[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intrahepatic-cholangiocarcinoma-icc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intrahepatic-cholangiocarcinoma-icc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,40,69,115,135,167,198,225,254,282,306,329,359,389,418,440,466,490,513,544,569,592,613,637],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100642786","phase-1-a-multicenter-prospective-randomized-open-label-phase-ibii-study-of-celecoxib-plus-pembrolizumab-and-gemcitabinecisplatin-versus-pembrolizumab-and-gemcitabinecisplatin-in-patients-with-ck56-high-unresectable-locally-advanced-or-metastatic-intrahepatic-cholangiocarcinoma-100642786",false,"NCT07632235","A Multicenter, Prospective, Randomized, Open-label Phase Ib\u002FII Study of Celecoxib Plus Pembrolizumab and Gemcitabine\u002FCisplatin Versus Pembrolizumab and Gemcitabine\u002FCisplatin in Patients With CK5\u002F6-High Unresectable Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA).\n* Unresectable locally advanced, recurrent, or metastatic disease.\n* No prior systemic therapy for advanced disease.\n* At least one measurable lesion according to RECIST v1.1.\n* ECOG performance status of 0-1.\n* Availability of adequate pre-treatment tumor tissue for central pathological review.\n* CK5\u002F6 H-score ≥ 1.0 as determined by central laboratory testing.\n* Adequate organ and bone marrow function as defined by protocol-specified laboratory criteria.\n* Patients with biliary obstruction must have undergone effective drainage and achieved clinical stabilization prior to enrollment.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Other primary malignancies including extrahepatic cholangiocarcinoma, gallbladder carcinoma, or ampullary carcinoma.\n* CK5\u002F6 H-score \\\u003C 1.0.\n* Prior systemic therapy for advanced or metastatic disease.\n* Active gastrointestinal bleeding, peptic ulcer disease, or high risk of gastrointestinal perforation.\n* Recent history of significant cardiovascular events including myocardial infarction, stroke, uncontrolled hypertension, or severe heart failure.\n* Known hypersensitivity to celecoxib, sulfonamides, NSAIDs, or aspirin-exacerbated respiratory disease.\n* Active autoimmune disease or conditions contraindicating pembrolizumab therapy.\n* Severe renal impairment.\n* Child-Pugh class C hepatic impairment.\n* Active uncontrolled infection.\n* Any condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.","ALL","18 Years",{"count":18,"type":19},112,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","This study aims to evaluate whether adding celecoxib to standard therapy can improve clinical outcomes in patients with advanced intrahepatic cholangiocarcinoma. The current standard treatment typically consists of immunotherapy combined with chemotherapy; however, there are significant inter-patient differences in treatment response. Therefore, this study further introduces the biomarker CK5\u002F6 to identify patient subgroups who are more likely to benefit, thereby exploring a more precise therapeutic strategy.\n\nAll eligible participants will be randomly assigned after enrollment to either the control group or the experimental group. The control group will receive the current standard first-line regimen, which includes the immunotherapy agent pembrolizumab combined with the chemotherapy agents gemcitabine and cisplatin. The experimental group will receive the same standard treatment, with the addition of oral anti-inflammatory therapy with celecoxib taken twice daily throughout the entire treatment period.\n\nEach treatment cycle lasts 21 days. During treatment, patients will undergo regular imaging assessments, laboratory tests, and safety evaluations to monitor tumor response and treatment-related adverse events, and will be followed until disease progression or discontinuation of treatment. In addition, blood and tissue samples will be collected during the study to investigate tumor biology and potential predictive biomarkers.\n\nThe primary endpoints of this study include progression-free survival and objective response rate, along with concurrent safety evaluation. Adverse events potentially associated with chemotherapy, immunotherapy, and celecoxib may occur, such as bone marrow suppression, gastrointestinal reactions, immune-related inflammatory responses, as well as renal or cardiovascular toxicities. The study team will closely monitor and promptly manage all adverse events.\n\nThis study aims to explore a CK5\u002F6-based stratified personalized combination therapy strategy, with the goal of improving treatment benefit in patients with advanced intrahepatic cholangiocarcinoma and providing evidence for optimizing future clinical treatment strategies.",[26],"Intrahepatic Cholangiocarcinoma (Icc)","RECRUITING","2026-06-22",{"date":30,"type":31},"2026-06-25","ACTUAL",{"date":33,"type":19},"2026-07-01",{"date":35,"type":19},"2030-12-31",{"name":37,"class":38},"Shanghai 6th People's Hospital","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":39},"100587217","phase-2-a-trial-of-apatinib-and-adebrelimab-in-combination-with-chemotherapy-in-patients-with-unresectable-icc-100587217","NCT06925516","A Trial of Apatinib and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable ICC","Efficacy and Safety of Apatinib Combined With Adebrelimab and GEMOX Regimen Chemotherapy as the First-line Treatment for Unresectable Intrahepatic Cholangiocarcinoma (ICC): A Single-arm, Multicenter, Phase II Study","ACADEMY","Inclusion Criteria:\n\n* 1\\. Provided informed consent and sign the informed consent form;\n* 2\\. Male or female, Aged 18-75 years (counted on the date of signing informed consent);\n* 3\\. Histologically or cytologically confirmed ICC;\n* 4\\. The patient is not a candidate for surgery, or the disease has progressed after prior surgery and\u002For local treatment.\n* 5\\. No previous systematic treatment for advanced ICC. Exceptions include patients who relapsed more than 6 months after adjuvant chemotherapy following radical resection. Local regional therapy (including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic arterial infusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) must have been completed at least 4 weeks prior to baseline radiological scanning, and any toxicity (except alopecia) induced by local regional therapy must have resolved to ≤ Grade 1 in accordance with National Cancer Institute - Common Terminology Criteria for Adverse Event version 5.0 (NCI-CTCAE v5.0);\n* 6\\. Have at least one measurable lesion (in accordance with RECIST v1.1, major diameter ≥ 10 mm of the measurable lesion in spiral CT scan or short diameter of swollen lymph node ≥ 15 mm; the lesion with previous local therapy can be used as target lesion after the progression is confirmed in accordance with RECIST v1.1)\n* 7\\. Child-Pugh class: Grade A;\n* 8\\. ECOG-PS score: 0-1;\n* 9\\. With a life expectancy of ≥ 12 weeks;\n* 10\\. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;\n* 11\\. If subjects have active hepatitis B (HBV) infection: HBV- deoxyribonucleic acid (DNA) must be \\\u003C 500 IU\u002FmL (or must be \\\u003C 2500 copy\u002FmL if copy\u002FmL is the only unit available in the study site) and are willing to receive antiviral therapy throughout the study (treatment in accordance with local standard of care, e.g., entecavir);\n* 12\\. Women of childbearing potential must agree to abstain from heterosexual intercourse or use reliable contraception from the time of signing informed consent until at least 120 days after the last study drug administration. A negative serum pregnancy test (HCG) must be confirmed within 7 days before starting study treatment. Lactating women are excluded;\n* 13\\. Men with female partners of childbearing potential must agree to abstain from heterosexual intercourse or use reliable contraception from the time of signing informed consent until at least 120 days after the last study drug administration. Men must also agree not to donate sperm during this period. For men whose partners are pregnant, condom use is required without additional contraception;\n\nExclusion Criteria:\n\n* 1\\. Known hepatocellular carcinoma, Combined Hepatocellular and Intrahepatic Cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, fibrolamellar carcinoma of liver;\n* 2\\. Other active malignant tumor except ICC within 5 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs of cervix, breast cancer in situ may be enrolled;\n* 3\\. Planning to or previously received organ or allogenic bone marrow transplantation;\n* 4\\. Treatment of other investigational product(s) within 28 days prior to the start of study treatment;\n* 5\\. Previous treatment with Immune Checkpoint Inhibitors: Prior use of any antibody\u002Fdrug targeting T-cell co-regulatory proteins (immune checkpoints), including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies (including topical use).\n* 6\\. Moderate-to-severe ascites with clinical symptoms, i.e., requiring therapeutic puncture or drainage, or Child-Pugh score \\>2, except the subjects with small amount of ascites in radiological examination but free from clinical symptoms; uncontrolled or moderate to severe pleural effusion, pericardial effusion.\n* 7\\. History of gastrointestinal bleeding within 6 months prior to the start of study treatment or clear tendency of gastrointestinal bleeding;\n* 8\\. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment;\n* 9\\. Known genetic or acquired hemorrhage (e.g., coagulation dysfunction) or thrombotic tendency, for example, subject with hemophilia; current or recent (within 10 days prior to the start of study treatment) use of full-dose of oral or intravenous anticoagulant or thrombolytic drug for the purpose of treatment (preventive use of low-dose aspirin or low molecular weight heparin is allowed);\n* 10\\. Current or recent (within 10 days prior to the start of study treatment) use of aspirin (\\> 325 mg\u002Fday, maximum dose for antiplatelet) or dipyridamole, ticlopidine, clopidogrel and cilostazol;\n* 11\\. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment, for example, cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism;\n* 12\\. Cardiac clinical symptom or disease that is not well controlled;\n* 13\\. Hypertension that cannot be well controlled through antihypertensive drugs, allowing to reach the above parameters by the use of antihypertensive therapy; previous hypertensive crisis or hypertensive encephalopathy;\n* 14\\. Major vascular disease within 6 months prior to the start of study treatment (for example, aortic aneurysm requiring surgical repair or peripheral arterial thrombosis in recent days); Serious, unhealed or splitting wound and active ulcer or untreated bone fracture; Major surgical therapy within 4 weeks prior to the start of study treatment (except diagnosis), or planned major surgery during the study;\n* 15\\. Evidence on intraperitoneal pneumatosis that can not be explained by puncture or recent surgery;\n* 16\\. Previous or current presence of metastasis to central nervous system; Metastatic disease involving main airway or blood vessels (e.g. Vena cava tumor invasion or complete occlusion of the major portal vein due to HCC, the major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein) or high-volume mediastinal tumor mass located in the center (distance from carina \\\u003C30 mm);\n* 17\\. History of hepatic encephalopathy; Current interstitial pneumonia or interstitial lung disease, or history of interstitial pneumonia or interstitial lung disease which required hormonal therapy, or other pulmonary fibrosis that may interfere with the judgement and treatment of immune-related pulmonary toxicity; organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug related pneumonitis, idiopathic pneumonia, subjects with evidence on active pneumonia or serious pulmonary function impairment on thoracic computed tomography (CT) in screening period (previous radiation pneumonitis in the radiation area will be allowed); active tuberculosis;\n* 18\\. Active autoimmune disease or history of autoimmune disease and may relapse (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[with the exception that it can be controlled by hormone replacement therapy\\]). Subjects with skin disease that do not require systemic treatment are eligible, for example, leukoderma, psoriasis, alopecia; subjects with controlled type 1 diabetes by insulin are eligible; subjects with asthma that has been completely resolved in childhood and don't need any treatment are eligible, but subjects with asthma that require a bronchodilator as medical intervention are not eligible;\n* 19\\. Use of immunosuppressive medication within 14 days prior to the start of study treatment, or systemic corticosteroid therapy to achieve the objective of immunosuppression (Prednisone at the dose of \\>10mg\u002Fday or equivalent);\n* 20\\. Known history of hypersensitivity to the active substance or to any other components of each investigational medicinal product;\n* 21\\. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; oral or intravenous therapeutic antibiotics within 2 weeks prior to the start of study treatment (subjects who are treated with antibiotics for prevention, e.g., preventive urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible for participation in the study);\n* 22\\. Congenital or acquired immunodeficiency (e.g., HIV infection);\n* 23\\. Hepatitis B and hepatitis C co-infection;\n* 24\\. Attenuated live vaccine therapy administered within 28 days prior to the start of study treatment, or are expected to receive such vaccines during Adebrelimab treatment or within 60 days after the last dose of Adebrelimab;\n* 25\\. Other factors that may affect the study results or lead to early study termination as judged by investigators, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant therapy, with serious laboratory examination abnormality, with family or social factors, that may affect subject's safety.","75 Years",{"count":50,"type":19},38,[23],"The study aims to evaluate the efficacy and safety of Apatinib and Adebrelimab in Combination With chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC)",[26],[55,56,57,58,59],"unresectable intrahepatic cholangiocarcinoma","cholangiocarcinoma","GEMOX chemotherapy","Antineoplastic Agents","Tyrosine kinase inhibitors","2026-06-15",{"date":62,"type":31},"2026-06-17",{"date":64,"type":31},"2025-04-25",{"date":66,"type":19},"2028-10-01",{"name":68,"class":38},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":20,"phases":79,"briefSummary":80,"conditions":81,"keywords":94,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":39},"100461298","phase-2-pds01adc-in-combination-with-hepatic-artery-infusion-pump-haip-and-systemic-therapy-for-subjects-with-metastatic-colorectal-cancer-intrahepatic-cholangiocarcinoma-or-metastatic-adrenocortical-carcinoma-100461298","NCT05286814","PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","* INCLUSION CRITERIA:\n\nInclusion Criteria- All Cohorts\n\n* Participants must have a documented diagnosis of one of the following cancers:\n\n  * Metastatic colorectal cancer (mCRC)\n  * Intrahepatic cholangiocarcinoma (ICC)\n  * Adrenocortical carcinoma (ACC) with liver dominant disease\n* Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than 28 days after initiation of study-directed HAIP intervention:\n\n  * mCRC: FOLFOX or FOLFIRI\n  * ICC: GemOx or FOLFOX\n  * ACC: GemOx\n* Age \\>= 18 years.\n* Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP).\n\nNOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. IOCBP must have a negative pregnancy test (HCG blood or urine) during screening.\n\n* All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study treatment for those able to father a child or 6 months after completion of study treatment for those of child-bearing potential (i.e., IOCBP). Highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Note: The use of condoms by participants who are able to get other individuals pregnant is required unless the partner of childbearing potential is permanently sterile.\n* Nursing (including breastfeeding) participants must agree to discontinue nursing.\n* Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase (i.e., CT C\u002FA\u002FP multiphase) amenable to placement of the HAIP.\n* Participant must sign the informed consent form to participate in this study.\n* HIV-positive participants may be considered for this study only if they have an undetectable viral load.\n* Participants must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176, \"Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors\".\n* Participant's liver metastases must not be amenable to resection\u002Fablation to No Evidence of Disease (NED) in one stage.\n\nInclusion Criteria-Metastatic Colorectal Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1).\n* Participants must have measurable liver metastatic disease.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 2.5 X institutional upper limit of normal\n  * creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation \\> 60 mL\u002Fmin\u002F1.73 m2.\n\nInclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required.\n* Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection.\n* Participants must have radiographically measurable disease.\n* Disease must be considered unresectable at the time of preoperative evaluation.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C=1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 2,000\u002F mm\\^3\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\>= 75,000\u002F mm\\^3\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 mg\u002Fdl\n  * creatinine \\\u003C= 1.5 mg\u002Fdl\n\nInclusion Criteria-Adrenocortical Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC), also referred to as \"adrenocortical cancer\".\n* Participants must have received at least one line of systemic chemotherapy.\n* Participants must have measurable liver metastatic disease.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 3 X institutional upper limit of normal\n  * creatinine \\\u003C 2 X institutional upper limit of normal\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria- All Cohorts\n\nParticipants who are receiving any other investigational agents.\n\n* Participants who have previously received rIL-12.\n* Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions:\n\n  * diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;\n  * participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses \\\u003C= 10 mg of prednisone or equivalent per day;\n  * administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is eligible.\n* History of organ transplant, except for transplants that do not require immunosuppression.\n* History of or active inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis).\n* Known hypersensitivity or allergic reactions attributed to any compounds of similar chemical or biologic composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies and history of allergic reactions attributed to compounds of similar chemical composition to FUDR or heparin.\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke \\\u003C 6 months prior to enrollment, myocardial infarction \\\u003C 6 months prior to enrollment, unstable angina, congestive heart failure (\\>= NYHA III) or serious cardiac arrhythmia requiring medication.\n* All conditions associated with significant necrosis of nontumor-bearing tissues.\n* Esophageal or gastroduodenal ulcers \\\u003C 6 months prior to treatment.\n* Active ischemic bowel disease.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active concurrent malignancies within the last five years other than colorectal primary except basal cell skin carcinoma and thyroid carcinoma.\n* Prior radiation to liver.\n* Participants with active Hepatitis B or C infection.\n* Significant acute or chronic infections (i.e., tuberculosis) history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings).\n* Any condition, including the presence of laboratory abnormalities and\u002For insufficient normal liver parenchyma, which places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.\n\nExclusion Criteria-Metastatic Colorectal Carcinoma\n\n-Participants with incontrovertible radiographic evidence of disease outside of the colon\u002Frectum (primary) and liver given unlikelihood of benefit from liver-directed therapy.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminant as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Participants who have undergone extra-hepatic metastasectomy and have a documented disease-free interval less than or equal to 4 months.\n* Participants with a history of MSI-high results who need to be treated with check-point inhibitors.\n* Prior treatment with FUDR.\n\nExclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n-Presence of distant metastatic disease. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminate as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Prior treatment with FUDR.\n* Diagnosis of sclerosing cholangitis.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n\nExclusion Criteria-Adrenocortical Carcinoma\n\n* Participants with incontrovertible radiographic evidence of additional abdominal disease outside of the liver (including the primary tumor) that is not amenable to complete surgical extirpation at the time of pump placement.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n* Diagnosis of sclerosing cholangitis.\n* Participants with pulmonary metastases that have progressed by RECIST criteria in the preceding 3 months prior to study enrollment.\n* Participants with known mismatch repair mutation who have not been treated with a checkpoint inhibitor. Acceptable methods of MSI testing for history of MSI results include immunohistochemistry (IHC) and next generation sequencing (NGS) of tumor material.","120 Years",{"count":78,"type":19},70,[23],"Background:\n\nOne way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment. The drug triggers the immune system to fight cancer.\\\u003CTAB\\>\n\nObjective:\n\nTo see if treatment with HAIPs to deliver liver-directed FUDR and Dexamethasone chemotherapy in combination with PDS01ADC is effective for certain cancers.\n\nEligibility:\n\nPeople aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver, or cancer of the adrenal glands that has spread to the liver, who are also receiving or planning to receive standard systemic chemotherapy for their disease.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nPregnancy test (if needed)\n\nTumor biopsy (if needed)\n\nElectrocardiogram\n\nComputed tomography (CT) scans\n\nParticipants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen.\n\nAll participants will have liver-directed FUDR and Dexamethasone chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. PDS01ADC will be injected under the skin every 4 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects.\n\nParticipants will also receive standard systemic chemotherapy for their disease, assigned based on diagnosis, through an IV by their medical oncologist (at NIH or by a local provider) every 2 weeks.\n\nParticipants will have 2 study visits at NIH each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests.\n\nParticipants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.",[82,26,83,84,85,86,87,88,89,90,91,92,93],"Metastatic Colorectal Cancer (Mcrc)","Intrahepatic Bile Duct Cancer","Colorectal Neoplasms","Colorectal Cancer","Cholangiocarcinoma","Bile Duct Neoplasms","Bile Duct Cancer","Adrenocortical Carcinoma (ACC)","Adrenal Cortical Carcinoma","Adrenal Gland Cancer","Adrenal Gland Neoplasms","Adrenal Cortex Neoplasms",[95,96,97,98,99,100,101,102,103,104],"Unresectable Liver Tumor","SMART System","Response Rates","Progression Free Survival (Pfs)","Patient Survival","Overall Survival (Os)","NHS-IL12","Mcrc","Icc","ACC","2026-06-09",{"date":107,"type":31},"2026-06-10",{"date":109,"type":31},"2022-10-24",{"date":111,"type":19},"2028-12-31",{"name":113,"class":114},"National Cancer Institute (NCI)","NIH",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":39},"100643566","adjuvant-therapy-for-high-risk-intrahepatic-cholangiocarcinoma-a-real-world-study-100643566","NCT07640048","Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study","A Real-World Study on Postoperative Adjuvant Therapy for Intrahepatic Cholangiocarcinoma Patients With High-Risk Recurrence Factors","Inclusion Criteria:\n\n* Histologically confirmed ICC within 12 weeks after curative resection\n* Any T stage; N0\u002FN+; M0.\n* At least one high-risk factor:\n\nPreoperative tumor penetration of the liver capsule or extrahepatic direct invasion; Preoperative imaging showing multifocal lesions or a single lesion \\>5 cm; Vascular invasion (preoperative or postoperative pathology); Regional lymph node metastasis.\n\n* No prior systemic therapy for ICC.\n* ECOG performance status 0-2.\n* Expected survival ≥3 months.\n* Adequate organ function.\n* Agreement to use effective contraception (or surgical sterilization) during the study and for 120 days after the last dose.\n* Signed informed consent and anticipated good compliance with the study protocol.\n\nExclusion Criteria:\n\n* Immunosuppressive therapy within 28 days prior to enrollment (excluding topical\u002Finhaled corticosteroids or physiologic steroid doses ≤10 mg\u002Fday prednisone equivalent).\n* Systemic anticancer herbs\u002Fimmunomodulators (e.g., thymosin, interferons) within 4 weeks, except for pleural effusion control.\n* Uncontrolled cardiovascular disease:\n\nUnstable angina\u002Fmyocardial infarction Arrhythmias with QTc ≥450 ms (men) or ≥470 ms (women) NYHA Class III-IV heart failure or LVEF \\\u003C50%\n\n* Active infections (IV antibiotics\u002Fantivirals required) or fever \\>38.5°C within 4 weeks; or major surgery within 3 weeks.\n* Active autoimmune\u002Fimmunodeficiency diseases (e.g., hepatitis, pneumonitis, rheumatoid arthritis), except:\n\nHypothyroidism on stable hormone replacement Type 1 diabetes with controlled glucose Uncontrolled asthma requiring systemic bronchodilators (resolved childhood asthma allowed).\n\n\\- Active infections: HIV\u002FAIDS\n\nHBV (DNA ≥500 IU\u002FmL) or HCV (RNA-positive) unless:\n\nHBV DNA \\\u003C500 IU\u002FmL + antiviral therapy ≥14 days\n\n* Prior\u002Fproposed organ transplantation (excluding corneal grafts).\n* Concurrent interventional trials or investigational drugs within 4 weeks without recovery to Grade ≤1 toxicity.\n* Hypersensitivity to study drug components.\n* Allogeneic transplant history\u002Fplans.\n* Uncontrolled psychiatric\u002Fsubstance abuse disorders.\n* Refractory hypertension (≥140\u002F90 mmHg despite treatment).\n* Clinically significant bleeding\u002Fthromboembolism:\n\nGI bleeding within 3 months Thrombotic events within 6 months (stroke, DVT\u002FPE)\n\n* Coagulopathy (INR \\>1.5, PT \\>ULN+4s, aPTT \\>1.5×ULN) or anticoagulant use.\n* Proteinuria ≥++ on dipstick or 24-h urine protein ≥1 g.\n* Other high-risk conditions per investigator judgment.",{"count":123,"type":19},90,"OBSERVATIONAL","This multicenter real-world study assesses the efficacy and safety of adjuvant therapies in postoperative intrahepatic cholangiocarcinoma (ICC) patients with high-risk recurrence factors.\n\n90 eligible patients will be assigned to: Cohort 1: GP (gemcitabine\u002Fcisplatin) + adebrelimab Cohort 2: Apatinib + adebrelimab Cohort 3: S-1 (tegafur\u002Fgimeracil\u002Foteracil) + adebrelimab Outcomes will be compared against historical real-world controls receiving standard chemotherapy.",[26],"2026-06-05",{"date":107,"type":31},{"date":130,"type":31},"2025-05-04",{"date":132,"type":19},"2029-12-31",{"name":134,"class":38},"Peking Union Medical College Hospital",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":20,"phases":145,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100572614","study-assessing-pet-imaging-with-zirconium-labelled-girentuximab-in-patients-with-hcc-btc-or-nen-100572614","NCT06735560","Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN","Prospective Pilot Study Assessing Imaging Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Patients With HepatoCellular Carcinoma, Biliary Tract Carcers or Gastro-Entero-Pancreatic Neuroendocrine Neoplasms.","ELEGANCE","Inclusion Criteria:\n\n1. Provided written informed consent.\n2. Patients aged ≥ 18 years.\n3. \\- For basket 1 and 2: HCC or ICC histologically proven: newly diagnosed patients or patients with suspected refractory, residual, or recurrent disease.\n\n   \\- For basket 3: Progressive GEP-NENs with low or heterogeneous expression of SSTR2 or progressive pancreatic NENs which previously received at least two systemic treatments (excluding SSA) or pancreatic NENs with germline or somatic VHL mutation or G3 GEP-NENs .\n4. Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT\u002FMRI.\n5. Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2.\n6. For cirrhotic patients: Child-Pugh ≤ B7.\n7. Patient affiliated to or beneficiary of the National Health Service.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.\n2. Chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 2 weeks prior to 89Zr-TLX250 administration.\n3. Radionucleide targeted therapy prior to inclusion within 3 months prior to inclusion.\n4. Radioembolization within 3 months prior to inclusion.\n5. Uncontrolled brain or spinal cord metastasis.\n6. Cardiac disease with New York Heart Association classification of III or IV.\n7. Life expectancy shorter than 4 months.\n8. Any major surgery within 4 weeks before enrollment.\n9. Any uncontrolled significant medical, psychiatric or surgical condition (active infection (subjects with known human immunodeficiency virus (HIV) positive)), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus (glycated haemoglobin (HbA1c) ≥9%), uncontrolled congestive heart disease, etc.) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or that would limit compliance with the objectives and assessments of the study.\n10. Other known malignancies (except for fully-resected non-melanoma skin cancer or cervical cancer in situ) unless definitively treated and proven no evidence of recurrence for 2 years.\n11. Women who are pregnant or breastfeeding. A serum pregnancy test will be performed at the start of the study for all female subjects of childbearing potential.\n12. Patient under guardianship or trusteeship.\n13. Patient under judicial protection.",{"count":144,"type":19},60,[146],"NA","Precision medicine represents a major goal in oncology. It has its underpinning in the identification of biomarkers with diagnostic, prognostic, or predictive values. Gastro-entero-pancreatic neuroendocrine neoplasia (GEP-NENs) are rare tumors, but their frequency is increasing. In this context, the tumor expression of carbonic anhydrase IX (CAIX), complemented by a restricted profile in normal tissues, provides an opportunity for therapeutic targeting and precision medicine. Indeed, radiolabeling the anti-CAIX monoclonal antibody girentuximab with Zirconium 89 has shown promise as a novel positron emission tomography (PET) tracer and labeling with 177 Lutetium promise as a therapeutic agent in clear cell renal cell carcinoma (ccRCC) in the context of a theranostic approach. The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET\u002FCT tracer for the imaging of Gastro-Entero-Pancreatic Neuroendocrine Neoplasms, Hepatocellular Carcinoma or IntraHepatic Cholangiocarcinoma.",[149,26,150],"Hepatocellular Carcinoma (HCC)","Neuroendocrine Tumors",[152,153,154,155,156],"immunoPET","CAIX","GEP-NEN","ICC","HCC","2026-05-11",{"date":159,"type":31},"2026-05-13",{"date":161,"type":31},"2025-11-04",{"date":163,"type":19},"2027-08-04",{"name":165,"class":38},"Nantes University Hospital",2,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":15,"minAge":175,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":20,"phases":178,"briefSummary":179,"conditions":180,"keywords":184,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":195,"leadSponsor":196,"locationsCount":39},"100629590","scout-dose-of-resin-microspheres-100629590","NCT07476651","Scout Dose of Resin Microspheres","Lung Shunt Fraction Measurement With Scout Dose of Resin Yttrium-90 Microspheres for Radioembolization (LASER)","LASER","Inclusion Criteria:\n\n* Adults aged 19 years or older\n\n  * Hepatocellular carcinoma diagnosed radiologically according to the American Association for the Study of Liver Disease diagnostic criteria or diagnosed histologically, histologically diagnosed intrahepatic cholangiocarcinoma, or liver metastases\n\n    * Volume of liver not included in the treatment field is at least 30% of the total non-tumorous liver volume\n\n      * Child-Pugh class A\n\n        * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 ⑥ Patients with lung shunt fraction ≤20% on MAA scan (planar image)\n\n          ⑦ Patients with no major organ abnormalities on blood tests performed within 2 months before treatment:\n\n          • A. Leukocytes ≥ 1,000\u002FµL and ≤ 20,000\u002FµL\n\n          • B. Hemoglobin ≥ 6.0 g\u002FdL (transfusion allowed to meet this criterion)\n\n          • C. Total bilirubin ≤ 2.0 mg\u002FdL\n\n          • D. Platelet ≥ 40,000\u002FµL\n\n          • E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants\n          * F. Aspartate transaminase (AST) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit)\n          * G. Alanine transaminase (ALT) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit)\n          * H. Creatinine ≤ 2.5 mg\u002FdL (no restriction for dialysis patients) ⑧ Patients with life expectancy of at least 3 months ⑨ For women of childbearing potential, those with negative serum pregnancy test ⑩ Patients who fully understand the content of the prospective observational study and provide written informed consent\n\nExclusion Criteria:\n\n1. Patients with biliary-enteric anastomosis or biliary stent\n2. Cases where the operator judges that even mild radiation pneumonitis could be fatal due to findings of emphysema or interstitial lung disease on chest CT\n3. Patients with a history of severe hypersensitivity reaction to iodinated contrast agents\n4. Patients with contraindications to angiography or catheter manipulation\n5. Patients with lung shunt fraction \\>20% on MAA scan (planar image)","19 Years",{"count":177,"type":19},30,[146],"This study looks at a liver cancer treatment called radioembolization and tests a new, possibly more accurate way to check if the treatment is safe for a patient's lungs.\n\nRadioembolization is a procedure where tiny beads containing a radioactive substance (yttrium-90) are injected into the arteries that feed a liver tumor. These beads lodge mainly in the tumor and deliver radiation directly to it, while sparing most of the normal liver. However, some of these beads can bypass the liver circulation and travel to the lungs. If too many reach the lungs, they can cause serious radiation damage called radiation pneumonitis.\n\nTo avoid this, doctors currently perform a \"test run\" before the real treatment. They inject a different particle called MAA into the liver artery and then do nuclear medicine scans to see how much of it goes to the lungs versus the liver. This percentage is called the lung shunt fraction. If the lung shunt is 20% or higher, radioembolization is not done; if it is between 10% and 20%, the decision depends on tumor size. The actual treatment usually happens 1-2 weeks after this test.\n\nMAA particles are similar in size to the treatment beads but not identical; some are smaller. Because of this, MAA may slightly overestimate how much of the treatment dose would really go to the lungs. Also, MAA is fully imported and has had periods of supply problems worldwide. For these reasons, there is a need for another, more accurate and more reliable way to measure lung shunt.\n\nThe LASER study tests an approach called a \"scout dose.\" In this method, doctors take a small amount of the actual treatment beads (SIR-Spheres, a resin yttrium-90 microsphere product) and inject a low radioactive dose (0.56 GBq) into the liver artery on the day of treatment. They then perform a PET\u002FCT scan and calculate how much of this scout dose went to the lungs and how much stayed in the liver. Because the scout dose uses the same type of beads as the real treatment, it may give a more accurate picture of the true lung shunt.\n\nThe study will enroll 30 adult patients who have liver tumors (liver cancer, intrahepatic cholangiocarcinoma, or liver metastases) and are already scheduled to receive radioembolization. All participants must have good liver function (Child-Pugh A), good performance status (ECOG 0-1), and an MAA-based lung shunt fraction below 20%. They also need to meet standard blood test criteria and have a life expectancy of at least three months.\n\nEach patient first undergoes the usual work-up: liver artery angiography, MAA injection, and nuclear scans, which are used to plan the treatment dose. One to two weeks later, on the treatment day, the patient has another angiogram, receives the 0.56 GBq scout dose into the liver artery, and has a scout PET\u002FCT scan while the catheter is kept in place. After calculating the lung shunt from the scout dose, the patient is brought back to the angiography room and receives the planned treatment dose, reduced by the amount already given as the scout dose. The next morning, a treatment Y90 PET\u002FCT scan is performed.\n\nThe main measurement of interest is the lung shunt fraction calculated three different ways: from the initial MAA scan, from the scout Y90 PET\u002FCT, and from the treatment Y90 PET\u002FCT. The researchers will compare how closely these three values agree. They will also look at how much radiation the tumor and normal liver receive (tumor dose, normal liver dose) and the radiation dose to the lungs, again using all three imaging methods.\n\nPatients will be followed for one year with regular clinic visits, blood tests, and CT or MRI scans according to usual care. The study will carefully record side effects such as fatigue, pain, poor appetite, and more serious problems like liver failure or radiation pneumonitis, and grade them using a standard international system (CTCAE v5.0). The researchers expect that adding the scout dose and extra scan will lengthen the procedure by about two hours and cause some discomfort from lying down longer, but they do not expect a major increase in serious risks compared with standard treatment.\n\nBy the end of the study, the team aims to show whether the scout dose method can safely and accurately replace or complement the traditional MAA-based test. If successful, this could improve the precision of radioembolization planning and offer a reliable alternative when MAA is not available",[181,149,182,183],"Radioembolization","Intrahepatic Cholangiocarcinoma (ICC)","Liver Metastasis",[185,186,187,188,189,190],"lung shunt fraction","scout dose","resin microspheres","yttrium","radioembolization","selective internal radiation therapy","2026-04-13",{"date":193,"type":31},"2026-04-16",{"date":191,"type":31},{"date":132,"type":19},{"name":197,"class":38},"Seoul National University Hospital",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":48,"enrollmentInfo":205,"targetDuration":4,"studyType":20,"phases":207,"briefSummary":208,"conditions":209,"keywords":212,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":39},"100582159","phase-2-hepatic-arterial-infusion-chemotherapy-haic-combined-with-durvalumab-and-lenvatinib-in-patients-with-locally-advanced-or-metastatic-intrahepatic-cholangiocarcinoma-a-phase-2-studyhaic-quad-trial-100582159","NCT06859684","Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)","HAIC-quad","Inclusion Criteria:\n\n1. Histologically confirmed intrahepatic cholangiocarcinoma, with a preliminary diagnosis of unresectable or metastatic disease and no previous systemic treatment.\n\n   Anatomical factors: ① Patients with invasion of the portal vein, hepatic vein or main bile duct, who cannot undergo resection and reconstruction; ② Patients with decompensated cirrhosis or severe portal hypertension, and the residual liver FLR does not meet the safe liver resection decision-making system Biological factors: ① Multiple tumors in the left and right livers; ② Metastasis to distant lymph nodes such as the para-aorta or distant organ metastasis\n2. Disease recurrence \\> 6 months after radical surgery; if adjuvant therapy is given after surgery, patients \\> 6 months after completion of adjuvant therapy (chemotherapy and\u002For radiotherapy) are eligible for inclusion.\n3. WHO\u002FECOG PS of 0 or 1\n4. There was at least 1 target lesion (TL) that met the RECIST 1.1 criteria\n\nExclusion Criteria:\n\n1. Patients who have received systemic treatment in the past.\n2. Patients with severe liver dysfunction (Child-Pugh C grade), or significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.\n3. Patients with severe and uncorrectable coagulation dysfunction.\n4. Patients with active hepatitis or severe infection who cannot be treated simultaneously.\n5. Patients with cachexia or multiple organ failure.",{"count":206,"type":19},25,[23],"At present, the first-line treatment for patients with advanced unresectable intrahepatic cholangiocarcinoma is mainly systemic treatment, but the improvement in efficacy is limited and is not enough to meet the current clinical treatment needs. Hepatic artery infusion chemotherapy (HAIC) has the advantages of increasing local drug concentration and reducing toxic side effects compared to systemic intravenous chemotherapy. In order to enable patients with advanced intrahepatic cholangiocarcinoma to obtain better treatment effects, this study plans to explore HAIC combined with durvalumab and lenvatinib as the first-line treatment for patients with locally advanced or metastatic ICC, in order to provide a better treatment choice for their comprehensive treatment.",[26,210,211],"HAIC","Durvalumab",[213,214,215,210],"locally advanced or metastatic intrahepatic cholangiocarcinoma","durvalumab","Lenvatinib","2026-03-05",{"date":218,"type":31},"2026-03-09",{"date":220,"type":31},"2025-03-01",{"date":222,"type":19},"2027-03-06",{"name":224,"class":38},"West China Hospital",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":48,"enrollmentInfo":232,"targetDuration":4,"studyType":20,"phases":234,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":245,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":252,"locationsCount":39},"100620146","phase-2-folfox-haic-combined-with-donafenib-and-pucotenlimab-as-first-line-treatment-for-unresectable-intrahepatic-cholangiocarcinoma-100620146","NCT07353827","FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma","A Prospective, Open-Label Clinical Study of FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Male or female participants aged 18 to 75 years.\n* Histologically or clinically diagnosed Hepatocellular Carcinoma (HCC) according to AASLD or EASL guidelines.\n* Disease stage classified as Barcelona Clinic Liver Cancer (BCLC) stage B (unresectable) or stage C.\n* No prior systemic treatment for advanced HCC (treatment-naïve).\n* At least one measurable lesion according to RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Child-Pugh liver function class A (score 5-6).\n* Life expectancy of at least 3 months.\n* Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, Platelets ≥ 75 × 10\\^9\u002FL, and Hemoglobin ≥ 90 g\u002FL.\n* Adequate liver function: Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 5 × ULN.\n* Adequate renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin.\n* Adequate coagulation function: INR ≤ 1.5 or PT ≤ 1.5 × ULN.\n* Participants suitable for hepatic artery catheterization and HAIC treatment as assessed by the investigator.\n* Willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to Oxaliplatin, Fluorouracil, Leucovorin, Donafenib, Pucotenlimab, or any of their excipients.\n* Previous treatment with anti-PD-1\u002FPD-L1 antibodies, anti-CTLA-4 antibodies, or other immunomodulatory agents.\n* Diagnosis of other malignant tumors within the past 5 years (excluding cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).\n* Presence of central nervous system (CNS) metastases.\n* Active, known, or suspected autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring systemic treatment.\n* History of gastrointestinal bleeding, esophageal or gastric varices with bleeding risk, or other active bleeding within 6 months prior to enrollment.\n* Severe cardiovascular disease, including unstable angina, myocardial infarction within 6 months, or uncontrolled hypertension.\n* Active infection requiring systemic antibiotic therapy.\n* Hepatitis B virus (HBV) DNA \\> 2000 IU\u002FmL (participants must receive antiviral treatment to suppress viral load).\n* Known Human Immunodeficiency Virus (HIV) infection or active Syphilis infection.\n* Anatomy unsuitable for hepatic arterial catheterization (e.g., severe vascular variation or occlusion).\n* Pregnant or breastfeeding women.\n* Any condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the integrity of the study data.",{"count":233,"type":19},36,[23],"This is a prospective, open-label, single-arm phase II study designed to evaluate the efficacy and safety of FOLFOX-based hepatic arterial infusion chemotherapy (HAIC) in combination with donafenib and pucotenlimab as first-line treatment in patients with unresectable intrahepatic cholangiocarcinoma.\n\nEligible patients will receive FOLFOX-HAIC administered every three weeks together with oral donafenib and intravenous pucotenlimab. Tumor response will be assessed according to RECIST v1.1. The primary objective of the study is to determine the objective response rate, and secondary objectives include progression-free survival, overall survival, disease control rate, and safety.",[26,237],"Hepatic Arterial Infusion Chemotherapy",[239,240,241,242,243,244],"Unresectable liver cancer","Hepatic arterial infusion chemotherapy","Oxaliplatin-based chemotherapy","Immune checkpoint inhibitor therapy","Targeted anti-angiogenic therapy","Phase II clinical trial","NOT_YET_RECRUITING","2026-01-11",{"date":248,"type":31},"2026-01-20",{"date":250,"type":19},"2026-02-01",{"date":111,"type":19},{"name":253,"class":38},"Sun Yat-sen University",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":39},"100618917","prospective-evaluation-of-68ga-fapi-pet-in-biliary-cancers-100618917","NCT07337850","Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers","FAP 2: Utility of Gallium-68-Fibroblast Activation Protein Inhibitor (FAPI) PET in Biliary Tract Cancers: A Prospective Study","FAPi-2","Inclusion Criteria:\n\n* Suspected biliary tract cancers- iHCC and GBC\n* Male and females ≥ 18 years;\n* Upfront advanced (suspected T3 ,T4, N1, vascular involvement)\n* iGBC (residual, N1)\n* Suspected post-treatment recurrence (biochemical or radiological)\n\nExclusion Criteria:\n\n* Informed consent withdrawal\n* Concurrent Malignancy","90 Years",{"count":144,"type":19},"The goal of this prospective observational study is to evaluate whether Gallium-68 Fibroblast Activation Protein Inhibitor (FAPI) PET\u002FCT can improve detection, staging, and recurrence assessment in adult patients (≥18 years) with suspected or confirmed biliary tract cancers, including gallbladder cancer, cholangiocarcinoma, and post-treatment suspected recurrence.\n\nThe main question(s) this study aims to answer are:\n\nCan FAPI PET\u002FCT provide greater sensitivity, specificity and diagnostic accuracy for primary tumors, nodal disease, and metastatic lesions compared to standard FDG PET\u002FCT?\n\nDoes FAPI PET\u002FCT offer additional diagnostic yield that may affect clinical decision-making and staging, potentially reducing need for invasive staging procedures?\n\nResearchers will compare FAPI PET\u002FCT with FDG PET\u002FCT to see if FAPI improves detection of metastatic or recurrent disease, especially peritoneal or liver metastasis and lymph node involvement.\n\nParticipants will:\n\nProvide written informed consent.\n\nUndergo FAPI PET\u002FCT imaging (baseline and\u002For at suspected biochemical or radiologic recurrence).\n\nHave quantitative imaging parameters evaluated (SUVmax, tumor-to-liver ratios, metabolic volume).\n\nMay undergo comparison with FDG PET\u002FCT and\u002For follow-up imaging or histopathology as gold standard.",[266,26],"Gall Bladder Cancer",[268,269,270,271,86,272],"FAPI PET\u002FCT","Gallium-68 FAPI","Biliary Tract Cancer","Gallbladder Cancer","Intrahepatic Cholangiocarcinoma (iHCC)","2026-01-01",{"date":275,"type":31},"2026-01-13",{"date":277,"type":31},"2024-09-25",{"date":279,"type":19},"2026-03",{"name":281,"class":38},"Tata Memorial Centre",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":20,"phases":291,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":245,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":302,"locationsCount":305},"100618230","phase-3-efficacy-and-safety-of-tt-00420-tinengotinib-tablets-versus-chemotherapy-in-patients-with-advanced-intrahepatic-cholangiocarcinoma-harboring-fgfr2-fusionsrearrangements-or-mutations-100618230","NCT07328919","Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions\u002FRearrangements or Mutations","A Phase III, Randomized Controlled, Open-Label, Multicenter Clinical Study Evaluating the Efficacy and Safety of TT-00420 Tablets Versus Chemotherapy in Patients With Surgically Unresectable Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions\u002FRearrangements or Mutations, Who Have Progressed or Relapsed After Prior First-Line Systemic Therapy","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Histologically or cytologically confirmed intrahepatic cholangiocarcinoma.\n3. Subjects diagnosed with stage III or IV intrahepatic cholangiocarcinoma according to the American Joint Committee on Cancer (AJCC) 8th Edition (2018) staging system, and assessed by the investigator as not eligible for curative surgical resection.\n4. Subjects who have experienced recurrence or progression after receiving only one prior line of systemic chemotherapy combined with immunotherapy (PD-1\u002FPD-L1 inhibitor), with or without targeted therapy. Sequential immunotherapy following the completion of chemotherapy cycles is also considered part of the first-line combined regimen. First-line systemic chemotherapy is defined as gemcitabine\u002Fcapecitabine with or without a platinum-based agent.\n\n   Note: Recurrence within 6 months after completion of adjuvant or neoadjuvant therapy will be considered as a line of systemic therapy. Local treatments do not count as systemic therapy.\n5. The presence of FGFR2 gene fusion\u002Frearrangement or mutation must be confirmed by detection using tumor tissue samples provided by the patient and analyzed by a central laboratory.\n6. At least one radiographically measurable lesion must be present according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. ECOG ≤ 1.\n8. Subjects must have adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Subjects with a history of prior treatment with TT-00420 tablets.\n2. Subjects with a known severe allergic reaction to any agent in the study and for whom no alternative study treatment is available.\n3. Subjects receiving corticosteroid therapy for CNS metastases are also ineligible.\n4. Concurrent active malignancy requiring active treatment. Malignancies diagnosed \\>5 years ago without the need for treatment, as well as cured localized tumors such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid carcinoma, are allowed.\n5. Administration of other anti-tumor drugs prior to randomization with an interval of ≤ 5 half-lives or 14 days (whichever is shorter), or failure to recover from adverse events of prior therapies (except for adverse events of ≤ Grade 1, or ≤ Grade 2 events judged by the investigator as not constituting a safety risk).\n6. Prior radiation therapy (large-field radiotherapy within 4 weeks, or local palliative radiotherapy within 2 weeks, before randomization), or failure to recover from related adverse events, is excluded. However, initiation of the investigational drug during the washout period is permitted with sponsor approval, if the investigator believes it is in the subject's best interest based on a favorable benefit-risk assessment.\n7. Subjects who have undergone major surgery within 4 weeks prior to randomization, or who have not recovered from related adverse events (with the exception of ≤ Grade 1 events or non-risk Grade 2 events per investigator's judgment), are excluded.\n8. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and\u002For ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening).",{"count":290,"type":19},138,[292],"PHASE3","This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions\u002Frearrangements or mutations, who have experienced recurrence or progression after prior first-line systemic chemotherapy.",[26,295],"Advanced Cholangiocarcinoma","2025-12-26",{"date":298,"type":31},"2026-01-09",{"date":300,"type":19},"2026-01",{"date":35,"type":19},{"name":303,"class":304},"TransThera Sciences (Nanjing), Inc.","INDUSTRY",20,{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":48,"enrollmentInfo":313,"targetDuration":4,"studyType":20,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":245,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":327,"locationsCount":39},"100608974","a-randomized-trial-of-surgical-decision-making-guided-by-tdtp-recist-100608974","NCT07208526","A Randomized Trial of Surgical Decision-Making Guided by TDTP-RECIST","A Multicenter Randomized Controlled Study on Surgical Decision-Making Guided by the TDTP-RECIST Evaluation System for Locally Advanced Intrahepatic Cholangiocarcinoma Following GOLP Conversion Therapy","Inclusion Criteria:\n\n\\-\n\nSubjects eligible to participate in this study must meet all of the following criteria:\n\n1. Male or female aged 18-75 years;\n2. Patients must provide signed informed consent prior to enrollment, demonstrating the ability to understand and willingness to sign the written informed consent form;\n3. Pathologically confirmed diagnosis of intrahepatic cholangiocarcinoma;\n4. Locally advanced disease, failure to achieve R0 resection, and absence of distant metastasis;\n5. At least one measurable lesion;\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0;\n7. Child-Pugh class A liver function;\n\nExclusion Criteria:\n\n\\-\n\nSubjects who meet any of the following exclusion criteria are not permitted to enroll in this study:\n\n1. Pathologically diagnosed hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma, or other non-cholangiocarcinoma malignant components;\n2. Patients with postoperative recurrence, or those who have previously received PD-1\u002FPD-L1 antibodies, CTLA-4 antibodies, lenvatinib, or chemotherapy;\n3. History or current diagnosis of other malignancies;\n4. Active tuberculosis infection;\n5. Active, known, or suspected autoimmune disease;\n6. History of interstitial lung disease, or non-infectious pneumonitis requiring steroid treatment;\n7. Significant clinically significant bleeding symptoms within 3 months prior to enrollment, or clear bleeding tendency;\n8. Suspected allergy to the investigational drug(s).",{"count":314,"type":19},270,[146],"This project aims to conduct a prospective, multicenter, randomized controlled clinical trial. The study plans to enroll 270 patients with locally advanced iCCA who have successfully undergone GOLP conversion therapy. Participants will be randomized at a 1:2:2 ratio into three arms: Control Arm (continued medication), Direct Surgery Arm, and TDTP-RECIST Assessment Arm. The primary endpoint is Overall Survival (OS).",[26,318,319,320],"Conversion Therapy","TDTP-RECIST","GOLP Regimen","2025-09-28",{"date":323,"type":31},"2025-10-06",{"date":325,"type":19},"2025-12-01",{"date":111,"type":19},{"name":328,"class":38},"Shanghai Zhongshan Hospital",{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":336,"sex":15,"minAge":16,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":340,"conditions":341,"keywords":346,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":39},"100606546","a-cell-free-dna-methylation-blood-based-test-for-biliary-tract-cancers-screening-100606546","NCT07176962","A Cell-free DNA Methylation Blood-Based Test for Biliary Tract Cancers Screening","A Cell-free DNA Methylation Liquid Biopsy for Diagnosis and Management of Biliary Tract Cancers","Inclusion Criteria Internal Training and Validation Cohorts\n\n* BTC patients\n\n  1. Willing to voluntarily participate and able to comply with study procedures; if unable to read or sign, informed consent must be signed by a legally authorized representative (LAR).\n  2. Age 18-80 years (inclusive).\n  3. Able to provide required blood samples.\n  4. Pathologically confirmed biliary tract carcinoma (TNM stage I-IV).\n  5. Stable vital signs; ECOG performance status 0-1.\n  6. Adequate organ function: AST\u002FALT ≤ 5 × ULN; Child-Pugh class A or B; WBC \\> 3 × 10⁹\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Creatinine clearance ≥ 60 mL\u002Fmin; Total bilirubin ≤ 3 × ULN.\n* Other gastrointestinal malignancies (to exclude BTC non-specific signals)\n\n  1. Voluntary participation with signed informed consent (or by LAR).\n  2. Age 18-80 years (inclusive).\n  3. Able to provide required blood samples.\n  4. Pathologically confirmed gastrointestinal malignancies other than BTC, including hepatocellular carcinoma, gastric cancer, colorectal cancer, and pancreatic cancer (TNM stage I-IV).\n  5. Stable vital signs; ECOG performance status 0-1.\n* Non-cancer participants (benign biliary disease)\n\n  1. Able to provide written informed consent.\n  2. Able to provide required blood samples.\n  3. Age 18-80 years (inclusive).\n  4. Pathologically or clinically diagnosed benign biliary diseases, including cholecystitis, cholelithiasis, choledocholithiasis, adenomyomatosis, gallbladder polyps, xanthogranulomatous cholecystitis, or primary sclerosing cholangitis.\n\nExternal Validation Cohorts\n\n* BTC patients\n\n  1. Voluntary participation with signed informed consent (or by LAR).\n  2. Imaging findings of malignant biliary stricture or mass, or serum CA19-9 \\> 100 U\u002FmL, highly suspicious for BTC, with planned surgery or biopsy for pathological confirmation.\n  3. Age 18-80 years (inclusive).\n  4. Able to provide required blood samples.\n  5. Stable vital signs; ECOG performance status 0-1.\n  6. Adequate organ function: AST\u002FALT ≤ 5 × ULN; Child-Pugh class A or B; WBC \\> 3 × 10⁹\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Creatinine clearance ≥ 60 mL\u002Fmin; Total bilirubin ≤ 3 × ULN.\n* Healthy volunteers\n\n  1. Able to provide written informed consent.\n  2. Able to provide required blood samples.\n  3. Age 18-80 years (inclusive).\n\nExclusion Criteria Training and Validation Cohorts\n\n* Cancer patients\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of curative cancer treatment within 3 years prior to blood collection.\n  5. Use of anti-tumor drugs within 30 days prior to blood collection.\n  6. Known bleeding disorders.\n  7. Known autoimmune diseases.\n  8. Concurrent other malignancies or multiple primary tumors.\n* Non-cancer participants\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of any malignant tumor.\n  5. Known bleeding disorders.\n  6. Known autoimmune diseases.\n  7. Clinically significant abnormalities on routine examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).\n\nExternal Validation Cohorts\n\n* Cancer patients\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of or ongoing curative cancer treatment within 3 years prior to blood collection.\n  5. Use of anti-tumor drugs within 30 days prior to blood collection.\n  6. Known bleeding disorders or autoimmune diseases.\n  7. Concurrent other malignancies (including multiple primaries) or known cancer susceptibility gene carriers.\n  8. Pathology confirmed benign disease after biopsy\u002Fsurgery.\n  9. Failure to confirm malignancy by pathology or imaging within 42 days after blood collection, or unclear lesion site\u002Fevidence.\n  10. Special exclusion criteria:\n* Pathology confirmed precancerous lesions.\n* Any local\u002Fregional or systemic anti-tumor therapy (including surgery, radiotherapy, targeted therapy, or immunotherapy) prior to blood collection.\n* Healthy volunteers\n\n  1. Pregnant or breastfeeding women.\n  2. History of organ transplantation or prior allogeneic bone marrow\u002Fstem cell transplantation.\n  3. Blood transfusion within 7 days prior to blood collection.\n  4. History of any malignant tumor.\n  5. Known bleeding disorders or autoimmune diseases.\n  6. Clinically significant abnormalities on health examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).",true,"80 Years",{"count":339,"type":19},1800,"Biliary tract carcinoma (BTC), including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, ranks sixth in incidence among gastrointestinal malignancies and tenth in cancer-related mortality worldwide. Due to the lack of specific early symptoms, high malignancy, and frequent recurrence and metastasis, the rate of curative resection is only about 16.5%, and the overall 5-year survival rate is less than 5%. Early and accurate detection is therefore critical for improving patient outcomes. Circulating tumor DNA (ctDNA), a fraction of circulating free DNA (cfDNA), carries genetic and epigenetic information from tumor cells and can be detected even at the early stages of cancer development. Among various liquid biopsy biomarkers, ctDNA methylation shows particular advantages in sensitivity and specificity for early cancer detection and monitoring. This study aims to evaluate the application of cfDNA methylation liquid biopsy in the diagnosis and management of BTC.",[266,26,342,343,344,345],"Extrahepatic Cholangiocarcinoma","Hilar Cholangiocarcinoma","Billiary Track Cancer","ctDNA",[347,348,349,344],"ctDNA methylation","Early diagnosis","Liquid biopsy","2025-09-10",{"date":352,"type":31},"2025-09-16",{"date":354,"type":31},"2020-01-01",{"date":356,"type":19},"2026-05-01",{"name":358,"class":38},"Yingbin Liu, MD, PhD, FACS",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":367,"targetDuration":369,"studyType":124,"phases":4,"briefSummary":370,"conditions":371,"keywords":375,"overallStatus":245,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":39},"100605388","preoperative-evaluation-of-lymph-nodes-of-cholangiocarcinoma-poelh-iii-100605388","NCT07161869","Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma (POELH-III)","Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma by Endoscopic Ultrasound (POELH-III)","POELH-III","Inclusion Criteria:\n\n* Presumed resectable pCCA OR\n* Presumed resectable iCCA OR\n* Presumed resectable mid-common bile duct CCA OR\n* Presumed unresectable pCCA worked-up for Liver Transplantation AND\n* Written informed consent must be given according to International Council on Harmonisation\u002FGood Clinical Practice guidelines, and national\u002Flocal regulations AND\n* Age \\> 18 years.\n\nExclusion Criteria:\n\n* Patients with a history of treated CCA\n* Patients with CCA for which a pancreatoduodenectomy is indicated, based on cross-sectional imaging\n* Patients with a history of treated liver malignancy\n* Patients with a contra-indication for EUS-tissue acquisition (f.e. uncorrectable coagulopathy or platelet disorder), in line with current clinical practice",{"count":368,"type":19},250,"12 Months","In the POELH-II trial (Clinicaltrials.gov ID NCT05678218) patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma had the outcomes of their preoperative endoscopic ultrasound (EUS) registered. This EUS procedure was done systematically, targeting lymph nodes (LNs) with the aim to identify LN metastases preoperatively.\n\nThe goal of this follow-up observational cohort study (POELH-III) is to assess the yield of preoperative EUS, with an improved EUS approach. The EUS protocol as used in the POELH-II trial was improved based on preliminary results of the POELH-II trial. The main questions it aims to answer is:\n\n\\- The number of patients precluded from surgical work-up due to positive regional or extraregional LNs identified by EUS guided tissue acquisition",[343,26,86,372,373,374],"Perihilar Cholangiocarcinoma","Common Bile Duct Neoplasms","Adenocarcinoma of Biliary Tract",[376,377,378,56,379],"poelh","EUS","Lymph node","biliary tract cancer","2025-09-08",{"date":382,"type":31},"2025-09-09",{"date":384,"type":19},"2025-10-01",{"date":386,"type":19},"2028-11-01",{"name":388,"class":38},"Erasmus Medical Center",{"id":390,"slug":391,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":20,"phases":399,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":245,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":417},"100602805","phase-2-perioperative-cisgem--rilvegostomig-in-high-risk-resectable-intra-hepatic-cholangiocarcinoma-100602805","NCT07128290","PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma","PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma Phase II Single Arm Study - Multicenter","PEHRICCA","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. WHO Performance Status 0-1\n3. Body weight \\> 30kg\n4. Histo\u002Fcytologically proven intrahepatic cholangiocarcinoma.\n5. Measurable disease as defined by RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors).\n6. Naive to systemic treatment and loco regional treatment for biliary tract cancer\n7. At least one of the following high-risk criteria of post resection relapse:\n\n   * Tumor Size ≥ 50 mm and\u002For multiple nodules\n   * cN+\n   * Risk of narrow margin (\\\u003C 10 mm)\n   * Macrovascular invasion\n8. Adequate organ function, as defined by the following:\n\n   * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 2,5 x Upper Limit of Normal (ULN)\n   * Total serum bilirubin ≤ 1.5 ULN This will not apply to patients with confirmed Gilbert's syndrome\n   * Prothrombin ratio \\> 70 % and\u002For Factor V \\> 70 % in case of oral anticoagulation therapy\n   * Serum albumin ≥ 30 g\u002FL\n   * Haemoglobin ≥ 10 g\u002Fdl and no transfusion within 4 weeks before inclusion\n   * Absolute Neutrophil Count (ANC) ≥ 1.5 G\u002FL\n   * Platelets ≥ 150 G\u002FL\n9. Creatinine clearance ≥ 45 ml\u002Fmin (calculated by CKD - EPI formula)\n10. Life expectancy ≥ 3 months\n11. Female postmenopausal for at least one year or surgically infertile for at least 6 weeks, or highly effective contraception for male and female patients of childbearing potential for the duration of study and for 7 months after the last dose of drug for female and 4 months for male.\n12. A negative pregnancy test for inclusion for all female patients of child-bearing potential.\n13. Patient covered by a plan of the French Social Security system.\n14. Written informed consent obtained from the patient prior to performing any protocol-related procedures\n15. Patient with available tumor tissue sample for the study or willing to have a biopsy\n\nExclusion Criteria:\n\n1. Existence of metastases or distant lymph node involvement considered as metastatic\n2. Locally advanced disease considered as definitively non resectable\n3. Cirrhosis with Child Pugh ≥ B7\n\n   1. Any history of liver decompensation: hepatic encephalopathy, presence of ascites\n   2. Presence of clinically significant portal hypertension (platelets counts \\\u003C 150G\u002FL and\u002For liver stiffness \\> 20kPa and\u002For presence of oesophageal and\u002For gastric varices)\n4. Mixed histology (hepatocholangiocarcinoma)\n5. Persistent toxicities (\\> grade 2 NCI-CTCAE version 5.0) caused by previous cancer therapy.\n6. Contraindication to immunotherapy: Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease\n7. Current or prior use of immunosuppressive medication within 14 days before the first dose of protocol treatment\n8. History of allogenic organ transplantation\n9. Known or suspected allergy or hypersensitivity to any of the study drugs or any of the study drug excipients (cisplatin, gemcitabine and Rilvegostomig)\n10. Live vaccine administration within 30 days prior to the first dose of study treatment Note: Patients, if enrolled, should not receive live vaccine whilst receiving investigational product and up to 6 months after the last dose of investigational product.\n11. Uncontrolled infection with human immunodeficiency virus (HIV). Required conditions for inclusion are as follows: undetectable viral RNA, CD4+ count ≥350 cells\u002FμL no history of AIDS-defining opportunistic infection within the past 12 months, stable condition for at least 4 weeks on the same anti-HIV medications.\n12. Active and untreated infection with hepatitis B and\u002For hepatitis C Note: Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive hepatitis B core antigen \\[HBc\\] antibody test) are eligible.\n13. Other active cancer or history of cancer within 2 years, except for carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured\n14. History of clinically significant arrhythmia, cardiomyopathy of any etiology; symptomatic congestive heart failure (as defined by New York Heart Association class ≥ 3), history of myocardial infarction within the past 6 months. Participation in another clinical study with an investigational product during the last 4 weeks\n15. Pregnant or breastfeeding woman.\n16. Person deprived of liberty or under guardianship or incapable of giving consent\n17. Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.",{"count":398,"type":19},49,[23],"The goal of this trial is to determine whether the combination of CISGEM and Rilvegostomig during the perioperative period works to improve outcomes of patient undergoing surgery of high-risk of intrahepatic cholangiocarcinoma",[26],[403,404,405,406,407],"Perioperative","Rilvegostomig","CISGEM","High-risk resectable","intrahepatic cholangiocarcinoma","2025-08-13",{"date":410,"type":31},"2025-08-17",{"date":412,"type":19},"2025-10-30",{"date":414,"type":19},"2029-04-30",{"name":416,"class":38},"Federation Francophone de Cancerologie Digestive",9,{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":20,"phases":428,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":39},"100598377","phase-2-cryoablation-combined-with-lenvatinib-plus-ql1706-iparomlimabtuvonralimab-in-patients-with-advanced-intrahepatic-cholangiocarcinoma-100598377","NCT07070700","Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab\u002FTuvonralimab) in Patients With Advanced Intrahepatic Cholangiocarcinoma","Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab\u002FTuvonralimab) in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-02): A Single-arm, Multi-cohort, Phase 2 Trial","CASTLE-ZS-02","Inclusion Criteria:\n\n* Written informed consent obtained.\n* Age ≥ 18 years at time of study entry.\n* Participants must have unresectable or metastatic histologically or cytologically confirmed intrahepatic cholangiocarcinoma\n* Participants must have failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity. Cohort A must have progressed after GemCis plus PD1\u002FPD-L1 inhibitor. Cohort B must have progressed after GemCis plus PD1\u002FPD-L1 inhibitor and anti-vascular endothelial growth factor antibody\u002Ftyrosine kinase inhibitors.\n* At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.\n* Performance status (PS) ≤ 2 (ECOG scale).\n* Life expectancy of at least 12 weeks.\n* Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500\u002FL, platelets ≥75 x103\u002FL; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g\u002FdL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (if using the Cockcroft-Gault formula )\n* Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n* History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment\n* Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.\n* Prior treatment with cryoablation.\n* RFA and resection administered less than 4 weeks prior to study treatment start.\n* Radiotherapy administered less than 4 weeks prior to study treatment start.\n* Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.\n* Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.\n* Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.\n* Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to: a) history of interstitial lung disease b) Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection) c) known acute or chronic pancreatitis d) active tuberculosis e) any other active infection (viral, fungal or bacterial) requiring systemic therapy f) history of allogeneic tissue\u002Fsolid organ transplant g) diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment. h) Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma\u002Fatopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study. i) Live vaccine within 30 days prior to the first dose of treatment or during study treatment. j) History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS\n* Medication that is known to interfere with any of the agents applied in the trial.\n* Any other efficacious cancer treatment except protocol specified treatment at study start.\n* Patient has received any other investigational product within 28 days of study entry.\n* Prior therapy with an anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n* Female subjects who are pregnant, breast-feeding or male\u002Ffemale patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). \\[Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner\\]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.",{"count":427,"type":19},56,[23],"This study will evaluate the efficacy and safety of cryoablation combined with lenvatinib plus QL1706 (iparomlimab\u002Ftuvonralimab) in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.",[26],"2025-08-10",{"date":433,"type":31},"2025-08-12",{"date":435,"type":19},"2025-08-20",{"date":437,"type":19},"2027-08-01",{"name":439,"class":38},"Fudan University",{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":447,"enrollmentInfo":448,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":450,"conditions":451,"keywords":453,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":465,"locationsCount":39},"100600726","an-exploratory-study-on-developing-an-integrated-approach-combining-multimodal-imaging-and-multi-omics-characterization-of-tumor-heterogeneity-for-precision-diagnosis-and-treatment-optimization-in-liver-cancer-100600726","NCT07101237","An Exploratory Study on Developing an Integrated Approach Combining Multimodal Imaging and Multi-omics Characterization of Tumor Heterogeneity for Precision Diagnosis and Treatment Optimization in Liver Cancer.","Integrative Multimodal Imaging and Multi-omics Profiling of HCC Heterogeneity: a Translational Exploratory Study Leveraging CEUS, Elastography, SMI, PAI, Multi-omics Analysis, and AI-driven Modeling to Advance Precision Diagnosis and Therapeutic Optimization","Inclusion Criteria:\n\n1. Age \\>18 and ≤70 years;\n2. Both sexes eligible;\n3. Diagnosed with primary HCC or ICC;\n4. Scheduled for surgical resection or conversion therapy;\n5. Pathologically confirmed HCC\u002FICC via surgery or biopsy;\n6. Posterior margin of the lesion ≤ 8 cm from the skin surface.\n\nExclusion Criteria:\n\n1. Pregnancy, lactation, or planned pregnancy during the study period;\n2. History of other malignancies;\n3. Cardiac, pulmonary, cerebral, or renal insufficiency;\n4. Lesion depth \\>8 cm from the skin surface on ultrasound;\n5. Massive ascites;\n6. Poor compliance (e.g., inability to hold breath during examination);\n7. Allergy to ultrasound contrast agents.","70 Years",{"count":449,"type":19},308,"Primary liver cancer, mainly including hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), represents the third leading cause of cancer-related mortality. Enhancing the precision of liver cancer diagnosis and providing early therapeutic efficacy and prognostic evaluation during clinical decision-making hold significant clinical importance. Ultrasound is the preferred imaging modality for liver cancer screening. Contrast-enhanced ultrasound (CEUS) can dynamically visualize the microvascular perfusion of liver cancer lesions. Liver elastography has become a commonly used clinical assessment tool for cirrhosis. Photoacoustic imaging (PAI), an emerging non-invasive functional imaging technique, enables visualization of specific molecules through their spectroscopic characteristics at designated wavelengths.\n\nThe objectives of this study include: (1) Conducting an observational investigation combining CEUS, elastography, and superb microvascular imaging (SMI) to collect imaging data; (2) Preserving tumor specimens from participants to investigate heterogeneous protein characteristics of primary liver cancer organoids using PAI; (3) Analyzing peripheral venous blood samples to study transcriptomic profiles. Artificial intelligence (AI) technology will be employed to establish models integrating ultrasound radiomics with tumor multi-omics characteristics, aiming to provide novel strategies for precision diagnosis and treatment of liver cancer.\n\nKey questions：(1) How to develop a multimodal imaging model combining CEUS, elastography, and SMI for predicting differentiation of liver cancer, microvascular invasion (MVI) and prognosis; (2) Whether PAI can identify heterogeneous proteins in liver cancer organoids through specific spectral recognition; (3) Whether AI can integrate multi-dimensional data to establish models based on ultrasound radiomics and multi-omics features.",[149,182,452],"Primary Liver Cancer",[454,156,455,456,457,458],"liver cancer","contrast-enhanced ultrasound (CEUS)","elastography","superb microvascular imaging (SMI)","photoacoustic imaging (PAI)","2025-07-31",{"date":461,"type":31},"2025-08-03",{"date":463,"type":31},"2024-08-01",{"date":35,"type":19},{"name":134,"class":38},{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":337,"enrollmentInfo":473,"targetDuration":4,"studyType":20,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":39},"100597853","phase-2-a-prospective-phase-ii-study-of-postoperative-concurrent-chemoradiotherapy-in-patients-with-intrahepatic-cholangiocarcinoma-100597853","NCT07063888","A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma","A Prospective Phase II Study of Adjuvant Concurrent Chemoradiotherapy With Simultaneous Integrated Boost Following Hepatectomy for Intrahepatic Cholangiocarcinoma With Narrow Margin or Nodal Involvement","Inclusion Criteria:\n\n* Age \\> 18 years, \\\u003C 80 years\n* Patients with primary surgical treatment\n* Postoperative pathology confirmed intrahepatic cholangiocarcinoma\n* Postoperative pathology showing narrow resection margin (\\\u003C1cm) or positive lymph nodes\n* R0\u002FR1 resection\n* Postoperative Child-Pugh score A5-B7\n* Patients meeting either of the following conditions must undergo preoperative or pre-radiotherapy PET-CT to exclude distant metastasis or lymph node metastasis beyond the region from the lower esophagus to the aortic bifurcation\n\n  1. Lymph node metastasis accounting for \\>50% of dissected nodes\n  2. Lymph node metastasis involving the paracardial region or below the renal vein level\n* Postoperative contrast-enhanced liver MRI to exclude Intrahepatic satellite nodules\n* Recovery from surgery with Eastern Cooperative Oncology Group performance status score of 0-2\n* Estimated life expectancy \\>3 months\n\nExclusion Criteria:\n\n* History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix\n* Had prior abdominal irradiation\n* Had prior liver transplantation\n* Had serious myocardial disease or renal failure\n* Had moderate or severe ascites with obvious symptoms 4 months after surgery\n* Duration from surgery ≥ 4 months",{"count":474,"type":19},66,[23],"This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant concurrent chemoradiotherapy with simultaneous integrated boost following hepatectomy for intrahepatic cholangiocarcinoma with narrow margin (\\\u003C1cm) or nodal involvement. Eligibility patients will receive IMRT or VMAT. The prescription dose to high-risk area of tumor bed or positive lymph node was planned at 55-60Gy and the prescription dose to lymphatic drainage regions was planned at 40-45Gy in 20-25 fractions. During radiotherapy, patients will concurrently receive capecitabine (1600 mg\u002Fm² on days 1-14, every 21 days for 2 cycles). After radiotherapy, maintenance therapy with capecitabine will continue (2000 mg\u002Fm² on days 1-14, every 21 days for 6 cycles). For patients who cannot tolerate capecitabine, S-1 will be used as an alternative. The primary endpoint is 2-year recurrence-free survival. The secondary endpoints are 2-year overall survival, local-regional control rate and incidence of grade 3 or higher adverse events.",[26,478,479,480],"Adjuvant Chemoradiotherapy","Narrow Margin","Lymph Node Involvement","2025-07-11",{"date":483,"type":31},"2025-07-14",{"date":485,"type":31},"2025-05-16",{"date":487,"type":19},"2028-05-15",{"name":489,"class":38},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":491,"slug":492,"hasResults":11,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":337,"enrollmentInfo":498,"targetDuration":4,"studyType":20,"phases":500,"briefSummary":501,"conditions":502,"keywords":503,"overallStatus":245,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":39},"100588856","phase-2-second-line-regimen-combined-with-radiotherapy-versus-without-radiotherapy-in-patients-with-locally-advancedoligometastatic-icc-after-failure-of-first-line-treatmentan-open-label-randomized-controlled-phase-ii-clinical-study-100588856","NCT06946849","Second-line Regimen Combined With Radiotherapy Versus Without Radiotherapy in Patients With Locally Advanced\u002FOligometastatic ICC After Failure of First-line Treatment：an Open-label, Randomized, Controlled Phase II Clinical Study","Second-line Regimen Combined With Radiotherapy Versus Without Radiotherapy in Patients With Locally Advanced\u002FOligometastatic Intrahepatic Cholangiocarcinoma After Failure of First-line Treatment：an Open-label, Randomized, Controlled Phase II Clinical Study","SED-RO-ICC","Inclusion Criteria:\n\n* (1) Advanced or metastatic intrahepatic cholangiocarcinoma confirmed by histopathology that cannot be surgically removed.\n\n  (2) Failed to receive first-line standard treatment. (3) Definition of oligometastatic\u002Flocally advanced unresectable BTC disease: not a candidate for surgical resection at all sites: surgery to all sites not recommended by multidisciplinary team, or unfit or declining surgery.\n\n  (4) Definition of oligometastatic disease: patients with distant organ metastasis or nonregional lymph node metastasis, or distant organ\u002Fnonregional lymph node metastasis and regional lymph node metastasis, as defined by the American Joint Committee on Cancer, 8th edition. The total number of metastases is ≤5 and the number of metastases in any single organ system (e.g., lung, liver) is ≤3.\n\n  (4) All sites of disease must be amenable to radiotherapy and can be safely treated. Each lesion is counted separately at the time of registration and contributes to the total number of metastases. For regional lymph nodes metastases, all positive regional lymph nodes are counted together as one lesion. For nonregional lymph node metastases, adjacent metastatic lymph nodes can be treated as one lesion. Lesions that have subsided during previous treatment (i.e., are no longer visible on CT scan or have eliminated affinity on positron emission tomography \\[PET\\]-CT) are not included in the total number. At least one metastatic lesion meets the RECIST v1.1 criteria for assessable lesions. Bone metastases without soft tissue involvement can be included but are not considered assessable lesions. However, if bone metastases have soft tissue involvement and meet the criteria for assessable lesions, they are considered measurable lesions.\n\n  (5) Patients who experience recurrence after curative surgery with a time interval of \\>6 months can be eligible for inclusion. If adjuvant therapy (excluding radiotherapy) is administered, the patient must have completed adjuvant therapy for a period of at least 6 months before meeting the inclusion criteria.\n\n  (5) Primary tumor lesions and all metastases of current diagnosis have not received local treatment, such as radiotherapy, surgery or radiofrequency ablation, prior to enrollment.\n\n  (6) The patient is over 18 years old and has an Eastern Cooperative Oncology Group score of 0-1; (7) Life expectancy is greater than 12 weeks. (8) Vital organ function meets the following requirements: absolute neutrophil count ≥1.5 × 109\u002Fl; platelet count ≥100 × 109\u002Fl; hemoglobin ≥9 g\u002Fdl; serum albumin ≥2.8 g\u002Fdl; total bilirubin ≤1.5 × upper limit of normal (ULN) and alanine transaminase, aspartate aminotransferase and\u002For alkaline phosphatase ≤2.5 × ULN (if there is liver metastasis, alanine transaminase and\u002For aspartate aminotransferase ≤5 × ULN; if there is liver metastasis or bone metastasis, alkaline phosphatase ≤5 × ULN); serum creatinine ≤1.5 × ULN or creatinine clearance \\>60 ml\u002Fmin. For patients with pulmonary lesions or previous lung irradiation who are known or suspected to have impaired lung function, the forced expiratory volume for 1 second of lung function must be above 1 l.\n\n  (9) Female subjects of childbearing age must have a negative urine or serum pregnancy test within 72 h prior to randomization. Subjects must agree to adequate contraception during the trial.\n\n  (10) Each patient is voluntarily enrolled, and the informed consent form is signed by the patient or their legal representative.\n\nExclusion Criteria:\n\n* (1) Histology includes components of mixed hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or biliary adenocarcinoma.\n\n  (2) Complete response to four cycles of first-line systemic treatment (i.e. no measurable target for radiotherapy).\n\n  (3) There is new metastasis during the four cycles of first-line systemic treatment and the number of metastases is more than five.\n\n  (4) Patient has uncontrolled brain metastases or vertebral body metastasis with spinal cord compression symptoms.\n\n  (5) The toxicity of previous antitumor treatment has not recovered to ≤1 based on National Cancer Institute Common Terminology Criteria for Adverse Events v4.03 (except for hair loss) or the level specified by the inclusion\u002Fexclusion criteria.\n\n  (6) Patient has uncontrolled pleural, pericardial or pelvic effusion that requires repeated drainage.\n\n  (7) Patient is a pregnant or breastfeeding woman. (8) Patient has a history of immunodeficiency or severe medical disease that is not well controlled and may have an effect on study treatment.\n\n  (9) Any other malignant tumor has been diagnosed within 5 years prior to or after the diagnosis of BTC, except for malignant tumors with a low risk of metastasis and death (5-year survival rate \\>90%), such as well-treated basal cell or squamous cell skin cancer or cervical cancer in situ.\n\n  (10) Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study.",{"count":499,"type":19},76,[23],"Second-line regimen with or without consolidative radiotherapy in patients with oligometastatic\u002Flocally advanced unresectable intrahepatic cholangiocarcinoma: an open-label, randomised, controlled study.",[26],[504],"Intrahepatic Cholangiocarcinoma, Radiotherapy, Second-line regimen","2025-04-19",{"date":507,"type":31},"2025-04-27",{"date":509,"type":19},"2025-06-01",{"date":511,"type":19},"2027-05-31",{"name":328,"class":38},{"id":514,"slug":515,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":20,"phases":523,"briefSummary":524,"conditions":525,"keywords":528,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":39},"100584340","phase-2-additional-chemotherapy-administered-directly-into-the-liver-using-a-chemo-pump-in-patients-with-bile-duct-cancer-inside-the-liver-treatable-by-surgery-100584340","NCT06888063","Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery","Preventing Liver Recurrence After Partial Hepatectomy for Intrahepatic Cholangiocarcinoma Using Adjuvant Hepatic Arterial Infusion Pump Chemotherapy - PUMP IV Trial","PUMP IV","Inclusion Criteria:\n\n* 18 years or older\n* ECOG or WHO performance status 0 or 1\n* Diagnosis of resectable iCCA on imaging. No histological confirmation is needed before surgery, according to standard of care.\n* Patient is able to undergo a laparotomy.\n* Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT-scan with early arterial phase with 1mm cuts. The default site for the catheter insertion is the GDA. Accessory or aberrant hepatic arteries are no contraindication for catheter placement.\n* Adequate bone marrow, liver, and renal function before inclusion (values may be max. 30 days old)\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^ 9\u002FL\n* White blood cell count (WBC) ≥ 2.5 x 10\\^9\u002FL\n* Platelets ≥ 100 x 10\\^9\u002FL\n* Glomerular filtration rate (GFR) ≥ 30 ml\u002Fmin\n* Haemoglobin (Hb) ≥ 5.5 mmol\u002FL\n* Total bilirubin ≤ 25 µmol\u002FL\n* Written informed consent must be given according to ICH\u002Fgood clinical practice (GCP), and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Presence of extrahepatic disease at the time of first presentation. Patients with locoregional lymph node disease or with small (≤ 1 cm) extrahepatic lesions that are too small to characterize or biopsy are eligible.\n* Second primary malignancy, except for adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence or with a life expectancy longer than 5 years.\n* Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency\n* Prior hepatic radiation, ablation, or resection for iCCA.\n* Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Some postoperative ascites is allowed.\n* (Partial) portal vein thrombosis in future liver remnant.\n* Pregnant or lactating women.\n* History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy.\n* Serious concomitant systemic disorders that would compromise the safety of the patient or his\u002Fher ability to complete the study, at the discretion of the investigator.\n* Organ allografts requiring immunosuppressive therapy.\n* Serious infections (uncontrolled or requiring treatment).\n* Participation in another interventional study for iCCA with survival as outcome.\n* Participation in another prospective study with an interventional medical product.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial",{"count":522,"type":19},40,[23],"The goal of this clinical trial is to learn if additional chemotherapy by means of a chemo pump can prevent return of disease in adult patients with bile duct cancer in the liver that can be treated with surgery. The main questions it aims to answer are:\n\n* Does addition of chemotherapy by means of a chemo pump lead to less return of disease within the liver two years after surgery?\n* Does addition of chemotherapy by means of a chemo pump lead to longer survival of patients?\n* Does addition of chemotherapy by means of a chemo pump lead to an increase in quality of life?\n\nParticipants will receive an implanted chemo pump, through which additional chemotherapy will be given to the liver in addition to surgery.",[83,26,526,527],"Intrahepatic Bile Duct Carcinoma","Intrahepatic Cholangiocarcinoma",[529,519,237,530,531,210,532,533,534,535],"PUMP","Hepatic Arterial Infusion Pump chemotherapy","HAIP","Intrahepatic cholangiocarcinoma","iCCA","Floxuridin","Chemopump","2025-03-14",{"date":538,"type":31},"2025-03-21",{"date":540,"type":31},"2024-11-20",{"date":542,"type":19},"2031-09",{"name":388,"class":38},{"id":545,"slug":546,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":447,"enrollmentInfo":552,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":39},"100582409","liver-transplantation-for-unresectable-intrahepatic-colangiocarcinoma-after-sustained-response-to-neoadjuvant-treatments-100582409","NCT06862934","Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments","Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments (iCOLA)","iCOLA","Inclusion Criteria:\n\n* Histological diagnosis of iCCA (biopsy-proven tumor)\n* Either first diagnosis or post-resection recurrence (occurring ≥ 6 months after resection)\n* Unresectability assessment due to tumor location (leading to insufficient live remnant with\u002Fout implementation of hypertrophic parenchymal techniques) or underlying liver disease. Non-resectability assessed by an expert surgical team with experience on both resection and transplantation (centralized at INT Milan).\n* Age between 18 and 70 years\n* No macrovascular tumor invasion (NB: portal vein and\u002For hepatic vein occlusion from the external tumor compression and classified as \"encasement\" could be considered after expert radiology review)\n* No extrahepatic spread\n* Disease stability for at least 6 months\n* CA 19-9 \\\u003C 200 u\u002Fml at transplant listing in absence of jaundice\n* No medical and surgical contraindications to liver transplantation\n* Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1\n* No concomitant malignancies or history of other malignancies in the previous 5 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Hilar and distal cholangiocarcinoma\n* Progression of disease under chemotherapy +\u002F- radiation therapy, assessed with either RECIST, mRECIST or Choi criteria\n* Evidence of lymph-nodal metastases\n* Evidence of extrahepatic disease\n* Prior extrahepatic metastatic disease\n* Concomitant malignancies or history of other malignancies in the previous 5 years\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n* Any reason why, in the opinion of the investigator, the patient should not participate to the study",{"count":553,"type":19},14,"This is single-arm, observational, academic, investigator-driven study investigating the efficacy of liver transplantation after successful and sustained downstaging\u002Ftumor control of liver-limited unresectable intrahepatic cholangiocarcinoma. The downstaging protocol includes chemotherapy +\u002F- immunotherapy and transarterial radioembolization (TARE) with Yttrium-90 in various combinations.",[26],[557,558,559],"liver transplantation","transarterial radioembolization","downstaging","2025-03-03",{"date":562,"type":31},"2025-03-06",{"date":564,"type":19},"2025-03-20",{"date":566,"type":19},"2027-12-31",{"name":568,"class":38},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":570,"slug":571,"hasResults":11,"nctId":572,"briefTitle":573,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":20,"phases":578,"briefSummary":579,"conditions":580,"keywords":581,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":39},"100581590","phase-2-phase-ii-clinical-study-of-gemox-hepatic-arterial-infusion-combined-with-lenvatinib-and-toripalimab-for-advanced-and-unresectable-intrahepatic-cholangiocarcinoma-and-gallbladder-cancer-100581590","NCT06852287","Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer","GOLD-HAIC","Inclusion Criteria\n\n1. Age 18 or above\n2. Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer\n3. A tumor that cannot be removed by three independent surgeons.\n4. Expected lifespan ≥ 12 weeks\n5. ECOG PS score 0-1 points\n6. The patient voluntarily participates and signs an informed consent form;\n7. Expected compliance is good, able to follow up on efficacy and adverse reactions according to the protocol requirements.\n\nExclusion criteria:\n\n1. Use any systemic research anti-cancer drugs\n2. Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which may include hormone replacement therapy)\n3. Asthma requires the use of bronchodilators for medical intervention\n4. Congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection\n5. Clinical symptoms or uncontrolled heart disease\n6. Severe infection within 4 weeks before the first use of medication\n7. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n8. Vaccination with attenuated live vaccine within 4 weeks before treatment\n9. Other systemic malignant tumors in the past 5 years",{"count":577,"type":19},33,[23],"For advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. However, the efficacy rates remain low. Hepatic artery infusion chemotherapy can reduce systemic drug dosages while increasing local drug concentrations, which is expected to enhance overall efficacy and minimize drug toxicity and side effects.\n\nThis study utilized a hepatic artery infusion chemotherapy regimen that combines gemcitabine with oxaliplatin, along with the small molecule tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. The aim was to improve treatment efficacy and create opportunities for conversion surgery. The primary endpoint was the objective response rate, while the secondary endpoints included the surgical resection rate, complete pathological response rate (pCR), overall survival (OS), and the incidence of adverse reactions.",[26,266],[582],"GemOX, Lenvatinib, Toripalimab","2025-02-25",{"date":585,"type":31},"2025-02-28",{"date":587,"type":31},"2024-09-01",{"date":589,"type":19},"2026-09-01",{"name":591,"class":38},"Tianjin Medical University Cancer Institute and Hospital",{"id":593,"slug":594,"hasResults":11,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":20,"phases":600,"briefSummary":601,"conditions":602,"keywords":603,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":612,"locationsCount":39},"100571517","phase-2-toripalimab-combined-with-gemcitabine-and-cisplatin-gemcis-as-preoperative-neoadjuvant-therapy-for-resectable-intrahepatic-cholangiocarcinoma-100571517","NCT06721286","Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma","Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma (ICC) With High Risk of Recurrence, Phase II, Single-center, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18, male or female;\n2. Pathological diagnosis confirmed intrahepatic cholangiocarcinoma, which could be resected surgically; One of the following conditions shall be met:\n\n   2.1 Single tumor, diameter greater than 5cm (T1b) 2.2 Single tumor with vascular invasion (T2), multiple tumors ≤ 3 2.3 Tumor penetrating visceral peritoneum (T3) or directly invading surrounding organs (T4) 2.4 Suspicious lymph node metastasis in Zone 8, 12 or 13\n3. Can not received systemic treatment before participating in the study;\n4. ECOG PS score 0-1;\n5. The main organs function normally, and there is no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases.\n6. Laboratory inspection shall meet the following requirements:\n\n   Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug; For men, they should be surgically sterilized or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug.\n7. The patient voluntarily participated and signed the informed consent form;\n8. It is expected that the compliance is good, and the efficacy and adverse reactions can be followed up according to the requirements of the scheme.\n\nExclusion Criteria:\n\n1. Patients who received PD-1, PD-L1, PD-L2, CTLA-4 before enrollment, or directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, 0X40, CD137);\n2. Any other research drugs within 4 weeks before enrollment;\n3. Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy);\n4. Congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection;\n5. Uncontrollable clinical cardiac symptoms or diseases, such as NYHA II and above heart failure unstable angina pectoris, myocardial infarction within one year, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;\n6. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first drug administration, or fever of unknown cause\\>38.5 ° C occurred during screening\u002Fbefore the first drug administration;\n7. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n8. Live attenuated vaccine shall be inoculated within 4 weeks before the first administration or planned during the study period;\n9. Suffered from or accompanied by other system malignant tumors in the last 5 years (except cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer);\n10. Allergic to any test drug;\n11. Pregnant and lactating women, fertile subjects are unwilling to take effective contraceptive measures;\n12. Uncontrollable psychosis;\n13. Other situations that the researcher thinks are not suitable for inclusion. If the patient has central nervous system metastasis, has serious laboratory examination abnormalities, and is accompanied by family or social factors, it will affect the safety of the subject, or the collection of data and samples.",{"count":78,"type":19},[23],"This study was a randomized controlled trial to evaluate the efficacy and safety of toripalimab combined with GemCis (gemcitabine and cisplatin) as preoperative neoadjuvant therapy for resectable ICC at high risk of recurrence.",[26],[527,604,605],"neoadjuvant therapy","toripalimab","2024-12-03",{"date":608,"type":31},"2024-12-06",{"date":610,"type":31},"2024-11-12",{"date":566,"type":19},{"name":591,"class":38},{"id":614,"slug":615,"hasResults":11,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":48,"enrollmentInfo":620,"targetDuration":4,"studyType":20,"phases":622,"briefSummary":623,"conditions":624,"keywords":625,"overallStatus":245,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":39},"100565926","phase-2-adebrelimab-combined-with-irinotecan-liposomes-5-fu-cf--lenvatinib-as-first-line-treatment-for-advanced-icc-100565926","NCT06648525","Adebrelimab Combined with Irinotecan Liposomes, 5-FU, CF ± Lenvatinib As First-line Treatment for Advanced ICC","Adebrelimab Combined with Irinotecan Liposomes, 5-fluorouracil, Calcium Folinate ± Lenvatinib As First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma: a Prospective Clinical Study","Inclusion Criteria:\n\n1. Age: 18 to 75 years old, male or female not limited;\n2. Histologically confirmed unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma with measurable tumor lesions (meeting RECIST 1.1 criteria);\n3. Have not received systemic anti-tumor treatment in the past;\n4. Patients who relapse more than 6 months after curative surgery or after completion of adjuvant therapy (chemotherapy and\u002For radiotherapy) meet the inclusion criteria;\n5. ECOG PS：0-1；\n6. Expected survival period ≥ 3 months;\n7. The main organ functions are normal, which meets the following criteria:\n\n1\\) Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): Hemoglobin (Hb) ≥ 85 g\u002FL; Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelet count (PLT) ≥ 80 × 109\u002FL; 2) Biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN; Serum total bilirubin (TBIL) ≤ 3 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate ≥ 50ml\u002Fmin; 3) Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; 4) Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ 50%; 8. Women of childbearing age must undergo a negative pregnancy test (β HCG) before starting treatment, and women and men of childbearing age (who have sexual relations with women of childbearing age) must agree to continuously use effective contraceptive measures during the treatment period and for 6 months after the last treatment dose; 9. Patients with a history of hepatitis B and C can be included in the study, but active hepatitis B patients must start antiviral therapy before starting the study treatment; 10. Participants voluntarily join the study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or those who have the ability to conceive but refuse to take contraceptive measures;\n2. History of other malignant tumors within the past 5 years, excluding cervical carcinoma in situ or squamous cell carcinoma of the skin that has been adequately treated, or basal cell carcinoma of the skin that has been largely controlled;\n3. Merge other serious uncontrolled diseases (such as individuals with a history of difficult to control mental illness or severe intellectual or cognitive impairment; severe heart failure, angina pectoris, myocardial infarction, arrhythmia, etc.);\n4. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function;\n5. Suffering from active, known or suspected autoimmune diseases. Subjects with hypothyroidism who only require hormone replacement therapy and those with skin diseases that do not require systemic treatment may be included;\n6. Easy to bleed, at risk of massive hemoptysis, and with a history of significant coagulation dysfunction;\n7. Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg);\n8. History of immunodeficiency, including HIV testing positive, having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation and allogeneic bone marrow transplantation;\n9. Severe active infections requiring intravenous antibiotic treatment occur during the screening period;\n10. Individuals with multiple factors that affect oral medication (such as inability to swallow, post gastrointestinal resection, chronic diarrhea, and intestinal obstruction);\n11. Individuals who are allergic to the experimental drug;\n12. Patients who cannot comply with the trial protocol or cooperate with follow-up;\n13. The researchers believe that participants should not participate in this experiment.",{"count":621,"type":19},68,[23],"This is a multicenter, open label, randomized, two-arm clinical study to observe and evaluate the efficacy and safety of adebrelimab combined with irinotecan liposomes, 5-fluorouracil, calcium folinate ± lenvatinib as first-line treatment for advanced intrahepatic cholangiocarcinoma (ICC).",[26],[626,627,215,527],"Adebrelimab","Irinotecan liposomes","2024-10-16",{"date":630,"type":31},"2024-10-18",{"date":632,"type":19},"2024-10",{"date":634,"type":19},"2028-04",{"name":636,"class":38},"Harbin Medical University",{"id":638,"slug":639,"hasResults":11,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":20,"phases":645,"briefSummary":646,"conditions":647,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":657},"100491372","phase-2-a-study-of-icp-192-in-patients-with-fgfr2-rearranged-unresectable-or-metastatic-intrahepatic-cholangiocarcinoma-100491372","NCT05678270","A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma","A Single-Arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of ICP-192 in Subjects With Unresectable or Metastatic Intrahepatic Cholangiocarcinoma With FGFR2 Fusions\u002FRearrangements Who Have Failed Prior Therapy","Inclusion Criteria:\n\n1. Signed the ICF and Age ≥ 18 years old, either sex.\n2. ECOG score of 0-1.\n3. Life expectancy \\> 3 months.\n4. Histopathologically or cytopathologically confirmed intrahepatic cholangiocarcinoma with unresectable, recurrent or metastatic (AJCC 2017, 8th edition, TNM stage IV) tumor that has progressed following at least one line of chemotherapy and progression\u002Frecurrence within 6 months after neoadjuvant\u002Fadjuvant chemotherapy may be included.\n5. FGFR2 fusion \u002Frearrangement as confirmed by the central laboratory.\n6. At least one measurable lesion at screening as target lesion per RECIST 1.1.\n7. Organ functions meeting the protocol requirements.\n8. Contraception according to the protocol requirements.\n\nExclusion Criteria:\n\n1. Presence of other malignancies requiring medical intervention.\n2. Prior treatment with selective FGFR inhibitors or FGFR antibodies.\n3. Treatment with biological products, radical radiotherapy, and other investigational drugs within 4 weeks prior to the first dose of study drug. Chemotherapy within 3 weeks prior to the first dose of study drug.\n4. Known symptomatic central nervous system (CNS) metastases.\n5. Patients who have not recovered from the toxicity caused by previous anti-tumor treatment and have ≥ Grade 2 adverse events (judged per CTCAE V5.0 evaluation criterion) at the first dose of study drug.\n6. Currently uncontrolled cardiovascular and cerebrovascular diseases, or a past medical history.\n7. Any unstable or uncontrolled systemic disease as judged by the investigator, such as: active infection requiring intravenous therapy, uncontrolled hypertension (After treatment systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg), and diabetes mellitus (HbA1c \\> 8%).\n8. Current active bleeding, such as deep venous thrombosis, portal hypertension signs leading to gastroesophageal venous bleeding.\n9. Wound with active infection.\n10. Major surgical procedures within 4 weeks prior to the first dose of the study drug or minor surgical procedures within 2 weeks prior to the first dose of the study drug.\n11. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity\n12. History and\u002For current evidence of extensive tissue calcification, including but not limited to calcification in soft tissues, kidney, intestine, myocardium, vasculature and\u002For the lungs, with the exception of lymph node calcification, mild pulmonary parenchymal calcification, and asymptomatic coronary artery calcification.\n13. Clinically serious gastrointestinal dysfunction that may affect the intake, transport or absorption of the study drug (such as poorly controlled nausea, vomiting, diarrhea; malabsorption syndrome; intestinal obstruction and small bowel resection, etc.), or the patient was unable to swallow the drug orally.\n14. Active HBV infection, Active HCV infection, HIV infection.\n15. Female subjects who are pregnant or breastfeeding, or plan to have a pregnancy within 6 months after the last dose of the study drug; or male subjects who plan to father a child during the study or within 6 months after the last dose of the study drug.\n16. The last dose of strong CYP3A inhibitor or CYP3A inducer (including food, western medicine, traditional Chinese medicine) is less than 5 half-lives before the first dose of study drug, or plans to take concomitant drugs or foods with strong CYP3A inhibition or induction during the study.\n17. Known allergy to any excipients of the study drug.\n18. Subjects with conditions that in the investigator's opinion are not suitable for participating in this trial.",{"count":78,"type":19},[23],"This is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. The purpose of this study is to evaluate the efficacy and safety in patients with FGFR2-Rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who failed prior therapy",[182],"2024-02-05",{"date":650,"type":31},"2024-02-07",{"date":652,"type":31},"2022-11-15",{"date":654,"type":19},"2026-12",{"name":656,"class":304},"Beijing InnoCare Pharma Tech Co., Ltd.",44]