[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-malignant-neoplasm-in-the-liver\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-malignant-neoplasm-in-the-liver":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,45,72,97,126,149,170,194,220],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100517385","phase-4-surgical-debulking-prior-to-peptide-receptor-radionuclide-therapy-in-well-differentiated-gastroenteropancreatic-neuroendocrine-tumors-100517385",false,"NCT06016855","Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors","Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors","Inclusion Criteria:\n\n* Signed and dated written informed consent\n* Male or female \\>= 18 years of age on the day of signing informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Histologically confirmed well-differentiated gastrointestinal or pancreatic neuroendocrine tumor that is grade 1 or grade 2 (Ki-67 =\\\u003C 20%)\n* Somatostatin receptor avidity of known or suspected neuroendocrine tumor (NET) lesion(s) assessed by a baseline copper-64 dotatate PET\u002FCT scan performed within 6 months (180 days) prior to surgical debulking on study day 0. The somatostatin receptor avidity of the majority of suspected NET lesion(s) must be \\>= normal liver uptake\n* Patient must have hepatic metastasis or hepatic metastases. Provided required hepatic metastatic disease is present, patient can also have any other site or sites of metastatic disease\n* White blood cell count (WBC) \\>= 2000\u002FuL (resulted =\\\u003C 90 days prior to surgical debulking on day 0 of participation in this study)\n* Platelets \\>= 75,000\u002FuL (resulted =\\\u003C 90 days prior to surgical debulking on day 0 of participation in this study)\n* Hemoglobin \\>= 8.0 g\u002FdL (resulted =\\\u003C 90 days prior to surgical debulking on day 0 of participation in this study)\n* Creatinine clearance (CrCl) \\>= 30 mL\u002Fminute (as calculated by the Cockcroft-Gault Formula with estimated creatinine clearance rate \\[eCCR\\] \\>= 30 mL\u002Fmin required for eligibility inclusion; or calculated\u002Fmeasured by an alternative established institutional standard consistently applied across participants at the site) (resulted =\\\u003C 90 days prior to surgical debulking on day 0 of participation in this study)\n* Total bilirubin =\\\u003C 3.0 times institutional upper limit of normal (ULN) (resulted =\\\u003C 90 days prior to surgical debulking on day 0 of participation in this study)\n* Serum albumin \\>= 3.0 g\u002FdL unless the prothrombin time is within normal range (resulted =\\\u003C 90 days prior to surgical debulking on day 0 of participation in this study)\n* Women must not be breastfeeding and further agree to not breastfeed during treatment with lutetium Lu 177 dotatate; and for at least 2.5 months after patient's final dose of lutetium Lu 177 dotatate\n* A woman of childbearing potential (WOCBP) - must have a negative serum or urine pregnancy test resulted within 28 days prior to initiation of first dose of lutetium Lu 177 dotatate on cycle 1, day 1; and must agree to follow instructions for using acceptable contraception from the time of signing consent, and until 7 months after her final dose of lutetium Lu 177 dotatate\n* A man able to father children who is sexually active with a WOCBP must agree to follow instructions for using acceptable contraception, from the time of signing consent, and until 4 months after his final dose of lutetium Lu 177 dotatate\n\nExclusion Criteria:\n\n* Patient has any tumor \\> 3 cm deemed to be inoperable\n* Patient has disease which is considered to be completely surgically resectable\n* Patient has grade 3 neuroendocrine neoplasm (well-differentiated or poorly-differentiated tumor)\n* Prior receipt of peptide receptor radionuclide therapy (PRRT)\n* Patient possesses untreated or growing brain metastases (growth within 90 days prior to surgical debulking on day 0 of participation in this study)\n* Unstable angina, congestive heart failure with New York Heart Association (NYHA) functional classification III or IV, or uncontrolled symptomatic cardiac arrythmia\n* Any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which in the judgment of the patient's study physician may reasonably be expected to interfere with patient's completion of the study","ALL","18 Years",{"count":19,"type":20},6,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1\u002F2 GEP-NETs",[26,27,28,29,30,31],"Digestive System Neuroendocrine Tumor G1","Digestive System Neuroendocrine Tumor G2","Metastatic Digestive System Neuroendocrine Neoplasm","Metastatic Malignant Neoplasm in the Liver","Pancreatic Neuroendocrine Tumor G1","Pancreatic Neuroendocrine Tumor G2","RECRUITING","2026-06-19",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":36},"2024-05-31",{"date":40,"type":20},"2028-05-28",{"name":42,"class":43},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100505577","phase-3-testing-pump-chemotherapy-in-addition-to-standard-of-care-chemotherapy-versus-standard-of-care-chemotherapy-alone-for-patients-with-unresectable-colorectal-liver-metastases-the-pump-trial-100505577","NCT05863195","Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial","A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial","Inclusion Criteria:\n\n* Patient must be \\>= 18 years of age\n* Patient must have confirmed unresectable liver confined metastatic colorectal cancer (CRC).\n\n  * Patient must not have radiographically or clinically evident extrahepatic disease (including but not limited to radiographically positive periportal lymph nodes).\n\n    * NOTE: Patients found to have positive periportal nodes at the time of HAI placement can remain on study.\n  * Patient may have calcified pulmonary nodules, and\u002For =\\\u003C 5 indeterminate and stable (for a minimum of 3 months on chemotherapy) pulmonary nodules each measuring =\\\u003C 6 mm in maximal axial dimension.\n  * Patient's primary tumor may be in place.\n* Patient must have received 3-6 months of previous first-line chemotherapy that meet one of the following three criteria: a) have received at least 6 but no more than 12 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 14 days) OR b) have received at least 4 but no more than 8 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 21 days) OR c) have developed new colorectal liver metastases (CRLM) within 12 months of completing adjuvant systemic therapy for stage II-III colorectal cancer.\n\n  * NOTE: First-line chemotherapy may have included any of the following regimens as listed in the National Comprehensive Cancer Network (NCCN) Guidelines: leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX) (or equivalent), leucovorin calcium (calcium folinate), 5-fluorouracil, and irinotecan (FOLFIRI) (or equivalent), leucovorin calcium (calcium folinate), 5-fluorouracil, oxaliplatin, and irinotecan (FOLFOXIRI), each with or without any of the following: bevacizumab, cetuximab, or panitumumab.\n* Patient must have stable or responding disease on first-line chemotherapy by RECIST 1.1 criteria\n* Patient must meet the following criteria for technical unresectability:\n\n  * A margin-negative resection requires resection of three hepatic veins, both portal veins, or the retrohepatic vena cava OR a resection that leaves less than two adequately perfused and drained segments.\n  * NOTE: Institutional multidisciplinary review is required to confirm unresectability and rule out radiographically positive extrahepatic disease.\n* Patient must undergo CT angiography (chest\u002Fabdomen\u002Fpelvis) to confirm acceptable hepatic arterial anatomy for HAI and to rule out extrahepatic disease within 4 weeks prior to randomization.\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 and be clinically fit to undergo surgery as determined by the pre-operative evaluation.\n* Leukocytes \\>= 3,000\u002FmcL (obtained =\\\u003C 14 days prior to protocol randomization)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL (obtained =\\\u003C 14 days prior to protocol randomization)\n* Platelets \\>= 100,000\u002FmcL (obtained =\\\u003C 14 days prior to protocol randomization)\n* Total Bilirubin =\\\u003C 1.5 mg\u002FdL (obtained =\\\u003C 14 days prior to protocol randomization)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3.0 x institutional upper limit of normal (ULN) (obtained =\\\u003C 14 days prior to protocol randomization)\n* Creatinine =\\\u003C 1.5 x institutional ULN OR creatinine clearance \\>= 50 mL\u002Fmin calculated by the Cockcroft-Gault method (obtained =\\\u003C 14 days prior to protocol randomization)\n* Calcium \\>= institutional lower limit of normal (LLN)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Testing for HIV is not required for entry onto the study\n\nExclusion Criteria:\n\n* Patient must not have a liver tumor burden exceeding 70% of total liver volume.\n* Patient must not have had prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 2 weeks prior to randomization).\n* Patient must not have had prior trans-arterial bland embolization, chemoembolization (TACE) or radioembolization (TARE).\n* Patient must not have had prior treatment with HAI\u002Ffloxuridine (FUDR)\n* Patient must not have microsatellite instability-high (MSI-H) colorectal cancer.\n* Patient must not have CRLM that could be resected with 2-stage hepatectomy, including associating liver partition and portal vein ligation (ALPPS).\n* Patient must not have an active infection, serious or non-healing active wound, ulcer, or bone fracture.\n* Patient must not have any serious medical problems which would preclude receiving the protocol treatment or would interfere with the cooperation with the requirements of this trial.\n* Patient must not have cirrhosis and\u002For clinical or radiographic evidence of portal hypertension\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study.",{"count":53,"type":20},408,[55],"PHASE3","This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs 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. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.",[58,29,59,60],"Metastatic Colorectal Carcinoma","Stage IV Colorectal Cancer AJCC v8","Unresectable Colorectal Carcinoma","2026-06-16",{"date":63,"type":36},"2026-06-18",{"date":65,"type":36},"2023-10-19",{"date":67,"type":20},"2034-06-30",{"name":69,"class":70},"ECOG-ACRIN Cancer Research Group","NETWORK",60,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":44},"100642329","phase-2-hrx215-a-first-generation-mkk4-inhibitor-drug-for-the-treatment-of-patients-with-colorectal-liver-metastasis-after-undergoing-a-portal-vein-embolization-100642329","NCT07612007","HRX215, A First Generation MKK4 Inhibitor Drug, for the Treatment of Patients With Colorectal Liver Metastasis After Undergoing a Portal Vein Embolization","Phase 2B Study to Determine Efficacy of HRX215, a First Generation MKK4 Inhibitor Drug, in Improving Regeneration of the Remnant Liver After Portal Vein Embolization (PVE) of Colorectal Liver Metastasis (CRLM)","Inclusion Criteria:\n\n* REGISTRATION: Adults 18-90 years\n* REGISTRATION: Individuals with metachronous colorectal carcinoma liver metastases (CRCLM) after resection of the primary OR synchronous CRCLM with planned simultaneous resection of primary and metastatic disease\n* REGISTRATION: Measurable intrahepatic disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) and considered resectable by multidisciplinary tumor board with at least one senior hepatic surgeon\n* REGISTRATION: Available CT suitable for volumetric studies on FLR ≤ 21 days\n* REGISTRATION: Clinical indication for PVE prior to major hepatectomy as evaluated by at least one senior hepatic surgeon\n* REGISTRATION: Estimated life expectancy ≥ 3 months as evaluated and approximated by a senior hepatic surgeon\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* REGISTRATION: Platelets ≥ 100,000\u002Fmm\\^3 (≤ 15 days prior to registration)\n* REGISTRATION: Polynuclear neutrophils ≥ 1000\u002Fmm\\^3 (≤ 15 days prior to registration)\n* REGISTRATION: Hemoglobin ≥ 9 g\u002FdL (≤ 15 days prior to registration) (post-transfusion participants can be included)\n* REGISTRATION: Creatinine ≤ 1.5 x upper limit of normal (ULN) (≤ 15 days prior to registration)\n* REGISTRATION: Bilirubin ≤ ULN (≤ 15 days prior to registration)\n* REGISTRATION: Albumin ≥ 3 g\u002FdL (≤ 15 days prior to registration)\n* REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (≤ 15 days prior to registration)\n* REGISTRATION: International normalized ratio ≤ 1.5 (≤ 15 days prior to registration)\n* REGISTRATION: Of note, a slight deviation from normal ranges of liver function tests, circulating cell counts, and kidney function can be assumed after systemic neoadjuvant chemotherapy prior to PVE (Field et al., 2008; Takamoto et al., 2010; Lock et al., 2017), which is accounted for in the above list. These parameters at inclusion will then serve as patient baseline\n* REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. Serum or urine human chorionic gonadotropin test is suitable. Can be done with a home test and results reported by participant to the site\n* REGISTRATION: Provide written informed consent\n* REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* RANDOMIZATION: Adults 18-90 years\n* RANDOMIZATION: Individuals with metachronous CRCLM after resection of the primary OR synchronous CRCLM with planned simultaneous resection of primary and metastatic disease\n* RANDOMIZATION: Estimated life expectancy ≥ 3 months as evaluated and approximated by a senior hepatic surgeon\n* RANDOMIZATION: Measurable intrahepatic disease as defined by RECIST and considered resectable by multidisciplinary tumor board with at least one senior hepatic surgeon\n* RANDOMIZATION: Available CT suitable for volumetric studies on FLR ≤ 21 days\n* RANDOMIZATION: Scheduled for PVE prior to major hepatectomy\n\nExclusion Criteria:\n\n* REGISTRATION: Cirrhosis or clinical ascites\n* REGISTRATION: Patients with synchronous CRCLM and scheduled staged approach (i.e., resection of metastatic hepatic disease after PVE followed by resection of the colorectal primary in a second operation)\n* REGISTRATION: Any liver cancer other than CRLM\n* REGISTRATION: Contraindications to imaging or perioperative management:\n\n  * Allergy\u002Fcontraindication to iodine contrast\n  * Anticoagulation with heparin\u002Fantivitamin K (AVK) that cannot be interrupted for 48 hours\n  * Antiplatelet therapy (e.g., clopidogrel) that cannot be interrupted for 5 days\n* REGISTRATION: Inability to discontinue cytochrome P450 (CYP)2D6 inhibitor concomitant medication from start of trial treatment to day 28\n* REGISTRATION: Inoperability due to underlying chronic diseases and co-morbidities as assessed by the hepatobiliary surgeon during screening visit\n* REGISTRATION: Anticipated need to start adjuvant chemotherapy prior to completion of 28 day treatment period\n* REGISTRATION: Positive test at screening for active hepatitis B virus (HBV)\u002Fhepatitis C virus (HCV), defined as history of seropositivity for hepatitis B virus (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy), i.e., positive test for anti-hepatitis B core antigen and negative test for anti-hepatitis B surface antibody. Ongoing, non-cured hepatitis C virus (HCV) infection. Likewise, autoimmune hepatitis will be excluded based on serological \\[antinuclear antibodies (ANA), smooth muscle antibodies (SMA), and biochemical parameters AST and ALT\\], patients with serological and\u002For biochemical findings suggestive of probable autoimmune hepatitis will be excluded\n* REGISTRATION: Legal incapacity (persons in custody or under guardianship)\n* REGISTRATION: Deprived of liberty subject (by judicial or administrative decision)\n* REGISTRATION: Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social, or psychological reasons\n* REGISTRATION: Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception. Participants of childbearing potential must use highly effective contraception (hormonal methods, intrauterine device (IUD)\u002Fintrauterine system (IUS), bilateral tubal occlusion, or vasectomized partner) during treatment and for a defined post-treatment period of 30 days. True abstinence is acceptable if consistent with lifestyle. Barrier methods alone are insufficient unless combined. Male participants with partners of childbearing potential must use condoms and avoid sperm donation during and after treatment\n* REGISTRATION: Any of the following prior therapies:\n\n  * Major surgical procedures ≤ 3 weeks prior to registration\n  * Bevacizumab as part of systemic cancer treatment ≤ 2 weeks prior to registration\n* REGISTRATION: Failure to recover from any adverse events related to any of the following therapies received prior to registration:\n\n  * Chemotherapy\n  * Immunotherapy\n  * Targeted therapies\n  * Other investigational agents\n  * Radiation therapy\n  * Major surgical procedures\n* REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* REGISTRATION: Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm in the neoadjuvant setting or during active treatment phase of this study (adjuvant treatment after active treatment phase is completed does not apply)\n* REGISTRATION: Another active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy at time of study inclusion or within the past five years with the exception of basal cell carcinoma or carcinoma in situ of the cervix. Patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria\n* REGISTRATION: History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias","90 Years",{"count":81,"type":20},80,[83],"PHASE2","This phase IIb trial tests the effect of HRX215 in treating patients with colorectal cancer that has spread from where it first started to the liver (liver metastasis) after undergoing a portal vein embolization (PVE). Currently, surgery to remove the tumor (hepatectomy) remains the only potential treatment for cure. However, less than 30% of patients are considered resectable (can be removed by surgery) at the time of diagnosis. The risk of liver failure and other complications rise with larger areas liver that is removed during surgery. Therefore, the potential for surgery is determined by the amount of liver that will remain after resection. PVE is a standard strategy to increase the potential for resection. A PVE is a procedure that blocks the portal vein (a blood vessel that carries blood to the liver) to prevent flow of blood to the tumor. HRX215 targets and binds to MKK4, a protein found on liver cells plays a part in cellular growth and prevents liver repair and regrowth of cells and tissue. Blocking the activity of MKK4 may help prevent liver failure, protect liver cells and improve liver mass. Giving HRX215 after a PVE may help improve the rate of liver regrowth and increase the likelihood of hepatectomy in patients with colorectal liver metastasis.",[58,29,86,59],"Resectable Colorectal Carcinoma","NOT_YET_RECRUITING","2026-06-10",{"date":90,"type":36},"2026-06-12",{"date":92,"type":20},"2026-09-01",{"date":94,"type":20},"2028-08-01",{"name":96,"class":43},"Mayo Clinic",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100500068","phase-1-au409-for-the-treatment-of-advanced-primary-liver-cancers-or-solid-tumor-with-liver-metastatic-disease-100500068","NCT05791448","AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease","First in Human Dose Escalation Study of AU409 in Patients With Advanced Primary Liver Cancers or Advanced Solid Tumor With Liver Predominant Metastatic Disease","Inclusion Criteria:\n\n* Age \\>= 18 years old\n* Patients must have histopathologically \u002Fcytologically confirmed advanced solid tumor, which is refractory to standard therapeutic options, or for which there are no standard therapeutic options. Failure of all approved therapies that have a marginal impact on survival is not required as long as the treating physician considers that treatment on study is appropriate for the subject and documents that the subject elects to defer the approved therapies\n* During the dose-escalation portion, patients must have primary liver malignancy (including hepatocellular carcinoma or cholangiocarcinoma) OR a solid tumor with liver dominant disease; liver dominant disease is defined as the majority of the tumor burden being in the liver per investigator assessment AND no more than two extrahepatic sites of disease (site of disease refers to organ or system). During the dose expansion portion of the study, eligibility may be limited to one or more tumor types depending on findings from the dose-escalation phase; this will be clarified in an amendment\n* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Patient must have recovered from any toxic effects of previous chemotherapy, targeted therapy or radiotherapy as judged by the Investigator to =\\\u003C grade 1 (except for alopecia). Residual sensory neuropathy =\\\u003C grade 2 is allowed. Residual endocrine adverse events (such as hypothyroidism or hypoadrenalism) that are manageable with replacement therapy are allowed\n* Previous chemotherapy\u002Fradiotherapy\u002Ftargeted\u002Fimmunotherapy therapy should have been completed at least 4 weeks prior to start of AU409 administration, or five half-lives, whichever is shorter (except for palliative radiation therapy that should be completed \\>= 14 days prior to study entry)\n* Patients must have an estimated life expectancy of at least 3 months\n* Women of child-bearing potential (WOCBP) 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. A male participant must agree to use highly effective contraception during the intervention period and for 60 days after the last dose of AU409 and refrain from donating sperm during this period. WOCBP are eligible to participate if they are not pregnant, not breastfeeding, and agree to follow the contraceptive guidance during the study intervention period and for at least 90 days after the last dose of AU409\n\n  * Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* Patients must agree, as part of the informed consent, to undergo liver biopsy (for a subset of patients enrolled at and above dose level 4) and to provide blood for pharmacokinetics analysis\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Hemoglobin \\>= 8 g\u002FdL (prior transfusion is allowed if completed 2 weeks prior to screening and hemoglobin remains \\>= 8 g\u002FdL)\n* For patients with HCC with splenic sequestration: ANC \\>= 1000\u002Fmm\\^3\n* For patients with HCC with splenic sequestration: Platelets \\>= 70,000\n* Calculated clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2. Actual body weight should be used for calculating creatinine clearance (e.g., using the Cockroft-Gault formula). For subjects with a Body Mass Index (BMI) \\> 30 kg\u002Fm\\^2, lean body weight should be used instead\n* Total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN) (subjects with known Gilbert's hepatic function disease can have bilirubin of up to 2 X ULN)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 X ULN; or AST\u002FALT =\\\u003C 5 X ULN if patient has liver tumors\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR) =\\\u003C 1.8 times upper limit of normal (unless patient is on anticoagulation)\n\nExclusion Criteria:\n\n* Patients who have had hypersensitivity to pentamidine or any excipients of AU409\n* Treatment with other anticancer therapies (including surgery, radiation therapy, chemotherapy, anti-angiogenic therapy, targeted therapy, or radiofrequency ablation therapy, etc.) or investigational therapy within 28 days prior to study entry (except for palliative radiation therapy that should be completed \\>= 14 days prior to study entry)\n* Hepatocellular carcinoma patients with a Child Pugh score \\>= B7\n* Patients with known central nervous system metastases which are untreated or symptomatic; patients with treated brain metastases (completed \\>= 30 days prior to screening) are allowed provided they are asymptomatic and are off steroids\n* Patient with a history of the following within 6 months prior to cycle 1 day 1: a myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia, cerebrovascular accident, transient ischemic attack, or seizure disorder. Atrial fibrillation is allowed if rate is controlled\n* Patients who have corrected QT (QTc) interval to \\> 470 msec (Fredericia's equation) on 2 out of 3 electrocardiogram (ECG)'s (if first ECG has QTc \\\u003C 470, no need to repeat, if first ECG has QTc \\> 470 repeat twice for a total of 3 ECG's)\n* Patients who are on therapeutic anticoagulation with warfarin; however, patients on therapeutic doses of with low molecular weight heparins or Factor Xa inhibitors are eligible\n* Patient with history of gastrointestinal surgery or malabsorptive conditions that may change the absorption of drugs and\u002For cause rapid transit (such as total gastrectomy, small bowel resection, etc.)\n* Patients who have known active hepatitis B. Patients with chronic hepatitis B who are on anti-viral therapy and have a hepatitis B viral load of =\\\u003C 500 IU\u002FmL are allowed on the study. Patients with chronic Hepatitis C are allowed\n* Patients who have active infection requiring treatment (except hepatitis B and C as noted above) including known human immunodeficiency virus (HIV) infection\n* Patients who have concurrent conditions resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents\n* Patients who have any other condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results\n* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants\n* Patients who are on medications that are considered to be strong inducers or inhibitors of the cytochrome P450 isoenzymes should have such medications discontinued or replaced. Such medications should be avoided for one week prior to first dose of treatment and during the trial participation. If these medications are absolutely necessary for the patient and cannot be replaced, enrollment may still be considered on a case by case basis if it is in the patient's best interest and after discussion with the principal investigator (PI)",{"count":105,"type":20},36,[107],"PHASE1","This phase I trial tests the safety, side effects, and best dose of a new intervention, AU409, in treating patients with primary liver cancers that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or advanced solid tumors that have spread to the liver (liver metastatic disease). AU409 may stop cancer from growing and spreading. This trial may help researchers determine if AU409 is safe and effective in treating patients with liver cancers and solid tumors with liver metastatic disease.",[110,111,112,29,113,114,115],"Advanced Cholangiocarcinoma","Advanced Hepatocellular Carcinoma","Advanced Malignant Solid Neoplasm","Refractory Malignant Solid Neoplasm","Stage III Hepatocellular Carcinoma AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","2026-05-29",{"date":118,"type":36},"2026-06-01",{"date":120,"type":36},"2023-03-29",{"date":122,"type":20},"2028-03-29",{"name":124,"class":43},"University of Southern California",2,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":44},"100437928","phase-2-short-stitch-versus-traditional-suture-for-the-prevention-of-incisional-hernia-after-open-hepatectomy-100437928","NCT04982653","Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy","Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients undergoing hepatectomy for malignant diagnosis (primary or secondary) from 5\u002F1\u002F2021 through 11\u002F1\u002F2024 will be eligible for inclusion in this study\n* Elective surgery\n* Age \\>= 18\n* Planned midline laparotomy incision or inverted-L incision\n\nExclusion Criteria:\n\n* Pre-existing abdominal hernia\n* History of mesh placement at prior laparotomy\n* Pregnant women",{"count":134,"type":20},140,[83],"This clinical trial compares two different kinds of surgical closing techniques, short stitch suture or traditional suture, in patients who are having liver tumor surgery. This study may help researchers learn if one technique can lower the chances of developing a hole in the wall of the abdomen (an abdominal hernia) at the incision site better than the other.",[138,29,139],"Liver and Intrahepatic Bile Duct Neoplasm","Primary Malignant Liver Neoplasm","2026-05-22",{"date":142,"type":36},"2026-05-26",{"date":144,"type":36},"2022-01-04",{"date":146,"type":20},"2027-02-02",{"name":148,"class":43},"M.D. Anderson Cancer Center",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":44},"100442303","phase-1-phase-iii-randomized-study-of-nbtxr3-activated-by-abscopal-or-radscopal-radiation-in-combination-with-immunotherapy-anti-pd-1l-1-for-patients-with-advanced-solid-malignancies-100442303","NCT05039632","Phase I\u002FII Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1\u002FL-1) for Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\n1. Patients with metastatic disease in the lung and\u002For liver, or soft tissue from any primary malignancy considered incurable by local therapies.\n\n   a. One prior anti-PD-1\u002FL1 therapy allowed.\n2. The target lesion(s) must be measurable as per irRECIST and repeated measurements at the same anatomical location should be achievable.\n\n   a. Participant must have at least 2 measurable lesions at screening. i. Abscopal cohort: At least one lesion will receive NBTXR3 and high dose radiation (high dose target lesion). The other lesion(s) (non-treated target lesion) will be followed for response and it will not receive NBTXR3 or RT.\n\n   ii. RadScopal™ cohort: At least one lesion will receive NBTXR3 and high dose radiation (high dose target lesion). The other lesion(s) will only receive low dose radiation (low dose target lesion).\n3. Amenable to undergo the image guided (EBUS or CT or MRI) intratumoral injection of NBTXR3, in up to two (2) high dose target lesions, as determined by the investigator or treating physician at screening.\n\n   a. Intratumoral NBTXR3 injections only allowed in lung or liver lesions.\n4. Selected high and low dose target lesions must be amenable to receive radiation therapy as determined by the investigator or treating radiation oncologist.\n\n   1. Allowed high dose RT regimens are 50 Gy in 4 fractions or 60 Gy in 10 fractions\n   2. Allowed low dose RT for RadScopal™ cohort is 1.4 Gy per fraction for 4 - 5 fractions to only low dose-target lesion(s) determined by the investigator or treating physician.\n5. Patients can receive radiation therapy for symptomatic metastatic disease prior to enrollment or during the study a.\n6. Age ≥ 18 years\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n8. Laboratory Values at screening:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL\n   2. Absolute Neutrophil Count (ANC) ≥ 1,500\u002Fmm3\n   3. Platelet count ≥ 100,000\u002Fmm3\n   4. Leukocytes ≥ 1500\u002Fmm3\n   5. Creatinine ≤ 1.5 x upper limit of normal (ULN)\n   6. Calc. creatinine clearance \\> 30mL\u002Fmin\n   7. Total bilirubin ≤ 2.0 mg\u002FdL\n   8. AST \u002F ALT ≤ 2.0 x upper limit of normal (ULN) or ≤ 3 x ULN for patients with liver metastases\n9. For participants to be treated for lung metastases, adequate lung function with expiratory volume in 1 second (FEV1) ≥ 0.8L or ≥ 35% predicted and carbon monoxide diffusing capability (DLCO) ≥ 40% with or without bronchodilator within 30 days prior to NBTXR3 injection. Participants to be treated for liver metastasis a pulmonary function test is not required.\n10. Patients who meet the criterion above without oxygen (02), but need acute (started within 7 ± 3 days) supplemental oxygen due to tumor-caused obstruction\u002Fhypoxia are eligible, provided the amount of the O2 needed has been stable.\n11. Negative urine or serum pregnancy test ≤ 7 days prior to NBTXR3 injection in all women of child-bearing potential (WOCBP). WOCBP must agree to follow instructions for method(s) of contraception for the duration the entire study period and 160 days (\\~5.33 months) after the last dose of anti-PD-1\u002FL-1 treatment. Local laws and regulations may require use of alternative and\u002For additional contraception methods. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements but should still undergo pregnancy testing.\n12. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n\n4.2 Exclusion criteria:\n\n1. Prior radiation therapy received to the selected high dose target lesion(s)\n\n   a. Previous radiation to low dose target lesions allowed as per investigator or treating radiation oncologist discretion.\n2. Symptomatic central nervous system metastases and\u002For carcinomatous meningitis\n\n   a. Participants with previously treated brain metastases may participate if those lesions are radiologically stable (i.e., without evidence of progression for at least 4 weeks by repeat imaging at screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to NBTXR3 injection.\n3. At screening, past medical history of:\n\n   1. Interstitial lung disease\n   2. Unresolved organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia)\n   3. Any Grade 4 radiation toxicity\n   4. Unresolved, radiation or ICI related\n\n   i. Pneumonitis ii. Bronchopulmonary hemorrhage iii. Abdominal hemorrhage e. Unresolved GI related events i. Diverticulitis ii. Colitis iii. Intra-abdominal abscess iv. GI obstructions v. Abdominal carcinomatosis vi. Any known risk factor for bowel perforation\n4. History of severe (Grade ≥ 3) immune-related adverse events observed with previous immunotherapy (anti-PD-1\u002FL1) or known sensitivity (Grade ≥ 3) to any excipients.\n5. Has received any approved or investigational anti-neoplastic agent or immunotherapy within 2 weeks prior to NBTXR3 injection.\n\n   1. Except anti-PD-1\u002FL1, which will not require a washout window.\n   2. A reduced washout window may be considered for therapies with short half-lives (i.e., kinase inhibitors) after discussion with Nanobiotix and investigator.\n6. 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).\n\n   a. Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement \\[≤ 10 mg prednisone\\] therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n7. Any live-virus vaccine used for prevention of infectious diseases administered within 4 weeks prior to NBTXR3 injection.\n\n   1. Except killed-virus Influenza vaccine\n   2. Exception of other vaccines (e.g. pneumonia) is at the discretion of the treating physician after conducting a personalized risk assessment on a case by case basis.\n8. Prior allogenic stem cell transplantation or organ allograft.\n9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment.\n10. Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection.\n11. Female patients who are pregnant or breastfeeding.\n12. Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 160 days (\\~5.33 months) for female participants, and 7 months for males participants or female partners of male participants that are of child-bearing potential, after the last dose of anti-PD-1\u002FL-1.\n\n    a. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \\\u003C 1% per year when used consistently and correctly.\n13. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.",{"count":156,"type":20},40,[107,83],"This phase I\u002FII trial studies the side effects and possible benefits of NBTXR3, radiation therapy, Anti PD-1 \u002F PD-L1 in treating patients with solid tumor that has spread to the lung (lung metastases) and\u002For liver (liver metastases). NBTXR3 may help make tumor cells more sensitive to the radiation therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with Anti PD-1 \u002F PD-L1 monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3, radiation therapy, Anti PD-1 \u002F PD-L1 may help to control the disease.",[112,29,160,161],"Metastatic Malignant Neoplasm in the Lung","Metastatic Malignant Solid Neoplasm","2026-02-04",{"date":164,"type":36},"2026-02-06",{"date":166,"type":36},"2023-05-08",{"date":168,"type":20},"2028-02-01",{"name":148,"class":43},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":44},"100423664","an-investigational-scan-intravoxel-incoherent-motion-diffusion-weighted-imaging-for-the-evaluation-of-colorectal-cancer-liver-metastases-treatment-response-100423664","NCT04796818","An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response","Evaluation of Treatment Response of Colorectal Cancer Liver Metastases With Intravoxel Incoherent Motion Diffusion Weighted Imaging","Inclusion Criteria:\n\n* Patients with treatment-naive resectable CLM, who will start chemotherapy with oxaliplatin with fluorouracil (5-FU)\u002Fleucovorin (FOLFOX), irinotecan with 5-FU\u002Fleucovorin (FOLFIRI), or a combination, such as fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFOXIRI), with or without a biologic agent\n* Patients with at least 1 colorectal liver metastasis measuring at least 1 cm\n* Patients with anticipated follow-up before and after surgery at MD Anderson\n\nExclusion Criteria:\n\n* Patients who have already received preoperative chemotherapy for the CLM or will undergo radiation therapy, ablative therapies, or other non-surgical therapies directed at the liver\n* Patients allergic to gadolinium\n* Patients with pacemakers\n* Greater than 400 pounds in weight",{"count":178,"type":20},70,[180],"NA","This trial evaluates the treatment response of colorectal cancer that has spread to the liver (liver metastases) using intravoxel incoherent motion diffusion weighted imaging (IVIM DWI). IVIM DWI is new kind of imaging scan that may help measure changes in disease before and after chemotherapy in patients with colorectal liver metastases.",[58,29,86,59,183,184,185],"Stage IVA Colorectal Cancer AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVC Colorectal Cancer AJCC v8","2026-01-12",{"date":188,"type":36},"2026-01-14",{"date":190,"type":36},"2020-08-12",{"date":192,"type":20},"2026-01-31",{"name":148,"class":43},{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100442359","phase-2-testing-the-use-of-chemotherapy-after-surgery-for-high-risk-pancreatic-neuroendocrine-tumors-100442359","NCT05040360","Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors","Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors","Inclusion Criteria:\n\n* Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 120 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam\n* Resection must have been an R0 or R1 per treating investigator's assessment and\u002For pathology report\n* Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be \\>= 3% and =\\\u003C 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and\u002For the study pathology chair with questions. If more than one Ki-67 is reported (e.g., primary tumor versus lymph node or metastatic site), the highest one should be considered for the study eligibility criteria\n* Participants with localized resected pNETS must have a Zaidi score of \\>= 3 derived by the following factors and points:\n\n  * 1 point; symptomatic tumor defined as one of the following:\n\n    * Gastrointestinal bleed\n    * Jaundice\n    * Gastrointestinal obstruction\n    * Pain from primary tumor prior to surgical resection\n    * Pancreatitis\n  * 2 points; primary pancreas tumor size \\> 2 cm\n  * 1 point; Ki-67 3% to 20%\n  * 1 point; lymph node positivity = 1\n  * 6 points; Ki-67 21% to 55%\n* Participants may have received resection\u002Fablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection\n* Participants must have recovered from effects of surgery as determined by the treating investigator\n* Participants must be \\>= 18 years old\n* Participants must have Zubrod performance status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Leukocytes \\>= 3 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Absolute neutrophil count \\>= 1.5 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Platelets \\>= 100 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Total bilirubin =\\\u003C institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to registration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x institutional ULN (within 28 days prior to registration)\n* Serum creatinine =\\\u003C 1.5 x institutional ULN (within 28 days prior to registration)\n* Calculated creatinine clearance \\>= 50 ml\u002Fmin (within 28 days prior to registration)\n* Participants must be able to swallow pills\n* Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol\n* No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n\nExclusion Criteria:\n\n* Participants must not have unresected or unablated metastatic disease\n* Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis\n* Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted\n* Participants must not have received somatostatin analogs after surgery\n* Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed\n* Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine\n* Participants must not have known absorption issues that would limit the ability to absorb study agents\n* Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration\n* Participants must not have active or uncontrolled infection\n* Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator\n* Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen",{"count":202,"type":20},141,[83],"This phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, 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 capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.",[29,206,207,208,209],"Pancreatic Neuroendocrine Tumor","Stage I Pancreatic Neuroendocrine Tumor AJCC v8","Stage II Pancreatic Neuroendocrine Tumor AJCC v8","Stage III Pancreatic Neuroendocrine Tumor AJCC v8","2025-12-10",{"date":212,"type":36},"2025-12-15",{"date":214,"type":36},"2022-05-05",{"date":216,"type":20},"2027-03-31",{"name":218,"class":70},"SWOG Cancer Research Network",448,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":21,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":19},"100550658","local-liver-treatment-for-multi-organ-colorectal-cancer-metastases-100550658","NCT06449937","Local Liver Treatment for Multi-organ Colorectal Cancer Metastases","Analysis of the Efficacy of Local Liver Treatment for Multi-organ Colorectal Cancer Metastases: A Prospective, Multicenter, Non-randomized Concurrent Controlled Study","Inclusion Criteria:\n\n* Male or female, 18-80 years of age.\n* Patients volunteered to join the study and signed informed consent, with good compliance and follow-up.\n* Primary colorectal tumors can be radically resected or resected and histopathologically diagnosed as colorectal cancer.\n* Patients with synchronous or metachronous diagnosis of liver metastasis and extrahepatic metastasis by computed tomography (CT) or magnetic resonance imaging (MRI).Extrahepatic metastases are stable and controllable as determined by Multi-disciplinary Treatment (MDT).\n* Patients receive only first- or second-line systemic therapy.\n* Radical local treatment can be performed after MDT evaluation, and the indications at least meet the following one:\n\n  * Hepatectomy: liver metastases can be completely (R0) removed and required to retain sufficient functional liver tissue;\n  * Ablation therapy: The maximum diameter of liver metastases\\\u003C3 cm, and the maximum number of ablation ≤ 5.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Life expectancy of at least 3 months.\n* Child-Pugh score ≤ 7.\n* Laboratory routine examination (blood routine, liver and kidney function, coagulation function, etc.) no significant abnormalities:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002Fl;\n  * Platelet count (PLT) ≥ 100\\*10\\^9\u002Fl;\n  * Hemoglobin ≥ 9g\u002Fdl;\n  * TBIL\\\u003C1.5 times the upper limit of normal (ULN);\n  * ALT and AST\\\u003C 5\\*ULN;\n  * Serum creatinine ≤ 1.5 \\* ULN or Creatinine clearance\\> 50 ml\u002Fmin;\n  * Albumin \\> 30 g\u002Fl.\n\nExclusion Criteria:\n\n* Patients with only liver metastasis confirmed by CT or MRI.\n* History of hepatic encephalopathy or liver transplantation.\n* Evidence of brain metastases.\n* Pregnant or breast-feeding women.\n* History of other malignant tumors (except thyroid cancer and carcinoma in situ) can be included in the study if the individual has remained disease-free for at least 5 years.\n* Patients with acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month, and the cardiovascular clinical symptoms or diseases were not well controlled.\n* NYHA class 3-4 or left ventricular ejection fraction (LVEF) \\\u003C 50 % by echocardiography.\n* Uncontrollable hypertension, blood pressure \\> 160 \u002F 95 mmHg after treatment, history of hypertensive crisis or hypertensive encephalopathy.\n* Uncontrollable infection \\> grade 2 (NCI-CTC version 5.0).\n* Patients with respiratory insufficiency : PaO2 \\\u003C 60 mmHg at rest , with or without PaCO2 \\> 50 mmHg.\n* Patients with a large amount of ascites (ultrasound examination showed an echoless area around the liver and spleen, pelvic cavity, and intestinal loops, and the mesentery and intestinal canal were seen floating in the echoless area ) or malignant ascites (cancer cells were found in ascites or ascites CEA was higher than peripheral blood).\n* Coagulation dysfunction ( INR \\> 1.5 or APTT \\> 1.5\\*ULN ), with bleeding tendency.\n* Long-term unhealed wounds or fractures, major surgery or severe traumatic injury, fracture or ulcer occurred within 4 weeks.\n* Patients with a history of mental drug abuse and who could not quit or had mental disorders.\n* According to the investigator's judgment, patients with concomitant diseases that seriously endanger patient safety or affect patient completion of the study.\n* According to the investigator's judgment, patients who are not suitable for inclusion.","80 Years",{"count":229,"type":20},130,[180],"The purpose of this study was to investigate the effect of only local radical treatment of liver metastases combined with systematic treatment in the treatment of patients with multiple organ metastases of colorectal cancer, whether it can benefit the prognosis and explore the risk factors related to the prognosis.",[58,233,29],"Multi-organ Metastatic Colorectal Cancer","2024-06-04",{"date":236,"type":36},"2024-06-10",{"date":238,"type":20},"2024-07",{"date":240,"type":20},"2028-07",{"name":242,"class":243},"Anhui Provincial Hospital","OTHER_GOV"]