[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-intrahepatic-cholangiocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-intrahepatic-cholangiocarcinoma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,39,67,94,115,137],{"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":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100582086","phase-2-hyperion-cca-a-phase-2-trial-of-systemic-therapy-with-or-without-liver-directed-radiation-therapy-for-patients-with-advanced-intrahepatic-cholangiocarcinoma-100582086",false,"NCT06858735","HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n1. Patients older than the age of 18 years old at the time of study entry.\n2. Patients with a body mass greater than 30 kg.\n3. Patients with a pathological diagnosis of intrahepatic cholangiocarcinoma and at least one intrahepatic tumor measuring 3 cm in greatest dimension\n4. Patients must have pathological or radiographic evidence of either:\n\n   c. locally advanced unresectable iCCA - a multidisciplinary discussion should be documented for patients who have liver confined disease, confirming that the patient is not resectable.\n\n   d. extrahepatic metastasis at the time of enrollment - allowable extrahepatic metastases may include disease in non-regional lymph nodes (note that metastatic involvement of regional lymph nodes in the hilum of the liver alone do not qualify as M1 disease), lung, and\u002For bone.\n5. Patients should receive at least 4 cycles of systemic therapy with gemcitabine\u002Fcisplatin with durvalumab. If one of the drugs (gemcitabine\u002Fcisplatin\u002Fdurvalumab) was held at any point for medical reasons during the initial 4 cycles, the patient is still eligible as long as the treating team agrees about the ability of the patient to continue systemic therapy.\n6. Patients must be appropriate candidates for radiation therapy with adequate liver function, at the discretion of the treating physician.\n7. A patient may pre-register at any time before cycle 4 of systemic therapy. To be eligible to pre-register for the trial, they must meet all other inclusion and exclusion criteria, except criteria number 5 regarding the number of cycles of systemic therapy.Pre-registration is not required to enroll.\n8. Adequate normal organ and marrow function as defined below:\n\n   Hemoglobin ≥9.0 g\u002FdL Absolute neutrophil count (ANC) ≥1.0 × 109 \u002FL Platelet count ≥75 × 109\u002FL Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n\n   AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN\n\n   Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:\n\n   Males:\n\n   Creatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg\u002FdL)\n\n   Females:\n\n   Creatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg\u002FdL)\n9. Must have a life expectancy of at least 12 weeks\n10. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to randomization\n11. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union \\[EU\\] Data Privacy Directive in the EU) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Participation in another clinical study with an investigational product during the last 1 month.\n2. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n3. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n\n   1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n   2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.\n4. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment other than stated in the inclusion criteria. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n5. Major surgical procedure (as defined by the treating physician) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n6. History of allogenic organ transplantation.\n7. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n   1. Patients with vitiligo or alopecia\n   2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n   3. Any chronic skin condition that does not require systemic therapy\n   4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n   5. Patients with celiac disease controlled by diet alone\n8. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n9. History of another primary malignancy except for\n\n   1. Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of IP and of low potential risk for recurrence\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   3. Adequately treated carcinoma in situ without evidence of disease\n10. History of leptomeningeal carcinomatosis\n11. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry. Patients with brain metastasis or metastases confirmed on imaging will be excluded.\n12. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart)\n13. History of active primary immunodeficiency\n14. Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of antiHBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Adjust wording as necessary and consider evaluating at screening for studies with known hepatotoxicity or other relevant requirements.\n\n    1. Participants co-infected with HBV and HCV, or co-infected with HBV and HDV, namely: HBV positive (presence of HBsAg and\u002For anti HBcAb with detectable HBV DNA); AND\n    2. HCV positive (presence of anti-HCV antibodies); OR\n    3. HDV positive (presence of anti-HDV antibodies). Subjects with HBV infection, characterised by positive HBsAg and\u002For anti-HBcAb with detectable HBV DNA (≥ 10 IU\u002Fml or above the limit of detection per local laboratory standard), must be treated with antiviral therapy, per institutional practice. Following antiviral therapy initiation, subjects must show adequate viral suppression (ie, HBV DNA ≤ 2000 IU\u002FmL) as prior to randomisation. Participants will remain on antiviral therapy for the study duration and for 6 months after the last dose of IP.\n    4. Subjects with HBV infection, characterised by positive HBsAg and\u002For anti-HBcAb with undetectable HBV DNA (\\\u003C 10 IU\u002Fml or under the limit of detection per local lab standard) do not require antiviral therapy prior to randomisation. These subjects will be tested at every cycle to monitor HBV DNA levels; if HBV DNA is detected (≥ 10 IU\u002Fml or above the limit of detection per local lab standard), antiviral therapy must be initiated, continued for the study duration and for 6 months after the last dose of IP.\n15. Known HIV infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load for 6 months, CD4+ count of \\>200, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 6 months on the same anti HIV medications.\n16. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    2. Systemic corticosteroids at physiologic doses not to exceed \\\u003C\\\u003C10 mg\u002Fday\\>\\> of prednisone or its equivalent\n    3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n17. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90days after the last dose of IP.\n18. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n19. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n20. Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n21. Patients who have received prior anti-PD-1 or anti PD-L1:\n\n    1. Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n    2. All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n    3. Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n    4. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.\n22. Judgment by the treating physician that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.","ALL","18 Years",{"count":18,"type":19},60,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This study will compare outcomes for M1 iCCA patients treated with and without L-RT by reviewing iCCA patients found to have M1 disease at initial diagnosis at a single institution between 2010 and 2021 who received L-RT.",[25],"Advanced Intrahepatic Cholangiocarcinoma","RECRUITING","2026-03-09",{"date":29,"type":30},"2026-03-11","ACTUAL",{"date":32,"type":30},"2025-06-10",{"date":34,"type":19},"2030-11-19",{"name":36,"class":37},"M.D. Anderson Cancer Center","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":20,"phases":48,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":38},"100389630","phase-2-hmpl-453-tartrate-in-advanced-intrahepatic-cholangiocarcinoma-100389630","NCT04353375","HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma","An Open-Label, Single-Arm, Multicenter Phase 2\u002F3b Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma Habouring FGFR2 Fusion\u002FRearrangement","Inclusion Criteria:\n\n1. Have fully understood the study and voluntarily signed the ICF;\n2. Age ≥ 18 years;\n3. a. pathologically or cytologically confirmed advanced treatment failure solid tumor with standard patients (applicable to cohorts2 stage I); b. histologically or cytologically confirmed histologically or cytologically confirmed locally advanced unresectable or metastatic ICC patients with FGFR2 fusions\u002Frearrangements\u002Fmutation (applicable to Cohort 1, Cohort 2 Stage II, Cohort 3 and Cohort 4)\n4. a. The patients have received at least one prior systemic treatment regimen for advanced ICC and has intolerable PD or toxicity(Cohort1-3); b. Patients who have not received any prior systemic therapy for advanced ICC(Cohort4)\n5. Measurable lesion according to RECIST v1.1;\n6. ECOG performance status of 0 or 1;\n7. Life expectancy ≥ 12 weeks;\n8. Female patients or male patients with partners of childbearing potential must take effective contraceptive measures per the protocol.\n\nExclusion Criteria:\n\n1. Patients who previously received selective FGFR targeting therapy;\n2. Received approved or researched systemic anti-tumor treatment within 3 weeks prior to the start of the study treatment;\n3. Radical radiotherapy within 4 weeks;\n4. Have received local anti-tumor treatment within 4 weeks;\n5. Major surgery requiring hospitalization or incomplete healing of the surgery incision within 4 weeks;\n6. Current or prior history of retinal detachment;\n7. Using a strong inducer or inhibitor of cytochrome P450 3A (CYP3A) within 2 weeks or 5 half-lives of the study treatment;\n8. Taking drugs or dietary supplementsthat may cause blood phosphorus and\u002For blood calcium to rise within 2 weeks prior to the start of the study treatment;\n9. International normalized ratio above 1.5 or partial activated prothrombin time above 1.5 times ULN;\n10. History of clinically significant active hepatopathy, including active viral hepatitis, or other active hepatitis, clinically significant moderate to severe liver cirrhosis;\n11. The patients with human immunodeficiency virus (HIV) infection;\n12. Active infection requiring systemic treatment within 1 week prior to the start of the study treatment;\n13. Screening blood phosphorus levels above ULN, or history of abnormal calcium phosphorus metabolism requiring clinical intervention or relevant medical history;\n14. Currently keratopathy confirmed by ophthalmological examination;\n15. Prior history of retinal detachment, or current diseases that may cause retinal detachment;\n16. Clinically significant arrhythmia or conduction abnormalities requiring clinical intervention;\n17. Patients with known deep venous thrombosis, treated with low molecular weight heparin (LMWH) or drugs with similar efficacy, and the investigator judges that the thrombosis is stable for ≥ 2 weeks ;\n18. Toxicities caused by prior anti-tumor treatment have not recovered to grade 0 or 1;\n19. The patient has any current disease or condition that affects drug absorption, or the patient cannot be orally administered;\n20. Combined with other malignant tumor or a history of other malignant tumor within 5 years prior to study screening;\n21. Patients currently has central nervous system metastases, meningeal metastases or spinal cord compression, except in individual cases;\n22. Any other medical condition or clinically significant laboratory abnormalities judged by the investigator would make the patients unsuitable to participate in this study.",{"count":47,"type":19},235,[22,49],"PHASE3","The goal of this clinical trial is to evaluate in patients with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusion\u002Frearrangement. The main questions it aims to answer are:\n\nTo evaluate the objective response rate (ORR) of HMPL-453 tartrate in the treatment of patients with advanced intrahepatic cholangiocarcinoma (ICC) habouring fibroblast growth factor receptor (FGFR) 2 fusions\u002Frearrangements after at least one line of systemic treatment failure or intolerance Participants will receive HMPL-453 tartrate 300 mg QD orally (for 14 consecutive days \\[Days 1 to 14\\] followed by 7 days off \\[Day 15 to 21\\], 21 days as a treatment cycle.\\]",[25,52],"Solid Tumor, Adult",[54,55,56],"FGFR2 funsion","HMPL-453","ICC","2025-12-25",{"date":59,"type":30},"2025-12-31",{"date":61,"type":30},"2020-09-03",{"date":63,"type":19},"2030-02-28",{"name":65,"class":66},"Hutchmed","INDUSTRY",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":20,"phases":78,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":38},"100604688","phase-2-iparomlimab-and-tuvonralimab-combined-with-gc-in-advanced-icc-100604688","NCT07152769","Iparomlimab and Tuvonralimab Combined With GC in Advanced ICC","Iparomlimab and Tuvonralimab Combined With Gemcitabine and Cisplatin (GC) Versus Sintilimab Combined With GC as First-Line Treatment for Advanced Intrahepatic Cholangiocarcinoma: A Single-Center, Open-Label, Randomized Controlled Phase II Study","ITUS","Inclusion Criteria:\n\n* Signed written informed consent obtained prior to any trial-related procedures.\n* Male or female， ≥18 years and ≤75 years.\n* Histologically confirmed unresectable advanced or metastatic intrahepatic cholangiocarcinoma (ICC). Patients who developed recurrence more than 6 months after radical surgery are eligible. If adjuvant therapy (chemotherapy and\u002For radiotherapy) was received, recurrence must have occurred more than 6 months after completion of adjuvant therapy.\n* At least one measurable tumor lesion according to RECIST version 1.1 criteria.\n* No prior systemic therapy (chemotherapy, targeted therapy, or immunotherapy) for advanced\u002Fmetastatic disease.\n* Life expectancy of at least 12 weeks.\n* ECOG Performance Status (PS) of 0 or 1.\n* Subjects must meet the following laboratory parameters: 1)Absolute Neutrophil Count (ANC): ≥ 1.5 × 10⁹\u002FL (without granulocyte colony-stimulating factor support within the last 14 days). 2)Platelets: ≥ 100 × 10⁹\u002FL (without transfusion within the last 14 days). 3)Hemoglobin: \\> 9 g\u002FdL (without transfusion or erythropoietin use within the last 14 days). 4)Total Bilirubin: ≤ 1.5 × Upper Limit of Normal (ULN). 5)Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT): ≤ 2.5 × ULN. 6)Creatinine Clearance: Calculated creatinine clearance (using the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin.\n* The subject is willing and able to comply with the protocol during the study period, including receiving treatment, adhering to contraceptive measures, and attending scheduled visits and examinations (including follow-up).\n\nExclusion Criteria:\n\n* Previous treatment with agents targeting stimulatory or co-inhibitory T-cell receptors other than PD-1\u002FPD-L1 (e.g., CTLA-4, OX-40, CD137).\n* Systemic administration of Chinese herbal medicines with claimed anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin; excluding local use for pleural effusion control) within 2 weeks prior to the first dose.\n* History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic therapy. Known history of primary immunodeficiency.\n\nSubjects with only positive autoimmune antibodies must be evaluated by the Investigator to confirm the absence of an autoimmune disease.\n\n* Current systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone equivalent) or any other form of immunosuppressive therapy within 4 weeks prior to the first study dose.\n* Presence of clinically uncontrolled pleural effusion or ascites (subjects who do not require drainage or whose effusion shows no significant increase for ≥3 days after stopping drainage may be enrolled).\n* Known history of allogeneic organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.\n* Known hypersensitivity to the active pharmaceutical ingredients or excipients of the investigational products used in this study.\n* Failure to recover adequately (i.e., to ≤ Grade 1 or baseline, excluding alopecia or fatigue) from toxicities and\u002For complications of any prior interventions before initiation of study treatment.\n* Known history of Human Immunodeficiency Virus (HIV) infection (i.e., HIV 1\u002F2 antibodies positive).\n* Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA exceeding the upper limit of normal (ULN) at the central laboratory of the participating site).\n* Active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection).\n* Administration of a live attenuated vaccine within 4 weeks prior to the first dose.\n* Positive pregnancy test within 7 days prior to the first dose or currently breastfeeding, for women of childbearing potential.\n* Presence of any severe and\u002For uncontrolled systemic disease\u002Fdisorder.\n* Any medical condition (including psychiatric or substance abuse disorders), prior\u002Fconcomitant treatment, or clinically significant laboratory abnormality that, in the investigator's opinion, would:Adversely affect trial data integrity, Limit the subject's ability to complete the study, Or pose undue risk to the subject.","75 Years",{"count":77,"type":19},104,[22],"This study is a randomized, controlled, open-label, single center clinical study. This study is designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Combined With GC versus Sintilimab Combined With GC as first-line therapy in advanced ICC.",[25],[56,82,83],"Iparomlimab and Tuvonralimab","Sintilimab","NOT_YET_RECRUITING","2025-08-26",{"date":87,"type":30},"2025-09-03",{"date":89,"type":19},"2025-10-15",{"date":91,"type":19},"2028-12-31",{"name":93,"class":37},"Fudan University",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":20,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":38},"100604251","phase-2-cryoablation-combined-with-shr-1701-plus-famitinib-in-patients-with-advanced-intrahepatic-cholangiocarcinoma-100604251","NCT07147088","Cryoablation Combined With SHR-1701 Plus Famitinib in Patients With Advanced Intrahepatic Cholangiocarcinoma.","Cryoablation Combined With SHR-1701 Plus Famitinib in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-03): A Single-arm, Phase 2 Trial.","CASTLE-ZS-03","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 GemCis plus PD1\u002FPD-L1 inhibitor for advanced cholangiocarcinoma due to disease progression or toxicity.\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":103,"type":19},36,[22],"This study will evaluate the efficacy and safety of cryoablation combined with SHR-1701, a bifunctional fusion protein targeting PD-L1 and TGF-β, plus famitinib, a multi-targeted receptor tyrosine kinase inhibitor, in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.",[25],"2025-08-21",{"date":109,"type":30},"2025-08-28",{"date":111,"type":19},"2025-09-01",{"date":113,"type":19},"2027-09-01",{"name":93,"class":37},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":75,"enrollmentInfo":122,"targetDuration":4,"studyType":20,"phases":124,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":38},"100589615","phase-1-personalized-tumor-neoantigen-mrna-therapy-for-advanced-intrahepatic-cholangiocarcinoma-100589615","NCT06956716","Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma","Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen mRNA Therapy in Combination With PD-1 Antibody and Chemotherapy for Advanced Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* (1) Subjects who meet all the following inclusion criteria will enter the pre-screening stage of this study and undergo the lesion puncture process:\n\n  1. Voluntarily sign the informed consent form;\n  2. Aged ≥18 years and ≤75 years, regardless of gender;\n  3. Imaging assessment of unresectable advanced intrahepatic cholangiocarcinoma;\n  4. Have not received systemic or local treatment.\n  5. According to the solid tumor efficacy evaluation criteria (RECIST 1.1), the investigators assess the lesions as measurable.\n  6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n  7. Adequate fresh tumor tissue samples can be obtained for exome and transcriptome sequencing analysis;\n  8. Normal function of the main organs of the heart, liver and kidney:\n\n     1. QTc (corrected QT interval) in the electrocardiogram: ≤450 milliseconds for men, or ≤470 milliseconds for women;\n     2. Coagulation function: international normalized ratio (INR) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5 times ULN;\n     3. Hematological indicators: white blood cells ≥3.5×109\u002FL; absolute neutrophil count (ANC) ≥1.5×109\u002FL; hemoglobin (HGB) ≥10 g\u002FdL; platelet count (PLT) ≥80×109\u002FL;\n     4. Biochemical indicators: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN (ALT or AST ≤ 5 times ULN is allowed for patients with liver metastasis and liver cancer); serum creatinine and urea nitrogen ≤ 1.5 times ULN;\n  9. Male and female patients of childbearing age with fertility agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last dose of the trial drug; women of childbearing age include premenopausal women and women within 2 years after menopause;\n  10. Able to follow the study protocol and follow-up procedures.\n\n  (2) Subjects who meet all the following inclusion criteria will enter the formal screening stage of this study and enter the study medication process:\n  1. Voluntary signing of the informed consent form;\n  2. Age ≥ 18 years and ≤ 75 years, regardless of gender;\n  3. Intrahepatic cholangiocarcinoma confirmed by pathology (histology or cytology);\n  4. Have not received any systemic treatment.\n  5. According to the solid tumor efficacy evaluation criteria (RECIST 1.1), the investigators assessed the patients as having measurable lesions.\n  6. The Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1;\n  7. The major organ functions of the heart, liver, and kidney were normal:\n\n     1. QTc (corrected QT interval) in the electrocardiogram: ≤450 milliseconds for men or ≤470 milliseconds for women;\n     2. Coagulation function: international normalized ratio (INR) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5 times ULN;\n     3. Hematological indicators: white blood cells ≥3.5×109\u002FL; absolute neutrophil count (ANC) ≥1.5×109\u002FL; hemoglobin (HGB) ≥10 g\u002FdL; platelet count (PLT) ≥80×109\u002FL;\n     4. Biochemical indicators: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN (ALT or AST ≤ 5 times ULN is allowed for patients with liver metastasis and liver cancer); serum creatinine and urea nitrogen ≤ 1.5 times ULN;\n  8. Male patients with fertility and female patients of childbearing age agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last administration of the trial drug; women of childbearing age include premenopausal women and women within 2 years after menopause;\n  9. Able to follow the study protocol and follow-up process.\n\n     Exclusion Criteria:\n* If the subject meets any of the following criteria, he\u002Fshe will be excluded from this study:\n\n  1. Those who suffer from other malignant tumors at the same time, but have been cured of basal cell carcinoma, thyroid cancer, cervical atypical hyperplasia, etc., have been in a disease-free state for more than 5 years or are considered by the researchers to be less likely to relapse;\n  2. Those who have received a history of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;\n  3. Those who are accompanied by immunosuppressants, that is, those who need to take immunosuppressants regularly 4 weeks before the screening period and during the clinical study, including but not limited to the following situations: those with severe asthma, autoimmune diseases or immunodeficiency, those who are treated with immunosuppressive drugs, and those with a known history of primary immunodeficiency; but type 1 diabetes, autoimmune-related hypothyroidism requiring hormone treatment, and vitiligo and psoriasis that do not require systemic treatment are excluded;\n  4. Active bacterial or fungal infection confirmed by clinical diagnosis; active tuberculosis or history of tuberculosis;\n  5. Positive test results for human immunodeficiency virus (HIV) antibody, positive test results for Treponema pallidum (TP), active hepatitis C (positive hepatitis C virus (HCV) antibody and positive HCV RNA), active hepatitis B;\n  6. Herpes virus infection (except for those with scabs for more than 4 weeks); respiratory virus infection (except for those who have recovered for more than 4 weeks);\n  7. Uncontrolled complications include but are not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other diseases that the investigator considers unsuitable for inclusion;\n  8. History of drug abuse, clinical, psychological or social factors that affect informed consent or research implementation; history of mental illness;\n  9. History of food, drug or vaccine allergy, or other potential immunotherapy allergy considered by the investigator.\n  10. Pregnant or lactating women;\n  11. Those who the investigator considers unsuitable for inclusion or may not be able to complete this trial for other reasons.",{"count":123,"type":19},30,[125,22],"PHASE1","The main purpose of this study is to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy iNeo-Vac-R01 combined with PD-1 monoclonal antibody and standard chemotherapy regimen for the treatment of patients with advanced intrahepatic cholangiocarcinoma.",[25],"2025-04-30",{"date":130,"type":30},"2025-05-04",{"date":132,"type":30},"2025-04-09",{"date":134,"type":19},"2028-04-01",{"name":136,"class":37},"Zhejiang University",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":75,"enrollmentInfo":144,"targetDuration":4,"studyType":20,"phases":146,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":38},"100573453","phase-2-clinical-study-of-vg161-in-advanced-intrahepatic-cholangiocarcinoma-100573453","NCT06746480","Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma","A Single-Arm, Multicenter, Open-Label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of VG161 in the Treatment of Advanced Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* 1\\. Subjects must fully understand and give informed consent to this study before the trial, and voluntarily sign a written informed consent form.\n\n  2\\. aged 18 to 75 years (inclusive), male or female. 3. patients with histologically or cytologically confirmed advanced intrahepatic cholangiocarcinoma.\n\n  4\\. According to the Guidelines for the Diagnosis and Treatment of Biliary Malignant Tumors (CSCO), patients must have previously received at least systemic first-line therapy for advanced intrahepatic cholangiocarcinoma and failed, or cannot tolerate treatment. Patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy were counted as having failed first-line treatment if disease progression occurred during chemotherapy or within 6 months after stopping chemotherapy; 5. According to RECIST 1.1 criteria, one or more CT examinations are determined to be measurable and meet the requirements for the volume administered for the first injection, tumor lesions and\u002For metastases (the injected lesions should preferably be the main tumor burden lesions) that can be injected under ultrasound or CT guidance, and the baseline longest diameter of the injected lesions (lymph node lesions are short diameters) is \\> 1.5 cm.\n\n  6\\. Herpes simplex virus type I (HSV-1) antibody test results (HSV-1 IgG or HSV-1 IgM) are positive.\n\n  7\\. ECOG performance score 0-1. 8. Expected survival time of more than 3 months. 9.Adequate organ function:\n  1. Blood routine (no blood transfusion or colony-stimulating factor treatment within 14 days): ANC ≥ 1.5 × 109\u002FL, PLT ≥ 75 × 109\u002FL, Hb ≥ 85 g\u002FL;\n  2. Liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN;\n  3. Child-Pugh A-B;\n  4. Renal function: Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 45ml\u002Fmin (calculated according to Cockcroft-Gault formula);\n  5. Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5 × ULN; 10.Eligible patients of childbearing potential (men and women) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) during the trial and for at least 90 days after the last dose; female patients of childbearing potential must have a negative blood pregnancy test within 7 days prior to enrollment.\n\n     Exclusion Criteria:\n* 1\\. received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of the study drug, of which oral fluorouracil and small molecule targeted drugs were within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever was longer).\n\n  2\\. Patients who have received transcatheter arterial chemoembolization (TACE) within 4 weeks before the first use of the study drug.\n\n  3\\. Received other clinical trial drugs that are not approved for marketing within 4 weeks before the first use of the study drug.\n\n  4\\. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose of study drug.\n\n  5\\. Have received a vaccine within 4 weeks prior to the first dose of study drug.\n\n  6\\. Patients who have received systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent doses of the same class of drugs) or other immunosuppressive agents within 14 days before the first dose of study drug; except for the following: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term corticosteroids (≤ 10 mg prednisone equivalent) for prophylaxis (e.g., prevention of contrast agent allergy).\n\n  7\\. The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except alopecia and other toxicities that are judged by the investigator to have no safety risk); 8. Patients with central nervous system metastasis, spinal cord metastasis and\u002For spinal cord compression.\n\n  9\\. in the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.\n\n  10\\. other active uncontrolled infections. 11. History of immunodeficiency, including positive HIV antibody test and positive Treponema pallidum antibody test.\n\n  12\\. Patients with active chronic hepatitis B or active hepatitis C. (Except hepatitis B virus carriers, hepatitis B virus stable after drug treatment \\[HBV-DNA negative or \\\u003C 500 IU\u002Fml\\] and cured hepatitis C patients \\[HCV RNA negative\\]) 13. History of serious cardiovascular disease:\n  1. Ventricular arrhythmia requiring clinical intervention;\n  2. QTc interval \\> 480 ms;\n  3. Acute coronary syndrome, congestive heart failure, stroke or other Grade III and above cardiovascular events within 6 months before the first use of study drugs;\n  4. New York Heart Association (NYHA) functional classification ≥ II or left ventricular ejection fraction (LVEF) \\\u003C 40%;\n  5. Uncontrolled hypertension after treatment (judged by the investigator); 14. Patients with active, or have had and have the possibility of relapse of autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); except for clinically stable autoimmune thyroiditis, autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone, type I diabetes treated with stable doses of insulin, vitiligo or recovered childhood asthma\u002Fallergy, without any intervention in adults.\n\n  15\\. Having received immunotherapy and have experienced immune-related adverse events (irAEs) such as immune-related pneumonia and myocarditis, which may affect the safety of the investigational drug as judged by the investigator.\n\n  16\\. Known alcohol or drug dependence. 17. Patients with mental disorders or poor compliance. 18. Pregnant or lactating women. 19. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.",{"count":145,"type":19},33,[22],"VG161 is a recombinant human-IL12\u002F15\u002FPDL1B oncolytic HSV-1 Injectable. This trial is a single-agent, single-arm, multicenter, open-label design clinical trial for advanced intrahepatic cholangiocarcinoma who have failed standard therapy. To evaluate the efficacy of VG161 administered by ultrasound or CT-guided intratumoral injection in patients with advanced intrahepatic cholangiocarcinoma, with the primary outcome measure being objective response rate (ORR).",[25],[150],"Advanced intrahepatic cholangiocarcinoma","2024-12-19",{"date":153,"type":30},"2024-12-24",{"date":155,"type":30},"2022-03-19",{"date":157,"type":19},"2025-12-01",{"name":159,"class":66},"CNBG-Virogin Biotech (Shanghai) Ltd."]