[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatocellular-carcinoma-hcc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatocellular-carcinoma-hcc":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,171,0,25,[9,41,71,99,124,144,163,189,219,246,277,303,324,355,379,400,420,439,456,482,504,537,563,587,640],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100652775","hcc-risk-prediction-model-based-on-multimodal-data-in-chronic-hepatitis-b-100652775",false,"NCT07780357","HCC Risk Prediction Model Based on Multimodal Data in Chronic Hepatitis B","Development and Application of an HCC Risk Prediction Model Based on Multimodal Data in Chronic Hepatitis B","Inclusion Criteria:\n\n1. Aged ≥18 years, both sexes eligible.\n2. Diagnosed with hepatitis B-related liver fibrosis or cirrhosis based on clinical assessment or liver histopathology.\n3. Undergoing antiviral treatment.\n4. Follow-up duration between 0.5- 5 years.\n5. Availability of baseline data and at least two longitudinal follow-up visits.\n6. Clinical outcomes during the follow-up period are traceable.\n\nExclusion Criteria:\n\n1. Diagnosis of Hepatocellular carcinoma (HCC) or liver transplantation at baseline or within 6 months after baseline\u002Fenrollment.\n2. Coexisting other chronic liver diseases, such as genetic\u002Fmetabolic liver diseases, drug-induced liver injury, or severe steatotic liver disease.\n3. Coexisting other malignancies (except those considered cured).","ALL","18 Years",{"count":20,"type":21},2000,"ESTIMATED","OBSERVATIONAL","We propose to construct and validate an early HCC risk prediction model in a multicenter retrospective cohort of hepatitis B-related fibrosis\u002Fcirrhosis patients, using multimodal data encompassing longitudinal clinical data, serum glycomics profiles, and liver biopsy histopathological images.",[25],"Hepatocellular Carcinoma (HCC)",[27],"HCC, Risk Prediction Model, Multimodal Data, Chronic Hepatitis B","NOT_YET_RECRUITING","2026-08-19",{"date":31,"type":32},"2026-08-21","ACTUAL",{"date":34,"type":21},"2026-08-20",{"date":36,"type":21},"2028-12-31",{"name":38,"class":39},"Beijing Friendship Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100575558","phase-2-building-evidence-for-ablative-internal-radiation-therapy-in-localized-hcc-beyond-the-up-to-7-criteria-100575558","NCT06773845","Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria","Building Evidence for Ablative Internal Radiation Therapy Using Yttrium-90 Glass Microspheres in Localized Hepatocellular Carcinoma Beyond the Up-To-7 Criteria","BEAT-UT7","Inclusion criteria\n\n* Adult aged 19 and over\n* HCC diagnosed by histology or non-invasive criteria of the American Association for the Study of Liver Disease\n* Unresectable HCC beyond the UT7 criteria: the sum of the diameter of the largest tumor (cm) and the number of tumors \\> 7\n* Localized HCC: all tumors are in the one to five geographically adjacent Couinaud segments\n* No current or previous HCC in the untreated liver (i.e., future liver remnant \\[FLR\\])\n* FLR volume \\> 30% of total non-tumorous liver volume\n* Child-Pugh class A\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n* No major organ dysfunction according to blood test performed within two months of study enrollment:\n\n  * Leukocytes ≥ 2,000\u002FµL and ≤ 15,000\u002FµL\n  * Hemoglobin ≥ 8.0 g\u002FdL (transfusion allowed to meet this criterion)\n  * Total bilirubin ≤ 2.0 mg\u002FdL\n  * Platelet ≥ 40,000\u002FµL\n  * International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants\n  * Aspartate transaminase (AST) ≤ 200 IU\u002FL (i.e., ≤ 5X upper normal limit)\n  * Alanine transaminase (ALT) ≤ 200 IU\u002FL (i.e., ≤ 5X upper normal limit)\n  * Creatinine ≤ 2.5 mg\u002FdL\n* Patients with a life expectancy of more than 3 months\n* For women of childbearing age, a negative serum pregnancy test\n* Patients who have adequately understood the clinical trial and consented in writing\n\nExclusion Criteria:\n\n* HCC with vascular invasion and\u002For bile duct invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI)\n* HCC with extrahepatic spread on chest CT and abdominal CT or MRI\n* Multinodular disseminated HCC: largest tumor size \\\u003C 6 cm, or number of tumors \\> 10\n* Patients who are not suitable for ablative radioembolization as indicated by pre-treatment mapping with 99mTc-macroaggregated albumin (MAA):\n\n  * Cases where the estimated lung dose exceeds 30 Gy when 350 Gy of tumor absorbed dose is administered to the tumor based on the multicompartment Medical Internal Radiation Dose (MIRD) model\n  * Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments\n  * Cases where the operator determines that there is substantial adhesion with the surrounding organs such as the bowel, making ablative radioembolization infeasible\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* Patients who have had active cancer within the last two years prior to the study enrollment\n* History of severe allergy of intolerance to contrast agents\n* Contraindication to angiography or selective visceral catheterization","19 Years",{"count":51,"type":21},100,"INTERVENTIONAL",[54],"PHASE2","At four major centers in Korea, patients with hepatocellular carcinoma (HCC) that exceed the up-to-7 criteria yet remain locally confined will undergo ablative radioembolization using Yttrium-90 glass microspheres, guided by a standardized dosimetry method. Their treatment response, survival outcomes, and adverse events will be monitored for two years following the procedure.",[25,57],"Radioembolization",[59,57,60],"Hepatocellular carcinoma","SIRT","RECRUITING","2026-08-18",{"date":34,"type":32},{"date":65,"type":32},"2025-03-11",{"date":67,"type":21},"2030-12-31",{"name":69,"class":39},"Seoul National University Hospital",8,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":52,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":40},"100641290","phase-1-a-phase-1-and-2-study-of-vmd-102-in-hepatocellular-carcinoma-and-other-solid-tumors-100641290","NCT07636785","A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors","A Phase 1 and 2 First-in-human, Open-label, Multicenter Study to Assess the Safety, Tolerability and Preliminary Efficacy of VMD-102 in Participants With Hepatocellular Carcinoma and Other Advanced Solid Tumors","SPKTAHC","Inclusion Criteria:\n\n* Histological or cytological or radiological diagnosis of advanced (unresectable and\u002For metastatic) HCC, MUM, RCC, NSCLC and CRC that is not responsive to standard of care (SOC), had progressed following SOC, is intolerant to SOC, or for whom the SOC is not considered appropriate by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, or 1.\n* Has at least one measurable target lesion according to RECIST v1.1 \\[Response Evaluation Criteria In Solid Tumors\\], or mRECIST \\[modified RECIST\\] for unresectable HCC participants, and either (a). has not been previously treated with local therapy (e.g., radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy), or (b). if the target lesion was within the field of local therapy, the lesion has shown an increase in size of 25% or greater following local therapy.\n* Adequate organ function evidenced by:\n\nHematology\n\n* Hemoglobin ≥ 9 g\u002FdL (SI Units: 90 g\u002FL) (post-transfusion if transfusion-dependent)\n* Platelet count ≥ 60000\u002Fmm3 (60 x109\u002FL) without support(transfusion) within 7 days of testing\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3 (1.5x109\u002FL) Chemistry\n* Total bilirubin (TBIL) ≤ 2.0 x upper limit of normal (ULN). (For participants with Gilbert's syndrome, TBIL ≤3.0 x ULN provided that direct bilirubin DBIL) is \\\u003C30% of the TBIL)\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) 1 ≤ 5 x U LN (participants with advanced HCC or liver metastases)\n* AST and\u002For ALT 1 ≤ 3 x ULN (participants without known liver disease or liver metastases)\n* Calculated creatinine clearance or 24h urine creatinine clearance ≥50 mL\u002Fmin using Cockroft-Gault formula.\n* Serum creatinine ≤ 1.5x ULN\n\nCoagulation (unless taking an anti-coagulant):\n\n* Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (except for participants receiving therapeutic anticoagulants)\n* International normalized ratio (INR) ≤ 1.5 unless the participant is receiving anticoagulant therapy as long as the participant is within therapeutic range of intended use of anticoagulants\n* Albumin ≥2.8g\u002Fd\u002FL.\n\n  * For HCC participants: the diagnosis must be made based on American Association for the Study of Liver Diseases (AASLD) Guidelines with confirmed advanced (unresectable) HCC staged by Barcelona Clinic Liver cancer criteria (BCLC). Cirrhosis will be staged by Child-Pugh score, and such a score ≤ 6 will be eligible for Phase 1 and ≤7 for Phase 2.\n  * Participants must either have available archival tumor tissue samples, or consent to fresh tumor tissue sampling prior to the first dose unless the biopsy is not safe or not feasible per investigator assessment and with medical monitor approval.\n  * Women of childbearing potential (WOCBP) must have a negative pregnancy test prior to enrolment and agree to use a highly effective and acceptable method of contraception from the time of informed consent (or screening) until 6 months after the last dose of investigational agent.\n  * Male participants who are sexually active with a female partner of childbearing potential must agree to use a condom with spermicide from first dose of investigational agent until 6 months after the last dose, and refrain from sperm donation during that period. Abstinence from heterosexual intercourse is an acceptable method only if the participant's usual lifestyle already includes abstinence.\n  * Participant has a life expectancy of ≥3 months.\n  * No history of liver transplantation.\n  * Ability to swallow and absorb an orally self-administered medication in tablet form.\n  * Have completed any prior chemotherapy, monoclonal antibody or immunotherapy (e.g., tumor vaccine, cytokine, or growth factor given to control the cancer) at least 4 weeks or 5 half-lives (whichever is shorter) before study drug administration. Exceptions to these prior therapy timeframes are possible, on a case by case basis, following discussion and mutual agreement between Investigator and Sponsor.\n  * Adverse effects related to prior anticancer therapies must have either returned to baseline or resolved to Grade 0 or 1. Some toxicities with higher grades such as alopecia, immunotherapy-induced hypothyroidism or adrenal insufficiency or panhypopituitarism requiring stable doses of hormone replacement therapy or rash from prior therapy may be permitted with medical monitor approval.\n\nExclusion Criteria:\n\n* Received anticancer therapy with radiation, immunotherapy, a biologic, surgery and\u002For tumor embolization within the past 2 weeks or 5 half-lives (whichever is longer).\n* Currently pregnant, nursing, or planning to become pregnant during the course of study.\n* The Fridericia Corrected QT (QTcF) interval ≥ 480 msec.\n* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (Section 14.8); or presence of clinically significant and uncontrolled cardiac disease, as assessed by the investigator. Such as but not limited to: symptomatic congestive heart failure, unstable angina, cardiac arrhythmia.\n* Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the participant's safety or interfere with assessment of the drug.\n* Psychological, familial, sociological, geographical or other concurrent conditions that would interfere with safety evaluation, limit the participant's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Participants with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.\n* Participants have multiple factors that affect their oral medication (such as inability to swallow and intestinal obstruction or resection).\n* Participants have long-term unhealed wounds or fractures.\n* Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.\n* Any current medical conditions, including impairment of GI function or GI disease, which would alter the absorption, distribution, metabolism or excretion of VMD-102 including but not limited to:\n\n  * Severe uncontrolled nausea or vomiting.\n  * Severe uncontrolled diarrhea or ongoing active diarrhea requires medications (e.g. bile acid sequestrant, loperamide).\n  * A history of short bowel syndrome; irritable bowel syndrome with diarrheal signs\u002Fsymptoms or require medications.\n  * Clinically diagnosed malabsorption secondary to bowel resection.\n  * Active Ulcerative colitis or Crohn's disease requiring medication for control.\n  * Surgical procedures of the GI tract impacting the drug absorption such as but not limited to small bowel resection and gastric bypass.\n* Unstable central nervous system (CNS) metastases. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least one cycle prior to the first dose and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are on stable doses of steroids for at least one cycle prior to the first dose.\n* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC or HCC due to cirrhosis caused from autoimmune-associated hepatitis.\n* Hepatitis B surface antigen (HBsAg) positive with detectable the hepatitis B virus load (HBV DNA) \\>100 IU\u002FmL. Participants on active HBV therapy with viral loads \\\u003C100 IU\u002FmL should stay on the same therapy throughout study intervention and at least 12 weeks after the study is over. Participants cannot be actively co-infected with hepatitis C virus (HCV; HCV RNA detectable) or hepatitis delta virus (HDV; HDV RNA detectable).\n* Positive HBsAg, with or without detectable HBV DNA, if there is evidence in the medical history of an advanced stage of cirrhosis ( Child-Pugh B) or history of decompensated chronic liver disease\n* HCV antibody (HCVAb) positive and HCV viral load (HCV RNA) detectable. Previous HCVAb positive with HCV RNA undetectable due to treatment (DAAs or interferon) is allowed but the treated participants must have completed their treatment at least 12 weeks prior to starting study intervention and HCV RNA must be documented at below the limit of quantification.\n* History of allogeneic tissue\u002Forgan transplantation (including bone marrow, stem cell, liver, or kidney transplants), except those that do not require immunosuppressive therapy (e.g., corneal or hair transplants).\n* Coronavirus disease 2019 (COVID-19) or any live attenuated vaccine within 4 weeks of study entry.\n* Participants with active alcohol and\u002For substances abuse, Phosphatidylethanol (Peth) must be \\\u003C50 ng\u002FmL).\n* Concurrent secondary malignancy other than that being treated in this study. Exceptions to this exclusion include malignancies treated curatively and have not recurred within 2 years prior to study entry or tumors treated with curative intent that have expected cure rates of \\>90% such as but not limited to: basal cell and squamous skin cancer and completely resected carcinoma in situs.\n* Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage. Exception may be possible, on a case by case basis, e.g. if no more than one paracentesis in a month and a drain is pre-placed for the participant to drain, following discussion and mutual agreement between Investigator and Sponsor\n* Participants have long-term unhealed wounds or fractures.\n* Participants receiving known potent P-glycoprotein (P-gp) efflux transporter inhibitors that cannot be discontinued 3 days prior to the start of study treatment and during the course of the Phase 1 study.\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drug, or excipients.\n* Known history of uncontrolled human immunodeficiency virus (HIV) infection.\n* Any other condition that, in the opinion of the Investigator or the medical monitor, could increase the risk to the participant, interfere with study participation, or affect the proper interpretation of study results and objectives. Such conditions may include but are not limited to, active infections, uncontrolled diabetes, psychiatric illness, social situations, and concomitant therapies.","75 Years",{"count":81,"type":21},111,[83,54],"PHASE1","This study is to evaluate the safety and tolerability to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), and (ii) preliminary anti-tumor efficacy (Phase 2), in participants with advanced HCC, metastatic uveal melanoma (MUM), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). The pharmacokinetics (PK), preliminary anti-tumor activity, and potential biomarkers of VMD-102 will also be assessed.\n\nVMD-102 will be the first selective PKC epsilon (PKCε or PKCe) kinase inhibitor to enter human clinical testing. Preclinical VMD-102 anti-tumor activities in mouse liver\u002FHCC tumor models and preclinical toxicology and pharmacology studies support this study.",[25,86,87,88,89],"Metastatic Uveal Melanoma","Renal Cell Carcinoma (RCC)","Nonsmall Cell Lung Cancer","Colorectal Cancer (CRC)","2026-08-17",{"date":29,"type":32},{"date":93,"type":32},"2026-07-16",{"date":95,"type":21},"2031-12",{"name":97,"class":98},"VM Discovery, Inc.","INDUSTRY",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":52,"phases":108,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100615320","phase-1-a-study-to-evaluate-the-safety-and-tolerability-of-pumitamig-alone-or-in-combination-with-ipilimumab-in-participants-with-first-line-advanced-or-unresectable-hepatocellular-carcinoma-hcc-rosetta-hcc-206-100615320","NCT07291076","A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)","ROSETTA HCC-206: An Open-Label, Multi-Center, Randomized Phase 1\u002F2 Study of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC)","Inclusion Criteria\n\n* Participants must have a histologically confirmed diagnosis of locally advanced or unresectable Hepatocellular Carcinoma (HCC).\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have no prior systemic therapy for advanced\u002F unresectable HCC.\n* Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n\nExclusion Criteria\n\n* Participants must not have significant bleeding or coagulation disorders or other obvious bleeding risk evidence.\n* Participants must not have an organ transplant or autoimmune disease.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":107,"type":21},198,[83,54],"The purpose of this study is to evaluate the safety and tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)",[25],[112,113,114,115],"First line HCC","Unresectable HCC","Ipilimumab","Pumitamig",{"date":62,"type":32},{"date":118,"type":32},"2026-03-16",{"date":120,"type":21},"2031-10-14",{"name":122,"class":98},"Bristol-Myers Squibb",67,{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100591345","streamlining-radioembolization-for-small-hcc-100591345","NCT06979219","Streamlining Radioembolization for Small HCC","Streamlining Radioembolization for HCC ≤ 5 cm With Y90 Resin Microspheres : Multicenter Prospective Registry Study","ISTAR-02","Inclusion Criteria:\n\n* adults aged \\>18 years\n* Patients diagnosed with hepatocellular carcinoma histologically and\u002For radiologically (LI-RADS 4 or 5)\n* hepatocellular carcinoma 5cm or smaller\n* Tumor number is 3 or smaller\n* Dysmorphic intratumoral vessel is absent or smaller than 3 mm\n* Child-Pugh class A\n* ECOG 0 or 1\n* the following lab should be met. 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 patient is receiving hemodialysis, no upper limit of creatinine)\n* Patients with a life expectancy of \\>3 mo\n* Patients who have adequately understood the clinical trial and consented in writing\n* Nonpregnant women of childbearing potential\n\nExclusion Criteria:\n\n1. Hepatic vein invasion on CT\u002FMRI\n2. Marked enhancement of portal vein or hepatic vein on arterial phase of CT\u002FMRI\n3. Dysmorphic intratumoral vessel ≥3mm\n4. Patient with transjugular intrahepatic portosystemic shunt\n5. Patient with bilioenteric anastomosis or biliary stent\n6. Patient with centrilobular emphysema or interstitial lung disease\n7. main portal vein invasion",{"count":133,"type":21},146,"In patients who has no sign suggesting high lung shunt fraction (TIPS, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel, tumor size \\\u003C 5cm), radioembolization is performed without MAA scan with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and streamlining radioembolization is feasible and safe.",[25],"2026-08-16",{"date":62,"type":32},{"date":139,"type":32},"2025-06-10",{"date":141,"type":21},"2029-12-31",{"name":69,"class":39},5,{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":152,"targetDuration":154,"studyType":22,"phases":4,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":161,"locationsCount":162},"100588675","same-day-radioembolization-for-large-hcc-100588675","NCT06944483","Same-day Radioembolization for Large HCC","Same-day Radioembolization for Large HCC (>5cm) With Y90 Resin Microspheres : Multicenter Prospective Registry Study","ISTAR-01","Inclusion Criteria:\n\n* Patients diagnosed with hepatocellular carcinoma histologically and\u002For radiologically (LI-RADS 4 or 5)\n* hepatocellular carcinoma 5cm or larger\n* dysmorphic intratumoral vessels 3mm or smaller\n* Child-Pugh class A\n* ECOG 0 or 1\n* the following lab should be met. 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 patient is receiving hemodialysis, no upper limit of creatinine)\n* Patients with a life expectancy of \\>3 mo\n* Patients who have adequately understood the clinical trial and consented in writing\n* Nonpregnant women of childbearing potential\n\nExclusion Criteria:\n\n* hepatic vein invasion on CT\u002FMRI\n* Marked enhancement of portal vein or hepatic vein on arterial phase of CT\u002FMRII\n* TIPS\n* dysmorphic intratumoral vessels \\> 3mm\n* main portal vein invasion\n* significant COPD or interstitial lung disease\n* biliary stent or enterobiliary anastomosis",{"count":153,"type":21},138,"12 Months","In patients who has no sign suggesting high lung shunt fraction (TIPS, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel), planning angiography, MAA scan, and radioembolization are performed in a single day with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and same-day radioembolization is feasible and safe.",[25],{"date":62,"type":32},{"date":159,"type":32},"2025-04-25",{"date":141,"type":21},{"name":69,"class":39},4,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":52,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":40},"100652439","phase-2-atezolizumab-bevacizumab-and-tocilizumab-in-advanced-hepatocellular-carcinoma-100652439","NCT07774247","Atezolizumab, Bevacizumab, and Tocilizumab in Advanced Hepatocellular Carcinoma","A Multicenter, Phase II Study to Evaluate the Safety and Efficacy of Atezolizumab, Bevacizumab, and Tocilizumab in Patients With Advanced Hepatocellular Carcinoma","AB-TCZ","Inclusion Criteria:\n\n1. Histologically, cytologically, or radiologically confirmed diagnosis of locally advanced, metastatic, and\u002For unresectable hepatocellular carcinoma (HCC).\n2. Age ≥19 years at the time of signing the informed consent form (ICF).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study drug.\n4. Child-Pugh class A (score 5-6) within 7 days prior to the first dose of study drug.\n5. Disease not amenable to curative surgical and\u002For locoregional therapy.\n\n   \\- Patients who have experienced disease progression after prior surgical and\u002For locoregional therapy are eligible.\n6. Ability to provide written informed consent prior to initiation of any study-specific procedures, including agreement to comply with the requirements and restrictions listed in this protocol.\n7. No prior systemic therapy for hepatocellular carcinoma, including investigational agents.\n\n   \\- Prior use of herbal or traditional medicines with known or potential anticancer activity is permitted only if discontinued prior to initiation of study treatment.\n8. Estimated life expectancy of at least 3 months.\n9. At least one measurable lesion according to RECIST version 1.1.\n\n   \\- Patients who have received prior locoregional therapy (e.g., radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, or transarterial embolization) are eligible if the target lesion has not been previously treated or if the lesion has demonstrated progression within the treated area per RECIST v1.1.\n10. Adequate hematologic and organ function, as defined by the following laboratory values obtained within 7 days prior to the first dose of study drug (no blood transfusion or albumin administration within 2 weeks prior to or during screening to meet eligibility criteria).\n\n    * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (≥1500\u002FμL)\n    * Lymphocyte count ≥ 0.5 x 109\u002FL (≥500\u002FμL)\n    * Platelet count ≥ 100 x 109\u002FL (≥100,000\u002FμL)\n    * Hemoglobin ≥ 90 g\u002FL (≥9.0 g\u002FdL)\n    * AST, ALT, and ALP ≤ 5 x ULN\n    * Total bilirubin ≤ 3 x ULN\n    * Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n    * Albumin ≥ 28 g\u002FL (≥2.8 g\u002FdL)\n    * For patients not receiving anticoagulants: INR or aPTT ≤1.5 x ULN, patients receiving low-molecular-weight heparin are eligible.\n11. Documented hepatitis virus status based on screening tests for HBV and HCV.\n\n    * For patients with active HBV infection: HBV DNA \\\u003C500 IU\u002FmL during screening, initiation of antiviral therapy at least 14 days prior to the first dose of study drug, and willingness to continue antiviral therapy throughout the study.\n    * For patients with active or prior HCV infection: negative HCV RNA (PCR).\n    * Patients with co-infection of HBV and HCV are not eligible.\n12. Reproductive status:\n\n    * Female patients must not be pregnant or breastfeeding.\n    * Negative serum pregnancy test within 72 hours prior to the first dose of study drug.\n    * Female patients must agree not to breastfeed from the time of consent until at least 6 months after the last dose of study drug.\n    * Females of childbearing potential and non-sterilized males must agree to use two effective methods of contraception during the study and for at least 6 months after the last dose.\n13. Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiogram or MUGA scan, with no severe valvular disease or clinically significant arrhythmia.\n14. Corrected QT interval using Fridericia's formula (QTcF) ≤470 msec.\n15. Willingness to provide blood samples.\n\nExclusion Criteria:\n\n1. Prior systemic therapy for locally advanced, metastatic, and\u002For unresectable hepatocellular carcinoma, including chemotherapy, biologic therapy, immunotherapy, hormonal therapy, or investigational agents.\n\n   \\- Prior adjuvant therapy is permitted if disease recurrence occurred at least 6 months after completion of the last treatment, including adjuvant therapy and radiotherapy.\n2. Presence of multiple primary malignancies.\n\n   \\- Exceptions include completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or other malignancies with no recurrence for ≥5 years.\n3. Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed hepatocellular-cholangiocarcinoma.\n4. Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding: Patients must undergo esophagogastroduodenoscopy (EGD) prior to enrollment, and all varices must be evaluated and treated according to institutional standard of care. If evaluation has been performed within 6 months prior to the first dose of study drug, repeat evaluation is not required.\n5. Residual toxicities from prior therapy that, in the investigator's opinion, may interfere with safety evaluation of the study drug, or patients for whom the possibility of surgical resection cannot be completely excluded at the time of enrollment.\n6. History of severe hypersensitivity reactions to other monoclonal antibody products.\n\n   * Prior exposure to or hypersensitivity to anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 antibodies, or other agents targeting T-cell regulation.\n   * Known hypersensitivity or allergy to atezolizumab, bevacizumab, or tocilizumab.\n7. Active autoimmune disease or a history of chronic or recurrent autoimmune disease, or use of systemic immunosuppressive medications within 2 weeks prior to the first dose of study drug.\n\n   * Patients with hypothyroidism requiring only hormone replacement therapy, vitiligo, psoriasis not requiring systemic treatment, or other conditions deemed stable and safe by the investigator may be eligible.\n   * Patients with primary or secondary immunodeficiency or active immunodeficiency are excluded.\n8. Current or prior history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings.\n\n   \\- Patients with radiation pneumonitis may be eligible if clinically stable (beyond the acute phase) without concern for recurrence.\n9. Known central nervous system (CNS) metastases.\n10. Presence of clinically significant pericardial effusion, pleural effusion, or ascites requiring treatment.\n11. Uncontrolled tumor-related pain: patients requiring chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control during study treatment are excluded.\n12. History of transient ischemic attack or cerebrovascular accident within 180 days prior to enrollment.\n13. History of significant cardiovascular disease, including any of the following:\n\n    * Myocardial infarction within 180 days prior to enrollment.\n    * Uncontrolled angina within 180 days prior to enrollment\n    * Congestive heart failure classified as New York Heart Association (NYHA) Class III or IV.\n    * Uncontrolled hypertension despite appropriate medical management (e.g., systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg persisting for ≥24 hours).\n    * Arrhythmia requiring treatment.\n    * Significant vascular disease, including recent peripheral arterial thrombosis or aneurysm requiring surgical intervention.\n14. Uncontrolled diabetes mellitus.\n15. Systemic infection requiring treatment within 14 days prior to the first dose of study drug and treated with intravenous antibiotics (prophylactic use of oral antibiotics is permitted).\n16. Use of systemic corticosteroids (\\>10 mg\u002Fday of prednisolone or equivalent) or other immunosuppressive medications within 28 days prior to the first dose of study drug (excluding short-term use for diagnostic, prophylactic, or similar purposes).\n17. Patients who received anticancer therapy (e.g., cytotoxic chemotherapy, targeted therapy, immunotherapy) within 28 days prior to the first dose of study drug.\n\n    \\- Adjuvant therapy completed more than 6 months prior is permitted.\n18. Pleurodesis or pericardiodesis within 28 days prior to the first dose of study drug.\n19. Current or recent (within 2 weeks) use of aspirin (\\>325 mg\u002Fday) or antiplatelet agents such as clopidogrel, dipyridamole, ticlopidine, or cilostazol for therapeutic purposes: prophylactic anticoagulation is permitted if INR \\\u003C1.5 × ULN and aPTT is within normal limits.\n20. Major surgery under general anesthesia within 28 days prior to the first dose of study drug.\n21. Surgery under local anesthesia within 14 days prior to the first dose of study drug.\n22. Palliative radiotherapy within 28 days prior to the first dose of study drug, or radiotherapy to bone metastases within 14 days prior to the first dose.\n23. Positive test for any of the following:\n\n    \\- HIV-1 antibody, HIV-2 antibody.\n24. Pregnant or breastfeeding patients, or those with a possibility of pregnancy or plans to become pregnant.\n25. Patients who received unapproved or investigational agents (e.g., investigational drugs, unapproved drug combinations, or unapproved formulations) within 28 days prior to enrollment.\n26. Patients deemed unable to provide informed consent due to comorbid conditions such as dementia.\n27. Patients unable or unwilling to sign the informed consent form.\n28. Known pre-existing central nervous system demyelinating disorders or seizure disorders.\n29. Known active diverticulitis, chronic ulcerative lower gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis), or other symptomatic lower gastrointestinal conditions that may predispose patients to gastrointestinal perforation.\n30. Current active infection or history of recurrent infections, including but not limited to tuberculosis, atypical mycobacterial infection, herpes zoster, or other bacterial, viral, fungal, or mycobacterial infections (excluding fungal nail bed infections).",{"count":172,"type":21},51,[54],"This is a Phase 2, open-label, single-arm, multicenter study designed to evaluate the safety and efficacy of atezolizumab, bevacizumab, and tocilizumab in patients with locally advanced, metastatic, and\u002For unresectable hepatocellular carcinoma (HCC). Approximately 51 patients will be enrolled at 6 study sites and will receive combination therapy consisting of atezolizumab, bevacizumab, and tocilizumab. Patients assigned to the study will receive atezolizumab 1,200 mg intravenously and bevacizumab 15 mg\u002Fkg intravenously on Day 1 of each 21-day cycle, alongside tocilizumab 4 mg\u002Fkg intravenously on Day 1 of each 42-day cycle for up to 5 doses. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. The study population includes adult patients with locally advanced, metastatic, and\u002For unresectable HCC who have received no prior systemic therapy for hepatocellular carcinoma. Eligible patients must have histologically, cytologically, or radiologically confirmed diagnosis, at least one measurable lesion according to RECIST version 1.1, Child-Pugh class A liver function, ECOG performance status 0 or 1, and adequate organ function. The primary objective is to assess the incidence of Grade 3 or higher immune-related adverse events (irAEs) occurring within 24 weeks after treatment initiation according to NCI CTCAE version 5.0. Secondary objectives include evaluation of objective response rate (ORR) and disease control rate (DCR) according to RECIST v1.1, progression-free survival, overall survival, and the rate of treatment discontinuation due to adverse events. Safety evaluations will include assessment of adverse events, serious adverse events, laboratory parameters, vital signs, and other clinical assessments. Exploratory objectives include evaluation of the correlation between treatment response and serum inflammatory markers (such as IL-6 and CRP) and immune cell profiles using blood samples collected at protocol-defined intervals. Tumor assessments will be performed at protocol-defined intervals using radiologic imaging every 6 weeks from Cycle 1 Day 1 up to Week 54, and every 9 weeks thereafter. The primary efficacy analysis will be based on the Full Analysis Set according to RECIST v1.1. This study is intended to evaluate the clinical activity and safety profile of prophylactic tocilizumab in combination with atezolizumab and bevacizumab in this patient population and to generate data to inform future clinical development.",[25],[177,178,179,180],"HCC","IL-6","Immunotherapy","Tocilizumab","2026-08-14",{"date":29,"type":32},{"date":184,"type":21},"2026-09-01",{"date":186,"type":21},"2029-09-01",{"name":188,"class":39},"CHA University",{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":196,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":52,"phases":199,"briefSummary":201,"conditions":202,"keywords":208,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":215,"leadSponsor":217,"locationsCount":40},"100651979","pragmatic-rct-of-ai-assisted-reading-for-malignant-hepatic-lesions-on-ce-ct-100651979","NCT07768085","Pragmatic RCT of AI-Assisted Reading for Malignant Hepatic Lesions on CE-CT","A Multicenter Randomized Controlled Trial of AI-Assisted Reading Compared With Standard Radiology Interpretation for Malignant Hepatic Lesions on Contrast-Enhanced CT: Diagnostic, Clinical and Workflow Outcomes","Inclusion Criteria:\n\n1. Age range 18 years and above\n2. Underwent dynamic contrast-enhanced abdominal CT examination with liver coverage\n3. Imaging must include at least three required phases: non-contrast, arterial phase, and venous phase; a delayed phase is optional\n4. Complete imaging data that meet AI system and radiologist interpretation requirements.\n\nExclusion Criteria:\n\n1. History of recent upper-abdominal surgery (within 30 days) or major hepatobiliary-pancreatic surgery affecting liver evaluation (e.g., liver transplantation or Whipple procedure); patients with prior simple cholecystectomy or single-lesion interventional procedures are not excluded\n2. History of recent hepatic trauma (within 30 days)\n3. Poor image quality or severe noise artifacts (e.g., metal or motion artifacts)\n4. Missing required imaging phases (required at least non-contrast, arterial, and venous phases) or inadequate scan range (e.g., lower-abdomen CT such as pelvic or rectal scans not covering the liver)",true,{"count":198,"type":21},40000,[200],"NA","The purpose of this multicenter pragmatic randomized controlled trial is to determine whether AI-assisted interpretation of multiphasic liver contrast-enhanced computed tomography (CE-CT) is non-inferior to standard radiology reporting with respect to missed clinically significant malignant focal liver lesions, \\*\\*with the non-inferiority margin prespecified in the statistical analysis plan before enrollment\\*\\*, and whether it improves lesion detection, diagnostic characterization, downstream clinical management, and reporting efficiency. On AI-assisted center-days, AI results will be revealed only after the first-line radiologist has saved an unaided initial assessment and may be used to revise the final report. On control center-days, examinations will be interpreted using the standard radiology workflow without access to AI tools.",[25,203,204,205,206,207],"Intrahepatic Cholangiocarcinoma (Icc)","Hepatic Metastasis","Hepatic Hemangioma","Cyst","Focal Nodular Hyperplasia",[209,210,211,212],"Dynamic Contrast-Enhanced CT","Focal Liver Lesions","Artificial intelligence","AI-assisted interpretation",{"date":90,"type":32},{"date":90,"type":21},{"date":216,"type":21},"2027-12-31",{"name":218,"class":39},"Shengjing Hospital",{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":52,"phases":229,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100609073","phase-2-gkl-006-combined-with-tace-in-treatment-of-unresectable-hepatocellular-carcinoma-100609073","NCT07209813","GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma","A Multicenter, Randomized, Open-Label, Controlled Phase 2 Study of GKL-006 Injection in Combination With Transarterial Chemoembolization (TACE) Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma","Main Inclusion Criteria:\n\n* Voluntarily participates in the study and provides written informed consent.\n* Male or female, age ≥ 18 and ≤ 80 years old\n* Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma.\n* Has CNLC stage II to IIIa disease.\n* Has at least one measurable lesion according to mRECIST.\n* Child-Pugh class A or B.\n* ECOG performance status of 0 - 2.\n* Adequate hematologic and organ function.\n\nMain Exclusion Criteria:\n\n* Has a known allergy to the investigational product or related components, including human serum albumin and IL-2.\n* Has another incurable malignancy within 5 years before screening or concurrently.\n* Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma.\n* Has received therapy aim to target lesion(s) within 12 weeks before screening.\n* Has hepatic encephalopathy within 4 weeks before screening.\n* Has clinically symptomatic ascites or pleural effusion requiring drainage, or has undergone thoracic or abdominal fluid drainage.\n* Has other active disease.","80 Years",{"count":228,"type":21},48,[54],"This is a multicenter, randomized, open-label, controlled Phase 2 study in patients with unresectable hepatocellular carcinoma (uHCC).\n\nThe purpose of this study is to compare the efficacy and safety of GKL-006 Injection in combination with transarterial chemoembolization (TACE) versus TACE alone.",[25,232],"Unresectable Hepatocellular Cancer",[59,234,235,179,236],"iNKT","GKL-006","Cell therapy","2026-08-13",{"date":90,"type":32},{"date":240,"type":32},"2025-11-14",{"date":242,"type":21},"2027-10-31",{"name":244,"class":98},"Beijing Gene Key Life Technology Co., Ltd",7,{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":52,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":276},"100452820","phase-1-study-of-zanzalintinib-in-combination-with-immuno-oncology-or-other-agents-in-participants-with-solid-tumors-100452820","NCT05176483","Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors","A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology or Other Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors","STELLAR-002","Key Inclusion Criteria:\n\n* Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.\n* Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n* Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.\n\n  * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.\n* Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.\n\n  * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)\u002FProgrammed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.\n  * Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.\n* Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.\n\n  * Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.\n* Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).\n\n  * Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence \\\u003C 12 months from the end of last therapy.\n  * Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.\n* Expansion Cohort 5 (post enfortumab vedotin \\[EV\\] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.\n\n  * Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1\u002FPD-L1 inhibitor or ineligible for PD-1\u002FPD-L1 inhibitor.\n  * Prior receipt of platinum-based therapy allowed but not required.\n  * Prior therapy with other agents allowed but not required.\n* Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.\n\n  * No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.\n* Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and\u002For unresectable HCC that is not amenable to curative treatment or locoregional therapy.\n* Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score \\[TPS\\] 1-49%) and without prior systemic anticancer therapy for metastatic disease.\n* Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.\n* Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.\n* Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.\n* Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.\n\n  * Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma\n* Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.\n* Cohort 15 (mCRPC, post-ARPI, visceral metastases): Men with metastatic adenocarcinoma of the prostate.\n* Cohort 16 (Drug-drug interaction \\[DDI\\]):\n\n  * Participants with a solid tumor that is unresectable or metastatic and for which life prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n  * Able to swallow capsules or tablets.\n* For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.\n* For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.\n* Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and\u002For stable on supportive therapy.\n* Karnofsky Performance Status (KPS) ≥ 70%.\n* Adequate organ and marrow function.\n* Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.\n* Females of childbearing potential must not be pregnant at screening.\n\nKey Exclusion Criteria:\n\n* For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1\u002FPD-L1, Lymphocyte-activation gene 3 (LAG-3) and cytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.\n* Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.\n* Administration of a live, attenuated vaccine within 30 days prior to first dose.\n* Uncontrolled, significant intercurrent or recent illness.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 460 ms for females and \\> 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.\n* Participants with inadequately treated adrenal insufficiency.\n* Pregnant or lactating females.\n* Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.\n* For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.\n* For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.\n* For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.\n* For Cohort 7 (HCC):\n\n  * Documented hepatic encephalopathy (HE) within 6 months before the first dose.\n  * Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.\n  * Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.\n  * Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma\n* For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and\u002For trifluridine + tipiracil (TAS-102).\n* For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.\n* For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable \\[MSS\\], 2L+), and 11 (HNSCC):\n\n  * Troponin T (TnT) or I (TnI) \\> 2 × institutional upper limit of normal (ULN).\n* For Cohort 16 (DDI):\n\n  * Known hypersensitivity to midazolam, warfarin, omeprazole, or caffeine.\n  * History of major head trauma (with loss of consciousness) within the past year or minor head trauma (without loss of consciousness) within 3 months prior to first dose of study treatment on Day 1.\n  * Primary liver tumor.\n  * Unable to refrain from or anticipates the use of the following:\n\n    * Any drugs known to be inducers or inhibitors of CYP3A4, CYP2C9, CYP2C19, and\u002For CYP1A2 within 14 days before the first dose of study treatment on Day 1 through the DDI assessments on Day 20.\n    * Drugs that are contraindicated with midazolam, warfarin, omeprazole, and\u002For caffeine during the DDI assessment part.\n    * Caffeine-containing beverages, products, and foods at least 3 days prior to and 3 days after probe substrate cocktail administration on Day 1 and Day 16.\n\n      * Poor peripheral venous access.\n\nNote: Additional Inclusion and Exclusion criteria may apply.",{"count":255,"type":21},1394,[83],"This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) and in combination with docetaxel and prednisone in participants with advanced solid tumors. In addition, the study will evaluate the effect of multiple dose administration of zanzalintinib on the single-dose pharmacokinetics of sensitive CYP3A4, CYP2C9, CYP2C19, or CYP1A2 substrates in participants with advanced solid tumors.\n\nIn the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.",[87,259,260,261,25,262,89,263,264,265,266],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Urothelial Carcinoma (UC)","Solid Tumor","Non-small Cell Lung Cancer (NSCLC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Non-Clear Cell Renal Cell Carcinoma (nccRCC)","Drug-Drug Interaction (DDI)","2026-08-03",{"date":269,"type":32},"2026-08-05",{"date":271,"type":32},"2021-12-14",{"date":273,"type":21},"2030-06-28",{"name":275,"class":98},"Exelixis",122,{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":285,"conditions":286,"keywords":287,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":4},"100650487","comparison-of-the-therapeutic-efficacy-of-non-touch-microwave-ablation-tumor-puncture-microwave-ablation-and-surgical-resection-for-subcapsular-hepatocellular-carcinoma-100650487","NCT07748481","Comparison of the Therapeutic Efficacy of Non-touch Microwave Ablation, Tumor-puncture Microwave Ablation and Surgical Resection for Subcapsular Hepatocellular Carcinoma","Inclusion Criteria:\n\nDiagnosed with hepatocellular carcinoma (HCC) confirmed by pathological biopsy or clinical diagnostic criteria; Imaging examinations including ultrasound confirm that the HCC lesion is subcapsular, defined as the minimum distance between the tumor and liver capsule ≤ 3 mm; Single tumor with maximum diameter ≤ 5 cm, or up to 3 multiple tumors each with maximum diameter ≤ 3 cm; Liver function classified as Child-Pugh grade A or B; No invasion of adjacent blood vessels or vital organs; no tumor thrombus in the main portal vein or hepatic vein, and no extrahepatic metastasis.\n\n\\- Exclusion Criteria:Patients with dysfunction of vital organs such as heart and lungs; Patients who received preoperative radiotherapy, chemotherapy, targeted therapy or immunotherapy, or patients complicated with other malignant tumors; Poor follow-up compliance and inability to complete the standardized follow-up procedures.\n\n\\-",{"count":284,"type":21},180,"Subcapsular hepatocellular carcinoma (HCC) has unique anatomical characteristics that may influence treatment selection and clinical outcomes. Surgical resection and liver transplantation are potentially curative treatments but may be limited by liver function, tumor characteristics, and perioperative risks. Microwave ablation has become an important minimally invasive treatment option for patients with HCC, particularly for lesions that are difficult to treat surgically. This prospective observational cohort study aims to compare the therapeutic efficacy, safety, and long-term outcomes of no-touch microwave ablation, tumor-puncture microwave ablation and surgical resection in patients with subcapsular HCC. Treatment outcomes, including local tumor control, treatment-related complications, recurrence, and survival outcomes, will be evaluated to provide evidence for individualized treatment strategies for patients with subcapsular HCC.",[25],[288,289,290,291,292,293,294],"Subcapsular hepatocellular carcinoma","surgical resection","local tumor control","overall survival","disease-free survival","no-touch microwave ablation","umor-puncture microwave ablation","2026-08-02",{"date":269,"type":32},{"date":298,"type":21},"2026-10-01",{"date":300,"type":21},"2029-05-01",{"name":302,"class":39},"The First Hospital of Jilin University",{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":310,"targetDuration":4,"studyType":52,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":40},"100622285","phase-2-the-safety-and-efficacy-of-ondansetron-in-reducing-immune-checkpoint-inhibitor-related-toxicities-100622285","NCT07381634","The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities","The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities: A Single-Center Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age: 18 to 80 years old, both male and female are acceptable.\n2. The imaging or pathological diagnosis is hepatocellular carcinoma;\n3. It is planned to carry out standard treatment for liver cancer, specifically including lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab.\n4. ECOG score: 0 to 2 points;\n5. Expected survival period ≥12 weeks;\n6. Baseline blood cell count tests and blood biochemistry must meet the following standards:\n\n   White blood cell count ≥3.0×10\\^9\u002FL; Hemoglobin ≥90 g\u002FL; The absolute neutrophil count is ≥1.5×10\\^9\u002FL; Platelet count ≥100×10\\^9\u002FL; Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin ≤ twice ULN; Serum creatinine ≤ 1.5 times ULN; Albumin ≥30 g\u002FL;\n7. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1. Those who have received treatment with ondansetron within 14 days;\n2. Patients with autoimmune diseases;\n3. Use of systemic glucocorticoids or other immunosuppressants within 14 days;\n4. Those who have previously discontinued ICI treatment due to irAEs;\n5. Those with severe liver dysfunction (Child-Pugh grade C);\n6. Those with contraindications to ondansetron such as serotonin syndrome or phenylketonuria;\n7. Patients allergic to ondansetron;\n8. Those who are currently using drugs that may have serious interactions with ondansetron, such as apopmorphine;\n9. The researcher evaluated that the patient was unable or unwilling to comply with the requirements of the research protocol.",{"count":311,"type":21},134,[54],"This study is a prospective, randomized, single-center randomized controlled clinical trial to investigate the safety and efficacy of ondansetron in reducing the toxicity associated with immune checkpoint inhibitor treatment. This study plans to enroll 134 patients with hepatocellular carcinoma who are scheduled to receive standard ICI treatment. This study will adopt the 2023 CSCO Guidelines for the Management of Immune checkpoint inhibitor-related toxicity as the main assessment criterion, and take the incidence and severity of irAEs as the main observation indicators to evaluate the effectiveness of ondansetron in reducing the toxicity related to immune checkpoint inhibitor treatment in patients with hepatocellular carcinoma.",[25,315],"IrAE",{"date":317,"type":32},"2026-08-04",{"date":319,"type":32},"2026-04-30",{"date":321,"type":21},"2027-06-20",{"name":323,"class":39},"First Affiliated Hospital of Wenzhou Medical University",{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":332,"targetDuration":334,"studyType":22,"phases":4,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":352,"locationsCount":354},"100583539","on-treatment-surveillance-of-tumor-evolution-and-response-to-systemic-treatment-in-bile-duct-and-liver-cancer-100583539","NCT06877637","On-treatment Surveillance of Tumor Evolution and Response to Systemic Treatment in Bile Duct and Liver Cancer","BILe Duct and LIver Cancer: ON-treatment Surveillance of Tumor Evolution And Response to Systemic Treatment","BILLIONSTARS","Inclusion Criteria:\n\n* \\> 18 years of age\n* Clinically diagnosed intrahepatic Cholangiocarcinoma (iCCC), perihilar Cholangiocarcinoma (pCCC), distal Cholangiocarcinoma (dCCC), gall bladder carcinoma (GBC) or mixed Hepatocellular carcinoma\u002FCholangiocarcinoma planned to undergo surgery\n* Histologically or cytologically confirmed Cholangiocarcinoma (iCCC, pCCC, dCCC, GBC, mixed HCC\u002FCCC) for patients planned to receive palliative systemic treatment or\n* Clinically diagnosed Hepatocellular carcinoma (HCC) planned for surgery, ablation or transarterial chemo-embolization. For patients planned to receive systemic treatment histological or cytological confirmation is required except for patients with LI-RADS 5 lesions.\n\nExclusion Criteria:\n\n* \\\u003C 18 years of age\n* Severe comorbidities\n* Inability to comprehend study information",{"count":333,"type":21},150,"2 Years","The BILLIONSTARS study is a prospective, single arm observational study inviting patients diagnosed with hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) who are to be recommended locoregional intervention by surgery, ablation or transarterial chemoembolization and\u002For antitumoral medical treatment. The aim is to investigate how tumor- and individual-related factors affect response to treatment. To this end, circulating tumor DNA, immune cells and various proteins will be analyzed in repeated blood samples taken before, during and after completion of systemic treatment. When applicable, analyses will also be performed on tumor tissue from resected tumors and biopsies, and in some cases also from autopsies",[25,337],"Cholangiocarcinoma",[339,340,341,342,343,344,345,346],"cholangiocarcinoma","hepatocellular carcinoma","bile duct cancer","liver cell cancer","circulating tumor DNA","targeted therapy","tumor heterogeneity","tumor evolution","2026-07-31",{"date":267,"type":32},{"date":350,"type":32},"2025-05-15",{"date":141,"type":21},{"name":353,"class":39},"Region Skane",3,{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":4},"100643894","a-post-approval-study-to-evaluate-safety-and-effectiveness-of-multicompartmental-dosimetry-planning-100643894","NCT07669727","A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.","A Post Approval Single-arm Study Evaluating Transarterial Radioembolization Treatment for Hepatocellular Carcinoma Using Multicompartment Dosimetry Planning","ADVANCE-MCD","Inclusion Criteria:\n\n* TheraSphere Microspheres treatment determined as the optimal therapy\n* Have unresectable solitary HCC\n* Treatment Naïve\n* ECOG 0 or 1\n* Adequate liver function\n* Adequate renal and marrow function\n* Negative pregnancy test and\u002For adequate contraception for the patient and his\u002Fher sexual partner\n\nExclusion Criteria:\n\n* Macrovascular invasion\n* Extrahepatic metastases\n* Previous or current ascites\u002Fencephalopathy\n* Previous liver radiation, TACE, or systemic therapy for the disease\n* History of organ allograft including bone marrow\n* Any significant comorbities or contraindications to TheraSphere",{"count":364,"type":21},140,"The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.\n\nTheraSphere Microspheres are microscopic radioactive glass spheres that deliver radiation therapy in the liver tissue where they are placed. This study investigates a procedure called multicompartment dosimetry (MCD). When using a multicompartment dosimetry approach, the doctor will look at images of the liver to see where there is tumor to determine where to treat. That area will be divided into \"compartments\" where the dose to tumor and the healthy liver are calculated separately. The goal of MCD is to give the tumor a higher radiation dose while protecting more of the healthy part of the liver.\n\nTraditional planning for the TheraSphere Microspheres procedure uses single compartment dosimetry (SCD) which treats the tumor and the healthy liver as one area so the dose is more evenly distributed and the dose to the tumor may be lower than with the MCD approach. The single compartment approach is standard and is well established however this research study is to see if giving TheraSphere Microspheres with an MCD planning method is safe and effective by evaluating the effect of radiation on the liver as well as how the tumor responds to higher doses",[25],[368,369,370,57],"Hepatocellular Carcinoma","TheraSphere","multicompartment dosimetry","2026-07-30",{"date":347,"type":32},{"date":374,"type":21},"2026-08",{"date":376,"type":21},"2029-05",{"name":378,"class":98},"Boston Scientific Corporation",{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":52,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":143},"100625223","phase-1-a-phase-1-study-of-the-safety-and-tolerability-of-ctx-10726-100625223","NCT07419841","A Phase 1 Study of the Safety and Tolerability of CTX-10726","A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-10726 in Patients With Advanced Malignancies","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed\u002Frefractory to standard therapy or for which no effective standard therapy is available, including:\n\n2a: Renal Cell Carcinoma (RCC)\n\n* Histologically confirmed diagnosis of renal cell carcinoma (with clear cell component) with advanced or metastatic disease that is not amenable to cure by surgery or other means.\n* Patients who have progressed after a minimum of 2 doses of a programmed cell death 1 (PD-1)\u002F programmed cell death ligand 1 (PDL1) treatment.\n* Patients must have received at least one regimen including a tyrosine kinase inhibitor (TKI).\n* Patients who received immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first dose or received major surgical treatment within 3 weeks before the first dose are not eligible.\n\n  2b: Hepatocellular Carcinoma (HCC)\n* Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPDL1 treatment.\n* Patient must have received one of the following regimens: ipilimumab+nivolumab, tremelimumab+durvalumab, atezolizumab+bevacizumab or lenvatinib+pembrolizumab.\n* Hepatic function: Child -Pugh A and Child-Pugh B7.\n* Receipt of local area treatment of the liver more than 4 weeks prior to the first dose is allowed.\n\n  2c. Gastroesophageal Cancer (GC)\n* Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPDL1 treatment.\n* Patients must have received prior treatment with platinum-based chemotherapy.\n\n  2d: Endometrial Cancer (EC)\n* Patients must have received at least 1 cycle of platinum-based chemotherapy.\n* Patients with newly diagnosed advanced endometrial cancer that have persistent lesion(s) after standard treatment with surgery and chemotherapy ± radiotherapy.\n* Patients with MSI- high or deficient DNA mismatch repair (dMMR) tumors who have progressed after a minimum of 2 doses of a PD-1\u002FPDL1 treatment.\n\n  3\\. Patients must have measurable disease per RECIST 1.1. Tumor sites that are considered measurable must not have received prior radiation.\n\n  4\\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n\n  5\\. Adequate organ function including:\n* Bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109\u002FL, platelet count of ≥ 100.0×109\u002FL, and hemoglobin of ≥ 9.0 g\u002FdL (with or without transfusion).\n* Hepatic function defined as serum total bilirubin ≤ 1.5 × ULN (\\\u003C3 x ULN in patients with Gilbert's syndrome), AST\u002FALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases).\n* Renal function defined as creatinine clearance ≥ 30 mL\u002Fmin by Cockcroft Gault equation.\n* Cardiac function with Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n\n  6\\. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commits to use 2 acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives) or abstinence for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment.\n\n  7\\. Female patients who are women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening within 7 days of dosing with CTX-10726.\n\n  8\\. Prior anticancer therapy \\> 28 days (or 2 half-lives for proteins, whichever is shorter), radiotherapy \\> 7 days (concurrent localized palliative radiotherapy is allowed during CTX-10726 treatment with medical monitor approval), therapeutic surgical intervention \\> 21 days, blood transfusion \\> 14 days, or biopsy or minor surgery (excluding placement of vascular access devices) \\> 7 days prior to the first dose of CTX-10726.\n\n  9\\. Resolution of all prior anti-cancer therapy toxicities ≤ Grade 2 (excluding alopecia).\n\n  10\\. Capable of understanding and complying with protocol requirements\n\n  11\\. Signed and dated institutional review board (IRB) approved informed consent form (ICF) before any protocol-directed screening procedures are performed.\n\nExclusion Criteria:\n\n1. Developed clinically significant adverse reaction to prior PD-1 or PD-L1 therapy, including immune related adverse reactions (irAE), that led to discontinuation of treatment. A prior irAE may be considered not exclusionary only after consultation with the Medical Monitor if it resolved or stabilized to Grade 1 or baseline before informed consent, has been clinically stable for at least 3 months, and does not require ongoing systemic corticosteroids or other systemic immunosuppressive therapy other than protocol-permitted physiologic replacement. Participants are not eligible if the prior irAE was severe or life-threatening, involved a high-risk organ system with potentially dangerous recurrence, was recurrent or occurred after rechallenge, required second-line immunosuppressive therapy beyond corticosteroids, suggested broad immune susceptibility, or could confound safety evaluation in this first-in-human study.\n2. Prior organ transplantation.\n3. History of arterial or venous thrombosis or stroke or transient ischemic attack within 6 months prior to the first dose.\n4. History of other neoplasms within 3 years prior to screening, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that has undergone successful surgery.\n5. Symptomatic or uncontrolled central nervous system (CNS) and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or with confirmed brain metastases are eligible for the study provided that they are asymptomatic and radiologically and neurologically stable without the need for corticosteroid treatment or seizure prophylaxis for \\>4 weeks before the first dose of study drug. Prior treatment with either surgery or radiation is permitted and all patients with a history of CNS or brain lesions require imaging during screening to confirm stability.\n6. A pleural, abdominal (eg, ascites) or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc) within 14 days of dosing with CTX-10726.\n7. Imaging at screening that shows the tumor surrounds important blood vessels or had obvious necrosis and voids, and the investigators deems that it might cause bleeding risk.\n8. The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures at the time of screening.\n9. A history of significant bleeding tendency or severe coagulopathy.\n10. Current therapeutic dose of anticoagulant or thrombolytic medication within 14 days of the first dose. Note: prophylactic use of low molecular heparin (ie, enoxaparin 40 mg\u002Fday) is allowed.\n11. Current or recent use of aspirin (\\> 325 mg\u002Fday) or other non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days of first dose.\n12. Known uncontrolled diabetes mellitus despite optimized anti-diabetes medications.\n13. The presence of poorly controlled hypertension (systolic blood pressure \\[SBP\\]\u002Fdiastolic blood pressure \\[DBP\\]) \\>140\u002F90 mmHg (eg, patient with SBP\u002FDBP \\> 140\u002F90 mmHg despite ≥3 anti-hypertensive medications within 7 days of dosing with CTX-10726).\n14. Pregnant or lactating WOCBP.\n15. Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and\u002For detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll.\n\n    1. Hepatitis B subjects who meet the following criteria are also eligible for inclusion: HBV viral load must be \\\u003C 1000 copies \u002Fml (200 IU\u002Fml) prior to initial dosing, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the duration of study chemotherapy drug treatment. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required.\n    2. HIV-infected subjects who meet the following criteria are eligible for inclusion: HIV-RNA levels below the lower limit of detection.\n16. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection).\n17. Patients that received attenuated vaccination within 4 weeks prior to screening or planning to receive attenuated vaccination during the study period.\n18. Current or recent systemic therapy with immunosuppressive agents within 7 days before the start of CTX-10726 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement (≤ 10 mg\u002Fday prednisone or equivalent) for patients with adrenal insufficiency are allowed.\n19. Active autoimmune disease or medical conditions requiring chronic steroid (i.e., \\> 10 mg\u002Fday prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible following discussion with the Medical Monitor.\n20. Active or prior documented idiopathic pulmonary fibrosis or idiopathic pneumonia; current acute lung disease, interstitial lung disease or pneumonia (except localized interstitial pneumonia due to radiotherapy induction), pulmonary fibrosis, severe respiratory distress, pulmonary insufficiency or continuous oxygenation.\n21. Other medical conditions in the opinion of the Investigator and\u002For Sponsor Medical Monitor may interfere with the conduct and\u002For interpretation of the current study, including:\n\n    1. Congestive heart failure (\\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant cardiac arrhythmias.\n    2. QTc interval (using Fridericia correction calculation) \\> 480 msec.",{"count":387,"type":21},70,[83],"This is a Phase 1, open-label, first-in-human study of CTX-10726 monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 Cohorts: Cohort 1 Dose Escalation and Cohort 2 Dose Expansion.",[391,25,392,87],"Gastroesophageal Cancer (GC)","Endometrial Cancer",{"date":347,"type":32},{"date":395,"type":32},"2026-05-28",{"date":397,"type":21},"2028-11-01",{"name":399,"class":98},"Compass Therapeutics",{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":408,"targetDuration":4,"studyType":52,"phases":410,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":40},"100613556","titan-hcc-neoadjuvant-and-adjuvant-ql1706-with-tace-in-resectable-hepatocellular-carcinoma-beyond-milan-criteria-100613556","NCT07268131","TITAN-HCC: Neoadjuvant and Adjuvant QL1706 With TACE in Resectable Hepatocellular Carcinoma Beyond Milan Criteria","Neoadjuvant TACE Plus Iparomlimab and Tuvonralimab （QL1706）and Adjuvant QL1706 in Resectable BCLC Stage A\u002FB Hepatocellular Carcinoma Patients Beyond Milan Criteria: the TITAN-HCC Phase II Trial","TITAN-HCC","Inclusion Criteria:\n\n* Age ≥18 years, male or female\n* Patients with histologically or pathologically confirmed hepatocellular carcinoma (HCC), or Patients meeting the clinical diagnostic criteria for hepatocellular carcinoma as defined by the American Association for the Study of Liver Diseases (AASLD)\n* BCLC stage A or B hepatocellular carcinoma deemed amenable to curative-intent surgery after multidisciplinary consultation, yet exceeding Milan criteria\n* Eligible for the TACE procedure predefined by the study center, with no contraindications\n* Child-Pugh score ≤7\n* ECOG PS ≤1\n* Measurable disease per RECIST 1.1 criteria\n* Life expectancy \\>12 weeks\n* Adequate organ function meeting the following laboratory values: Hematological: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL Platelet count (PLT) ≥75×10⁹\u002FL Hemoglobin (HGB) ≥90 g\u002FL Hepatic: Total bilirubin (TBIL) ≤3× upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN Serum albumin ≥28 g\u002FL Note: Patients may be enrolled if values stabilize after standard liver support therapy for ≥1 week, as assessed by the investigator. Renal: Serum creatinine (Cr) ≤1.5×ULN or Creatinine clearance ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula) Coagulation: International normalized ratio (INR) ≤2×ULN or Activated partial thromboplastin time (APTT) ≤2×ULN\n* Willing and able to provide written informed consent prior to any study-related procedures\n\nExclusion Criteria:\n\n* Patients with histopathologically confirmed variant hepatocellular carcinoma (HCC) subtypes, including: Fibrolamellar hepatocellular carcinoma Sarcomatoid hepatocellular carcinoma Mixed hepatocellular-cholangiocarcinoma\n* Prior local therapy targeting the index lesion(s), including but not limited to: Transarterial chemoembolization (TACE) Transarterial embolization (TAE) Transarterial radioembolization (TARE) Hepatic arterial infusion chemotherapy (HAIC) Radiofrequency ablation (RFA) Cryoablation High-intensity focused ultrasound (HIFU) Radiation therapy\n* Prior systemic anti-cancer therapy for hepatocellular carcinoma, including but not limited to: Molecular targeted agents (e.g., tyrosine kinase inhibitors, anti-angiogenic drugs) Conventional chemotherapy Immunotherapy: Immune checkpoint inhibitors (e.g., PD-1\u002FPD-L1\u002FCTLA-4 inhibitors) Immune checkpoint agonists Cellular immunotherapy (e.g., CAR-T, NK cell therapy) Biological therapy: Cancer vaccines Cytokines (e.g., interferons, interleukins) Growth factor inhibitors\n* Presence of portal vein tumor thrombus, hepatic vein or inferior vena cava tumor thrombus, or distant metastasis\n* History of bleeding events within 6 months prior to initial treatment, including but not limited to: Acute hemorrhage from esophageal or gastric varices caused by portal hypertension AND\u002FOR 6. Untreated or inadequately treated\n* Clinically significant cardiovascular or cerebrovascular disease, including any of the following within 3 months prior to initial treatment: Congestive heart failure (NYHA Class ≥II) Myocardial infarction Cerebrovascular accident (stroke\u002FTIA) Unstable arrhythmia Unstable angina OR 8. History of congenital long QT syndrome OR 9. Screening ECG showing QTc interval \\>500 ms (calculated by Fridericia's formula)\n* Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within 2 years prior to initial treatment, with the following exceptions: Non-systemic replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal\u002Fpituitary insufficiency)\n* Known HIV-positive status or history of active acquired immunodeficiency syndrome (AIDS)\n* History of allogeneic stem cell transplantation or solid organ transplantation\n* History of other active malignancies within 5 years prior to initial treatment, except for those with negligible risk of metastasis or death (e.g., 5-year overall survival rate \\>90%), including: Adequately treated carcinoma in situ of the cervix Non-melanoma skin cancer Localized prostate cancer (Gleason score ≤6, treated if required) Superficial bladder cancer (Ta\u002FTis, non-invasive)\n* Women who are pregnant or breastfeeding\n* Concurrent participation in another clinical trial, unless: It is a non-interventional study (e.g., observational\u002Fregistry study), OR The patient is in the follow-up phase of an interventional trial, defined as: ≥4 weeks since last dose in the prior trial, OR ≥5 half-lives of the investigational drug (whichever is shorter)\n* Systemic corticosteroid (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapy within 2 weeks prior to initial treatment, with the following exceptions: Adrenal replacement therapy (prednisone ≤10 mg\u002Fday or equivalent) Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption Short-term corticosteroid prophylaxis for hypersensitivity reactions (e.g., premedication for CT scans)\n* Any clinical or laboratory abnormality or compliance issue deemed by the investigator to render the patient unsuitable for enrollment in this clinical study",{"count":409,"type":21},30,[200],"This is a single-arm, single-center, prospective trial designed to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with ipalimab\u002Ftuvonralimab (QL1706) in the peri-operative setting for resectable hepatocellular carcinoma exceeding the Milan criteria, and to explore biomarkers predictive of therapeutic response.",[25],{"date":347,"type":32},{"date":415,"type":32},"2025-12-09",{"date":417,"type":21},"2029-10-31",{"name":419,"class":39},"Fudan University",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":4},"100649353","peripheral-blood-biomarkers-and-response-to-atezolizumab-plus-bevacizumab-in-hepatocellular-carcinoma-100649353","NCT07734857","Peripheral Blood Biomarkers and Response to Atezolizumab Plus Bevacizumab in Hepatocellular Carcinoma","Peripheral Blood Biomarkers for Predicting Response to Atezolizumab Plus Bevacizumab in Hepatocellular Carcinoma: A Single-Center Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Age 18-80 years\n* Histologically or clinically confirmed unresectable or advanced HCC, classified according to the BCLC staging system\n* Planned to receive first-line atezolizumab plus bevacizumab therapy, with no prior systemic therapy for unresectable or advanced HCC\n* At least one measurable target lesion with a longest diameter of ≥10 mm on CT or MRI according to RECIST 1.1, with mRECIST assessment performed when applicable\n* Availability of baseline and follow-up clinical and radiological data\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of another active malignancy, except for malignancies that have been curatively treated and remain recurrence-free\n* Prior systemic treatment with immune checkpoint inhibitors or anti-angiogenic agents for unresectable or advanced HCC\n* Expected inability to complete the required clinical or radiological follow-up assessments\n* Severe comorbid conditions that may interfere with study participation\n* No qualified residual blood sample available for planned biomarker analyses because of insufficient volume, contamination, loss, or other sample-related issues\n* Any condition deemed unsuitable for participation by the investigator",{"count":51,"type":21},"This single-center prospective observational cohort study aims to evaluate the predictive value of peripheral blood-based biomarkers for treatment response in patients with hepatocellular carcinoma (HCC) receiving first-line atezolizumab plus bevacizumab (T+A) therapy. Residual peripheral blood samples obtained during routine clinical testing will be analyzed without additional blood draws. The study hypothesizes that baseline and longitudinal peripheral blood biomarkers are associated with treatment response and can be used to identify patients more likely to benefit from T+A therapy. Treatment response will be evaluated based on the best overall response (BOR) during treatment. The primary efficacy assessment will be performed according to RECIST 1.1, while modified RECIST (mRECIST) will be used as a supportive assessment. Predictive models based on peripheral blood biomarkers will be developed using RECIST 1.1-defined treatment response as the primary analysis, with mRECIST used for supportive and sensitivity analyses.",[25],"2026-07-27",{"date":432,"type":32},"2026-07-29",{"date":434,"type":21},"2026-07-10",{"date":436,"type":21},"2028-07-30",{"name":438,"class":39},"Shanghai Zhongshan Hospital",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":453,"leadSponsor":455,"locationsCount":70},"100648744","the-efficacy-and-safety-of-donafenib-plus-pd-1l1-monoclonal-antibodies-plus-tace-or-haic-as-first-line-treatment-for-unresectable-hepatocellular-carcinoma-a-multi-center-retrospective-clinical-study-100648744","NCT07724951","The Efficacy and Safety of Donafenib Plus PD-1\u002FL1 Monoclonal Antibodies Plus TACE or HAIC as First-line Treatment for Unresectable Hepatocellular Carcinoma A Multi-center, Retrospective Clinical Study","The Efficacy and Safety of Donafenib Plus PD-1\u002FL1 Monoclonal Antibodies Plus Transarterial Chemoembolization (TACE) or Hepatic Arterial Infusion Chemotherapy (HAIC) as First-line Treatment for Unresectable Hepatocellular carcinomaA Multicenter, Retrospective Clinical Study","Inclusion Criteria:\n\n* Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, an anti-PD-1\u002FL1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC), with retrievable records in the hospital electronic information system between June 1, 2021 and November 30, 2024.\n* Diagnosis of hepatocellular carcinoma confirmed by the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) clinically or by histology\u002Fcytology.\n* Age ≥18 years, regardless of sex.\n* No prior systemic therapy before the administration of donafenib, anti-PD-1\u002FL1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC).\n* The maximum interval between the initiation of donafenib, anti-PD-1\u002FL1 monoclonal antibody, and transarterial interventional therapy (TACE or HAIC) does not exceed 8 weeks, and at the time the last of these treatment modalities is initiated, the subject must not have experienced disease progression.\n* For patients who have previously undergone hepatectomy, the resection must be R0, and tumor recurrence must have occurred more than 24 months after surgery.\n* At least one evaluable lesion (according to RECIST v1.1 criteria).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1.\n* Child-Pugh class A or B.\n* Adequate major organ function, defined by the following criteria:\n\nComplete blood count (without blood transfusion or use of granulocyte colony-stimulating factor \\[G-CSF\\] within 14 days prior to screening):\n\n1. Hemoglobin ≥90 g\u002FL;\n2. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL;\n3. Platelet count ≥75×10⁹\u002FL;\n\n   \\- Blood biochemistry (without albumin use within 14 days prior to screening):\n4. Albumin ≥28 g\u002FL;\n5. Total bilirubin ≤2× upper limit of normal (ULN);\n6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× ULN;\n7. Alkaline phosphatase (ALP) ≤5× ULN;\n8. Creatinine ≤1.5× ULN;\n\n   \\- Coagulation function:\n9. International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN;\n10. Activated partial thromboplastin time (APTT) ≤1.5× ULN.\n\nExclusion Criteria:\n\n* Incomplete or unavailable patient information data; patient refused follow-up or was lost to follow-up;\n* Duration of donafenib, PD-1\u002FL1 monoclonal antibody combined with transarterial intervention therapy was less than 1 month;\n* Prior histologically\u002Fcytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other components;\n* History of malignancy other than hepatocellular carcinoma, unless meeting the following criteria: a) The patient received potentially curative treatment and there has been no evidence of disease for 5 years; b) Successfully treated resected cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or other carcinoma in situ;",{"count":447,"type":21},400,"This is a multicenter, retrospective study planned to enroll patients with unresectable hepatocellular carcinoma (uHCC) who received first-line donafenib combined with an anti-PD-1\u002FL1 monoclonal antibody and either TACE or HAIC at 8 sites between June 1, 2021 and November 30, 2024. The study consists of two cohorts: Cohort A consists of patients who received donafenib + PD-1\u002FL1 inhibitor + TACE, and Cohort B consists of patients who received donafenib + PD-1\u002FL1 inhibitor + HAIC, with a planned enrollment of 200 patients per cohort. Relevant data will be collected to evaluate the efficacy and safety of donafenib combined with an anti-PD-1\u002FL1 monoclonal antibody and either TACE or HAIC in the treatment of uHCC in real-world clinical practice.",[25],"2026-07-24",{"date":430,"type":32},{"date":347,"type":21},{"date":454,"type":21},"2028-07-31",{"name":438,"class":39},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":52,"phases":465,"briefSummary":466,"conditions":467,"keywords":468,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":479,"leadSponsor":480,"locationsCount":40},"100649361","ai-guided-surveillance-and-curative-salvage-of-recurrence-after-hepatocellular-carcinoma-resection-or-ablation-100649361","NCT07732504","AI-Guided Surveillance and Curative Salvage of Recurrence After Hepatocellular Carcinoma Resection or Ablation","A Pragmatic, Multicenter, Open-Label, Blinded-Outcome, Parallel-Group Randomized Controlled Trial of AI-Guided Risk-Adaptive Surveillance for Early Detection and Curative-Intent Salvage of Hepatocellular Carcinoma Recurrence After Resection or Thermal Ablation","HCC-AI-RECLAIM","Inclusion Criteria:\n\n* Age 18 years or older at the time of informed consent.\n* First diagnosis of hepatocellular carcinoma, confirmed by histopathology for participants undergoing liver resection, or by histopathology or accepted guideline-concordant imaging criteria for participants undergoing thermal ablation.\n* Completion of first curative-intent treatment consisting of either R0 liver resection with microscopically tumor-negative margins or complete radiofrequency or microwave ablation of all known hepatocellular carcinoma.\n* Qualifying multiphasic contrast-enhanced CT or MRI obtained 28 to 56 days after completion of the final curative-intent procedure.\n* Qualifying imaging confirming no viable tumor at the resection bed or ablation site, no new intrahepatic hepatocellular carcinoma, and no macrovascular invasion, regional nodal disease, or extrahepatic metastasis.\n* No unresolved lesion requiring immediate diagnostic evaluation or treatment at the time of randomization.\n* Randomization within 14 days after the qualifying post-treatment imaging assessment and before the first protocol-scheduled surveillance examination.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Child-Pugh class A liver function.\n* Medically fit for at least one protocol-defined curative-intent salvage treatment should an anatomically amenable recurrence be detected.\n* Able to undergo repeated protocol-required multiphasic contrast-enhanced CT or MRI examinations.\n* Availability of the minimum mandatory baseline data elements required to generate an output from the locked artificial intelligence system.\n* Able and willing to comply with trial procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Any previous episode of hepatocellular carcinoma or previous hepatocellular carcinoma-directed treatment before the current index diagnosis.\n* Microscopically or macroscopically positive surgical margins (R1 or R2 resection).\n* Residual viable tumor after thermal ablation.\n* Any radiological evidence of residual, recurrent, nodal, or metastatic hepatocellular carcinoma at screening.\n* Macrovascular invasion, regional lymph-node metastasis, or extrahepatic metastasis associated with the index hepatocellular carcinoma.\n* Index treatment involving liver transplantation, combined resection and ablation, transarterial therapy, radiotherapy, systemic anticancer therapy, or another hepatocellular carcinoma-directed treatment other than the qualifying R0 resection or complete radiofrequency or microwave ablation.\n* Previous liver transplantation, active placement on a liver-transplant waiting list, or planned liver transplantation in the absence of documented recurrent hepatocellular carcinoma.\n* Planned or ongoing adjuvant antineoplastic treatment intended to reduce hepatocellular carcinoma recurrence after the qualifying procedure. Guideline-concordant antiviral treatment and management of the underlying liver disease are permitted.\n* Concurrent participation in another interventional study expected to affect hepatocellular carcinoma recurrence, survival, surveillance intensity, or eligibility for curative-intent salvage treatment.\n* Combined hepatocellular-cholangiocarcinoma or another non-hepatocellular primary hepatic malignancy.\n* A permanent medical contraindication that would preclude all protocol-defined curative-intent salvage treatment options.\n* Inability to undergo any protocol-permitted contrast-enhanced CT or MRI modality because of contraindication to all available imaging and contrast options.\n* Active malignancy other than hepatocellular carcinoma that requires anticancer treatment or is expected to materially interfere with survival, surveillance adherence, or outcome assessment during the primary 24-month follow-up period.\n* Uncontrolled hepatic decompensation, including refractory ascites or clinically significant hepatic encephalopathy.\n* Pregnancy at the time of randomization.\n* Inability or unwillingness to provide informed consent or comply with protocol-specified follow-up.",{"count":20,"type":21},[200],"Hepatocellular carcinoma, the most common type of primary liver cancer, can recur after liver resection or thermal ablation performed with curative intent. Follow-up imaging is commonly scheduled at fixed intervals, although the risk of recurrence differs among patients and may change over time. This study will test whether a locked artificial intelligence system can use routinely collected clinical, laboratory, and imaging information to recommend when the next surveillance scan should occur.\n\nAdults with no radiological evidence of viable hepatocellular carcinoma after microscopically margin-negative liver resection or complete radiofrequency or microwave ablation will be randomly assigned in a 1:1 ratio to artificial intelligence-guided risk-adapted surveillance or fixed-interval surveillance. In the artificial intelligence-guided group, participants classified as having high, intermediate, or low current recurrence risk will generally undergo the next protocol-scheduled contrast-enhanced imaging examination after 3, 4, or 6 months, respectively. Participants in the control group will undergo protocol-scheduled imaging every 4 months. The risk thresholds are designed so that the expected total number of protocol-scheduled imaging examinations is approximately comparable between the two groups over 24 months.\n\nThe artificial intelligence system provides surveillance recommendations only. It does not diagnose recurrence, determine eligibility for liver transplantation, or select anticancer treatment. Clinically indicated examinations may be performed at any time in either group. When recurrence is confirmed, participants in both groups will undergo the same protocol-defined multidisciplinary evaluation, and potentially curative-intent treatment may be considered when clinically appropriate.\n\nThe primary purpose is to determine whether artificial intelligence-guided surveillance increases the probability of being alive at 24 months without having a recurrence that is no longer amenable to protocol-defined curative-intent treatment. The study evaluates the timing and allocation of surveillance rather than an adjuvant anticancer treatment and is not intended to prevent the biological occurrence of recurrence.",[25],[469,470,471,472,473,474,475],"Artificial Intelligence","Risk-Adapted Surveillance","Recurrence Surveillance","Early Detection of Recurrence","Clinical Decision Support","Liver Resection","Radiofrequency Ablation","2026-07-23",{"date":432,"type":32},{"date":298,"type":21},{"date":67,"type":21},{"name":481,"class":39},"Tongji Hospital",{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":489,"targetDuration":4,"studyType":52,"phases":491,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":4},"100648886","phase-2-dapagliflozin-add-on-in-unresectable-hcc-with-metabolic-syndrome-100648886","NCT07729592","Dapagliflozin Add-on in Unresectable HCC With Metabolic Syndrome","A Single-Center, Phase II, Randomized Controlled Clinical Study to Evaluate Dapagliflozin as an Addition to First-Line Treatment for Unresectable Hepatocellular Carcinoma With Metabolic Syndrome","Inclusion Criteria:\n\n1. Patients diagnosed with hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) stage B (with large tumor burden exceeding the up-to-seven criteria) or stage C, as determined by consensus of a multidisciplinary hepatobiliary surgical team, corresponding to TNM stages II-IV with preserved liver function (intermediate to advanced HCC), who are deemed unresectable.\n2. No prior systemic therapy for HCC.\n3. First-line treatment regimen must include an immune checkpoint inhibitor with\u002Fwithout interventional therapy .\n4. Diagnosis of metabolic syndrome according to the National Cholesterol Education Programme-Adult Treatment Panel III (NCEP-ATP III) criteria, requiring at least 3 of the following 5 criteria:\n\n(1) Central obesity (waist circumference): ≥ 90 cm in males, ≥ 80 cm in females; (2) Elevated triglycerides: ≥ 150 mg\u002FdL (1.7 mmol\u002FL), or receiving specific treatment for this lipid abnormality; (3) Reduced high-density lipoprotein cholesterol (HDL-C): \\\u003C 40 mg\u002FdL (1.0 mmol\u002FL) in males, \\\u003C 50 mg\u002FdL (1.3 mmol\u002FL) in females, or receiving specific treatment for this lipid abnormality; (4) Elevated blood pressure: systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, or previously diagnosed hypertension and receiving antihypertensive treatment; (5) Elevated fasting glucose: ≥ 100 mg\u002FdL (5.6 mmol\u002FL), or previously diagnosed type 2 diabetes mellitus.\n\n5\\. Age between 18 and 75 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Life expectancy \\> 3 months. 8. At least one measurable lesion according to RECIST version 1.1 (i.e., longest diameter ≥ 10 mm on contrast-enhanced spiral CT or contrast-enhanced MRI, or short-axis diameter ≥ 15 mm for enlarged lymph nodes; lesions previously treated with local therapy may be considered target lesions only if disease progression has been clearly documented per RECIST v1.1).\n\n9\\. Adequate organ function, meeting the following laboratory criteria:\n\n* White blood cell count ≥ 4.0 × 10⁹\u002FL\n* Neutrophil count ≥ 1.5 × 10⁹\u002FL\n* Platelet count ≥ 80.0 × 10⁹\u002FL\n* Hemoglobin ≥ 90 g\u002FL\n* Serum albumin ≥ 2.8 g\u002FdL\n* Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n* ALT\u002FAST\u002FALKP ≤ 2.5 × ULN\n* Serum creatinine ≤ 1.5 × ULN or creatinine clearance \\> 60 mL\u002Fmin\n* No concomitant severe organic disease. 10. Ability to understand and willingness to provide written informed consent prior to any study-specific procedures, and agreement to comply with the study medication administration and post-treatment follow-up schedule as per protocol.\n\nExclusion Criteria:\n\n1. Concomitant severe impairment of vital organ function (including cardiac, pulmonary, renal, or other major organ systems), active infections other than viral hepatitis, or other severe comorbid conditions that would render the patient unable to tolerate treatment.\n2. Prior treatment with any sodium-glucose cotransporter 2 (SGLT2) inhibitor, including but not limited to canagliflozin, ertugliflozin, dapagliflozin, empagliflozin, luseogliflozin, and tofogliflozin.\n3. Presence of contraindications to any component of the combination therapy, including immune checkpoint inhibitors, targeted therapy, or interventional therapy.\n4. History of other active malignancies.\n5. Concurrent autoimmune diseases, or other conditions requiring long-term systemic corticosteroid therapy.\n6. Known or suspected hypersensitivity to the study drug or to any agent administered in association with this trial.\n7. History of organ transplantation.\n8. Pregnant or breastfeeding women.\n9. Any other condition that, in the investigator's judgment, may interfere with patient enrollment or evaluation of study outcomes.\n10. Refusal to comply with the follow-up requirements as specified in the protocol, or refusal to provide written informed consent.",{"count":490,"type":21},44,[54],"The goal of this interventional study (clinical trial) is to evaluate the efficacy and safety of adding dapagliflozin to first-line standard therapy in patients with unresectable hepatocellular carcinoma (HCC) and comorbid metabolic syndrome.\n\nThe main questions it aims to answer are:\n\nDoes the addition of dapagliflozin to first-line therapy improve the objective response rate (ORR) compared with first-line therapy alone in this patient population?\n\nWhat are the differences between the two treatment groups in terms of overall survival (OS), progression-free survival (PFS), and safety\u002Ftolerability profiles?\n\nResearchers will compare the combination group (dapagliflozin plus first-line standard therapy) with the control group (first-line standard therapy alone) to determine whether the addition of dapagliflozin provides superior clinical benefit.\n\nParticipants in the combination group will receive dapagliflozin in addition to their prescribed first-line standard therapy, while participants in the control group will receive first-line standard therapy alone. All participants will be regularly monitored for tumor response, survival outcomes, and adverse events throughout the study period.\n\nThe findings of this trial are expected to provide clinical evidence supporting the use of dapagliflozin as an adjunctive therapy in patients with advanced unresectable HCC and metabolic syndrome, potentially enhancing the tumor response rate to existing standard-of-care treatments.",[25],[177,495],"dapagliflozin","2026-07-22",{"date":430,"type":32},{"date":499,"type":21},"2026-07",{"date":501,"type":21},"2029-07",{"name":503,"class":39},"Sun Yat-sen University",{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":513,"conditions":514,"keywords":520,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":536},"100647926","breath-research-narrow-validation-for-gastrointestinal-cancer-detection-100647926","NCT07714538","Breath Research Narrow Validation for Gastrointestinal Cancer Detection","BRAVE","Inclusion Criteria:\n\nAdult participants ≥ 18 years old who meet at least one of the following criteria\n\nColorectal arm:\n\n1. Cancer: Histologically-confirmed CRC\\*\n2. Control: Non-specific abdominal symptoms with normal or benign colonoscopy findings\n\nPancreatic arm:\n\n1. Cancer: Histologically-confirmed PDAC\\*\n2. Control: Non-specific abdominal symptoms with a radiologically-normal pancreas\n\nOesophagogastric arm:\n\n1. Cancer: Histologically-confirmed OGC\\*\n2. Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings\n\nOesophageal squamous arm:\n\n1. Cancer: Histologically-confirmed OSCC\\*\n2. Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings\n\nLiver arm:\n\n1. Cancer: Histologically- or radiologically-confirmed HCC or CCC\\*\n2. Control: Non-specific abdominal symptoms with a radiologically-normal liver\n\n   * Patients with suspected cancer (e.g. based on imaging) but who do not have histological confirmation prior to participating in the study may still be recruited and followed up to determine whether or not a diagnosis of cancer was subsequently confirmed.\n\nExclusion Criteria:\n\n* Patients who have already received chemotherapy, radiotherapy or surgery for their cancer\n* History of another cancer (other than non-melanoma skin cancers) within three years\n* Participants with co-morbidities preventing breath collection\n* Unable or unwilling to provide informed consent\n* (For Oesophagogastric arm only): Allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, Maltodextrin (Corn, Potato), Xanthan Gum, Potassium Chloride, tyrosine, phenylalanine, and glutamic acid\n* (For Colorectal arm only): Participants receiving bowel prep in the previous 7 days",{"count":512,"type":21},1000,"The investigators of this study are developing a simple breath test to help detect gastrointestinal (gut) cancers earlier, including cancers of the oesophagus (food pipe), stomach, pancreas, liver and bowel. These cancers often cause non-specific symptoms that are similar to benign conditions, making early diagnosis difficult. Delays between the onset of symptoms and referral for a diagnostic test such as an endoscopy or a scan, can allow the cancer to progress.\n\nThe breath test detects small molecules called volatile organic compounds (VOCs) that are released in exhaled breath. Some of these VOCs are strongly associated with these cancers and may help identify high-risk patients who require urgent investigation.\n\nIn practice, patients who come to their GP with concerning symptoms will be offered the breath test. If the test is positive, patients can be referred promptly for a diagnostic test, while those with a negative result can be reassured and offered re-testing if symptoms persist. Earlier diagnosis could improve access to curative treatment while reducing unnecessary invasive investigations.\n\nPrevious studies have identified a panel of VOCs that appear to distinguish patients with gastrointestinal cancers from those without cancer. This study aims to confirm these findings in a new group of participants to determine whether the same biomarkers can be reliably identified.\n\nParticipants will provide a breath sample, usually before a hospital procedure they are already scheduled to undergo, and complete a short questionnaire about their medical history and medications. Some participants will also be asked to drink a nutritional supplement before providing a second breath sample. The results will help determine whether the breath test is reliable enough for further clinical evaluation",[515,516,517,518,337,25,519],"Oesophageal Squamous Cell Carcinoma","Oesophageal Adenocarcinoma","Gastric Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","Colorectal Adenocarcinoma",[521,522,523,524,525,526,527],"Early Detection","Volatile Organic Compunds","Oesophageal Cancer","Gastric Cancer","Colorectal Cancer","Liver Cancer","Pancreatic Cancer","2026-07-21",{"date":476,"type":32},{"date":531,"type":21},"2026-07-20",{"date":533,"type":21},"2028-08-02",{"name":535,"class":39},"Imperial College London",6,{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":544,"targetDuration":4,"studyType":52,"phases":545,"briefSummary":547,"conditions":548,"keywords":549,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":558,"leadSponsor":560,"locationsCount":40},"100647514","early-phase-1-safety-and-feasibility-of-cik-cell-therapy-in-hcc-after-tumor-resection-100647514","NCT07709299","Safety and Feasibility of CIK Cell Therapy in HCC After Tumor Resection","Safety and Feasibility of Autologous Cytokine Induced Killer (CIK) Cells Infusion as an Adjuvant Therapy in Post Resection Hepatocellular Carcinoma (HCC) Patients","Inclusion Criteria:\n\n* Age between 18 and 80 years\n* Documented HCC at BCLC stage 0-A, having undergone surgical tumor resection\n* Single tumor or ≤3 nodules, each ≤3 cm\n* Child-Pugh score A-B\n* ECOG performance status 0-1\n* Confirmed cancer-free status one month after surgery\n* Written informed consent\n* Leukocyte count \\> 3 × 10⁹\u002FL\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FµL\n* Hemoglobin ≥ 8.5 g\u002FdL\n* Platelet count \\> 50 × 10⁹\u002FL\n* BUN and serum creatinine ≤ 1.5 × upper limit of normal No extrahepatic abdominal disease spread, confirmed by abdominal CT\u002FMRI\n\nExclusion Criteria:\n\n* Active infection or uncontrolled viremia (particularly HBV, HCV, or HIV)\n* Any cell therapy or immunotherapy in the past 6 months, or current participation in another clinical study\n* Another malignancy (prior or concurrent) differing from HCC in primary site or histology\n* Clinically significant cardiovascular disease (e.g., heart failure, serious arrhythmia, symptomatic coronary artery disease)\n* History of organ transplantation\n* Primary or secondary immunodeficiency, or active autoimmune disease\n* Severe allergic disorder or history of anaphylaxis\n* Pregnancy or breastfeeding at study entry\n* Women of childbearing potential intending to become pregnant",{"count":536,"type":21},[546],"EARLY_PHASE1","This study tests whether it is safe and feasible to give patients with hepatocellular carcinoma (liver cancer) an infusion of their own (autologous) immune cells, called cytokine-induced killer (CIK) cells, after they have had surgery to remove their liver tumor. The patient's own blood cells are collected and grown in a laboratory to create the CIK cells, which are then given back to the patient through six intravenous infusions over about two months. Patients are followed for six months to check for side effects and early signs of whether the cancer returns.",[25],[550,551,59,552,553,554],"Cytokine-induced killer cell","CIK Cells","HCC recurrence","HCC resection","Adjuvant therapy","2026-07-14",{"date":93,"type":32},{"date":499,"type":21},{"date":559,"type":21},"2028-07",{"name":561,"class":562},"Royan Institute","OTHER_GOV",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":196,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":572,"conditions":573,"keywords":576,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":4},"100647408","application-of-super-resolution-ultrasound-srus-in-liver-tumor-100647408","NCT07707661","Application of Super-Resolution Ultrasound (SRUS) in Liver Tumor","SRUS","Inclusion Criteria:\n\n1. Any gender, 18 years or older;\n2. People newly diagnosed with liver tumors, including:\n\n   ① Hepatocellular carcinoma; ② Cholangiocarcinoma; ③ Liver metastases; ④ Liver hemangioma; ⑤ Focal nodular hyperplasia of the liver.\n3. Need to have a contrast-enhanced ultrasound as part of routine care;\n4. Willing to join this study and sign the informed consent after discussing it with the doctor.\n\nExclusion Criteria:\n\n1. During the data collection process, if the participant is unable to cooperate fully, preventing the collection from being completed;\n2. If the skin in the collection area is broken or scabbed, or if there's too much ascites in the abdominal cavity interfering with sound signal penetration, making data collection impossible;\n3. Previous puncture biopsy or other treatments for existing liver malignant tumors;\n4. Patients with a history of allergy, allergic constitution, or severe intolerance to sulfur hexafluoride or other components of the ultrasound contrast agent;\n5. Patients who refuse to participate in this study;\n6. Any uncontrollable comorbidities that could limit the patient's adherence to the study requirements or affect their ability to sign the written informed consent;\n7. Poor overall condition or inability to tolerate relevant examinations;\n8. Participants whom the researcher deems unsuitable for inclusion in the study",{"count":571,"type":21},350,"The macroscopic vascular supply of liver tumors varies considerably according to histological subtype, lesion size, and disease stage. Current clinical imaging modalities primarily characterize liver tumors based on their macroscopic vascular perfusion patterns. Conventional color Doppler ultrasonography enables qualitative assessment of tumor vascularity, facilitates the differentiation of benign from malignant hepatic lesions, delineates the anatomical relationship between tumors and major intrahepatic vessels, and detects vascular invasion. Nevertheless, these macroscopic vascular characteristics arise from complex microvascular architectures, including vascular distribution patterns, microvessel density, vessel morphology and tortuosity, blood flow velocity, and flow direction. Despite the critical role of tumor microcirculation in tumor progression and therapeutic response, the heterogeneity of microvascular hemodynamics among different liver tumors remains inadequately characterized.\n\nThe emergence of Super Resolution Ultrasound Imaging (SRUS) has markedly advanced ultrasound imaging by overcoming the acoustic diffraction limit, enabling visualization of microvessels with diameters as small as approximately 20 μm. Unlike conventional ultrasound techniques, SRUS preserves the inherent advantages of ultrasound, including deep tissue penetration and a large field of view, while achieving an approximately tenfold improvement in spatial resolution. This unique combination effectively bridges the long-standing gap between imaging depth and spatial resolution in vascular imaging. Furthermore, by localizing and tracking individual circulating microbubbles,SRUS enables quantitative assessment of microvascular blood flow velocity over a broad dynamic range without Doppler angle dependence. Consequently, super-resolution ultrasound imaging offers an unprecedented opportunity to characterize and compare the microvascular hemodynamic features of benign and malignant liver lesions, thereby improving the accuracy of preoperative differential diagnosis, tumor staging, therapeutic response assessment, and prognostic evaluation.",[25,574,205,207,575],"Intrahepatic Cholangiocellular Carcinoma","Liver Metastasis",[177,568,577,578],"ICC","LM","2026-07-12",{"date":93,"type":32},{"date":582,"type":21},"2026-07-01",{"date":584,"type":21},"2027-09-01",{"name":586,"class":39},"Eastern Hepatobiliary Surgery Hospital",{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":593,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":52,"phases":597,"briefSummary":598,"conditions":599,"keywords":615,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":636,"leadSponsor":638,"locationsCount":143},"100647234","phase-1-fapi-pet-imaging---an-exploratory-study-100647234","NCT07705074","FAPI PET Imaging - An Exploratory Study","FAPI PET Imaging - a Multicentric Exploratory Evaluation","FAPIPET","Inclusion Criteria:\n\n* Written informed consent obtained and documented by the participant's signature.\n* Age ≥18 years at the time of consent.\n* Clinically established or suspected diagnosis or recurrence of an oncologic or non-oncologic disease as defined in chapter 7.1 of study protocol.\n* Availability of standard-of-care imaging (e.g., clinically established PET tracer or anatomical imaging such as CT\u002FMRI) to allow comparative evaluation.\n\nExclusion Criteria:\n\n* Severe claustrophobia that would preclude PET imaging.\n* Inability to remain still for the duration of the PET\u002FMR examination.\n* Current pregnancy or breastfeeding; no pregnancy test is required for women who are postmenopausal for ≥12 months or have undergone surgical sterilization, bilateral oophorectomy, or hysterectomy.\n* Previous hypersensitivity reactions to radiotracer administration\n* Inability to understand the study information, for example due to language barriers.\n* Subjects incapable of judgment (e.g. individuals under legal or medical incapacity).\n* Participants scheduled for PET\u002FMR imaging: Presence of MRI-incompatible metallic implants, electronic devices (e.g. pacemakers, cochlear implants), or other ferromagnetic foreign bodies.",{"count":596,"type":21},770,[83,54],"This study is testing a new imaging tracer called \\[18F\\]FAPI-74 with PET scans. Researchers want to find out how well this tracer shows certain diseases in the body, including several types of cancer and some non-cancer conditions like fibrosis and sarcoidosis.\n\n\\[18F\\]FAPI-74 attaches to a protein found on cells that are active in tumors and areas of scarring or inflammation. This may help doctors see these areas more clearly than with imaging methods used today, especially in diseases where current scans do not work well.\n\nPeople who join this study will get one injection of the tracer into a vein, then have one PET\u002FCT or PET\u002FMR scan. This takes about 2 hours in total. Researchers will compare the results with imaging the participant already had as part of their regular care, such as other PET scans, CT, or MRI. No extra treatment is given, and no other visits are needed.\n\nThe study will take place at 5 hospitals in Switzerland and plans to include about 770 adults with a confirmed or suspected diagnosis of one of the conditions being studied. The main goal is to see how clearly the tracer shows up on the scan. Researchers will also look at whether this new scan changes how confident doctors feel about a diagnosis, or changes the patient's treatment plan.",[600,601,602,603,604,605,25,606,607,260,608,609,610,611,612,613,614],"Thyroid Pathology","Head and Neck Cancer (H&N)","Sinonasal Tract Tumor","Sarcoidosis","Thyroid Cancer","Breast Cancer","Gastric Cancer (GC)","Pancreatic Cancer, Adult","Multiple Myeloma or Plasmacytoma","Mesothelioma","Hepatic Fibrosis","Endometriosis (Diagnosis)","Lung Fibrosis","Neck Node Metastasis","Prostate Cancer (CRPC)",[616,617,618,619,620,621,622,623,624,625,626,627,628,629,630,631],"[18F]FAPI-74","Fibroblast Activation Protein","FAP-targeted imaging","PET\u002FCT","Radiotracer","Diagnostic imaging","Multicentric study","Radiopharmaceutical","FAPI","FAPI-74","nuclear medicine","University Hospital Zurich","swiss multicenter trial","Cancer-associated fibroblast imaging","oncologic imaging","non-oncologic imaging","2026-07-09",{"date":634,"type":32},"2026-07-15",{"date":374,"type":21},{"date":637,"type":21},"2029-09",{"name":639,"class":39},"Martin Huellner",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":196,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":648,"conditions":649,"keywords":652,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":40},"100610220","a-noninvasive-and-screening-mirna-signature-for-gastrointestinal-cancer-100610220","NCT07224750","A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer","MiGIC","Inclusion Criteria:\n\n1. Adults aged 18 years or older at the time of blood sample collection.\n2. Patients with a confirmed diagnosis of one of the following gastrointestinal cancers: Hepatocellular carcinoma (HCC), Cholangiocarcinoma (CCA), Pancreatic ductal adenocarcinoma (PDAC), Esophageal squamous cell carcinoma (ESCC), Gastric cancer (GC), Colorectal cancer (CRC), Non-cancer control participants, including healthy volunteers or patients with benign gastrointestinal conditions.\n3. Availability of retrospective blood samples collected according to institutional protocols.\n4. Willingness to allow use of de-identified clinical and demographic data for research purposes.\n\nExclusion Criteria:\n\n* other active malignancies; insufficient sample quality\u002Fvolume; recent chemotherapy\u002Fradiotherapy\u002Fsurgery; any condition preventing reliable participation.",{"count":512,"type":21},"Gastrointestinal (GI) cancers remain a major global health burden, largely due to the lack of effective and accessible early screening strategies. Current diagnostic approaches-including endoscopy, computed tomography (CT), and magnetic resonance imaging (MRI)-are either invasive, resource-intensive, or insufficiently sensitive for detecting early-stage disease, and are therefore not suitable for population-wide screening or for simultaneously identifying multiple GI tumor types. As a result, many patients are diagnosed at advanced stages, when therapeutic options are limited and prognosis is poor.\n\nCirculating microRNAs (miRNAs) offer a promising alternative, as they are stable in peripheral blood and reflect tumor-related molecular alterations. In this study, the investigators aim to develop and validate a robust, noninvasive miRNA-based signature capable of distinguishing GI cancers from non-malignant controls. By integrating multi-cohort datasets and applying machine learning-based feature selection and predictive modeling, the investigators will construct a screening panel optimized for reproducibility, scalability, and early-stage detection. This noninvasive miRNA signature has the potential to support accessible, cost-effective, and clinically practical population-level screening for GI cancers, ultimately facilitating earlier diagnosis and improving outcomes for participants.",[25,337,518,650,606,651],"Esophageal Squamous Cell Carcinoma (ESCC)","Colorectal Cancer Screening",[653,654,655,656,657],"Noninvasive screening","Circulating miRNA","Machine learning","Gastrointestinal cancer","Blood-based cancer detection","2026-07-06",{"date":660,"type":32},"2026-07-07",{"date":662,"type":32},"2024-06-21",{"date":664,"type":21},"2028-06-18",{"name":666,"class":39},"City of Hope Medical Center"]