[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-tract-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-tract-carcinoma":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,68,97,148,170,194,220,248,274,302,329,355],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":39,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100614270","phase-1-a-study-of-ide892-as-monotherapy-and-combination-in-mtap-deleted-advanced-solid-tumors-100614270",false,"NCT07277413","A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors","A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n* Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.\n* Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma \\[pleural or peritoneal\\], gastroesophageal cancers \\[squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers\\], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC \\[adenocarcinoma, squamous cell carcinoma, and adeno-squamous\\] or UC \\[including mixed urothelial-squamous histology\\]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).\n* Are willing and able to provide blood\u002Ftumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.\n* Must be willing and able to provide the blood\u002Fserum\u002Fplasma samples\n* Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)\n* Have at least 1 measurable lesion according to RECIST version 1.1\n* Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1\n* Have life expectancy \\> 3 months\n* Have adequate bone marrow and organ function\n* Able to swallow and retain orally administered study drug\u002FIMP.\n* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures\n* Male and female: willing to use contraception\n\nExclusion Criteria:\n\n* Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids\n* Have a known primary central nervous system (CNS) malignancy\n* Have had other malignancies within 2 years prior to the first dose, with some exceptions\n* Impaired cardiac function or clinically significant cardiac diseases\n* Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter\n* Have a history of severe infections within 4 weeks prior to the start of study treatment\n* Hypertension (e.g., \\> 150\u002F100 mmHg) that cannot be controlled by medications despite optimal medical therapy\n* Other acute or chronic medical or psychiatric condition\n* Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening\n* Known or suspected viral hepatitis with a positive test at screening\n* Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1\n* Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks\n* Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP\n* Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein\n* Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4\u002F5, Strong inhibitors of P-gp and\u002For BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP\n* Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study\n* Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892\n* Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and\u002For Protein arginine N-methyltransferase (PRMT) inhibitor\n* Major surgery within 4 weeks before study entry\n* Prior irradiation to \\> 25% of the bone marrow\n* Known or suspected hypersensitivity to IDE892\n\nDisease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1\u002FPD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.\n* If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.\n\nEligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors\n* Must have progressed following at least 1 prior line of therapy\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease","ALL","18 Years",{"count":19,"type":20},260,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.",[26,27,28,29,30,31,32,33,34,35,36,37,38],"NSCLC Adenocarcinoma","Gastroesophageal Cancer (GC)","Gastric Adenocarcinoma","Adenocarcinoma of Esophagus","Squamous Cell Car. - Esophagus","Urothelial Carcinoma (UC)","Bladder Cancer","Mesothelioma","Pleural Mesothelioma","Peritoneal Mesothelioma","Non-Small Cell Lung Cancer NSCLC","Pancreatic Cancer","Biliary Tract Carcinoma",[40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"MTAP deletion","MTAP loss","MTAP-deficient tumors","homozygous MTAP loss","IDE892","IDE397","MAT2A inhibitor","PRMT5","advanced solid tumors","metastatic cancer","recurrent cancer","dose escalation","dose expansion","phase 1 clinical trial","ctDNA","RECRUITING","2026-06-19",{"date":58,"type":59},"2026-06-23","ACTUAL",{"date":61,"type":59},"2026-03-04",{"date":63,"type":20},"2028-04-30",{"name":65,"class":66},"IDEAYA Biosciences","INDUSTRY",14,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100448747","phase-1-a-phase-iiia-study-of-azd8205-given-alone-or-combined-in-participants-with-advancedmetastatic-solid-malignancies-100448747","NCT05123482","A Phase I\u002FIIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced\u002FMetastatic Solid Malignancies","A Phase I\u002FIIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Relapsed\u002Fmetastatic solid tumors treated with prior adequate standard of care therapy for tumor type and stage of disease or where in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and\u002For tolerability to prior therapy.\n* Measurable disease per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n* Life expectancy ≥ 12 weeks\n* Adequate bone marrow, hepatic, and renal function as defined in the protocol\n\nAdditional Inclusion Criteria For Sub-Study 1 Part A:\n\n• Histologically or cytologically confirmed metastatic or locally advanced\u002Frecurrent breast cancer, ovarian cancer, BTC or endometrial cancer\n\nAdditional Inclusion Criteria For Sub-Study 1 Part B:\n\n* Histologically or cytologically confirmed metastatic or locally advanced and recurrent disease for the respective cohort:\n\n  1. Cohort B1 (Biliary Tract Cancer)\n  2. Cohort B2 (Ovarian Cancer)\n  3. Cohort B3 (Breast Cancer)\n  4. Cohort B4 (Endometrial Cancer)\n  5. Cohort B5 (Squamous Non-Small Cell Lung Cancer)\n\n     Additional Inclusion Criteria For Sub-Study 2 Part A:\n* Minimum body weight ≥ 30 kg.\n* Histologically or cytologically confirmed metastatic or locally advanced\u002Frecurrent breast cancer, ovarian cancer, BTC, endometrial cancer or squamous non-small cell lung cancer.\n\nAdditional Inclusion Criteria For Sub-Study 3 Part A:\n\n* Minimum body weight ≥ 30 kg (for participants enrolled in cohorts including rilvegostomig only).\n* Histologically or cytologically confirmed metastatic or locally advanced\u002Frecurrent breast cancer, ovarian cancer, BTC, endometrial cancer or squamous non-small cell lung cancer.\n\nAdditional Inclusion Criteria For Sub-Study 4 Part A:\n\n* Minimum body weight ≥ 30 kg (for participants enrolled in cohorts including rilvegostomig only).\n* Histologically or cytologically confirmed metastatic or locally advanced\u002Frecurrent breast cancer, endometrial cancer or squamous non-small cell lung cancer.\n* Participants must have progressed following at least one but no more than 3 prior lines of treatment for metastatic or relapsed disease and have no satisfactory alternative treatment option as judged by the Investigator.\n\nKey Exclusion Criteria:\n\n* Treatment with any of the following:\n\n  1. Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment\n  2. Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 28 days (whichever is shorter) prior to the first dose of study treatment\n  3. Any other anticancer treatment within the following time periods prior to the first dose of study intervention:\n\n     1. Cytotoxic treatment: 21 days\n     2. Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)\n     3. Biological products including immuno-oncology agents: 28 days\n* Spinal cord compression or a history of leptomeningeal carcinomatosis.\n* Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \\> 10 mg prednisone\u002Fday or equivalent for at least 4 weeks prior to start of study.\n* Active infection including tuberculosis and HBV, HCV or HIV\n* History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Participants with any of the following cardiac criteria:\n\n  1. History of arrhythmia which is symptomatic or requires treatment (NCI CTCAE v5.0 Grade 3); symptomatic or uncontrolled atrial fibrillation, or asymptomatic sustained ventricular tachycardia.\n  2. Uncontrolled hypertension.\n  3. Acute coronary syndrome\u002Facute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months.\n  4. History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.\n  5. Symptomatic heart failure (NYHA class ≥ 2).\n  6. Prior or current cardiomyopathy.\n  7. Severe valvular heart disease.\n  8. Mean resting QTcF \\> 470 msec.\n  9. Risk factors for QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.\n* Patients with history of myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML (as determined by prior diagnostic investigation)\n\nAdditional Exclusion Criteria For Sub-Study 2 Part A:\n\n* Thromboembolic event within 3 months before the first dose of study intervention - No longer applicable per amendment 7\n* Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n* History of organ transplant\n\nAdditional Exclusion Criteria For Sub-Study 2 Part B\n\n• Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)\n\nAdditional Exclusion Criteria For Sub-Study 3 Part A:\n\n* Concomitant use of medications or herbal supplements known to be strong cytochrome P (CYP) 3A4 inducers\u002Finhibitors.\n* Any history of persisting (\\> 2 weeks) severe cytopenia due to any cause\n* Patients with any known predisposition to bleeding\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib.\n* Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)\n\nAdditional Exclusion Criteria For Sub-Study 4 Part A:\n\n* Patients have received prior therapy with AZD9574 or more than 1 prior line of any other PARPi-based regimen\n* Concomitant use of medications or herbal supplements known to be strong cytochrome P (CYP) 3A4 inducers\u002Finhibitors.\n* Previous treatment with rilvegostomig for the cohort treated with rilvegostomig\n* Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD9574",{"count":76,"type":20},460,[23,78],"PHASE2","This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone or in combination with anti-cancer agents",[81,38,82,83,84],"Breast Cancer","Ovarian Cancer","Endometrial Cancer","Squamous Non-Small Cell Lung Cancer",[86],"First In Human, antibody drug conjugate, cancer, solid tumour, Phase I, Phase IIa","2026-06-16",{"date":89,"type":59},"2026-06-17",{"date":91,"type":59},"2021-10-18",{"date":93,"type":20},"2027-09-29",{"name":95,"class":66},"AstraZeneca",67,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":147},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":105,"type":20},27,[78],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[109,110,38,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136],"Amyloidosis","Basal Cell Carcinoma","Bladder Carcinoma","Breast Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hepatocellular Carcinoma","Hodgkin Lymphoma","Lung Carcinoma","Malignant Solid Neoplasm","Mantle Cell Lymphoma","Melanoma","Merkel Cell Carcinoma","Multiple Myeloma","Myelodysplastic Syndrome","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Renal Cell Carcinoma","Squamous Cell Carcinoma","Urothelial Carcinoma","2026-05-15",{"date":139,"type":59},"2026-05-18",{"date":141,"type":59},"2025-12-18",{"date":143,"type":20},"2026-12-18",{"name":145,"class":146},"Mayo Clinic","OTHER",1,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":147},"100600596","phase-2-study-of-zg005-in-combination-with-platinum-based-chemotherapy-in-participants-with-advanced-biliary-tract-carcinoma-100600596","NCT07099547","Study of ZG005 in Combination With Platinum-Based Chemotherapy in Participants With Advanced Biliary Tract Carcinoma","A Study to Evaluate the Efficacy and Safety of ZG005 in Combination With Platinum-Based Chemotherapy as First-Line Treatment in Participants With Advanced Biliary Tract Carcinoma","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Subjects with a histopathological or cytologically diagnosis of Gallbladder cancer.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Participants were deemed unsuitable for participating in the study by the investigator for any reasons.","75 Years",{"count":157,"type":20},60,[78],"This is a randomized, open-label, phase II study evaluating first-line treatment for advanced gallbladder cancer. It aims to assess the efficacy, safety, pharmacokinetics, and immunogenicity of the ZG005 in Combination with gemcitabine and cisplatin as first-line therapy in Participants with advanced gallbladder cancer.",[38],"2026-04-27",{"date":163,"type":59},"2026-05-01",{"date":165,"type":59},"2025-12-02",{"date":167,"type":20},"2027-12",{"name":169,"class":66},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100519790","phase-2-study-of-gemcitabine-cisplatin-ab680-and-ab122-during-first-line-treatment-of-advanced-biliary-tract-cancers-quic-100519790","NCT06048133","Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)","Study of Gemcitabine, Cisplatin, Quemliclustat (AB680) and Zimberelimab (AB122) During First-line Treatment of Advanced Biliary Tract Cancers (QUIC)","Inclusion Criteria:\n\n1. Patients with cytologically or histologically confirmed BTC by AJCC version 8.\n2. Patients must have late stage (locally advanced, recurrent or metastatic) BTC. Patients must not have received systemic treatment for advanced disease. Prior adjuvant therapy is allowed as long as recurrences occurred 6 months or later from all treatment completion.\n3. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n4. Age ≥ 18 years at the time of consent.\n5. ECOG Performance Status of 0-2 within 28 days prior to registration.\n6. Presence of measurable or evaluable disease, as defined by RECIST v1.1.\n7. Adequate organ function as detailed in the protocol.\n8. Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 14 days prior to registration. NOTE: Biliary cancer may secrete hormones to produce a false-positive pregnancy test. Female subjects of childbearing potential with a positive pregnancy test should have a thorough history and additional work up as determined by the treating physician to rule out pregnancy (e.g. serial βHCG measurements, ultrasound). Once pregnancy has been ruled out, the subject may proceed with screening and enrollment.\n9. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study and for up to 14 months after the last dose of study drug(s). Males able to father a child must be willing to abstain from heterosexual vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study and for up to 11 months after the last dose of study drug(s). See the protocol for specific timeframes for each drug.\n10. Ability of the subject to understand and comply with study procedures for the entire length of the study, as determined by the enrolling physician or protocol designee.\n\nExclusion Criteria:\n\n1. Prior therapy with gemcitabine, cisplatin, or any immune checkpoint inhibitors for the treatment of BTC.\n2. Known hypersensitivity to recombinant proteins, or any excipient contained in treatment medication formulations.\n3. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n\n   NOTE: participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study.\n4. History of solid organ or allogeneic bone marrow transplantation.\n5. Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.\n6. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial.\n7. Untreated central nervous system (CNS) metastasis. Screening of asymptomatic patients for CNS metastasis is not required for enrollment.\n8. Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of IP(s) hazardous, including but not limited to\n\n   * Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis.\n   * Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the study treatments.\n9. History of trauma or major surgery within 28 days prior to the first dose of IP. (Note that placement of central venous access catheter (e.g., port or similar) is not considered a major surgical procedure.\n10. Treatment with palliative radiation therapy within 14 days of study treatment initiation.\n11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n12. Significant dementia or other mental condition that precludes the participant's ability to consent to the study.\n13. Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational products.",{"count":178,"type":20},33,[78],"This is a phase 2 study of gemcitabine, cisplatin, zimberelimab (AB122) and quemliclustat (AB680) in subjects with untreated advanced biliary tract cancers (BTC). The study will include a safety run-in involving 6 study participants. The goal of the safety run-in is to screen for early safety signals of the proposed drug combination. Trial enrollment can continue while full safety assessment is being completed for the first 6 subjects.\n\nParticipants will receive 4 cycles of combination therapy as described. After 4 cycles (\\~6 months), cisplatin will be discontinued, while gemcitabine, zimberelimab (AB122), and quemliclustat (AB680) will be continued. Subjects will be treated until disease progression or development of intolerable toxicities. In total, there will be up to 39 participants on the study.",[38,182,183],"Cholangiocarcinoma","Bile Duct Cancer","2026-01-21",{"date":186,"type":59},"2026-01-23",{"date":188,"type":59},"2024-03-08",{"date":190,"type":20},"2027-07",{"name":192,"class":146},"Nataliya Uboha",4,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":155,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":147},"100490650","phase-2-gemox-combined-with-donafenib-and-tislelizumab-in-advanced-biliary-tract-carcinoma-100490650","NCT05668884","GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma","Effects and Safety of GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma：a Prospective, Single-arm, Multi-center Phase II Study","Inclusion Criteria:\n\n* Age ≥18 years and ≤75 years;\n* ECOG physical condition score: 0\\~1;\n* Histologically or cytologically confirmed advanced biliary tract carcinoma (including gallbladder, intrahepatic and extrahepatic cholangiocarcinoma);\n* Preoperative imaging assessment of the disease stage was III\u002FIV;\n* At least one measurable lesion (according to mRECIST criteria)\n* Child-Pugh classification : A or B\n* The main organs function well, and the examination indicators meet the following requirements:\n* Routine blood tests: Hemoglobin ≥90 g\u002FL (no blood transfusion within 14 days);Neutrophil count ≥1.5×10\\^9\u002FL; Platelet count ≥80×10\\^9\u002FL;\n* Biochemical examination: Total bilirubin ≤2×ULN (upper normal value); ALT or AST ≤ 2.5×ULN; Endogenous creatinine clearance ≥ 50 mL \u002Fmin (Cockcroft-Gault formula);\n* thyroid function:Thyroid function is normal, thyroid stimulating hormone TSH is defined to be within the normal range. If baseline TSH is outside the normal range, T3 and T4 can be included if they are within the normal range;\n* Myocardial enzyme profile:The myocardial enzyme profile was in the normal range (if simple laboratory abnormalities that were not clinically significant as determined by the investigators could also be included);\n* Estimated survival time ≥ 3 months;\n* Sign the informed consent voluntarily;\n* Good compliance, and family members willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Patients with other uncured malignant tumors;\n* Pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period;\n* Previous antitumor therapy for the disease in this study;\n* Participated in clinical trials of other drugs within one month;\n* Patients with a known history of other systemic serious diseases before screening;\n* Obstructive jaundice (after active treatment such as biliary drainage or stent, the patients can be included in the group after the liver function returns to normal);\n* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal in the clinical laboratory of the study center);\n* Active HCV infected persons (HCV antibody positive with HCV RNA levels above the lower limit of detection);\n* Allergic to any investigational drug or excipient;\n* Long-term unhealed wounds or incomplete healing fractures;\n* Previous organ transplantation history;\n* Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders;\n* A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n* Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.",{"count":202,"type":20},93,[78],"In this phase 2 study, the investigators aim to evaluate the effects and safety of combined therapy using oxaliplatin and gemcitabine chemotherapy, Donafenib and Tislelizumab for patients with advanced biliary tract carcinoma.",[38],[207,208,209,210],"Donafenib","Tislelizumab","Effects","Safety","2026-01-12",{"date":213,"type":59},"2026-01-14",{"date":215,"type":59},"2022-10-18",{"date":217,"type":20},"2027-03-31",{"name":219,"class":146},"Fudan University",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":155,"enrollmentInfo":228,"targetDuration":4,"studyType":21,"phases":230,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":4},"100597733","phase-2-a-trial-of-recaticimab-and-adebrelimab-in-combination-with-chemotherapy-in-patients-with-unresectable-btc-100597733","NCT07062328","A Trial of Recaticimab and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable BTC","Efficacy and Safety of Recaticimab (PCSK9 Inhibitor) and Adebrelimab Combined With Chemotherapy as First-line Treatment for Unresectable\u002F Advanced Biliary Tract Carcinoma: A Single-arm, Phase II Study","HP-BTC-002","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 confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.;\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 BTC. 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\\. No prior treatment with immune-mediated therapy, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, with the exception of therapeutic anticancer vaccines and adjuvant immunotherapy administered after curative resection\n* 7\\. 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* 8\\. Child-Pugh class: Grade A\n* 9\\. ECOG-PS score: 0-1;\n* 10\\. With a life expectancy of ≥ 12 weeks;\n* 11\\. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;\n* 12\\. For active hepatitis B, it is required that effective antiviral treatment be received (according to local standard therapy, such as entecavir or tenofovir), with HBV DNA ≤ 2000 IU\u002FmL or a reduction of HBV DNA by 10 times after antiviral treatment, and the patient must agree to continue effective anti-HBV treatment throughout the study period;\n* 13\\. 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* 14\\. 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\\. Other active malignant tumor exceptBTCwithin 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* 2\\. A previous diagnosis of nephrotic syndrome, severe liver disease, Cushing's syndrome, or other diseases that significantly affect lipid levels; a history of low cholesterol, low lipidemia, or related family history, or a family history of allergy to PCSK inhibitors\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\\. Moderate or severe ascites with clinical symptoms that require therapeutic puncture and drainage, or Child-Pugh score \\>2 (excluding those with only a small amount of ascites on imaging without accompanying clinical symptoms); uncontrolled or moderate to large pleural effusion, pericardial effusion;\n* 6\\. History of gastrointestinal bleeding within 6 months prior to the start of study treatment or clear tendency of gastrointestinal bleeding;For example, those with a risk of bleeding or severe esophageal and gastric varices, active local gastrointestinal ulcer lesions, persistent positive fecal occult blood test cannot be enrolled (if the fecal occult blood test is positive at baseline, it can be rechecked. If it remains positive after re-examination, an endoscopy (EGD) should be performed. Those who are found to have esophageal and gastric varices with a high risk of bleeding by EGD cannot be enrolled);\n* 7\\. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment\n* 8\\. 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* 9\\. 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* 10\\. 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* 11\\. Cardiac clinical symptom or disease that is not well controlled;\n* 12\\. 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* 13\\. 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* 14\\. Evidence on intraperitoneal pneumatosis that can not be explained by puncture or recent surgery;\n* 15\\. 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* 16\\. 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* 17\\. 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* 18\\. 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* 19\\. Known history of hypersensitivity to the active substance or to any other components of each investigational medicinal product;\n* 20\\. 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* 21\\. Congenital or acquired immunodeficiency (e.g., HIV infection);\n* 22\\. Hepatitis B and hepatitis C co-infection;\n* 23\\. 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* 24\\. 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.\n* 25.Other conditions in which the investigator deems the subject unsuitable for participation in the clinical trial.",{"count":229,"type":20},39,[78],"The study aims to evaluate the efficacy and safety of Recaticimab and Adebrelimab in Combination With chemotherapy in patients with metastatic biliary tract carcinoma (BTC).",[38],[234,235,236,237],"GP chemotherapy","Antineoplastic Agents","PCSK9 Inhibitor","Immune Checkpoint Inhibitors","NOT_YET_RECRUITING","2025-07-02",{"date":241,"type":59},"2025-07-14",{"date":243,"type":20},"2025-07-10",{"date":245,"type":20},"2028-04-20",{"name":247,"class":146},"Sun Yat-sen University",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":255,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":147},"100529016","intraductal-radiofrequency-thermoablation-and-radiotherapy-combined-treatment-for-extrahepatic-cholangiocarcinoma-100529016","NCT06168292","Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma","Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma: A Prospective, Single-arm, Multicenter Study","Inclusion Criteria:\n\n1. Patients 20 years of age or older, who voluntarily agree to participate in the study and sign the informed consent.\n2. Patients with cytopathologically diagnosed inoperable extrahepatic cholangiocarcinoma\n\nExclusion Criteria:\n\n1. Patients who refuse to sign the informed consent\n2. Patients with metastatic cancer (stage IV) or malignant ascites\n3. Patients with intrahepatic cholangiocarcinoma\n4. Patients who are unable to undergo endoscopic procedures as determined by the investigator.\n5. Patients with a life expectancy of 3 months or less\n6. Patients with ID-RFA contraindications: pacemaker, pregnancy, uncorrected bleeding tendency (PT INR \\> 1.5, platelets \\\u003C 50,000\u002Fmm3)","20 Years",{"count":257,"type":20},53,[259],"NA","\\[Study objectives\\] To evaluate the efficacy and safety of the combined treatment of radiotherapy and endoscopic intraductal radiofrequency ablation in patients with locoregional extrahepatic cholangiocarcinoma.",[38,262,263],"Radiotherapy","Radio-frequency Ablation","2025-06-16",{"date":266,"type":59},"2025-06-19",{"date":268,"type":59},"2024-04-01",{"date":270,"type":20},"2030-06-30",{"name":272,"class":273},"National Cancer Center, Korea","OTHER_GOV",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":155,"enrollmentInfo":282,"targetDuration":4,"studyType":21,"phases":284,"briefSummary":285,"conditions":286,"keywords":287,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":301},"100569839","phase-2-irinotecan-liposomes-5-fulv-versus-capecitabine-in-patients-of-recurrence-after-resection-of-resectable-btc-100569839","NCT06699459","Irinotecan Liposomes +5-FU\u002FLV Versus Capecitabine in Patients of Recurrence After Resection of Resectable BTC","Irinotecan Liposomes +5-FU\u002FLV or Capecitabine in Patients at High Risk of Recurrence After Resection of Resectable Biliary Tract Carcinoma: A Prospective Phase II Study","NICRRBTC","Inclusion Criteria:\n\n* Age 18-75 years old.\n* Patients with histologically confirmed, resectable biliary malignancies with R0 resection.\n* Postoperative pathology indicated the following risk factors: positive lymph nodes, vascular invasion, nerve invasion and so on.\n* Has not received systemic chemotherapy before.\n* The ECOG score is 0 to 1.\n* Bone marrow and organ function were good: ① Neutrophils (ANC) ≥1.5×109\u002FL, platelets (PLT) ≥100×109\u002FL, hemoglobin (Hb) ≥90g\u002FL, white blood cells (WBC) ≥3.0×109\u002FL, albumin (ALB) ≥32 g\u002FL, and no bleeding tendency; ② Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤2.5× upper limit of normal range (ULN), ≤5×ULN with liver metastasis; Total bilirubin ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin (calculated according to Cockroft-Gault).\n* Expected survival ≥3 months.\n* Volunteer to participate in the study and sign the informed consent. If the subject does not have the ability to read the informed consent (e.g., illiterate subjects), a witness must witness the informed process and sign the informed consent.\n\nExclusion Criteria:\n\n* Patients allergic to the investigational drug and its excipients.\n* Known or suspected central nervous system or lymphatic metastasis.\n* Cannot discontinue use or has not discontinued use of CYP3A, CYP2C8, and UGT1A1 potent depressants or inducers (e.g., anticonvulsants \\[phenytoin, phenobarbital, or carbamazepine\\] within 2 weeks prior to enrollment), rifampicin, rifambutin, St.John's Wort, Grapefruit juice, clarithromycin, Itraconazole, Lopinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Terrapivir, voriconazole, Azanavir, Gefilozil, Indinavir, etc.).\n* There are signs and symptoms of intestinal obstruction.\n* Other malignancies within the past 5 years or currently, except for cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancers.\n* Autoimmune disease or long-term steroid use.\n* Patients who are pregnant or nursing women, and patients who refuse to receive contraception during their reproductive age.\n* Patients deemed unsuitable for participation in this study.\n* Vulnerable groups, including people with mental illness, cognitive impairment, critically ill patients, etc.",{"count":283,"type":20},76,[78],"Irinotecan liposome combined with 5-FU\u002FLV has shown good efficacy and has certain advantages in reducing the adverse reactions of conventional chemotherapy drugs. Adjuvant treatment of high-risk factors after surgery for biliary tract tumors can be further explored and attempted. Therefore, this study intends to conduct an exploratory study comparing oral capecitabine with irinotecan liposome +5-FU\u002FLV for adjuvant therapy in high-risk patients after resection of resectable biliary malignancies, and evaluate the effectiveness and safety of irinotecan liposome +5-FU\u002FLV as adjuvant therapy for high-risk patients after resection of resectable biliary malignancies. So it can provide more treatment options for patients with postoperative adjuvant therapy of biliary tract malignant tumor.\n\nThe DFS rate one year after surgery for biliary malignancy was assumed to be 51.4% with a maximum response rate of poor efficacy and 71.4% with a minimum response rate of good efficacy. A two-stage design was adopted with α=0.05 and certainty (1-β) =0.8, and Minimax was adopted. If a response occurs in 7 out of 14 patients or less, treatment options are rejected; In the second phase, if 24 or fewer responses occur in 38 patients, the protocol is rejected. A total of 38 samples were designed in two stages. The 1-year DFS rate was at least 65.8% in the total population of the test and control groups.",[38],[38,288,289,290,291],"Adjuvant treatment","Resectable","Irinotecan liposomes","Capecitabine","2024-11-20",{"date":294,"type":59},"2024-11-21",{"date":296,"type":20},"2024-11-14",{"date":298,"type":20},"2026-11-15",{"name":300,"class":146},"Sir Run Run Shaw Hospital",6,{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":155,"enrollmentInfo":309,"targetDuration":4,"studyType":21,"phases":311,"briefSummary":312,"conditions":313,"keywords":316,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":147},"100542913","a-randomized-multicenter-phase-ii-basket-study-of-hypofractionated-radiotherapystereotactic-body-radiotherapy-followed-by-immunotherapy-based-systemic-therapy---l-rhamnosus-m9-for-the-first-line-treatment-of-advanced-digestive-system-malignancies-100542913","NCT06349044","A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy\u002FStereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +\u002F- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies.","A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy\u002FStereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +\u002F- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies","Inclusion Criteria:\n\n* histopathologically confirmed diagnosis of malignant tumors of the gastrointestinal tract (including Her-2 negative adenocarcinoma of the gastroesophageal junction\u002Fgastric adenocarcinoma, hepatocellular carcinoma, malignant tumors of the biliary system, colorectal cancer);\n* advanced patients evaluated as initially non-operable resectable who have not received any antitumor therapy;\n* have at least one measurable or evaluable lesion according to RECIST v1.1 criteria in addition to the primary lesion, with non-operable resectable lymph node metastases to the liver, lung, bone, pelvis, retroperitoneum and\u002For superficial sites (except for brain metastases), as evaluated by discussion in the framework of the MDT\n* age 18-75 years;\n* ECOG score of 0-1;\n* be able to accept the treatment regimen during the study;\n* sign a written informed consent.\n\nExclusion Criteria:\n\n* a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder of clinical severity that, in the judgment of the investigator, may preclude the signing of an informed consent form or interfere with the patient's adherence to oral medication;\n* prior immunotherapy for any indication or a history of severe hypersensitivity reactions to other monoclonal antibodies;\n* clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months;\n* organ transplantation requiring immunosuppressive therapy;\n* a history of other malignant disease within the last five years;\n* persons with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;\n* Subjects whose baseline blood routine and biochemical indexes do not meet the following criteria: hemoglobin ≥80g\u002FL; absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \\\u003C1.5 times the upper limit of normal; serum creatinine \\\u003C1 times the upper limit of normal; and serum creatinine \\\u003C1 times the upper limit of normal. times the upper limit of normal;\n* the patient currently has active gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator;\n* persons with active bleeding or bleeding tendencies;\n* women who are pregnant or breastfeeding;\n* allergy to any of the study drug ingredients.",{"count":310,"type":20},120,[259],"Based on the interaction between radiation therapy and immunotherapy and the potential potentiation of Probio-M9 for the treatment of ICIs, this study is planned to design an integrated treatment protocol for the first-line treatment of advanced gastrointestinal tumors through the use of macrofractionated radiotherapy as a means of immune activation, combined with the synergistic effect of Probio-M9 microbial agents and PD-1 inhibitors.",[314,121,38,315],"Her-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction\u002FGastric Adenocarcinoma","Colorectal Adenocarcinoma",[317,318,319],"radiotherapy","immunotherapy","L. rhamnosus M9","2024-08-22",{"date":322,"type":59},"2024-08-27",{"date":324,"type":59},"2024-03-20",{"date":326,"type":20},"2025-12-31",{"name":328,"class":146},"Zhejiang Cancer Hospital",{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":21,"phases":338,"briefSummary":339,"conditions":340,"keywords":341,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":4},"100556877","phase-2-pemigatinib-combined-with-durvalumab-for-previously-treated-biliary-tract-carcinoma-100556877","NCT06530823","Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma","Pemigatinib Combined With Durvalumab for the Safety and Efficacy in Second-Line Treatment of Biliary Tract Cancer: A Single-Arm, Multicenter Phase II Clinical Trial","Inclusion Criteria:\n\n1. Age ≥18 years, men and women;\n2. ECOG performance status of 0-1;\n3. Histologically confirmed advanced gallbladder cancer or cholangiocarcinoma patients who have received one prior line of therapy;\n4. Adult patients with advanced, metastatic, or unresectable cholangiocarcinoma or gallbladder cancer confirmed to have FGFR2 fusion or rearrangement;\n5. Diagnosed with locally advanced disease according to the 8th edition of AJCC, with clinical staging of cT3\u002F4NxM0\u002F1 for gallbladder cancer, intrahepatic cholangiocarcinoma, or hilar cholangiocarcinoma, or cT2N2M0, cT3\u002F4NxM0\u002F1 for distal cholangiocarcinoma based on enhanced CT or MRI;\n6. Use of contraception during the study period;\n7. Life expectancy ≥3 months;\n8. All patients must provide tumor tissue specimens (fresh or paraffin-embedded) for FGFR2 expression analysis before enrollment and after surgery (5 slides within 3 years are required);\n9. At least one measurable lesion according to RECIST 1.1 criteria, which has not been irradiated;\n10. Within 7 days prior to the first administration of the study drug, the organ function levels of the enrolled patients must meet the following requirements:\n\n    1. Hematopoietic function: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet count (PLT) ≥ 100×10\\^9\u002FL, hemoglobin (Hb) ≥90g\u002FL, and no blood transfusion or component blood transfusion within 14 days prior to testing;\n    2. Hepatic function: Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (APK) ≤2.5 times ULN, serum creatinine ≤1.5 times ULN and creatinine clearance (based on the Cockcroft-Gault formula) ≥50mL\u002Fmin, serum albumin (ALB) ≥30g\u002FL, Child-Pugh class A;\n    3. Coagulation function: For patients not receiving anticoagulant therapy, international normalized ratio (INR), activated partial thromboplastin time (APTT) ≤1.5 times ULN; patients receiving anticoagulant therapy should maintain therapeutic levels of anticoagulants;\n    4. Thyroid function: Thyroid-stimulating hormone (TSH) ≤1×ULN, if TSH \\>1×ULN, free T3 (FT3) and free T4 (FT4) levels should also be assessed, and if normal, the patient may be enrolled;\n    5. Renal function: Urine protein ≤1+. If urine protein \\>1+, a 24-hour urine protein test is required, and the total amount must be ≤1 gram for enrollment;\n    6. Normal cardiac function, i.e., normal electrocardiogram or clinically insignificant abnormalities, and left ventricular ejection fraction (LVEF) \\>50% as shown by echocardiography;\n11. Serum pregnancy test results must be negative within 7 days prior to the first administration of the trial medication for women of childbearing age; men with reproductive capacity or women who may become pregnant must use highly effective contraception (e.g., oral contraceptives, intrauterine devices, abstinence, or barrier methods combined with spermicides) throughout the trial and continue for 12 months after treatment;\n12. Volunteers willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Patients who have not received standard first-line treatment for advanced biliary tract tumors;\n2. Pregnant or breastfeeding women, and women of childbearing age with positive pregnancy test results at baseline;\n3. Patients diagnosed with central nervous system metastasis by CT\u002FMR\u002FPET-CT;\n4. Patients who have previously received live vaccine administration or other antitumor treatments such as radiotherapy;\n5. Patients who have participated in or are currently participating in other drug or therapy clinical trials within 4 weeks prior to the first administration of the study medication;\n6. Patients who have undergone major surgical procedures within 4 weeks prior to the first administration of the study medication or have not recovered from the side effects of such surgery, or patients who have undergone radiotherapy within 2 weeks prior to the first administration of the study medication;\n7. Patients with any primary immunodeficiency, active autoimmune disease, or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, vitiligo, patients with a history of asthma who have completely resolved in childhood and do not require any intervention in adulthood may be included; patients with asthma requiring medical intervention with bronchodilators are excluded;\n8. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation, and patients currently using immunosuppressants or corticosteroids for immunosuppressive purposes (dosage \\>10mg\u002Fday prednisone or other equivalent corticosteroids) and still in use within 2 weeks prior to enrollment;\n9. Patients with other malignancies within the past 5 years, except for cured skin basal cell or squamous cell carcinoma, superficial bladder cancer, early prostate cancer, in situ cervical cancer, or breast cancer;\n10. Patients who have received hematopoietic growth factors within 1 week prior to the first administration of the study medication, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc.;\n11. Patients with positive HIV antibodies or syphilis antibodies, and patients with active hepatitis B or C;\n12. Known allergies to recombinant humanized PD-L1 monoclonal antibody drugs and their components;\n13. Patients with symptomatic pleural effusion, pericardial effusion, or ascites requiring clinical treatment;\n14. Patients with severe cardiovascular diseases within the last 12 months, such as clinically significant coronary heart disease, NYHA≥II congestive heart failure, uncontrolled arrhythmias, myocardial infarction;\n15. Within 6 months prior to the first administration of the study medication, the following conditions have occurred: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmias or angina; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, cerebral embolism.\n16. Patients who have undergone any type of gastrointestinal surgery, or have upper gastrointestinal obstruction, bleeding, digestive dysfunction, or malabsorption syndrome that may affect the absorption of the study medication;\n17. Concurrent severe uncontrollable infections or other severe uncontrollable comorbidities, moderate or severe renal impairment;\n18. Active pulmonary diseases, such as interstitial pneumonia, pneumonia, chronic obstructive pulmonary disease, asthma, or a history of active tuberculosis.\n19. Abnormal coagulation function (INR\\>2.0, PT\\>16s), with a tendency to bleed or currently receiving thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin, low molecular weight heparin is allowed;\n20. Significant clinical bleeding symptoms or a clear tendency to bleed within 3 months, such as coughing or expectorating blood ≥2.5ml, history of gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, bleeding gastric ulcers or patients with vasculitis, etc.; if the baseline fecal occult blood test is positive, it can be retested, and if it is still positive after retesting, a gastroscopy is required, and if gastroscopy indicates severe esophageal and gastric varices, the patient may not be enrolled (patients who have undergone gastroscopy within 3 months and excluded such conditions are excluded);\n21. Known genetic or acquired bleeding and thrombotic tendencies, such as hemophilia, coagulation disorders, thrombocytopenia, etc.;\n22. History of substance abuse that cannot be quit or history of mental disorders.\n23. Use of warfarin or any other coumarin derivative anticoagulants within 14 days prior to the first administration of the study medication.\n24. Other severe, acute, or chronic medical diseases or laboratory abnormalities that the investigator judges may increase the risk associated with participating in the study or may interfere with the interpretation of the study results.\n25. Patients deemed to have poor compliance by the investigator, or other conditions that make them unsuitable for participating in this trial.",{"count":337,"type":20},38,[78],"This study is a single-arm, multicenter Phase II clinical trial designed to preliminarily assess the safety and efficacy of the combination therapy of pemigatinib and durvalumab in the second-line treatment of patients with advanced malignant biliary tract cancer.\n\nThe study anticipates enrolling 38 participants characterized by the following criteria: 1) A confirmed diagnosis of advanced, metastatic, or unresectable biliary tract cancer by histopathological examination; 2) Presence of FGFR2 fusion or rearrangement confirmed by testing; 3) Prior receipt of first-line treatment for biliary tract cancer.\n\nThe primary questions the study aims to address are:\n\n1. Can the combination of pemigatinib and durvalumab improve the prognosis of participants with previously treated biliary tract cancer (BTC)?\n2. What is the safety profile of the treatment with pemigatinib and durvalumab?\n\nParticipants will receive:\n\n1. Oral administration of 13.5 mg pemigatinib once daily, in combination with durvalumab 1500 mg via intravenous infusion.\n2. Follow-up visits will be scheduled every 6 weeks.\n\nInvestigators will observe and document the objective tumor response rate of the participants, as well as progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and adverse events.",[38,182],[342,343,344,345,318],"biliary tract carcinoma","cholangiocarcinoma","FGFR mutation","targeted thearpy","2024-07-28",{"date":348,"type":59},"2024-07-31",{"date":350,"type":20},"2024-08-01",{"date":352,"type":20},"2028-08-01",{"name":354,"class":146},"Eastern Hepatobiliary Surgery Hospital",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":155,"enrollmentInfo":362,"targetDuration":4,"studyType":21,"phases":364,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":147},"100551704","irinotecan-hydrochloride-liposome-combined-with-capecitabine-and-lenvatinib-in-patients-with-biliary-tract-carcinoma-100551704","NCT06463548","Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma","Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Capecitabine and Lenvatinib for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma","Inclusion Criteria:\n\n1. Age ≥18 and ≤75 years\n2. Has histologically confirmed diagnosis of advanced (metastatic) and\u002For unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)\n3. For subjects who have progressed after receiving previous first-line therapy, relapse within 6 months after the end of (neo) adjuvant therapy is considered as first-line therapy failure\n4. The previous treatment regimen should be free of capecitabine and Lenvatinib, and the time of recurrence diagnosis should be greater than 6 months after the last dose, with no delayed toxic reactions\n5. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1)\n6. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1\n7. Has a life expectancy of greater than 3 months\n8. LVEF≥50%，no obvious abnormalities in myocardial enzyme spectra\n9. Good bone marrow function：ANC ≥1.5×109\u002FL, Hb≥90g\u002FL.PLT ≥100×109\u002FL, WBC≥3.0×109\u002FL\n10. Liver function：ALT\u002FAST ≤ 2.5 x ULN; When there is liver metastasis, ALT\u002FAST ≤ 5 x ULN，total bilirubin ≤1.5 x ULN\n11. Renal function：Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60mL\u002Fmin (according to Cockcroft-Gault formula)\n12. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international standardized ratio (INR) ≤1.5×ULN\n13. Urine routine results showed that urine protein \\\u003C2+; For patients with urine protein ≥2+ at baseline, 24-hour urine collection and 24-hour urine protein quantification \\\u003C1g should be performed.\n14. Patients with biliary obstruction or no evidence of persistent infection should receive adequate biliary drainage; Active or suspected infection is not allowed\n15. Adverse reactions caused by previous treatment must be restored to grade 1 or baseline according to CTCAE5.0 (except for toxicity such as alopecia, grade 2 and below peripheral neuropathy, which can be included after the investigator determines that there is no safety risk).\n16. Non-pregnant or lactating female; Effective contraception should be used by female\u002FMale of childbearing age during the study period and for 6 months after the end of study treatment\n17. There were no contraindications for the use of irinotecan liposomes, capecitabine and Lenvatinib\n18. The patient had good compliance, could understand the research process of this study, and signed a written informed consent\n\nExclusion Criteria:\n\n1. Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and skin basal cell carcinoma)\n2. Uncontrolled pleural effusion or ascites\n3. History of gastrointestinal bleeding or significant tendency to gastrointestinal bleeding within 6 months before the study, such as esophageal and gastric varices with bleeding risk, active local ulcers, and continuous positive fecal occult blood\n4. A deep vein thrombosis or embolism event occurred within 6 months before the start of treatment\n5. any known brain or meningeal metastases\n6. Subjects were co-administered a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing\n7. Subjects underwent large organ surgery (except needle biopsy, central venous catheterization, port catheterization, stenting for relief of biliary obstruction, percutaneous hepatobiliary drainage, and cholecystostomy) or an elective surgical program within 4 weeks before the first dose of the study drug\n8. Subjects had an active infection or unexplained fever \\>38.5 degrees during screening or before the first dose (the investigator determined that the subject's fever due to the tumor could be enrolled)\n9. Subjects with congenital or acquired immune dysfunction, such as HIV infection or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA≥1000 IU\u002Fml; Hepatitis C reference: HCV RNA≥1000 IU\u002Fml) Chronic hepatitis B virus carriers with HBV DNA \\\u003C 2000 IU\u002Fml must also receive antiviral therapy during the trial to be enrolled\n10. Subject has homozygous mutation or double heterozygous mutation of UGT1A1 allele\n11. There are serious concomitant diseases: such as uncontrolled diabetes after hypoglycemic drug treatment, uncontrolled hypertension, serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, uncontrolled epilepsy, central nervous system disease or mental disorder history, clear gastrointestinal bleeding tendency, intestinal paralysis, intestinal obstruction, etc\n12. Grade 1 diarrhea with an increase in the number of stools \\> 4 times per day compared to baseline; The moderate and severe effluents from stoma increased; Limited activities of daily living with the aid of tools or even self-rational activities of daily living; Life-threatening; Need urgent medical attention\n13. Had participated in other clinical investigators within 4 weeks before enrollment\n14. Unsuitable for participation in the trial by the investigator assessed",{"count":363,"type":20},30,[259],"To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.",[38],"2024-06-14",{"date":369,"type":59},"2024-06-18",{"date":371,"type":20},"2024-07-01",{"date":373,"type":20},"2026-12-31",{"name":375,"class":146},"Yunpeng Liu"]