[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-liver-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-liver-cancer":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,53,81,105,143,168,201,224,243],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100428822","phase-1-gpc3-targeted-t-cell-therapy-ect204-in-adults-with-advanced-hcc-100428822",false,"NCT04864054","GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC","An Open-Label, Dose Escalation, Multi-Center Phase I\u002FII Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC)","ARYA-3","Inclusion Criteria:\n\n* Histologically confirmed HCC, that is unresectable, recurrent, and\u002For metastatic.\n* GPC3-positive tumor expression confirmed by immunohistochemistry (IHC).\n\n  * For the dose-escalation cohort: ≥10-20% tumor cells, ≥2+ IHC.\n  * Beginning with the RP2D confirmatory cohort: ≥ 50% tumor cells, 2+\u002F3+ IHC.\n* Must have received at least first-line systemic therapy for HCC and have experienced disease progression on, or intolerance to, that therapy.\n* Life expectancy of at least 4 months per the Investigator's opinion.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Measurable disease by RECIST v1.1.\n* Child-Pugh score of A6 or better.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Pre-existing illness (e.g., symptomatic congestive heart failure) that would limit compliance with study requirements.\n* Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.\n* History of malignancy other than HCC within 5 years before screening, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancies with low risk of recurrence.\n* Known brain metastases or other active central nervous system (CNS) involvement, including leptomeningeal disease. Subjects with brain metastases that have been adequately treated (no evident neurological deficit and no steroid or anti-epileptic therapy for brain metastases) are eligible.\n* Pregnant or lactating women.\n* Currently receiving or ending (\\\u003C 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery.\n* Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.\n* Active autoimmune disease requiring systemic immunosuppressive therapy.\n* Presence of portal vein tumor thrombus (PVTT) classified as grade Vp4, or any invasion into the inferior vena cava (IVC), except for subjects with IVC invasion who have been treated and radiographically stable for at least 6 months prior to screening.\n* Ascites requiring active treatment, such as a requirement for paracentesis or escalation of diuretic doses. Exception: Subjects maintained on a stable dose of diuretics with controlled, asymptomatic ascites are eligible.\n* Active gastrointestinal (GI) bleeding event ≥ Grade 3 per National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), version 5.0, within 6 months prior to screening.\n* Coagulation abnormality defined as international normalized ratio (INR) \\> 1.7, unless the elevation is due to therapeutic anticoagulation that, in the Investigator's judgment, can be safely managed in the context of study procedures.\n* History of organ transplant.\n* HCC involving greater than 50% of the liver volume.\n* Experienced allergies to any component of the study drug (ECT204), mouse immunoglobulin, or iron-dextran, or have a history of severe hypersensitivity, including anaphylaxis.\n* Previously received other gene therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T\\] therapy); exception: prior oncolytic virus therapy is permitted.).\n* Contraindication for undergoing leukapheresis procedure or receipt of conditioning agents","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is an open-label, multi-center, Phase 1\u002F2 clinical trial evaluating the safety, tolerability, and efficacy of ECT204, an investigational ARTEMIS® T-cell therapy, in adult subjects with GPC3-positive hepatocellular carcinoma (HCC) who have experienced disease progression on, or intolerance to, prior systemic therapy.",[28,29,30,31],"Hepatocellular Carcinoma","Liver Cancer, Adult","Liver Neoplasm","Metastatic Liver Cancer",[28,33,34,35,30,31,36,37,38,39],"Advanced HCC","Late-Stage HCC","Liver Cancer","Metastatic HCC","T-cell therapy","Immunotherapy","HCC","RECRUITING","2026-06-05",{"date":43,"type":44},"2026-06-09","ACTUAL",{"date":46,"type":44},"2022-03-11",{"date":48,"type":21},"2027-12-31",{"name":50,"class":51},"Eureka Therapeutics Inc.","INDUSTRY",8,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100557070","phase-1-a-phase-1-trial-of-erx-315-in-participants-with-advanced-solid-tumors-100557070","NCT06533332","A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors","A First-in-Human, Phase 1 Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of Escalating Doses of ERX-315 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Patients must be at least 18 years of age at the time of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Patients must have histologically or cytologically confirmed solid tumor, primarily including but not limited to breast, ovarian, pancreatic, endometrial and hepatocellular carcinoma, that is advanced unresectable and\u002For metastatic disease for whom standard therapies do not exist or are no longer effective\n* Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Adequate baseline organ function and hematologic function\n* Life expectancy \\>3 months\n\nExclusion Criteria:\n\n* Systemic anti cancer therapy within 4 weeks of first dose of study drug\n* Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.\n* Uncontrolled intercurrent illnesses\n* Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease.",{"count":61,"type":21},36,[24],"This is a Phase 1 study to assess the safety of ERX-315 in patients with advanced solid tumors that have failed approved systemic therapies.",[65,66,67,68,31,69],"Advanced Solid Tumor","Metastatic Breast Cancer","Metastatic Ovarian Cancer","Metastatic Endometrial Cancer","Metastatic Pancreatic Cancer","2026-05-27",{"date":72,"type":44},"2026-05-29",{"date":74,"type":44},"2024-10-14",{"date":76,"type":21},"2027-06-30",{"name":78,"class":79},"EtiraRx Australia Pty Ltd","OTHER",5,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100581631","phase-2-68ga-psma-11-pet-directed-radioligand-therapy-in-metastatic-hepatocellular-carcinoma-hcc-100581631","NCT06852820","68Ga-PSMA-11 PET-directed Radioligand Therapy in Metastatic Hepatocellular Carcinoma (HCC)","A Pilot Study of 68Ga-PSMA-11 PET-directed Radioligand Therapy in Patients With Metastatic Hepatocellular Carcinoma (HCC)","Inclusion Criteria:\n\n* Participants must have histologically, cytologically or radiographically confirmed hepatocellular carcinoma by LI-RADS30 with metastatic and\u002For unresectable disease.\n* Participants must have received one prior line of systemic therapy for the treatment of metastatic and\u002For unresectable HCC including anti-PD-L1 therapy. Participants will be enrolled at the time of progression on first-line therapy for metastatic and\u002For unresectable disease.\n* Age \\>18 years. Because no dosing or adverse event data are currently available on the use of 177Lu-PSMA-617 (Lu-177 vipivotide tetraxetan) in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status 0 or 1.\n* Participants must have normal organ and marrow function as defined below:\n\nAbsolute Neutrophil Count ≥ 1,500\u002FmcL. Hemoglobin \\> 9 g\u002FdL. Platelet count ≥ 75,000\u002FmcL. Serum creatinine ≤ 1.5 x institutional upper limit of normal or CrCl ≥60 mL\u002Fmin using the Cockroft-Gault formula for participants with creatinine levels \\>1.5 ULN.\n\nChild-Pugh class A or B7.\n\n* At least one target lesion measurable by RECIST 1.1 criteria.\n* PSMA-PET demonstrating PSMA PET positive lesion (higher uptake in the tumor compared with background liver uptake).\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Participants of childbearing age are using an appropriate method of contraception.\n\nExclusion Criteria:\n\n* Participants receiving any other investigational agents.\n* Subject has received investigational therapy within 4 weeks or within 5 half-lives of the therapeutic agent (whichever is shorter).\n* Ongoing grade 3 or higher toxicity from prior anticancer systemic therapy.\n* Prior treatment with Y90 radioembolization for hepatocellular carcinoma.\n* Participants who have undergone major surgery within 3 months of screening and have not adequately recovered.\n* Known additional malignancy that currently requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.\n* Participants with untreated brain metastases and\u002For carcinomatous meningitis will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with previously treated brain metastases may participate provided they are stable without evidence of new or enlarging brain metastases and are not using steroids for at least 7 days prior to trial treatment.\n* Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Participants with known psychiatric or substance use disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the treating investigator.\n* Subject is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 7 months for females and 14 weeks for males after the last dose of trial treatment. Pregnant or breastfeeding women are excluded from this study because 177Lu-PSMA-617 has not been previously studied in this population and the potential for teratogenic or abortifacient effects are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to the treatment of the mother with 177Lu-PSMA-617, breastfeeding should be discontinued if the mother is treated with 177Lu-PSMA-617. These potential risks may also apply to 68Ga-PSMA-11 used in this study.\n* Subject has received live vaccine within 30 days prior to the first dose of trial treatment.\n* Subject with recent variceal bleeding, gastrointestinal bleeding or high risk of bleeding.",{"count":89,"type":21},10,[25],"The purpose of this study is to look at the effects (good and bad) of a drug called 177Lu-PSMA-617 (also known as the study drug) when given to participants who have prostate specific membrane antigen (PSMA) positive liver cancer.",[35,28,31],[94],"Ga-PSMA-11","2026-05-06",{"date":97,"type":44},"2026-05-08",{"date":99,"type":21},"2026-06",{"date":101,"type":21},"2027-04-01",{"name":103,"class":79},"Melissa Lumish",1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":104},"100631403","phase-1-dual-target-gpc3b7-h3-car-nk-cells-for-advanced-hcc-100631403","NCT07500220","Dual-Target GPC3\u002FB7-H3 CAR-NK Cells for Advanced HCC","A Phase 1\u002F2, Open-Label, Dose-Escalation and Dose-Expansion Study of Allogeneic Dual-Target GPC3\u002FB7-H3 (CD276) Chimeric Antigen Receptor Natural Killer Cells in Adults With Unresectable, Relapsed\u002FRefractory, or Metastatic Hepatocellular Carcinoma","DUET-HCC","Inclusion Criteria:\n\n* Age 18 to 75 years.\n* Histologically or cytologically confirmed HCC, or radiologically diagnosed HCC with mandatory tissue confirmation of target expression before enrollment.\n* Unresectable, locally advanced, or metastatic HCC not amenable to curative surgery, transplant, or further locoregional therapy; BCLC stage C, or stage B that is not suitable for or has progressed after locoregional therapy.\n* Disease progression on, intolerance to, or ineligibility for at least 1 prior standard systemic regimen.\n* Central pathology showing GPC3 positivity in \\>=25% of viable tumor cells by IHC and B7-H3 positivity in \\>=10% of tumor cells and\u002For tumor-associated stromal\u002Fvascular cells by IHC.\n* At least 1 measurable lesion by RECIST 1.1; intrahepatic lesions must be assessable by contrast-enhanced triphasic CT or MRI.\n* ECOG performance status 0 to 1.\n* Child-Pugh class A or stable Child-Pugh B7 without uncontrolled ascites or recent encephalopathy.\n* Estimated life expectancy \\>=12 weeks.\n* Adequate organ function: WBC \\>=2.5 x 10\\^9\u002FL; platelets \\>=60 x 10\\^9\u002FL; hemoglobin \\>=9 g\u002FdL; serum albumin \\>=30 g\u002FL; creatinine clearance \\>=40 mL\u002Fmin; AST\u002FALT \\\u003C=5 x ULN; total bilirubin \\\u003C=2.5 x ULN; INR\u002Fprothrombin time within protocol-defined range.\n* If HBsAg positive or anti-HBc positive, HBV DNA must be \\\u003C200 IU\u002FmL and the participant must be on appropriate antiviral therapy before lymphodepletion. Controlled HCV is allowed if per protocol.\n* Negative serum pregnancy test for participants of childbearing potential and agreement to effective contraception.\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Prior gene-modified cellular therapy (for example prior CAR-T, CAR-NK, or TCR-engineered therapy) within the protocol-defined washout period or with unresolved clinically significant toxicity.\n* Active, uncontrolled infection, including uncontrolled bacterial, viral, or fungal infection; uncontrolled HIV; active HBV or HCV with uncontrolled viral load; or active tuberculosis.\n* Known active CNS metastases or leptomeningeal disease requiring escalating steroids or urgent local intervention.\n* Liver transplant or other solid-organ transplant history, or current requirement for chronic immunosuppression.\n* Clinically significant ascites requiring frequent drainage, grade \\>=2 hepatic encephalopathy within 4 weeks, or recent clinically significant variceal\u002FGI bleeding.\n* Extensive liver replacement by tumor (for example \\>=70%) or complete major portal vein\u002Fhepatic venous obstruction judged to create excessive treatment risk.\n* Major surgery, locoregional therapy, radiotherapy, or systemic anticancer therapy too close to lymphodepletion per protocol-defined washout period.\n* Active autoimmune disease requiring systemic immunosuppressive therapy, or chronic systemic corticosteroids above protocol threshold.\n* Clinically significant cardiovascular disease (recent myocardial infarction, unstable arrhythmia, uncontrolled heart failure), uncontrolled pulmonary disease, or other serious comorbidity that materially increases study risk.\n* Pregnant or breastfeeding.\n* Any other active malignancy that is progressing or requires current systemic treatment.\n* Any medical or psychiatric condition that, in the investigator's judgment, would compromise safety, protocol compliance, or interpretation of results.","75 Years",{"count":115,"type":21},30,[24,25],"open-label trial of an allogeneic dual-target CAR-NK product directed against GPC3 and B7-H3 for adults with advanced hepatocellular carcinoma. The design intentionally uses GPC3 as the primary target anchor because GPC3 is the dominant HCC cell-therapy antigen in current clinical development, while adding B7-H3 to reduce antigen escape and to broaden coverage across tumor and tumor-microenvironment compartments. The study first evaluates safety and dose-limiting toxicities, then expands at the recommended phase 2 dose.",[119,31],"Advanced Hepatocellular Carcinoma (HCC)",[39,121,122,123,124,125,126,127,128,129,130,131,132,133],"liver cancer","epatocellular carcinoma","GPC3","glypican-3","B7-H3","CD276","CAR-NK","dual-target","NK cell therapy","adoptive cell therapy","cell therapy","immunotherapy","allogeneic","2026-03-24",{"date":136,"type":44},"2026-03-30",{"date":138,"type":44},"2026-03-02",{"date":140,"type":21},"2028-03-17",{"name":142,"class":51},"Beijing Biotech",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":151,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":167},"100596279","streamlining-radioembolization-for-ccc-and-metastatic-liver-cancer-100596279","NCT07043387","Streamlining Radioembolization for CCC and Metastatic Liver Cancer","Streamlining Radioembolization for Cholangiocarcinoma or Metastatic Liver Cancer ≤ 7 cm : Multicenter Prospective Registry Study","ISTAR-03","Inclusion Criteria:\n\n* Adult aged 19 and over\n\n  * metastatic liver cancer or cholangiocarcinoma\n\n    * the diameter of the largest tumor ≤ 7cm, tumor number 5 or less\n\n      * FLR volume \\> 30% of total non-tumorous liver volume\n\n        * Dysmorphic intratumoral vessel : absent, if present, 3mm or thinner ⑥ Child-Pugh class A\n\n          * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 ⑧ No major organ dysfunction according to blood test performed within two months of study enrollment A. Leukocytes ≥ 1,000\u002FµL and ≤ 20,000\u002FµL B. Hemoglobin ≥ 6.0 g\u002FdL (transfusion allowed to meet this criterion) C. Total bilirubin ≤ 2.0 mg\u002FdL D. Platelet ≥ 40,000\u002FµL E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants F. Aspartate transaminase (AST) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit) G. Alanine transaminase (ALT) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit) H. Creatinine ≤ 2.5 mg\u002FdL (If patients is undergoing hemodialysis, no limit of creatinine) ⑨ Patients with a life expectancy of more than 3 months ⑩ For women of childbearing age, a negative serum pregnancy test. ⑪ Patients who have adequately understood the clinical trial and consented in writing\n\nExclusion Criteria:\n\n* hepatic vein invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI)\n* Hepatic vein enhancement on arterial phase CT\u002FMRI\n* dysmorphic intratumoral vessel \\> 3mm on arterial phase CT\u002FMRI\n* TIPS is present\n* Lobar portal vein enhancement on arterial phase CT\u002FMRI due to AP shunt\n* main portal vein tumor thrombosis\n* Cases where the operator judges that the occurrence of even mild radiation pneumonitis could be fatal, based on marked emphysema or interstitial lung disease findings on chest CT\n* biliary stent or bilioenteric anastomosis\n* History of severe allergy of intolerance to contrast agents\n* Contraindication to angiography or selective visceral catheterization","19 Years",{"count":20,"type":21},"OBSERVATIONAL","TARE uses radioactive microspheres (20-60 μm), which are trapped in tumors due to abnormal vasculature, while normal liver sinusoids (≤15 μm) prevent their passage. However, some microspheres may drain into hepatic veins and reach the lungs, risking radiation pneumonitis. Pre-procedural evaluation with angiography and nuclear imaging (MAA scan with SPECT\u002FCT) is required to calculate lung shunt fraction (LSF). TARE is contraindicated if LSF \\>20%, and may be used with caution if LSF is 10-20%.\n\nFindings associated with high LSF include large tumors, hepatic vein invasion, TIPS, and dysmorphic intratumoral vessels. In contrast, small or medium sized (\\\u003C7 cm) cholangiocarcinoma or metastatic liver cancers without hepatic vein invasion or dysmorphic vessels show consistently low LSF (\\\u003C5%). Over 10 years at SNUH, no cases of radiation pneumonitis have been observed in such patients. Therefore, \"streamlining TARE\" omits pre-procedural nuclear imaging for this group to reduce procedural delays, reserving nuclear imaging for patients who need it most.\n\nSIR-Spheres (SIRTEX) facilitate single-session TARE as they are provided in a bulk vial, unlike TheraSphere which requires advance preparation based on dosimetry.\n\nProtocol Overview :\n\nProcedure: Same-day angiography, cone-beam CT, and TARE using SIR-Spheres.\n\nDosimetry: Lung shunt fraction is assumed as 5%, estimated lung dose is capped at 10 Gy.\n\nTumor dose goal: 80\\~400 Gy (around 250Gy)(single-compartment MIRD), or 300 \\~ 1000 Gy (multi-compartment MIRD). minimal tumor dose by partition dosimetry : 100Gy\n\nSoftware: Simplicit90Y for planning, Y90 PET\u002FCT the next day for post-treatment dosimetry.\n\nFollow-up: 1 year; additional treatments follow institutional guidelines.\n\nThis streamlined approach maximizes efficiency while maintaining safety in selected patients.",[156,31,157],"Metastatic Colorectal Carcinoma (mCRC)","Cholangiocarcinoma","2025-07-21",{"date":160,"type":44},"2025-07-24",{"date":162,"type":44},"2025-06-22",{"date":164,"type":21},"2029-06-30",{"name":166,"class":79},"Seoul National University Hospital",4,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":17,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":187,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100411195","phase-1-et140203-t-cells-in-pediatric-subjects-with-hepatoblastoma-hcn-nos-or-hepatocellular-carcinoma-100411195","NCT04634357","ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma","An Open-Label, Dose Escalation, Phase I\u002FII Clinical Trial of ET140203 T Cells in Pediatric Subjects With Relapsed\u002FRefractory Hepatoblastoma (HB), Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS), or Hepatocellular Carcinoma (HCC)","ARYA-2","Inclusion Criteria:\n\n1. Histologically confirmed HB, HCN-NOS, or HCC with serum AFP \\>100ng\u002FmL at the time of screening and following the most recent line of therapy.\n2. Disease reoccurrence after remission following initial standard-of care (SOC) treatment (i.e., relapse) or failure of response to SOC treatment (i.e., refractory).\n3. Age ≥ 1 year and ≤ 21 years.\n4. Molecular Human Leukocyte Antigen (HLA) class I allele typing that confirms subject carries at least one HLA-A2 allele.\n5. Life expectancy of \\> 4 months per the Investigator's opinion.\n6. Lansky or Karnofsky Performance Scale ≥ 70.\n7. For enrollment to the dose-finding cohort, subjects must have at least one (1) lesion ≥ 5 mm in diameter or two (2) or more lesions ≥ 3 mm in diameter. For the dose-expansion cohort, subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n8. Child-Pugh score of A6 or better.\n9. Adequate organ function.\n\nExclusion Criteria:\n\n1. Recurrent HB who are candidates for complete surgical resection (e.g., isolated pulmonary relapse amendable to pulmonary metastasectomy).\n2. Pre-existing illness including heart failure, uncontrolled pulmonary disease not cancer-related, or psychiatric illness\u002Fsocial situation that would limit compliance with study requirements.\n3. Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.\n4. Any known active malignancy (other than HB, HCN-NOS, or HCC).\n5. Pregnant or lactating women.\n6. Received the following within two (2) weeks of leukapheresis or within two (2) weeks of conditioning chemotherapy: cytotoxic chemotherapy, radiation, other anti-cancer therapies (including immunotherapeutic agents), immunosuppressive therapy, or systemic corticosteroids at doses greater than 5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids. (Note: Topical and inhaled corticosteroids in standard doses and physiological replacement doses of corticosteroids for adrenal insufficiency are allowed).\n7. Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.\n8. Contraindication for receipt of conditioning chemotherapeutic agents including Fludarabine and Cyclophosphamide.\n9. Active autoimmune disease requiring systemic immunosuppressive therapy.\n10. Compromised circulation in the main portal vein, hepatic vein, or vena cava due to partial or complete obstruction which, in the opinion of the Investigator, would make the subject unsuitable for the study.\n11. History of organ transplant.\n12. HB, HCN-NOS, or HCC involving greater than 50% of the liver (volumetric).","1 Year","21 Years",{"count":179,"type":21},15,[24,25],"Open-label, dose escalation, multi-center, Phase I\u002FII clinical trial to assess the safety\u002Ftolerability and determine the recommended Phase II Dose (RP2D) of ET140203 T-cells in pediatric subjects who are AFP-positive\u002FHLA-A2-positive and have relapsed\u002Frefractory HB, HCN-NOS, or HCC.",[183,184,185,31,35,186],"Hepatoblastoma","Hepatocellular Carcinoma (HCC)","Liver Neoplasms","HEMNOS",[188,189,190,184,35,37,31,191,186],"Relapsed\u002FRefractory Hepatoblastoma (HB)","Pediatric","Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS)","Liver neoplasms","2025-04-07",{"date":194,"type":44},"2025-04-09",{"date":196,"type":44},"2022-07-19",{"date":198,"type":21},"2028-01-31",{"name":50,"class":51},2,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":208,"enrollmentInfo":209,"targetDuration":210,"studyType":153,"phases":4,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":104},"100409823","liver-transplantation-in-patients-with-unresectable-colorectal-liver-metastases-100409823","NCT04616495","Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases","TRASMETIR","Inclusion Criteria:\n\n* ≥ 18 and ≤ years\n* Good performance status, ECOG 0 or 1\n* Resected adenocarcinoma in colon or rectum (R0 resection)\n* Unresectable liver metastases\n* No extrahepatic disease\n* Normal blood tests\n* Response to ≤ 2 lines of chemotherapy (RECIST criteria)\n* ≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list\n* Signed informed consent\n\nExclusion Criteria:\n\n* Body mass index ≥ 30\n* Positive HIV or HCV\n* Pregnancy at the time of inclusion\n* BRAF mutated status\n* Deterioration of general condition (10% weight loss in the prior 6 months)\n* Other malignancy with disease free survival \\\u003C 5 years\n* Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected.\n* Palliative resection of primary colorectal adenocarcinoma\n* Liver metastases size \\> 5 cm (in the last imaging technique)\n* CEA \\> 80 ng\u002Fml (at time of enrolment in waiting list)\n* No neoadjuvant chemotherapy treatment\n* General contraindication to liver transplantation","65 Years",{"count":115,"type":21},"5 Years","Multicentric prospective and observational study to assess the 5-year overall survival in a cohort of patients with unresectable liver-only colorectal metastases, well controlled by chemotherapy prior to liver transplantation.",[213,31,214],"Colorectal Cancer","Liver Metastases","2023-09-21",{"date":217,"type":44},"2023-09-22",{"date":219,"type":44},"2021-09-01",{"date":221,"type":21},"2028-09",{"name":223,"class":79},"Hospital Universitario La Fe",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":241,"locationsCount":104},"100509416","pdopdo-tilpdots-for-drug-screen-100509416","NCT05913141","PDO\u002FPDO-TIL\u002FPDOTS for Drug Screen","Patient-derived Organoids, Patient-derived Organoids-tumor-infiltrating Lymphocyte Coculture System, and Patient-derived Organotypic Tissue Spheroids for Drug Screen","Inclusion Criteria:\n\n1. ≥18 years old, male or female.\n2. Liver cancer or metastatic liver cancer diagnosed clinically or pathologically, at least one measurable lesion.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.\n4. Patient has given written informed consent.\n5. The function of important organs meets the requirements.\n6. Non-surgical sterilization or women of childbearing age need to use a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period.\n\nExclusion Criteria:\n\n1. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included).\n2. The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount \\> 10 mg\u002Fday of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment.\n3. Have clinical symptoms or diseases that are not well controlled.\n4. Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization.\n5. Arterial\u002Fvenous thrombosis in the first 6 months of randomization.\n6. According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.","90 Years",{"count":115,"type":21},"This clinical trial aims to use the patient-derived organoid (PDO), Patient-derived organoids-tumor-infiltrating lymphocyte coculture system (PDO-TIL) and patient-derived organotypic tissue spheroids (PDOTS) to simulate the tumor microenvironment in cancer patients. The culture system can be used for pre-clinical validation of drugs and screening of drugs to treat sensitive people and provide individualized treatment for patients with liver cancer. This model is used to explore the molecular mechanism of drug resistance and to find intervention strategies to further improve the response rate of drugs. This study is expected to provide an ideal platform for drug screening and drug resistance research in liver cancer patients, which can replace experimental animal models, and guide personalized medication for liver cancer patients, so as to improve the overall prognosis of patients.",[35,31],"2023-06-13",{"date":237,"type":44},"2023-06-22",{"date":239,"type":21},"2023-06",{"date":99,"type":21},{"name":242,"class":79},"Shanghai Zhongshan Hospital",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":104},"100457772","phase-1-anti-cea-car-t-cells-to-treat-colorectal-liver-metastases-100457772","NCT05240950","Anti-CEA CAR-T Cells to Treat Colorectal Liver Metastases","A Clinical Study to Evaluate the Safety and Efficacy of Anti-CEA CAR-T Cells in the Treatment of Postoperative Minimal Residual Lesions in Colorectal Cancer Patients With Liver Metastases","Inclusion Criteria:\n\n1. ≥18 years old, ≤75 years old, male or female;\n2. Patients diagnosed with liver metastasis of colorectal cancer underwent radical surgery for the primary lesion of colorectal cancer, and R0 resection was performed for the liver metastasis (R0 resection was required for other organ metastasis). There was no measurable disease or tumor remnants (except invisible or unmeasurable disease) were found by imaging examination after surgery;\n3. Patients with CEA expression detected by immunohistochemistry in primary tumor and liver metastasis tumor tissues (CEA expression detected by pathology was more than 50%);\n4. Life expectancy ≥6 months;\n5. Performance status (PS) score 0-2, Karnofsky performance status (KPS) score above 60;\n6. Patients with ctDNA MRD still positive or positive again after adjuvant chemotherapy (including preoperative neoadjuvant chemotherapy);\n7. Important organ functions are sufficient, such as New York Heart Association (NYHA) heart function grade III or above, hemoglobin ≥90g\u002FL, hypoxia; Liver function: total bilirubin ≤1.5×ULN (total bilirubin ≤3×ULN in liver metastasis), ALT≤2.5×ULN, AST≤2.5×ULN (ALT or\u002Fand AST≤5×ULN in liver metastasis); Renal function: serum creatinine ≤1.5×ULN and creatinine clearance rate ≥50 mL\u002Fmin. The creatinine clearance rate was only calculated when serum creatinine ≤1.5×ULN. Minimum reserve of lung function (dyspnea no higher than grade 1 and oxygen saturation \\> 91% without oxygen);\n8. Sufficient mononuclear cells (PBMC) can be obtained from peripheral veins without contraindications;\n9. Patients of childbearing age had no birth plan within 1 year after cell infusion and took effective contraceptive measures.\n\nExclusion Criteria:\n\n1. Have a history of severe central nervous system diseases;\n2. Residual disease or tumor remnants can be seen in imaging, or tumor lesions cannot be resected in other tissues or organs;\n3. The presence of serious non-malignant diseases, including autoimmune diseases, primary immunodeficiency diseases or obstructive or restrictive respiratory diseases;\n4. Prior treatment with CAR-T or other gene-modified T cells;\n5. Participated in other clinical studies within 30 days prior to screening or plan to participate in other clinical studies during the study period;\n6. Patients with active Hepatitis B (HBV-DNA copy number \\>105copies\u002Fml), active Hepatitis C (HCV-RNA copy number \\>ULN), HIV infection, treponema pallidum infection at screening time;\n7. The existence of uncontrollable systemic infectious diseases;\n8. Other multiple malignant tumors in addition to colorectal cancer and its metastasis;\n9. Chinese herbal medicine, systemic glucocorticoids or other immunosuppressants may be required within 2 weeks prior to enrollment or during the trial period, which may negatively affect lymphocyte activity or number;\n10. Pregnancy and lactation;\n11. The existence of severe gastroduodenal ulcer, severe ulcerative colitis and other serious intestinal inflammation;\n12. The existence of serious respiratory diseases;\n13. Those who cannot provide enough white tablets for tumor pathology for next-generation sequencing (NGS) detection (at least 3 white tablets are expected);\n14. The investigator judged that there were other conditions that were not suitable for the clinical study.",{"count":251,"type":21},18,[24],"Recurrence of liver metastasis in colorectal cancer after R0 resection is mainly due to the invisible minimal residual disease, which are the main factors leading to metastasis and recurrence. Positive circulating tumor DNA (ctDNA) is the direct evidence of the minimal residual disease (MRD). In recent years, Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) has made great breakthroughs, and has achieved good therapeutic effects in hematological tumors, but the research on solid tumors is limited. CEA expression is generally elevated in gastrointestinal tumors and is associated with high aggressiveness of tumors. At present, solid tumor cell therapy targeting CEA has been carried out at home and abroad, and has achieved certain efficacy. Anti-CEA CAR-T cells targeting CEA have been constructed in the pre-clinical study of this project, and the pre-clinical study results suggest good safety and effectiveness. Formation of minimal residual disease is associated with circulating blood in the residual tumor cells. Using this feature, this project intends to conduct a phase I clinical study on patients with minimal residual disease \u002Fpositive ctDNA after R0 resection of colorectal cancer liver metastasis, so as to conduct preliminary exploration of anti-CEA CAR-T cell therapy, evaluate the safety and effectiveness of the therapy, determine the maximum tolerated dose (MTD), and provide guidance for subsequent drug dosage and clinical trials.",[213,31],[256,257,258,259],"colorectal cancer","liver metastasis","CAR-T cell","minimal residue disease","2022-03-09",{"date":46,"type":44},{"date":263,"type":21},"2022-08-25",{"date":265,"type":21},"2026-12-25",{"name":267,"class":79},"Changhai Hospital"]