15. Female patient is pregnant or breast feeding or planning to become pregnant within and 6 months after the end of treatment.\n16. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.",{"count":132,"type":22},40,[55],"This study trial is a prospective, multicentre, exploratory, single-arm, open-label phase II study to evaluat ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma",[28,136],"IDH Mutation",[138,139,140,141],"mIDH1 cholangiocarcinoma","ivosidenib maintenance","cholangiocarcinoma","R0-resection","2026-08-11",{"date":114,"type":33},{"date":145,"type":33},"2025-11-18",{"date":147,"type":22},"2031-12",{"name":149,"class":40},"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest",15,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":52,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":175},"100580714","phase-1-a-study-of-phst001-in-advanced-solid-tumors-100580714","NCT06840886","A Study of PHST001 in Advanced Solid Tumors","An Open-label, Phase 1a\u002F1b, Dose Escalation and Dose Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PHST001 in Adult Patients With Advanced Relapsed and\u002For Refractory Solid Tumors","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies.\n* Adequate organ function per laboratory testing\n* Pregnancy prevention requirements\n* Measurable disease per RECIST v1.1 (or RANO) as assessed by the local site Investigator\u002Fradiology\n* Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale\n\nKey Exclusion Criteria:\n\n* Diagnosis of immunodeficiency\n* History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Participants with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Participants with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded.\n* Active known CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are radiologically stable (i.e., without evidence of progression for at least 2 weeks by repeat imaging \\[note that the repeat imaging should be performed during study screening\\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.\n* Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant.\n* Received previous treatment with another agent targeting CD24.",{"count":159,"type":22},272,[54],"This is a multi-center, first-in-human (FIH), open-label, Phase 1a\u002F1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) in adult participants with advanced relapsed and\u002For refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). In Phase 1b cohort expansions, the study will focus on participants with advanced relapsed and\u002For refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.",[163,164,165,28,166],"Advanced Solid Tumors","Ovarian Cancer","Endometrial Cancer","CNS Tumor",{"date":114,"type":33},{"date":169,"type":33},"2025-03-31",{"date":171,"type":22},"2031-04",{"name":173,"class":174},"Pheast Therapeutics","INDUSTRY",20,{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":52,"phases":185,"briefSummary":187,"conditions":188,"keywords":192,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100630364","phase-4-olutasidenib-ddi-study-in-patients-with-idh1-mutation-positive-malignancies-100630364","NCT07486713","Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies","A Multi-Center, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Olutasidenib on the Pharmacokinetics of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates in Patients With IDH1 Mutation-Positive Malignancies Being Treated With Olutasidenib","Inclusion Criteria:\n\n* Adult male or female ≥ 18 years of age at the time of signing the informed consent form\n* Must have an Eastern Cooperative Oncology Group performance status ≤ 2.\n* Must have recovered from the non-hematologic toxic effects of prior treatment to Grade ≤ 1, or baseline value (excluding infertility, alopecia, or Grade 1 neuropathy)\n* Must have a diagnosis of IDH1m+ malignancy to be treated with olutasidenib (e.g. acute myeloid leukemia \\[AML\\], gastrointestinal \\[GI\\] cancers, glioma). Patient should not have received olutasidenib within the 2 weeks prior to the first dose of study drug.\n* Patient must have an adequate organ function, defined by the following:\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≤ 2.5 × upper limit of normal (ULN).\n* Bilirubin ≤ 1.5× ULN (≤ 3 × ULN in patients with Gilbert Syndrome) or ≤ 3 × ULN for patients with AML involvement.\n* Creatinine clearance ≥ 30 mL\u002Fmin using Cockcroft-Gault equation.\n* Female patients who are women of childbearing potential (WOCBP) must have a negative serum (β-hCG) pregnancy test at screening and negative urine test (positive urine tests are to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug. WOCBP are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.\n* WOCBP, must agree to use two methods of birth control (e.g. hormonal and a barrier method such as a condom), or must be considered highly unlikely to conceive during the dosing period and for 3 months after last study treatment.\n* Male patients with female partners of childbearing potential may be enrolled if they both agree to use highly effective methods of contraception during the dosing period and for 3 months after last study treatment.\n* Male patients must refrain from donating sperm during the dosing period and for 3 months after last study treatment.\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breastfeeding.\n* Patients who are active smokers. Those who have ceased smoking \\> 1 month before the Screening Visit will be allowed.\n* Ingestion of alcohol within 72 hours prior to first study drug administration and during the study period.\n* Any patient's who plans to become pregnant or father a child (including ova or sperm donation) while enrolled in this study or within 3 months after last dose of study drug.\n* Known allergy or history of hypersensitivity to study drugs or their excipients.\n* Human immunodeficiency virus (HIV) positivity.\n* Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or by RNA polymerase chain reaction (PCR) at screening.\n* Any patient's with a serious infection requiring intravenous or systemic antibiotics within 7 days prior to initiation of study treatment, or any active infection that, in the opinion of the Investigator, could impact patient's safety (e.g. COVID-19).\n* Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and\u002For 3A4 inhibitors within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug\n* Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and\u002For 3A4 inducers within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n* History of or active, clinically significant, cardiovascular, respiratory, GI, renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorder that, in the Investigator's opinion (or following review by the Sponsor), could affect the conduct of the study or the absorption, metabolism or excretion of the study treatment.\n* If less than the minimum time has elapsed from prior anticancer treatment to first dose of study treatment as follows:\n\n  1. Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, or major surgery within 4 weeks prior to the first scheduled study treatment; for longer acting agents such as nitrosourea, mitomycin or antibody therapies, a minimum of 6 weeks.\n  2. Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent).\n* History of prior second malignancy unless disease-free for ≥ 12 months or considered surgically cured. Patients with nonmelanoma skin cancers or with carcinomas in situ at any time following curative intent surgery and low grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to the study, or previously resected are also eligible.\n* Patients with symptomatic central nervous system metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy.\n* Marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\> 480 milliseconds \\[msec\\]) (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 1) using Fridericia's QT correction formula.\n* Patients with New York Heart Association Class III or IV heart failure.",{"count":184,"type":22},16,[186],"PHASE4","A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.",[189,190,28,191],"AML (Acute Myeloid Leukemia)","Glioma","Solid Tumor Malignancies",[193,194,195,196],"IDH1 Mutation","Hematology and Oncology","Oncology","Drug-Drug Interactions","2026-08-07",{"date":142,"type":33},{"date":200,"type":33},"2026-02-23",{"date":202,"type":22},"2027-06-30",{"name":204,"class":174},"Rigel Pharmaceuticals",2,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":52,"phases":215,"briefSummary":217,"conditions":218,"keywords":223,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":75},"100585191","hepquant-study-to-assess-the-role-of-blood-based-biomarkers-and-quantitative-mr-imaging-for-patients-receiving-radiation-therapy-for-liver-cancer-100585191","NCT06899152","HepQuant: Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer","HepQuant: Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer","HepQuant","The following criteria must be met for subjects to be considered for the trial. Additional exclusion criteria must be met for subjects interested in the HepQuant subset of the trial. The first 20 qualifying subjects will be enrolled for the additional HepQuant test.\n\nInclusion Criteria:\n\n* Age \\> 18\n* Patient has the psychological ability and general health needed to provide informed consent, completion of study requirements, and required follow-up\n* Patient provides study-specific informed consent prior to study entry\n* All primary histologies (Hepatocellular carcinoma or Cholangiocarcinoma) as well as hepatic metastases are eligible\n* Prior history of radiation therapy (external beam or radioembolization) is allowed, with no limit to the number of prior courses of radiation therapy\n* Any number of lesions (with no size limit) of pathologically documented (histologically or cytologically) or radiographically proven tumor\u002Fmetastasis that are being targeted\n* Prior history of liver resection, transarterial chemoembolization (TACE), or ablation are allowed with no restriction on number of prior therapies, or time from current study registration\n* Prior history of chemotherapy, immunotherapy, or targeted biological therapy is allowed\n* Concurrent enrollment on other prospective registry or treatment intention trials is allowed\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding females\n* Subjects with history of claustrophobia impacting ability to perform MRI during the study\n* Subjects who fulfill any of the contraindications for MRI; examples include any ferromagnetic material, any metallic shrapnel or fragments or implanted electronic devices contained within the body or metal-containing tattoos\n* Unable to participate in MR assessments due to physical limitations of equipment tolerances (MRI bore size and\u002For weight limit)\n* Any person unable to lie still within the environment of the MRI scanner or maintain a breath hold for the required period to acquire images\n\nExclusion criteria for HepQuant SHUNT DuO testing ONLY:\n\n* Known history or suspected hypersensitivity to human serum albumin, or its preparations\n* Subjects with extensive resection of large segments of small intestine (short gut) or severe gastroparesis (e.g., diabetic or medication-induced gastroparesis)\n* Subjects on either a non-selective beta blocker (propranolol, nadolol), or an angiotensin converting enzyme (ACE) inhibitor, or angiotensin receptor blocker (ARB) who are unwilling or unable to delay taking their normal dose the morning of their testing\n* Subjects who are allergic to any ingredient in the formulations or components in the HepQuant SHUNT DuO kit including the human serum albumin (HSA) or cholate compounds (theoretical - none yet reported)\n* Subjects unwilling or unable to fast for at least 5 hours. Fasting means no intake of food or food supplements, including fiber preparations or biosimilars; or any preparations or resins (cholestyramine, colestipol, colesevelam) that might act within the gut lumen to bind the orally administered d4-cholate in the HepQuant test.",{"count":132,"type":22},[216],"NA","This is a pilot and feasibility study assessing the role of quantitative multiparametric MRI and blood-based biomarkers for the measurement of liver function in patients receiving radiation therapy for liver cancer, including hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver metastases regardless of primary histology, that are undergoing photon radiation either in the de-novo or re-irradiation setting. The goal of this study is to prospectively evaluate the feasibility of using quantitative multiparametric MRI to monitor liver function at baseline and following liver radiation therapy.",[219,220,221,28,222],"Liver Cancer","Hepatocellular Carcinoma","Hepatocellular Cancer","Liver Metastases",[224,225,226],"Blood-based biomarkers","Quantitative MR imaging","Radiotherapy",{"date":142,"type":33},{"date":229,"type":33},"2025-07-16",{"date":231,"type":22},"2031-07",{"name":233,"class":40},"Montefiore Medical Center",{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":52,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":75},"100639729","phase-1-tcr1188-abc-cells-in-kras-mutated-cancers-100639729","NCT07594067","TCR1188-ABC Cells in KRAS-mutated Cancers","Phase I, Open-Label Study of Autologous Mutant KRAS and ILT4-Redirected T-cell Receptor Cells (TCR1188-ABC)","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age\n2. Patients with one of the following diagnoses:\n\n   1. Histologically confirmed metastatic pancreatic adenocarcinoma or cholangiocarcinoma\n   2. Histologically confirmed metastatic colorectal cancer\n   3. Histologically confirmed metastatic non-small cell lung cancer\n3. HLA-A\\*11:01 positive as confirmed by a CLIA certified laboratory.\n4. KRAS G12V mutation positive disease as confirmed on tissue, blood, or plasma by next generation sequencing by a CLIA certified laboratory.\n5. Received prior treatment for their primary malignancy as follows:\n\n   1. Pancreatic Cancer\u002FCholangiocarcinoma Patients: At least one prior line of standard of care therapy for advanced stage disease. For pancreatic cancer patients, this must include a gemcitabine or fluorouracil (5 FU)-based regimen.\n   2. Colorectal Cancer Patients: At least three prior lines of standard of care therapy for advanced stage disease. Prior treatment must include all of the following unless the patient was ineligible for a specific therapy type: i). a fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimen, ii). an anti-vascular endothelial growth factor (VEGF) agent, and iii). regorafenib, trifluridine-tipiracil, or fruquintinib. Patients with microsatellite instability-high (MSI-H) disease must also have received, or be ineligible for, prior treatment with an immune checkpoint inhibitor.\n   3. Non-Small Cell Lung Cancer Patients: At least one prior line of standard of care therapy for advanced stage disease.\n6. Evidence of radiographically detectable disease within 8 weeks of physician-investigator confirmation of eligibility.\n7. Adequate organ function within 4 weeks of eligibility confirmation by a physician-investigator defined as:\n\n   1. Serum creatinine ≤ 1.5 mg\u002Fdl or creatinine clearance ≥ 50 cc\u002Fmin per the Cockcroft-Gault Equation; Patient must not be on dialysis.\n   2. ALT\u002FAST ≤ 5 x ULN (patients with liver metastases) or ALT\u002FAST ≤ 2.5 x ULN (patients without liver metastases)\n   3. Total bilirubin ≤ 1.5 mg\u002FdL x ULN, unless the subject has Gilbert's syndrome (if so, direct bilirubin must be ≤ 2.0 mg\u002FdL x ULN)\n   4. Left Ventricle Ejection Fraction (LVEF) ≥ 50% confirmed by ECHO\u002FMUGA\n   5. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \\> 92% on room air\n8. Patients must have adequate hematologic reserve within 4 weeks of eligibility confirmation by a physician-investigator and must not be dependent on transfusions to maintain these hematologic parameters. Adequate hematologic reserve is defined as:\n\n   1. Hemoglobin ≥ 8 g\u002FdL\n   2. Absolute neutrophil count ≥ 1000\u002FμL\n   3. Platelet count ≥ 100,000\u002FμL\n9. ECOG Performance Status that is either 0 or 1.\n10. Signed, written informed consent\n\nExclusion Criteria:\n\n1. Active hepatitis B or hepatitis C infection\n2. Patients with a severe acquired or inherited immunodeficiency, including HIV positive patients with a CD4 count ≤ 350 cells\u002FμL. In order to qualify, HIV positive patients must also be on an established antiretroviral therapy regimen with a viral load of \\\u003C400 copies\u002FmL.\n3. Any other active, uncontrolled infection.\n4. Class III\u002FIV cardiovascular disability according to the New York Heart Association Classification (see Appendix 5).\n5. Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study.\n6. Active invasive cancer, other than the proposed cancer included in the study, within 2 years prior to eligibility confirmation by a physician-investigator. \\[Note: non-invasive cancers treated with curative intent (e.g., non-melanoma skin cancer) may still be eligible\\].\n7. Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods, as described in protocol Section 4.3.\n8. Patients requiring chronic treatment with systemic steroids or immunosuppressant medications. Low-dose physiologic replacement therapy with corticosteroids equivalent to prednisone 10 mg\u002Fday or lower, topical steroids and inhaled steroids are acceptable. For additional details regarding use of steroid and immunosuppressant medications, please see Section 5.6.\n9. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg daily of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.\n10. Patients with unstable angina, serious uncontrolled cardiac arrhythmia, and\u002For myocardial infarction within 6 months of physician-investigator confirmation of eligibility.\n11. Prior history of myocarditis.\n12. Patients with pneumonitis\u002Finterstitial lung disease requiring steroid treatment.\n13. Patients with active\u002Funtreated brain metastases. \\[Note: History of treated metastases may still be eligible.\\]\n14. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40) or tocilizumab.",{"count":242,"type":22},30,[54],"This is a Phase I, open-label dose finding study to assess the safety, manufacturing feasibility, and preliminary efficacy of TCR1188-ABC cells in patients with KRAS-mutated cancers. Initially, patients with KRAS G12V mutation positive metastatic pancreatic adenocarcinoma, cholangiocarcinoma, colorectal cancer, or non-small cell lung cancer (NSCLC) will be targeted for participation. Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.",[28,246,247,248],"Colorectal Cancer","Non-Small Cell Lung Cancer","Pancreatic Adenocarcinoma","2026-08-05",{"date":251,"type":33},"2026-08-06",{"date":253,"type":22},"2026-08",{"date":255,"type":22},"2042-07",{"name":257,"class":40},"University of Pennsylvania",{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":52,"phases":268,"briefSummary":269,"conditions":270,"keywords":276,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":242},"100609377","phase-1-a-study-of-ly4337713-in-participants-with-fap-positive-solid-tumors-100609377","NCT07213791","A Study of LY4337713 in Participants With FAP-Positive Solid Tumors","A Dose Escalation and Dose Optimization Phase 1a\u002F1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)","FiREBOLT","Inclusion Criteria:\n\n* Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment\n* Must have histologically or cytologically confirmed diagnosis of one of the following:\n\n  * Adenocarcinoma of the pancreas\n  * Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer\n  * HER2-positive breast cancer\n  * Triple negative breast cancer (TNBC)\n  * Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)\n  * Other solid tumors\n\n    * Gastric cancer (adenocarcinoma)\n    * Colorectal cancer (CRC)\n    * Esophageal cancer (squamous cell carcinoma or adenocarcinoma)\n    * Cholangiocarcinoma\n* Must have received prior treatments as indicated below:\n\n  * Phase 1a\n\n    * Adenocarcinoma of the pancreas: Participants must have received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.\n    * HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4\u002F6 inhibitor.\n    * HER2-positive breast cancer: Participants must have received at least 2 lines of HER2-targeted therapy, which should include at least 1 antibody-drug conjugate (ADC) for metastatic disease (if locally available).\n    * TNBC: Participants must have received at least 2 lines of therapy for metastatic disease.\n    * Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.\n    * Other solid tumors (gastric cancer, CRC, esophageal and cholangiocarcinoma): Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; including prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.\n  * Phase 1b:\n\n    * Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy.\n* Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.\n* Measured creatinine clearance ≥60 milliliters per minute (mL\u002Fmin)\n\nExclusion Criteria:\n\n* Have known active central nervous system (CNS) metastases or carcinomatous meningitis.\n* Have significant cardiovascular disease\n* Have prolongation of the corrected QTcF \\>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT\u002F(RR0.33)\n* Have evidence of ongoing and untreated urinary tract obstruction\n* Had previous hemi- or total-body radiation.\n* Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T therapy, T-cell receptor \\[TCR\\] therapy, etc.)\n* Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).",{"count":267,"type":22},241,[54],"This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.",[271,272,273,88,274,275,28],"Ovarian Neoplasms","Breast Neoplasms","Pancreatic Intraductal Neoplasms","Esophageal Neoplasms","Stomach Neoplasms",[277,278,279,280],"Cancer-associated fibroblasts (CAF)","Lutetium-177","LuFAP","Lu-177-FAP",{"date":251,"type":33},{"date":283,"type":33},"2025-10-22",{"date":285,"type":22},"2033-03",{"name":287,"class":174},"Eli Lilly and Company",{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":296,"targetDuration":83,"studyType":23,"phases":4,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":315,"locationsCount":317},"100583539","on-treatment-surveillance-of-tumor-evolution-and-response-to-systemic-treatment-in-bile-duct-and-liver-cancer-100583539","NCT06877637","On-treatment Surveillance of Tumor Evolution and Response to Systemic Treatment in Bile Duct and Liver Cancer","BILe Duct and LIver Cancer: ON-treatment Surveillance of Tumor Evolution And Response to Systemic Treatment","BILLIONSTARS","Inclusion Criteria:\n\n* \\> 18 years of age\n* Clinically diagnosed intrahepatic Cholangiocarcinoma (iCCC), perihilar Cholangiocarcinoma (pCCC), distal Cholangiocarcinoma (dCCC), gall bladder carcinoma (GBC) or mixed Hepatocellular carcinoma\u002FCholangiocarcinoma planned to undergo surgery\n* Histologically or cytologically confirmed Cholangiocarcinoma (iCCC, pCCC, dCCC, GBC, mixed HCC\u002FCCC) for patients planned to receive palliative systemic treatment or\n* Clinically diagnosed Hepatocellular carcinoma (HCC) planned for surgery, ablation or transarterial chemo-embolization. For patients planned to receive systemic treatment histological or cytological confirmation is required except for patients with LI-RADS 5 lesions.\n\nExclusion Criteria:\n\n* \\\u003C 18 years of age\n* Severe comorbidities\n* Inability to comprehend study information",{"count":297,"type":22},150,"The BILLIONSTARS study is a prospective, single arm observational study inviting patients diagnosed with hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) who are to be recommended locoregional intervention by surgery, ablation or transarterial chemoembolization and\u002For antitumoral medical treatment. The aim is to investigate how tumor- and individual-related factors affect response to treatment. To this end, circulating tumor DNA, immune cells and various proteins will be analyzed in repeated blood samples taken before, during and after completion of systemic treatment. When applicable, analyses will also be performed on tumor tissue from resected tumors and biopsies, and in some cases also from autopsies",[300,28],"Hepatocellular Carcinoma (HCC)",[140,302,303,304,305,306,307,308],"hepatocellular carcinoma","bile duct cancer","liver cell cancer","circulating tumor DNA","targeted therapy","tumor heterogeneity","tumor evolution","2026-07-31",{"date":311,"type":33},"2026-08-03",{"date":313,"type":33},"2025-05-15",{"date":71,"type":22},{"name":316,"class":40},"Region Skane",3,{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":184},"100562756","ivosidenib-in-locally-advanced-or-metastatic-cholangiocarcinoma-with-idh1-r132-mutation-after-at-least-one-prior-systemic-treatment---an-observational-study-100562756","NCT06607302","Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study","Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - a Prospective, Multicenter, Observational Study in Germany","IDHIRA","Inclusion Criteria:\n\n* Age 18 years or older.\n* Histologically confirmed locally advanced or metastatic CCC with a documented IDH1 R132 mutation diagnosed by an appropriate diagnostic test\n* Patients must have at least one prior systemic therapy\n* Decision for treatment with ivosidenib according to current SmPC.\n* Signed written informed consent before or within 6 weeks of first ivosidenib dose (inclusion of patients up to 6 weeks after first ivosidenib intake is allowed for patients not participating in the PRO module)\n* For patients participating in the PRO module (optional):\n\n  * Dated signature of informed consent form before start of study treatment.\n  * Willingness and capability to participate in PRO assessment in German language.\n* Other criteria according to current SmPC.\n\nExclusion Criteria:\n\n* Participation in an interventional clinical trial within 30 days prior to enrolment or concurrent participation in an interventional clinical trial except for the follow-up period.\n* Other contraindications according to current SmPC.",{"count":327,"type":22},100,"Cholangiocarcinoma is a rare and aggressive tumor of the bile duct associated with a poor prognosis and very limited treatment options. The IDH1 inhibitor ivosidenib provides a new, targeted treatment option for this disease. Ivosidenib was approved by European Medicines Agency (EMA) in May 2023 as monotherapy in adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.\n\nThe prospective, multicenter, observational study IDHIRA will collect first real-world data on ivosidenib treatment in a broad patient population in Germany. Ivosidenib will be administered according to the current SmPC. Thus, IDHIRA will generate real-world evidence on effectiveness, quality of life (QoL) and safety of ivosidenib.",[28],"2026-07-30",{"date":309,"type":33},{"date":333,"type":33},"2024-10-08",{"date":335,"type":22},"2027-12",{"name":337,"class":174},"iOMEDICO AG",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":52,"phases":347,"briefSummary":348,"conditions":349,"keywords":356,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":41},"100649839","phase-1-iks04-regimen-in-advanced-solid-tumors-that-express-ca242-100649839","NCT07738939","IKS04 Regimen in Advanced Solid Tumors That Express CA242","A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of the IKS04 Regimen Targeting CA242","Key Inclusion Criteria:\n\n* Advanced or metastatic CRC, BTCs, GEA, and PDAC that is histologically or cytologically confirmed\n* Disease that has progressed despite prior treatment, for which additional effective therapy is not available, not tolerable, is contraindicated, or the participant refuses standard therapy.\n* Platelets ≥ 100,000 \u002FmcL\n* Hemoglobin ≥ 9.0 g\u002FdL., no transfusions with RBCs are allowed within 2 weeks prior to first trial drug administration\n* ANC ≥ 1500\u002FmcL\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional upper limit of normal (ULN) ≤ 5 x ULN if liver metastases present\n* Total bilirubin ≤ 1.5 x ULN, unless participant has Gilbert's Syndrome\n* Albumin \\> 2.5 g\u002FdL\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n\nPart I\n\n* Fresh biopsy tissue or formalin-fixed paraffin-embedded (FFPE) tumor tissue block or slides available for retrospective assessment of CA242 positivity in a central laboratory.\n* Measurable and non-measurable disease\n\nPart II\n\n* Fresh biopsy tissue or FFPE tumor tissue block or slides for assessment of CA242 positivity in a central laboratory prior to administration of first dose of study drug.\n* Measurable disease only\n\nKey Exclusion Criteria:\n\n* Participants with a significant pulmonary disease or condition, including:\n\n  * Significant symptomatic chronic obstructive pulmonary disease (COPD), as assessed by the Investigator.\n  * History or any current evidence on imaging studies of interstitial lung disease (ILD), pulmonary fibrosis.\n  * History of pulmonary inflammatory disease, pneumonitis, acute respiratory distress syndrome (ARDS).\n  * History of pneumonia within 3 months prior to the first trial drug administration.\n* Participants who have received previous treatment with any CA242 directed ADC or any ADC containing a PBD payload for their current tumor indication.\n* Participant may not have received more than 5 prior lines of systemic therapy.\n* Received treatment with a strong cytochrome P450 (CYP) 3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first trial drug administration\n* Central nervous system metastatic disease unless treated prior to first dose of trial drug.\n* Active second malignancy or history of another malignancy within the last 2 years with specific exceptions as per protocol\n* Active, known or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome requiring systemic steroids or other immunosuppressive medications, such as:\n\n  * Myocarditis, pneumonitis, glomerulonephritis.\n  * Autoimmune hepatitis, inflammatory bowel disease (IBD)\n  * Sjogren's syndrome\n  * Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE)\n  * Myositis\n  * Myasthenia gravis\n  * Guillain-Barré Syndrome\n  * Multiple sclerosis\n  * Granulomatosis with polyangiitis (Wegner's granulomatosis)\n  * Vasculitis",{"count":346,"type":22},120,[54],"This study will evaluate the safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of the IKS04 Regimen and identify a recommended phase 2 dose (RP2D) or recommended dose for further evaluation in expansion (RDE). The regimen includes Isumab04 (unconjugated antibody) followed by the IKS04 antibody-drug conjugate, both directed against the CA242 (CanAg) tumor-associated antigen and administered intravenously (IV) in patients with advanced solid cancers.",[246,350,351,352,353,354,355,28],"Gastro Esophageal Junctional Cancer","Gastric Cancer (GC)","GEJ Adenocarcinoma","PDAC - Pancreatic Ductal Adenocarcinoma","Biliary Tract Cancer (BTC)","Gall Bladder Cancer",[357,358,359,360],"CA242","advanced gastrointestinal tumors","IKS04","Isumab04","2026-07-27",{"date":309,"type":33},{"date":364,"type":22},"2026-11",{"date":366,"type":22},"2029-12",{"name":368,"class":174},"Iksuda Therapeutics Ltd.",{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":52,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":75},"100649071","phase-2-precision-integrated-strategies-and-efficacy-evaluation-for-biliary-tract-cancers-an-umbrella-platform-study-100649071","NCT07729917","Precision Integrated Strategies and Efficacy Evaluation for Biliary Tract Cancers: An Umbrella Platform Study","Inclusion Criteria:\n\n* The patient voluntarily joins this study and signs the informed consent form.\n* Age: ≥18 years, male or female.\n* Histologically or cytologically confirmed advanced biliary tract malignancies, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.\n* No prior systemic therapy for advanced BTC (biliary tract cancer).\n* At least one measurable lesion as per RECIST v1.1 (spiral CT scan long diameter ≥10 mm or short diameter of enlarged lymph node ≥15 mm; lesions previously treated with local therapy may be considered target lesions only after documented progression according to RECIST v1.1).\n* ECOG performance status: 0-1.\n* Expected survival ≥12 weeks.\n* Adequate major organ function.\n* Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before the first dose, must not be breastfeeding, and must voluntarily agree to use effective contraceptive measures during the study period and for 6 months after the last dose of chemotherapy. For male subjects with a female partner of childbearing potential, they must be surgically sterile or agree to use effective contraceptive measures during the study period and for 3 months after the last dose of chemotherapy; sperm donation is not allowed during the study.\n* Subjects are expected to have good compliance and be able to follow the protocol requirements for efficacy and adverse event follow-up.\n\nExclusion Criteria:\n\n* Has another active malignancy other than BTC within 5 years or concurrently.\n* Has poorly controlled cardiac clinical symptoms or diseases.\n* Has hypertension that cannot be reduced to normal range with antihypertensive medication; has a history of hypertensive crisis or hypertensive encephalopathy.\n* Any clinically significant gastrointestinal disorders, including bleeding, inflammation, obstruction, or diarrhea \\> grade 2.\n* Has experienced thrombotic or embolic events within 6 months before the start of study treatment.\n* Use of strong CYP3A4\u002FCYP2C19 inducers (including rifampin and its analogues, and St. John's Wort) or strong CYP3A4\u002FCYP2C19 inhibitors and\u002For strong UGT1A inhibitors within 14 days prior to signing the informed consent form.\n* Has uncontrolled infection at screening.\n* Patients with congenital or acquired immunodeficiency.\n* Has a history of brain metastases or has brain metastases.\n* Women who are pregnant or plan to become pregnant during the study treatment period.\n* Other patients deemed unsuitable for inclusion by the treating physician.",{"count":376,"type":22},240,[55],"This study is a prospective, multicenter, open-label, umbrella phase II clinical trial. Based on different multigene expression profiling subtypes and potential molecular characteristics of various pathways, 8 treatment arms and 13 treatment groups are preliminarily designed. After successful screening, investigators will assign eligible subjects to a treatment group based on the patient's genetic test report (if available) and performance status. For subjects without a genetic test report, they will be allocated to Arm H to receive immunotherapy combined with chemotherapy or other regimens.",[380,28],"Bile Duct Carcinoma",{"date":382,"type":33},"2026-07-28",{"date":384,"type":22},"2026-08-10",{"date":386,"type":22},"2030-12-31",{"name":388,"class":40},"Zhejiang University",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":398,"conditions":399,"keywords":405,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":420},"100647926","breath-research-narrow-validation-for-gastrointestinal-cancer-detection-100647926","NCT07714538","Breath Research Narrow Validation for Gastrointestinal Cancer Detection","BRAVE","Inclusion Criteria:\n\nAdult participants ≥ 18 years old who meet at least one of the following criteria\n\nColorectal arm:\n\n1. Cancer: Histologically-confirmed CRC\\*\n2. Control: Non-specific abdominal symptoms with normal or benign colonoscopy findings\n\nPancreatic arm:\n\n1. Cancer: Histologically-confirmed PDAC\\*\n2. Control: Non-specific abdominal symptoms with a radiologically-normal pancreas\n\nOesophagogastric arm:\n\n1. Cancer: Histologically-confirmed OGC\\*\n2. Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings\n\nOesophageal squamous arm:\n\n1. Cancer: Histologically-confirmed OSCC\\*\n2. Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings\n\nLiver arm:\n\n1. Cancer: Histologically- or radiologically-confirmed HCC or CCC\\*\n2. Control: Non-specific abdominal symptoms with a radiologically-normal liver\n\n   * Patients with suspected cancer (e.g. based on imaging) but who do not have histological confirmation prior to participating in the study may still be recruited and followed up to determine whether or not a diagnosis of cancer was subsequently confirmed.\n\nExclusion Criteria:\n\n* Patients who have already received chemotherapy, radiotherapy or surgery for their cancer\n* History of another cancer (other than non-melanoma skin cancers) within three years\n* Participants with co-morbidities preventing breath collection\n* Unable or unwilling to provide informed consent\n* (For Oesophagogastric arm only): Allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, Maltodextrin (Corn, Potato), Xanthan Gum, Potassium Chloride, tyrosine, phenylalanine, and glutamic acid\n* (For Colorectal arm only): Participants receiving bowel prep in the previous 7 days",{"count":397,"type":22},1000,"The investigators of this study are developing a simple breath test to help detect gastrointestinal (gut) cancers earlier, including cancers of the oesophagus (food pipe), stomach, pancreas, liver and bowel. These cancers often cause non-specific symptoms that are similar to benign conditions, making early diagnosis difficult. Delays between the onset of symptoms and referral for a diagnostic test such as an endoscopy or a scan, can allow the cancer to progress.\n\nThe breath test detects small molecules called volatile organic compounds (VOCs) that are released in exhaled breath. Some of these VOCs are strongly associated with these cancers and may help identify high-risk patients who require urgent investigation.\n\nIn practice, patients who come to their GP with concerning symptoms will be offered the breath test. If the test is positive, patients can be referred promptly for a diagnostic test, while those with a negative result can be reassured and offered re-testing if symptoms persist. Earlier diagnosis could improve access to curative treatment while reducing unnecessary invasive investigations.\n\nPrevious studies have identified a panel of VOCs that appear to distinguish patients with gastrointestinal cancers from those without cancer. This study aims to confirm these findings in a new group of participants to determine whether the same biomarkers can be reliably identified.\n\nParticipants will provide a breath sample, usually before a hospital procedure they are already scheduled to undergo, and complete a short questionnaire about their medical history and medications. Some participants will also be asked to drink a nutritional supplement before providing a second breath sample. The results will help determine whether the breath test is reliable enough for further clinical evaluation",[400,401,402,403,28,300,404],"Oesophageal Squamous Cell Carcinoma","Oesophageal Adenocarcinoma","Gastric Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","Colorectal Adenocarcinoma",[406,407,408,409,246,219,410],"Early Detection","Volatile Organic Compunds","Oesophageal Cancer","Gastric Cancer","Pancreatic Cancer","2026-07-21",{"date":413,"type":33},"2026-07-23",{"date":415,"type":22},"2026-07-20",{"date":417,"type":22},"2028-08-02",{"name":419,"class":40},"Imperial College London",6,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":52,"phases":428,"briefSummary":429,"conditions":430,"keywords":432,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":75},"100586076","implementing-a-randomized-control-trial-to-test-the-expanded-web-based-decision-aid-100586076","NCT06910670","Implementing a Randomized Control Trial to Test the Expanded Web-based Decision Aid","Eligibility Criteria:\n\n* Enrolled in the WU-PE-CGS study (IRB#202106129); that eligibility entails:\n\n  * Diagnosis of cholangiocarcinoma\n  * Diagnosis of multiple myeloma, must be African American\n  * Diagnosis of colorectal cancer, must be African American and age 65 or older at time of diagnosis\n* At least 18 years old.\n* Able to understand an IRB-approved informed consent document and agree to participation\n* Have access to a personal computer, tablet or mobile device",{"count":376,"type":22},[216],"The overall goal of the randomized control trial (RCT) will be to evaluate the efficacy of modifications to a web-based tool for patient decision-making regarding return of genomic results that will more closely focus on rare cancers. Participants will be given access to a web-based decision aid (or a standard control) that guides participants in making decisions about what type of genomic results they would like to receive from testing performed in the PE-CGS study (NCT06340646).",[28,246,431],"Multiple Myeloma",[433,434,435],"Genetic testing","Decision aid","Participant engagement",{"date":413,"type":33},{"date":438,"type":33},"2025-04-03",{"date":440,"type":22},"2026-12-31",{"name":442,"class":40},"Washington University School of Medicine",{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":52,"phases":451,"briefSummary":452,"conditions":453,"keywords":456,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":75},"100542267","washington-university-participant-engagement-and-cancer-genomic-sequencing-center-wu-pe-cgs-100542267","NCT06340646","Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)","Eligibility Criteria:\n\n* Patients with cholangiocarcinoma, multiple myeloma, or early onset colon or rectal cancer.\n\n  * If diagnosed with multiple myeloma, must be African-American.\n  * If diagnosed with colon or rectal cancer, must be African-American AND must be no older than 65 years old at the time of diagnosis.\n  * At least 18 years old\n  * Able to understand and willing to sign an IRB-approved written informed consent document",{"count":450,"type":22},990,[216],"The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. Participants in this study will be presented with the choice of types of genomic results to receive, and the Engagement Optimization Unit (EOU) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict.",[28,431,454,455],"Colon Cancer","Rectal Cancer",[435,433,28,431,457,458],"Colorectal cancer","Underrepresented populations","2026-07-11",{"date":461,"type":33},"2026-07-14",{"date":463,"type":33},"2022-10-18",{"date":465,"type":22},"2027-01-31",{"name":442,"class":40},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":52,"phases":476,"briefSummary":477,"conditions":478,"keywords":479,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":493},"100506440","phase-1-combination-of-gns561-and-trametinib-in-patients-with-advanced-kras-mutated-cholangiocarcinoma-100506440","NCT05874414","Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma","Phase 1b\u002F2a Study of GNS561 in Combination With Trametinib in Advanced KRAS Mutated Cholangiocarcinoma","Inclusion criteria:\n\n1. Histologically confirmed intrahepatic CCA with a documented KRAS mutation.\n2. Patients greater than or equal to 18 years of age.\n3. Patients must have disease progression that is not amenable to potentially curative treatment.\n4. Patients must have received one or two lines of chemotherapy.\n5. Patients must have at least one measurable disease by RECIST v1.1.\n6. Performance status (ECOG) 0-1.\n7. Adequate organ baseline function defined as follows: absolute neutrophil count ≥1000 cells\u002FμL, platelet count ≥75,000 cells\u002FμL, hemoglobin ≥9 g\u002FdL, aspartate aminotransferase or alanine aminotransferase less than or equal to 3 × upper limit of normal, estimated glomerular filtration rate ≥60 mL\u002Fmin, corrected QT interval by Fridericia's (QTcF) interval ≤470 msec.\n8. Women of childbearing potential must present with a negative serum pregnancy test and agree to use adequate contraception during the study and until 6 months after the end of treatment. Male patients with women partners of childbearing potential must agree with the contraception procedures of the study protocol.\n9. Patients must be able to understand and be willing to comply with the requirements of the study protocol.\n10. Patients participate voluntarily and sign informed consent form(s).\n\nExclusion criteria:\n\n1. Previous treatment with a MEK inhibitor or autophagy inhibitor.\n2. Previous treatment with three or more lines of prior chemotherapy.\n3. Extrahepatic CCA with recent (within 6 weeks) placement of a stent or episodes of unstable biliary stents (manifest as obstruction, migration of the stent, infevtion or mechanical failure of the stent) within 6 weeks according to investigator's judgement.\n4. Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n   1. Cardiovascular disorders: congestive heart failure New York Heart Association ≥ class 2 or left ventricular ejection fraction (LVEF) \\\u003C50%, arrythmias or cardiac conduction abnormalities. Uncontrolled arterial hypertension or inadequately controlled arterial hypertension, at the discretion of the investigator, based on an average of = \\>3 BP readings over = \\>2 sessions.\n   2. Patients who have retinal condition (retinal tear, exudate, hemorrhage) or history of retinal vein occlusion or central serous retinopathy or retinal pigment epithelial detachment.\n   3. History of interstitial lung disease or pneumonitis.\n   4. Patients who have clinically significant pleural effusion or ascites.\n   5. Patients who have neurological condition (e.g., tremor, ataxia, hypotension, confusion), history of seizures or active central nervous system metastases.\n   6. Impairment of gastrointestinal function or gastrointestinal disease (e.g., diarrhea, active ulcer disease, history of gastrointestinal perforation\u002Fhemorrhage, malabsorption or other conditions that under the judgment of the principal investigator (PI) may impair absorption of study drugs).\n   7. Patients who are taking antineoplastic drugs for concomitant cancer or history of malignancy other than CCA within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%) such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n   8. Any other condition that would, in the Investigator s judgment, contraindicate the patients' participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection, unable to swallow medication, social\u002Fpsychological issues, etc).\n5. Known active viral hepatitis, including HBV and HCV.\n6. Patients with known allergic reaction to quinoline derivatives (e.g., quinine, chloroquine, mefloquine) and\u002For hypersensitivity to study drugs.\n7. Patients who have not recovered for certain AEs due to previous lines of therpay.\n8. Female patients who are pregnant or lactating at the time of enrollment.",{"count":475,"type":22},98,[54,55],"This is an open-label, multicenter Phase 1b\u002F2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure of standard-of-care first line therapy",[28],[480,28,481,482,483],"GNS561","Trametinib","Phase1b\u002F2a","Bile Duct cancer","2026-07-10",{"date":486,"type":33},"2026-07-13",{"date":488,"type":33},"2023-08-21",{"date":490,"type":22},"2028-06",{"name":492,"class":174},"Genfit",11,{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":501,"enrollmentInfo":502,"targetDuration":4,"studyType":52,"phases":504,"briefSummary":505,"conditions":506,"keywords":516,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":532,"locationsCount":75},"100461298","phase-2-pds01adc-in-combination-with-hepatic-artery-infusion-pump-haip-and-systemic-therapy-for-subjects-with-metastatic-colorectal-cancer-intrahepatic-cholangiocarcinoma-or-metastatic-adrenocortical-carcinoma-100461298","NCT05286814","PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","* INCLUSION CRITERIA:\n\nInclusion Criteria- All Cohorts\n\n* Participants must have a documented diagnosis of one of the following cancers:\n\n  * Metastatic colorectal cancer (mCRC)\n  * Intrahepatic cholangiocarcinoma (ICC)\n  * Adrenocortical carcinoma (ACC) with liver dominant disease\n* Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than 28 days after initiation of study-directed HAIP intervention:\n\n  * mCRC: FOLFOX or FOLFIRI\n  * ICC: GemOx or FOLFOX\n  * ACC: GemOx\n* Age \\>= 18 years.\n* Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP).\n\nNOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. IOCBP must have a negative pregnancy test (HCG blood or urine) during screening.\n\n* All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study treatment for those able to father a child or 6 months after completion of study treatment for those of child-bearing potential (i.e., IOCBP). Highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Note: The use of condoms by participants who are able to get other individuals pregnant is required unless the partner of childbearing potential is permanently sterile.\n* Nursing (including breastfeeding) participants must agree to discontinue nursing.\n* Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase (i.e., CT C\u002FA\u002FP multiphase) amenable to placement of the HAIP.\n* Participant must sign the informed consent form to participate in this study.\n* HIV-positive participants may be considered for this study only if they have an undetectable viral load.\n* Participants must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176, \"Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors\".\n* Participant's liver metastases must not be amenable to resection\u002Fablation to No Evidence of Disease (NED) in one stage.\n\nInclusion Criteria-Metastatic Colorectal Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1).\n* Participants must have measurable liver metastatic disease.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 2.5 X institutional upper limit of normal\n  * creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation \\> 60 mL\u002Fmin\u002F1.73 m2.\n\nInclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required.\n* Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection.\n* Participants must have radiographically measurable disease.\n* Disease must be considered unresectable at the time of preoperative evaluation.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C=1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 2,000\u002F mm\\^3\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\>= 75,000\u002F mm\\^3\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 mg\u002Fdl\n  * creatinine \\\u003C= 1.5 mg\u002Fdl\n\nInclusion Criteria-Adrenocortical Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC), also referred to as \"adrenocortical cancer\".\n* Participants must have received at least one line of systemic chemotherapy.\n* Participants must have measurable liver metastatic disease.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 3 X institutional upper limit of normal\n  * creatinine \\\u003C 2 X institutional upper limit of normal\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria- All Cohorts\n\nParticipants who are receiving any other investigational agents.\n\n* Participants who have previously received rIL-12.\n* Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions:\n\n  * diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;\n  * participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses \\\u003C= 10 mg of prednisone or equivalent per day;\n  * administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is eligible.\n* History of organ transplant, except for transplants that do not require immunosuppression.\n* History of or active inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis).\n* Known hypersensitivity or allergic reactions attributed to any compounds of similar chemical or biologic composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies and history of allergic reactions attributed to compounds of similar chemical composition to FUDR or heparin.\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke \\\u003C 6 months prior to enrollment, myocardial infarction \\\u003C 6 months prior to enrollment, unstable angina, congestive heart failure (\\>= NYHA III) or serious cardiac arrhythmia requiring medication.\n* All conditions associated with significant necrosis of nontumor-bearing tissues.\n* Esophageal or gastroduodenal ulcers \\\u003C 6 months prior to treatment.\n* Active ischemic bowel disease.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active concurrent malignancies within the last five years other than colorectal primary except basal cell skin carcinoma and thyroid carcinoma.\n* Prior radiation to liver.\n* Participants with active Hepatitis B or C infection.\n* Significant acute or chronic infections (i.e., tuberculosis) history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings).\n* Any condition, including the presence of laboratory abnormalities and\u002For insufficient normal liver parenchyma, which places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.\n\nExclusion Criteria-Metastatic Colorectal Carcinoma\n\n-Participants with incontrovertible radiographic evidence of disease outside of the colon\u002Frectum (primary) and liver given unlikelihood of benefit from liver-directed therapy.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminant as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Participants who have undergone extra-hepatic metastasectomy and have a documented disease-free interval less than or equal to 4 months.\n* Participants with a history of MSI-high results who need to be treated with check-point inhibitors.\n* Prior treatment with FUDR.\n\nExclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n-Presence of distant metastatic disease. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminate as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Prior treatment with FUDR.\n* Diagnosis of sclerosing cholangitis.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n\nExclusion Criteria-Adrenocortical Carcinoma\n\n* Participants with incontrovertible radiographic evidence of additional abdominal disease outside of the liver (including the primary tumor) that is not amenable to complete surgical extirpation at the time of pump placement.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n* Diagnosis of sclerosing cholangitis.\n* Participants with pulmonary metastases that have progressed by RECIST criteria in the preceding 3 months prior to study enrollment.\n* Participants with known mismatch repair mutation who have not been treated with a checkpoint inhibitor. Acceptable methods of MSI testing for history of MSI results include immunohistochemistry (IHC) and next generation sequencing (NGS) of tumor material.","120 Years",{"count":503,"type":22},70,[55],"Background:\n\nOne way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment. The drug triggers the immune system to fight cancer.\\\u003CTAB\\>\n\nObjective:\n\nTo see if treatment with HAIPs to deliver liver-directed FUDR and Dexamethasone chemotherapy in combination with PDS01ADC is effective for certain cancers.\n\nEligibility:\n\nPeople aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver, or cancer of the adrenal glands that has spread to the liver, who are also receiving or planning to receive standard systemic chemotherapy for their disease.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nPregnancy test (if needed)\n\nTumor biopsy (if needed)\n\nElectrocardiogram\n\nComputed tomography (CT) scans\n\nParticipants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen.\n\nAll participants will have liver-directed FUDR and Dexamethasone chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. PDS01ADC will be injected under the skin every 4 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects.\n\nParticipants will also receive standard systemic chemotherapy for their disease, assigned based on diagnosis, through an IV by their medical oncologist (at NIH or by a local provider) every 2 weeks.\n\nParticipants will have 2 study visits at NIH each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests.\n\nParticipants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.",[507,508,509,88,246,28,510,90,511,512,513,514,515],"Metastatic Colorectal Cancer (Mcrc)","Intrahepatic Cholangiocarcinoma (Icc)","Intrahepatic Bile Duct Cancer","Bile Duct Neoplasms","Adrenocortical Carcinoma (ACC)","Adrenal Cortical Carcinoma","Adrenal Gland Cancer","Adrenal Gland Neoplasms","Adrenal Cortex Neoplasms",[517,518,519,520,521,522,523,524,525,526],"Unresectable Liver Tumor","SMART System","Response Rates","Progression Free Survival (Pfs)","Patient Survival","Overall Survival (Os)","NHS-IL12","Mcrc","Icc","ACC","2026-07-09",{"date":484,"type":33},{"date":530,"type":33},"2022-10-24",{"date":120,"type":22},{"name":73,"class":74},{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":540,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":542,"conditions":543,"keywords":546,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":75},"100610220","a-noninvasive-and-screening-mirna-signature-for-gastrointestinal-cancer-100610220","NCT07224750","A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer","MiGIC","Inclusion Criteria:\n\n1. Adults aged 18 years or older at the time of blood sample collection.\n2. Patients with a confirmed diagnosis of one of the following gastrointestinal cancers: Hepatocellular carcinoma (HCC), Cholangiocarcinoma (CCA), Pancreatic ductal adenocarcinoma (PDAC), Esophageal squamous cell carcinoma (ESCC), Gastric cancer (GC), Colorectal cancer (CRC), Non-cancer control participants, including healthy volunteers or patients with benign gastrointestinal conditions.\n3. Availability of retrospective blood samples collected according to institutional protocols.\n4. Willingness to allow use of de-identified clinical and demographic data for research purposes.\n\nExclusion Criteria:\n\n* other active malignancies; insufficient sample quality\u002Fvolume; recent chemotherapy\u002Fradiotherapy\u002Fsurgery; any condition preventing reliable participation.",true,{"count":397,"type":22},"Gastrointestinal (GI) cancers remain a major global health burden, largely due to the lack of effective and accessible early screening strategies. Current diagnostic approaches-including endoscopy, computed tomography (CT), and magnetic resonance imaging (MRI)-are either invasive, resource-intensive, or insufficiently sensitive for detecting early-stage disease, and are therefore not suitable for population-wide screening or for simultaneously identifying multiple GI tumor types. As a result, many patients are diagnosed at advanced stages, when therapeutic options are limited and prognosis is poor.\n\nCirculating microRNAs (miRNAs) offer a promising alternative, as they are stable in peripheral blood and reflect tumor-related molecular alterations. In this study, the investigators aim to develop and validate a robust, noninvasive miRNA-based signature capable of distinguishing GI cancers from non-malignant controls. By integrating multi-cohort datasets and applying machine learning-based feature selection and predictive modeling, the investigators will construct a screening panel optimized for reproducibility, scalability, and early-stage detection. This noninvasive miRNA signature has the potential to support accessible, cost-effective, and clinically practical population-level screening for GI cancers, ultimately facilitating earlier diagnosis and improving outcomes for participants.",[300,28,403,544,351,545],"Esophageal Squamous Cell Carcinoma (ESCC)","Colorectal Cancer Screening",[547,548,549,550,551],"Noninvasive screening","Circulating miRNA","Machine learning","Gastrointestinal cancer","Blood-based cancer detection","2026-07-06",{"date":554,"type":33},"2026-07-07",{"date":556,"type":33},"2024-06-21",{"date":558,"type":22},"2028-06-18",{"name":560,"class":40},"City of Hope Medical Center",{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":570,"conditions":571,"keywords":577,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":585,"locationsCount":586},"100542403","an-exosome-based-liquid-biopsy-for-the-differential-diagnosis-of-primary-liver-cancer-100542403","NCT06342414","An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer","ELUCIDATE","Inclusion Criteria:\n\n* A histologically confirmed diagnosis of hepatocellular carcinoma\n* A histologically confirmed diagnosis of intrahepatic cholangiocarcinoma\n* Received standard diagnostic and staging procedures as per local guidelines\n* Availability of at least one blood-derived sample, drawn before receiving any curative-intent treatment\n\nExclusion Criteria:\n\n* Lack of or inability to provide informed consent\n* Synchronous hepatocellular carcinoma and intrahepatic cholangiocarcinoma\n* Primary liver cancer other than hepatocellular carcinoma or intrahepatic cholangiocarcinoma\n* Secondary liver cancer",{"count":569,"type":22},400,"It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery.",[220,572,28,573,574,575,576],"Intrahepatic Cholangiocarcinoma","Primary Liver Cancer","Primary Liver Carcinoma","Hepatic Cancer","Hepatic Carcinoma",[578,579,580],"Exosome","micro RNA","Differential Diagnosis",{"date":554,"type":33},{"date":583,"type":33},"2024-03-15",{"date":558,"type":22},{"name":560,"class":40},5,{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":540,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":52,"phases":596,"briefSummary":597,"conditions":598,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":75},"100536139","targeted-navigation-in-hepatocellular-carcinoma-hcc-100536139","NCT06260943","Targeted Navigation in Hepatocellular Carcinoma (HCC)","Targeted Navigation to Achieve Health Equity: Increasing Access to Care, Patient Engagement and Research Participation","Inclusion Criteria:\n\n* HCC Patients:\n\n  * Enrolled or eligible for enrollment in Unified Prospective Registry and Biorepository of Patients with Chronic Liver Disease or Hepatobiliary Cancers Including Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma.\n  * Diagnosis of hepatocellular carcinoma, confirmed by clinical chart review and International Classification of Diseases, Tenth Revision (ICD-10) C22.0.\n  * Adults, age 18 or older\n  * Able to provide informed consent\n* All other interviewees:\n\n  * Advocates who will self-identify as having had HCC.\n  * Others who self-identify as either a caregiver or support person of an HCC patient.\n\nPhysicians\u002FLicensed Independent Practitioners, Social Workers, Nurse Navigators, and Research Coordinators will all self-identify as being involved in the care of HCC patients.\n\nExclusion Criteria:\n\n* Unable to speak Spanish or English\n* West Haven Grade 2 or higher hepatic encephalopathy19 or other cognitive impairment.\n* Adults unable or unwilling to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Given that this study is minimal risk and there are no risks to a potential fetus, investigators will not exclude pregnant women; however, no data about pregnancy or their fetus is being collected",{"count":595,"type":22},210,[216],"The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment.",[220,28,599],"Hepatobiliary Cancer","2026-06-30",{"date":602,"type":33},"2026-07-02",{"date":604,"type":33},"2024-04-15",{"date":606,"type":22},"2026-10-31",{"name":608,"class":40},"University of Miami",{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":613,"acronym":614,"eligibilityCriteria":615,"healthyVolunteers":540,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":52,"phases":617,"briefSummary":618,"conditions":619,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":637,"leadSponsor":639,"locationsCount":75},"100590778","evaluation-of-skin-tests-in-biotherapy-allergies-100590778","NCT06971848","Evaluation of Skin Tests in Biotherapy Allergies","ETCABIO","Inclusion Criteria :\n\n* Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects.\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n* If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).\n\nExclusion Criteria:\n\n* Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests.\n* Poor understanding of the French language\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure",{"count":503,"type":22},[216],"Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway.\n\nThese biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction).\n\nUnlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.",[620,621,622,623,624,625,626,627,628,629,630,246,631,632,28,404],"Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck","Melanoma Neoplasms","Small Cell Bronchial Carcinomas","Bronchial Carcinoma","Pleural Mesothelioma","Hodgkin's Lymphoma","Chronic Lymphocytic Leukemia","Follicular Lymphoma","Myeloma","AL Amyloidosis","Hepatocarcinoma","Esophageal Squamous Cell Carcinoma","Heart Cancer","2026-06-17",{"date":635,"type":33},"2026-06-18",{"date":633,"type":33},{"date":638,"type":22},"2028-07",{"name":640,"class":641},"University Hospital, Angers","OTHER_GOV",{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":648,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":650,"targetDuration":4,"studyType":52,"phases":652,"briefSummary":653,"conditions":654,"keywords":656,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":667,"locationsCount":75},"100635870","suprapapillary-metal-stent-vs-routine-transpapillary-drainage-in-malignant-hilar-biliary-obstruction-smart-b-trial-100635870","NCT07558304","Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)","Randomized Clinical Trial of Suprapapillary Drainage With Metal Stent vs. Routine Internal-External Transpapillary Drainage in Patients With Malignant Hilar Biliary Obstruction","SMART-B","Inclusion Criteria:\n\n1. Age \\>18 years.\n2. Malignant proximal biliary obstruction on imaging (magnetic resonance cholangiopancreatography or contrast-enhanced abdominal computed tomography) with histopathological confirmation or high clinical and radiological suspicion.\n3. Total bilirubin \\> 3 mg\u002FdL.\n4. Patients not candidates for potentially curative surgical resection due to locally advanced disease, metastatic disease, or inadequate clinical condition.\n5. Patients with potentially resectable neoplasms, defined as the possibility of achieving complete resection (R0), who meet at least one of the following criteria:\n\n5.1 Estimated future liver remnant \\\u003C40%, in whom percutaneous portal vein embolization of the side to be resected will also be indicated after initial drainage.\n\n5.2 Prolonged jaundice with total bilirubin \\>10 mg\u002FdL for more than 14 days. 5.3 Malnutrition, defined as ≥10% unintentional weight loss or albumin \\\u003C3 g\u002FdL, presumably attributable to cholestasis.\n\n5.4 Indication for neoadjuvant chemotherapy.\n\nExclusion Criteria:\n\n1. Tumor with distal extension to the duodenal papilla, precluding suprapapillary drainage.\n2. Prior biliary drainage procedure, either percutaneous (PTBD) or endoscopic (ERCP).\n3. Acute cholangitis, clinically defined as fever (axillary temperature \\>38°C) and leukocytosis (white blood cell count \\>10,000\u002Fmm³).\n4. Uncorrectable coagulopathy.\n5. Iodinated contrast allergy not amenable to desensitization.",{"count":651,"type":22},84,[216],"Malignant hilar biliary obstruction is a condition in which the bile ducts near the liver become blocked due to cancer. This blockage can lead to jaundice (yellowing of the skin and eyes), itching, infection, and impaired liver function. To relieve the obstruction, doctors commonly perform procedures to drain bile and restore its flow.\n\nThere are different techniques available for biliary drainage. One common method is percutaneous transpapillary internal-external drainage, in which a catheter is placed through the liver and across the natural opening of the bile duct into the intestine. Another approach is percutaneous suprapapillary drainage using a self-expanding metal stent, which allows bile to drain without crossing into the intestine and may reduce the risk of contamination and infection.\n\nCurrently, there is no clear consensus on which of these two techniques is safer or more effective for patients with malignant proximal biliary obstruction. Some studies suggest that avoiding manipulation of the intestinal opening of the bile duct may reduce complications such as infection, but high-quality comparative evidence is lacking.\n\nThe purpose of this study is to compare percutaneous suprapapillary drainage with a self-expanding metal stent versus routine percutaneous transpapillary internal-external drainage in patients with malignant proximal biliary obstruction. The study aims to compare the rate of drainage-related complications between the two techniques, as well as to evaluate treatment success, stent patency, and the need for reintervention. In addition, in patients with potentially resectable disease undergoing preoperative biliary drainage, the study will assess and compare surgical outcomes between the two approaches. The results of this study may help determine the safest and most effective drainage strategy for these patients and improve future clinical decision-making.",[28,510,655],"Malignant Biliary Obstruction",[28,657,658,659,660,655],"Percutaneous biliary drainage","Self-expanding metal stent","Suprapapillary drainage","Malignant hilar biliary obstruction","2026-06-12",{"date":663,"type":33},"2026-06-16",{"date":665,"type":22},"2026-06-15",{"date":120,"type":22},{"name":668,"class":40},"Hospital de Clinicas de Porto Alegre",{"id":670,"slug":671,"hasResults":12,"nctId":672,"briefTitle":673,"officialTitle":674,"acronym":675,"eligibilityCriteria":676,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":677,"targetDuration":4,"studyType":52,"phases":678,"briefSummary":679,"conditions":680,"keywords":684,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":695,"lastUpdatePostDateStruct":696,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":702,"locationsCount":75},"100642684","phase-1-dual-target-her2cea-car-nk-cells-in-advanced-biliary-tract-cancer-100642684","NCT07641036","Dual-Target HER2\u002FCEA CAR-NK Cells in Advanced Biliary Tract Cancer","A Phase 1\u002F2, Open-Label, Biomarker-Selected Study of Allogeneic Dual-Target HER2\u002FCEACAM5 Chimeric Antigen Receptor Natural Killer Cells (EB-HC01) in Participants With Unresectable or Metastatic Cholangiocarcinoma and Other Biliary Tract Cancers","DUET-BTC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable, recurrent, or metastatic intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma.\n* Disease progression after at least 1 prior gemcitabine\u002Fplatinum-containing regimen in the advanced setting; prior durvalumab and prior HER2-targeted therapy are allowed.\n* Central biomarker confirmation of HER2 positivity (IHC 3+ or IHC 2+\u002FISH+ or ERBB2 amplification) and CEACAM5\u002FCEA positivity (membranous expression in \\>=20% of viable tumor cells by IHC).\n* At least 1 measurable lesion according to RECIST 1.1.\n* ECOG performance status 0-1.\n* Adequate marrow, renal, hepatic, and cardiac function as defined by the protocol.\n* Resolved biliary obstruction or stable internal\u002Fexternal drainage for \\>=7 days before lymphodepletion, with no active cholangitis.\n* Life expectancy \\>=12 weeks.\n* Willingness to provide archival or fresh tumor tissue and serial blood samples for central biomarker testing and correlative studies.\n* Agreement to use protocol-specified contraception\n\nExclusion Criteria:\n\n* Prior HER2-directed or CEA-directed gene-modified cell therapy.\n* Untreated or unstable CNS metastases or leptomeningeal disease.\n* Active uncontrolled infection, including uncontrolled cholangitis, sepsis, or clinically significant uncontrolled hepatitis or HIV infection.\n* Ongoing systemic immunosuppression greater than 10 mg\u002Fday prednisone equivalent within 7 days before lymphodepletion.\n* Clinically significant interstitial lung disease, uncontrolled heart failure, unstable arrhythmia, or recent myocardial infarction.\n* Child-Pugh B or C liver disease, hepatic encephalopathy, or clinically significant refractory ascites.\n* Prior allogeneic solid organ transplant or allogeneic stemcell transplant.\n* Active autoimmune disease requiring systemic therapy within the previous 2 years.\n* Pregnancy or breastfeeding.\n* Any condition that, in the investigator's judgment, would make lymphodepletion or EB-HC01 infusion unsafe or would interfere with protocol compliance.",{"count":242,"type":22},[54,55],"This example phase 1\u002F2, open-label, biomarker-selected study evaluates EB-HC01, an allogeneic dual-target CARNK product composed of a 1:1 mixture of HER2-CAR-NK and CEACAM5-CAR-NK cells, in adults with unresectable or metastatic cholangiocarcinoma or other biliary tract cancers after standard therapy. Part A determines safety, dose-limiting toxicities (DLTs), and the recommended phase 2 dose (RP2D) after reduced-intensity lymphodepletion. Part B evaluates preliminary anti-tumor activity, CAR-NK persistence, and biomarker-response associations.",[28,572,681,682,683],"Extrahepatic Cholangiocarcinoma","Gallbladder Carcinoma","Biliary Tract Cancer",[685,686,687,688,689,690,140,691,692,693,694],"CAR-NK","dual-target cell therapy","HER2","ERBB2","CEA","CEACAM5","biliary tract cancer","allogeneic","off-the-shelf","adoptive cell therapy","2026-06-06",{"date":697,"type":33},"2026-06-11",{"date":699,"type":33},"2026-03-02",{"date":701,"type":22},"2028-10-17",{"name":703,"class":174},"Beijing Biotech"]