[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resectable-intrahepatic-cholangiocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resectable-intrahepatic-cholangiocarcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100519953","phase-2-testing-the-combination-of-the-anticancer-drug-durvalumab-with-chemotherapy-gemcitabine-and-cisplatin-at-improving-outcomes-for-high-risk-resectable-liver-cancer-before-surgery-100519953",false,"NCT06050252","Testing the Combination of the Anticancer Drug Durvalumab With Chemotherapy (Gemcitabine and Cisplatin) at Improving Outcomes for High-Risk Resectable Liver Cancer Before Surgery","A Phase II Trial of Durvalumab With Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA) that is resectable by imaging evaluation. Choice of staging modality is left up to the discretion of the treatment team; we favor high-quality CT scan of the chest\u002Fabdomen\u002Fpelvis with liver or biliary protocol. Eligibility will be confirmed through central imaging review.\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \\>= 10 mm (\\>= 1 cm) with CT scan, MRI, or calipers by clinical exam.\n* Patients must be an acceptable risk surgical candidate at the time of enrollment, as determined by a board-certified surgeon with expertise in hepatobiliary surgery.\n* High-risk iCCA is defined as the presence of any of these factors:\n\n  * Tumor size \\> 5 cm.\n  * Multifocality or satellitosis limited to the same lobe.\n  * Vascular invasion.\n  * Suspected or confirmed (via biopsy) regional lymph node metastases.\n\n    * Suspected is defined as lymph nodes that are deemed suspicious for metastasis based on large size (criteria vary per anatomical location; 6-10 mm for abdominal and 8-10 mm for pelvic), enhancement pattern, and shape. These may also include lymph nodes that display fludeoxyglucose F 18 (FDG)-avidity on positron emission tomography (PET) scan, if obtained, in the course of disease work-up (not mandatory).\n  * CA 19-9 \\> 200 U\u002FmL.\n* Patients are treatment naïve for iCCA.\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of durvalumab (MEDI4736) in combination with cisplatin and gemcitabine in patients \\\u003C 18 years of age, children are excluded from this study.\n* Body weight \\> 30 kg.\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1 (Karnofsky \\>= 70%).\n* Leukocytes \\>= 3,000\u002FmcL.\n* Hemoglobin \\>= 9.0 g\u002FdL.\n* Absolute neutrophil count \\>= 1,500\u002FmcL.\n* Platelets \\>= 100,000\u002FmcL.\n* Neuropathy grade =\\\u003C 1 by CTCAE.\n* Albumin \\>= 2.8 g\u002FdL.\n* Serum bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN).\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 × institutional ULN.\n* Serum creatinine =\\\u003C 1.5 x institutional ULN.\n* Measured creatinine clearance \\> 60 mL\u002Fmin or glomerular filtration rate (GFR) \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 (by the Cockcroft-Gault equation).\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women \\>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\> 1 year ago, had chemotherapy-induced menopause with last menses \\> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n* Life expectancy \\>= 12 weeks.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. If non-protocol anticancer agents for non-study indications is required concurrently with the protocol therapy, the case should be discussed and approved by the study chair and the sponsor (Cancer Therapy Evaluation Program \\[CTEP\\]).\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy\u002Fintervention prior to enrollment.\n* Major surgical procedure (as defined by the Investigator) within 14 days prior to the first dose of durvalumab. Note: Local surgery of isolated lesions for palliative intent or biliary stents is acceptable.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).\n  * Systemic corticosteroids at physiologic doses not to exceed \\\u003C\\\u003C10 mg\u002Fday\\>\\> of prednisone or its equivalent.\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of durvalumab.\n* Patients who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab, gemcitabine, cisplatin, or other platinum-containing compounds.\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous.\n* Pregnant women are excluded from this study because durvalumab (MEDI4736) is an anti-PD-L1 monoclonal antibody agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with durvalumab, breastfeeding should be discontinued if the mother is treated with durvalumab. These potential risks may also apply to other agents used in this study. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after durvalumab administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of durvalumab.\n* Patients with active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia.\n  * Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement.\n  * Any chronic skin condition that does not require systemic therapy.\n  * Patients without active disease in the last 5 years may be included but only after consultation with the study physician.\n  * Patients with celiac disease controlled by diet alone.\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis \\[TB\\] testing in line with local practice), hepatitis B (known positive HBV surface antigen \\[HBsAg\\] result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* History of allogenic organ transplantation.\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.","ALL","18 Years",{"count":19,"type":20},27,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well giving durvalumab with standard chemotherapy, gemcitabine and cisplatin, before surgery works in treating patients with high risk liver cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab with gemcitabine and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed in patients with high risk resectable cholangiocarcinoma.",[26],"Resectable Intrahepatic Cholangiocarcinoma","RECRUITING","2026-07-01",{"date":30,"type":31},"2026-07-02","ACTUAL",{"date":33,"type":31},"2024-07-10",{"date":35,"type":20},"2027-02-12",{"name":37,"class":38},"National Cancer Institute (NCI)","NIH",58,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100643162","phase-2-preoperative-durvalumab-cisplatin-gemcitabine-with-or-without-futibatinib-targeted-therapy-for-the-treatment-of-resectable-intrahepatic-cholangiocarcinoma-optic-trial-100643162","NCT07639528","Preoperative Durvalumab, Cisplatin, Gemcitabine With or Without Futibatinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, OPTIC Trial","Phase II, Open Label, Non-Randomized, Study of Optimal Preoperative Therapy for Intrahepatic Cholangiocarcinoma (OPTIC)","Inclusion Criteria:\n\n* Patients must have a confirmed biopsy proven diagnosis of resectable intrahepatic cholangiocarcinoma (IHCC) confined to the liver, bile duct, and \u002For regional lymph nodes confirmed by high-quality cross-sectional imaging by CT or MRI of the chest and MRI of the abdomen, and pelvis performed within 42 days (6 weeks) prior to enrollment. (MRI protocol: With and without gadolineum with T1 and T2 weighted sequences)\n\n  * Note: Distant extrahepatic disease is not allowed\n  * Note: When using CTs in addition to MRI, a high resolution triple phase thin-cut, CT with intravenous +\u002F- oral contrast is the preferred imaging technique for assessing radiographic tumor response\n* Patients must have measurable disease per RECIST 1.1\n* Patients must be treatment naïve\n* Patients must be age ≥ 18 years\n* Patient with CORE biopsy for diagnosis that is sufficient enough to do NGS\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FmcL\n* Hemoglobin (Hgb) ≥ 8 g\u002FdL (blood transfusion allowed up to 7 days prior to starting on study drug)\n* Serum total bilirubin ≤ 2 X Institutional upper limit of normal (ULN)\n\n  * For Gilbert's disease: these value does not apply and treatment will be done per treating physician\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) ≤ 5 x institutional ULN\n\n  * For Gilbert's disease: these value does not apply and treatment will be done per treating physician\n* Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 5 x institutional ULN\n\n  * For Gilbert's disease: these value does not apply and treatment will be done per treating physician\n* Creatinine ≤ 1.5 X Institutional ULN\n* Calcium-phosphorus product \\\u003C 55 mg\\^2 \u002FdL2 (5.5mg\u002FdL)\n* Total corrected serum calcium within local normal limits\n* Inorganic phosphorus within local normal limits\n* For patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration. Please note this lab is not a requirement for eligibility, however, if it has been completed previously as part of the patient's health care, it should be documented for eligibility\n* For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with a known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Please note this lab is not a requirement for eligibility, however if it has been completed previously as part of the patient's health care, it should be documented for eligibility\n* The futibatinib and other therapeutic agents used in this trial are known to be teratogenic. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 11 and 14 months for POCBP and men respectively, following completion of study drug therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from 28 days prior to starting gemcitabine\u002Fcisplatin\u002Fdurvalumab (including dose interruptions) for the duration of study participation, and 11 and 14 months for POCBP and men respectively, months after completion of study drug administration.\n\nMale subjects must practice true abstinence or agree to use a condom during sexual contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with gemcitabine\u002Fcisplatin\u002Fdurvalumab and for 14 months following, even if he has undergone a successful vasectomy.\n\n* Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n  * Has not undergone a hysterectomy or bilateral oophorectomy\n  * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n\n    * POCBP must have a negative pregnancy test prior to registration on study\n    * Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements\n    * Patients must have the ability to swallow, retain and absorb oral medications\n\nExclusion Criteria:\n\n* Patients with peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. In CTCAE version 5.0 grade 2 sensory neuropathy is defined as \"moderate symptoms; limiting instrumental activities of daily living (ADLs)\n* Patients who are receiving any other investigational agents\n* Patients who have current evidence of corneal or retinal disorder\u002Fkeratopathy including, but not limited to, bullous\u002Fband keratopathy, inflammation or ulceration, keratoconjunctivitis, confirmed by ophthalmic examination\n\n  * Note: Patients with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study\n* Patients who have used medications known to prolong the QT interval and\u002For are associated with a risk of Torsades de Pointes (TdP) 7 days prior to first dose of study drug\n* Patients who have clinically significant cardiac disease including any of the following: Congestive heart failure requiring treatment (New York Heart Association grade ≥ 2), or uncontrolled hypertension (refer to the European Society of Cardiology and European Society of Hypertension guidelines (Williams et al 2018)\n* Patients with corrected QT interval using Fridericia formula (QTcF) \\> 470 msec (males and females)\n\n  * Note: If the QTcF is \\> 470 msec in the first electrocardiogram (ECG), a total of 3 ECGs separated by at least 5 minutes should be performed. If the average of these 3 consecutive results for QTcF is ≤ 470 msec, the patient meets eligibility in this regard\n* Patient with known history of congenital long QT syndrome\n* Patients who have current evidence of concerning endocrine alterations of calcium\u002Fphosphate homeostasis, eg, parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc., in the opinion of the investigator OR and taking medications which increase serum phosphorus and\u002For calcium concentration\n* Patients who have abnormal calcium or phosphorus, or calcium-phosphorus product ≥ 55 mg\\^2 \u002FdL2:\n\n  * Inorganic phosphorus above local normal limits\n  * Total corrected serum calcium above local normal limits\n* Patients who are currently receiving or are planning to receive during participation in this study, treatment with agents that are known strong inducers or inhibitors of CYP3A4\n\n  * Note: Patients are not permitted to receive enzyme-inducing anti-epileptic drugs\n* Patients with known central nervous system (CNS) disease, except for treated brain metastasis. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded.\n\n  * Note: Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (radiosurgery \\[RS\\]; gamma knife, linear accelerator \\[LINAC\\], or equivalent) or a combination as deemed appropriate by the treating physician\n* Patients who have the following would be excluded (as they would be contraindicated from receiving the trial drugs)\n\n  * Patients with history of ototoxicity or hearing issues (contraindicated for cisplatin administration)\n  * Patients with the following should not receive immunotherapy\n\n    * History or active autoimmune disease\n    * Previous immunotherapy use\n    * Require immunosuppressive medications greater than 10mg of prednisone\n    * History of pneumonitis or interstitial lung disease\n    * History of grade ≥ 2 myocarditis\n    * Prior anaphylactic reaction to immune checkpoint inhibitors (ICI)\n    * Greater than grade 2 neuropathy\n    * Previous fibroblast growth factor receptor (FGFR) drug use\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the study drugs\n* Patients who have an concurrent severe and\u002For uncontrolled medical conditions which could compromise participation in the study, including, but not limited to any of the following:\n\n  * Uncontrolled diabetes\n  * Ongoing or active infection requiring systemic treatment\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Unstable symptomatic arrhythmia\n  * Myocardial infarction within 6 months of enrollment into the study\n  * Serious active, uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints\n* Patients with active other primary malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen (at treating physician's discretion)\n* Patients who are pregnant or nursing\n* Patients with active alcohol use or illicit drug use that would, in the opinion of the principal investigator (PI) or a sub investigator (sub-I), prevent the subject from complying with the study protocol and\u002For endanger the subject during their participation in the study",{"count":48,"type":20},44,[23],"This phase II trial tests the safety and effectiveness of preoperative immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine with or without futibatinib targeted therapy in treating patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine and\u002For targeted therapy with futibatinib before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. Patients whose molecular profiling test result show a genetic change called FGFR2 fusion, rearrangement, or activating mutation, receive immunotherapy, chemotherapy and targeted therapy while patients without a FGFR2 fusion, rearrangement, or activating mutation just receive immunotherapy and chemotherapy. Giving targeted therapy based on molecular profile test results prior to attempted resection for patients with intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes in patients with resectable intrahepatic cholangiocarcinoma.",[26],"NOT_YET_RECRUITING","2026-06-05",{"date":55,"type":31},"2026-06-10",{"date":57,"type":20},"2027-12-10",{"date":59,"type":20},"2031-12-10",{"name":61,"class":62},"Northwestern University","OTHER",1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100459637","phase-2-selective-internal-radiation-therapy-and-capecitabine-chemotherapy-treatment-for-liver-cancer-100459637","NCT05265208","Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer","A Multicenter Open-label Randomized Controlled Prospective Phase II Study Evaluating the Efficacy of Selective Internal Radiation Therapy (Yttrium-90 Glass Microspheres) Combined With Capecitabine in the Neoadjuvant Setting of Operable Intrahepatic CHOlangiocarcinoma","SIROCHO","Inclusion Criteria:\n\n1. Age \\> 18 years-old,\n2. ECOG Performance Status \\\u003C2,\n3. Histologically-proven ICC,\n4. No previous treatment for ICC,\n5. Tumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board,\n6. Significant risk of close margins, defined as:\n\n   1. Resection margin predicted by the surgeon \\\u003C1 cm\n   2. Tumour \\>5 cm\n   3. Multifocal lesion deemed resectable, validated by a Surgical Review Board\n7. Registration with a social security scheme,\n8. Patient information and signature of informed consent or legal representative.\n\nNon-inclusion Criteria:\n\n1. Severe fibrosis (F3) ou cirrhosis (F4),\n2. Inadequate haematological, hepatic, renal and coagulation functions:\n\n   1. Haemoglobin ≤ 8,5 g\u002Fdl\n   2. Neutrophils \\\u003C 1,5 Giga\u002FL\n   3. Platelets \\\u003C 60 Giga\u002FL\n   4. Bilirubin \\> 34 µmol\u002FL\n   5. ASAT\u002FALAT \\> 5 x ULN\n   6. Creatinine clearance \\\u003C 30 ml\u002Fmin (MDRD)\n   7. TP et INR \\> 2,3 ULN\n   8. TCA \\> 1,5 x ULN\n3. Uracil blood level \\>16 ng\u002FmL,\n4. Respiratory insufficiency,\n5. Comorbidity precluding surgical resection, such as severe heart disease,\n6. Presence of microvacuolar steatosis \\> 60% or regenerative nodular hyperplasia, for patients for whom a major hepatectomy is planned,\n7. Contraindication to hepatic artery catheterization (vascular abnormalities, bleeding diathesis),\n8. Previous chemotherapy (including for another cancer),\n9. Previous abdominal (supra-mesocolic) radiotherapy (including for another cancer),\n10. Other invasive malignancies,\n11. Patient participate to an interventional study that tests another medical intervention before surgery,\n12. Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 30 days after the end of the treatment adjuvant,\n13. Minors, individual deprived of liberty, or under any kind of guardianship,\n14. Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons.\n\nExclusion Criteria:\n\n1. Pulmonary shunt with dose \\>30Gy,\n2. Digestive shunting, non-correctible by interventional radiology,\n3. Absence of fixation of MAA in the tumour.",{"count":73,"type":20},62,[23],"Treatment of intrahepatic cholangiocarcinoma (ICC) remains difficult. Many patients have unresectable tumors, and survival after resection was only slightly improved with the use of adjuvant capecitabine. One of the major prognostic factors is the resection margin, patients with invaded (R1) or narrow (\\\u003C5mm) margins having a higher risk of recurrence.\n\nSelective Internal Radiation Therapy (SIRT) with Yttrium-90 microspheres (also known as SIRT) is an interesting treatment in unresectable ICC. In a phase 2 study, the investigators showed a response rate of 39% and a disease control rate of 98%. Interestingly, 9 of the 41 patients were able to see their tumors downstages to surgery. It was also recently suggested in a retrospective study that patients resected after SIRT had a better prognosis than patients that could be operated upfront, despite less favorable initial tumor characteristics.\n\nGiven the absence of validated neoadjuvant treatment, the promising activity of SIRT and chemotherapy combination in the unresectable setting, and the prognostic significance of close surgical margins, the aim of this trial is therefore to study this combination treatment in the neoadjuvant setting of resectable ICC.",[26],[78],"Selective Internal Radiation Therapy","2025-08-05",{"date":81,"type":31},"2025-08-06",{"date":83,"type":31},"2022-02-04",{"date":85,"type":20},"2030-02-04",{"name":87,"class":62},"Center Eugene Marquis",7]