[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-cholangiocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-cholangiocarcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,51,81,143,165,190,216],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100495130","phase-2-study-of-futibatinib-in-patients-with-advanced-cholangiocarcinoma-with-fgfr2-fusion-or-rearrangement-100495130",false,"NCT05727176","Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement","Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements","FOENIX-CCA4","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.\n2. Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement\n3. Received at least one prior systemic gemcitabine and platinum-based regimen for CCA\n4. Documentation of radiographic disease progression on the most recent prior therapy\n5. Measurable disease\n6. performance status 0 or 1\n7. Adequate organ function\n\nExclusion Criteria:\n\n1. History or current evidence of calcium and phosphate homeostasis disorder\n2. Current evidence of clinically significant retinal disorder\n3. Treatment with any of the following within the specified time frame prior to the first dose of futibatinib:\n\n   1. Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks\n   2. Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks\n   3. Any non investigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib. Endocrine therapy is allowed for patients with breast or prostate cancer\n   4. Targeted therapy or immunotherapy within 3 weeks or within 5 half lives Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter.\n   5. Patients with prior FGFR-directed therapy\n4. A serious illness or medical condition(s) including (but not limited to) the following:\n\n   1. Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month\n   2. Known acute systemic infection\n   3. Myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV New York Heart Association \\[NYHA\\] Classification) within the previous 2 months; if \\>2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms\n   4. Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib.\n   5. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the patient inappropriate for entry into this study.\n5. Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment.\n6. Pregnant or lactating female.\n7. Known hypersensitivity or severe reaction to futibatinib or its excipients.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.",[27,28,29],"Advanced Cholangiocarcinoma","FGFR2 Fusions","Gene Rearrangement",[31,32,33,34,35,36,37],"Futibatinib","Advanced cholangiocarcinoma","cholangiocarcinoma","FGFR2","Fusion","Rearrangemen","TAS-120","RECRUITING","2026-06-25",{"date":41,"type":42},"2026-06-26","ACTUAL",{"date":44,"type":42},"2023-07-05",{"date":46,"type":21},"2026-12",{"name":48,"class":49},"Taiho Oncology, Inc.","INDUSTRY",65,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100500068","phase-1-au409-for-the-treatment-of-advanced-primary-liver-cancers-or-solid-tumor-with-liver-metastatic-disease-100500068","NCT05791448","AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease","First in Human Dose Escalation Study of AU409 in Patients With Advanced Primary Liver Cancers or Advanced Solid Tumor With Liver Predominant Metastatic Disease","Inclusion Criteria:\n\n* Age \\>= 18 years old\n* Patients must have histopathologically \u002Fcytologically confirmed advanced solid tumor, which is refractory to standard therapeutic options, or for which there are no standard therapeutic options. Failure of all approved therapies that have a marginal impact on survival is not required as long as the treating physician considers that treatment on study is appropriate for the subject and documents that the subject elects to defer the approved therapies\n* During the dose-escalation portion, patients must have primary liver malignancy (including hepatocellular carcinoma or cholangiocarcinoma) OR a solid tumor with liver dominant disease; liver dominant disease is defined as the majority of the tumor burden being in the liver per investigator assessment AND no more than two extrahepatic sites of disease (site of disease refers to organ or system). During the dose expansion portion of the study, eligibility may be limited to one or more tumor types depending on findings from the dose-escalation phase; this will be clarified in an amendment\n* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Patient must have recovered from any toxic effects of previous chemotherapy, targeted therapy or radiotherapy as judged by the Investigator to =\\\u003C grade 1 (except for alopecia). Residual sensory neuropathy =\\\u003C grade 2 is allowed. Residual endocrine adverse events (such as hypothyroidism or hypoadrenalism) that are manageable with replacement therapy are allowed\n* Previous chemotherapy\u002Fradiotherapy\u002Ftargeted\u002Fimmunotherapy therapy should have been completed at least 4 weeks prior to start of AU409 administration, or five half-lives, whichever is shorter (except for palliative radiation therapy that should be completed \\>= 14 days prior to study entry)\n* Patients must have an estimated life expectancy of at least 3 months\n* Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. A male participant must agree to use highly effective contraception during the intervention period and for 60 days after the last dose of AU409 and refrain from donating sperm during this period. WOCBP are eligible to participate if they are not pregnant, not breastfeeding, and agree to follow the contraceptive guidance during the study intervention period and for at least 90 days after the last dose of AU409\n\n  * Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* Patients must agree, as part of the informed consent, to undergo liver biopsy (for a subset of patients enrolled at and above dose level 4) and to provide blood for pharmacokinetics analysis\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Hemoglobin \\>= 8 g\u002FdL (prior transfusion is allowed if completed 2 weeks prior to screening and hemoglobin remains \\>= 8 g\u002FdL)\n* For patients with HCC with splenic sequestration: ANC \\>= 1000\u002Fmm\\^3\n* For patients with HCC with splenic sequestration: Platelets \\>= 70,000\n* Calculated clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2. Actual body weight should be used for calculating creatinine clearance (e.g., using the Cockroft-Gault formula). For subjects with a Body Mass Index (BMI) \\> 30 kg\u002Fm\\^2, lean body weight should be used instead\n* Total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN) (subjects with known Gilbert's hepatic function disease can have bilirubin of up to 2 X ULN)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 X ULN; or AST\u002FALT =\\\u003C 5 X ULN if patient has liver tumors\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR) =\\\u003C 1.8 times upper limit of normal (unless patient is on anticoagulation)\n\nExclusion Criteria:\n\n* Patients who have had hypersensitivity to pentamidine or any excipients of AU409\n* Treatment with other anticancer therapies (including surgery, radiation therapy, chemotherapy, anti-angiogenic therapy, targeted therapy, or radiofrequency ablation therapy, etc.) or investigational therapy within 28 days prior to study entry (except for palliative radiation therapy that should be completed \\>= 14 days prior to study entry)\n* Hepatocellular carcinoma patients with a Child Pugh score \\>= B7\n* Patients with known central nervous system metastases which are untreated or symptomatic; patients with treated brain metastases (completed \\>= 30 days prior to screening) are allowed provided they are asymptomatic and are off steroids\n* Patient with a history of the following within 6 months prior to cycle 1 day 1: a myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia, cerebrovascular accident, transient ischemic attack, or seizure disorder. Atrial fibrillation is allowed if rate is controlled\n* Patients who have corrected QT (QTc) interval to \\> 470 msec (Fredericia's equation) on 2 out of 3 electrocardiogram (ECG)'s (if first ECG has QTc \\\u003C 470, no need to repeat, if first ECG has QTc \\> 470 repeat twice for a total of 3 ECG's)\n* Patients who are on therapeutic anticoagulation with warfarin; however, patients on therapeutic doses of with low molecular weight heparins or Factor Xa inhibitors are eligible\n* Patient with history of gastrointestinal surgery or malabsorptive conditions that may change the absorption of drugs and\u002For cause rapid transit (such as total gastrectomy, small bowel resection, etc.)\n* Patients who have known active hepatitis B. Patients with chronic hepatitis B who are on anti-viral therapy and have a hepatitis B viral load of =\\\u003C 500 IU\u002FmL are allowed on the study. Patients with chronic Hepatitis C are allowed\n* Patients who have active infection requiring treatment (except hepatitis B and C as noted above) including known human immunodeficiency virus (HIV) infection\n* Patients who have concurrent conditions resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents\n* Patients who have any other condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results\n* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants\n* Patients who are on medications that are considered to be strong inducers or inhibitors of the cytochrome P450 isoenzymes should have such medications discontinued or replaced. Such medications should be avoided for one week prior to first dose of treatment and during the trial participation. If these medications are absolutely necessary for the patient and cannot be replaced, enrollment may still be considered on a case by case basis if it is in the patient's best interest and after discussion with the principal investigator (PI)",{"count":59,"type":21},36,[61],"PHASE1","This phase I trial tests the safety, side effects, and best dose of a new intervention, AU409, in treating patients with primary liver cancers that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or advanced solid tumors that have spread to the liver (liver metastatic disease). AU409 may stop cancer from growing and spreading. This trial may help researchers determine if AU409 is safe and effective in treating patients with liver cancers and solid tumors with liver metastatic disease.",[27,64,65,66,67,68,69],"Advanced Hepatocellular Carcinoma","Advanced Malignant Solid Neoplasm","Metastatic Malignant Neoplasm in the Liver","Refractory Malignant Solid Neoplasm","Stage III Hepatocellular Carcinoma AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","2026-05-29",{"date":72,"type":42},"2026-06-01",{"date":74,"type":42},"2023-03-29",{"date":76,"type":21},"2028-03-29",{"name":78,"class":79},"University of Southern California","OTHER",2,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":80},"100513775","phase-2-at-home-cancer-directed-therapy-versus-in-clinic-for-the-treatment-of-patients-with-advanced-cancer-100513775","NCT05969860","At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer","Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic","Inclusion Criteria:\n\n* Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required.\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) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines.\n\n  * Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Patients may receive any combination of any above listed medications or regimens:\n  * Eligible disease cancer types:\n\n    * Anal cancer\n    * Appendiceal carcinoma\n    * Basal cell carcinoma\n    * Bladder cancer\n    * Biliary cancer\n    * Breast cancer\n    * Central Nervous System malignancy including glioblastoma\n    * Cervical cancer\n    * Cholangiocarcinoma\n    * Colorectal carcinoma\n    * Endometrial cancer\n    * Fallopian tube cancer\n    * Gastroesophageal cancer \\[including gastric, esophageal, and gastroesophageal junction (GEJ) cancers\\]\n    * Germ cell carcinoma\n    * Head and Neck cancer\n    * Hepatocellular Carcinoma\n    * Liver\n    * Lung\n    * Lymphoma\n    * Melanoma\n    * Merkel Cell\n    * Multiple Myeloma\n    * Myelodysplastic syndrome\n    * Myeloid Disorders\n    * Neuroendocrine carcinoma\n    * Ovarian cancer\n    * Pancreatic adenocarcinoma\n    * Penile carcinoma\n    * Peritoneal carcinoma\n    * Prostate cancer\n    * Renal cell cancer\n    * Sarcoma\n    * Squamous cell Carcinoma of the Skin\n    * Testicular cancer\n    * Urethral carcinoma\n    * Vaginal carcinoma\n    * Vulvar carcinoma\n  * Eligible Regimens\n\n    * Fluorouracil (5-FU) +\u002F- leucovorin +\u002F- bevacizumab +\u002F- trastuzumab\n    * 5FU +\u002F- leucovorin +\u002F- bevacizumab +\u002F- nivolumab\n    * Atezolizumab +\u002F- bevacizumab\n    * Atezolizumab +\u002F- bevacizumab + cobimetinib, atezolizumab +\u002F- bevacizumab + vemurafenib, atezolizumab +\u002F- bevacizumab + cobimetinib + vemurafenib\n    * Avelumab\n    * Avelumab + axitinib\n    * Bevacizumab\n    * Bevacizumab + capecitabine\n    * Bevacizumab + irinotecan (+\u002F- capecitabine)\n    * Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib\n    * Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus\n    * Bevacizumab + trifluridine\u002Ftipiracil\n    * Bortezomib\n    * Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor\n    * Bortezomib + venetoclax\n    * Carfilzomib\n    * Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor\n    * Carfilzomib + venetoclax\n    * Cemiplimab\n    * Cisplatin\n    * Cisplatin\u002F5-FU\n    * Cisplatin\u002Fetoposide\n    * Cisplatin + durvalumab\n    * Cisplatin + gemcitabine\n    * Cisplatin + gemcitabine + durvalumab\n    * Daratumumab (+ oral \\[PO\\] cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Degarelix\n    * Durvalumab\n    * Durvalumab + tremelimumab\n    * Eribulin\n    * FOLFIRI +\u002F- bevacizumab (5FU +\u002F- leucovorin + irinotecan)\n    * Fam-trastuzumab deruxtecan\n    * Fulvestrant\n    * Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib\n    * Gemcitabine\n    * Gemcitabine + durvalumab\n    * Gemcitabine + paclitaxel protein-bound\n    * Goserelin acetate\n    * Irinotecan\n    * Irinotecan + capecitabine\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + cabozantinib\n    * Nivolumab-relatlimab\n    * Octreotide\n    * Paclitaxel\n    * Pembrolizumab\n    * Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +\u002F- trametinib, pembrolizumab + trametinib)\n    * Pemetrexed\n    * Pertuzumab\n    * Pemetrexed + pembrolizumab\n    * Rituximab\n    * Trastuzumab + paclitaxel\n    * Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+\u002F- tucatinib +\u002F- capecitabine)\n    * Decitabine\n    * These regimens can be used only if patients are receiving one of the regimens above:\n\n      * Darbepoetin-alfa\n      * Epoetin\n      * Filgrastim\n* Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of bone metastases, including agents such as:\n\n  * Zoledronic acid\n  * Denosumab\n* Patient has had adequate tolerability of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent\n* Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization.\n* Residing within the area serviced by supplier and paramedic network\n* Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution\n* Age \\>= 18 years at time of registration\n* Signed informed consent form by patient\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n* Ability to complete questionnaire(s) by themselves or with assistance\n* RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by the CCBW Command Center that the patient has adequate tolerability to the standard of care cancer therapy and no drug-related infusion reactions since pre-registration and prior to registration\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Note: Patients are permitted concomitant standard of care oral drugs such as ribociclib, abemaciclib, or palbociclib in combination with endocrine therapy (e.g., Leuprolide, fulvestrant intramuscular \\[IM\\], etc.); tucatinib and capecitabine in combination with trastuzumab and pertuzumab for HER2 positive breast cancer; dexamethasone, cyclophosphamide, lenalidomide or pomalidomide for multiple myeloma; temozolomide, lomustine, or afinitor in combination with avastin for glioblastoma. In addition, all oral anti-hormonal agents for breast and prostate cancer are permitted (e.g., tamoxifen, arimidex, abiraterone, etc.) if used in combination with any of the drugs\n* Requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)\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* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction =\\\u003C 6 months\n  * Wound healing disorder\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":89,"type":21},220,[24],"This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.",[93,94,95,96,97,98,99,100,101,102,103,104,105,106,65,107,108,109,110,111,112,113,114,115,27,116,117,118,64,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133],"Advanced Anal Carcinoma","Advanced Biliary Tract Carcinoma","Advanced Bladder Carcinoma","Advanced Breast Carcinoma","Advanced Carcinoid Tumor","Advanced Cervical Carcinoma","Advanced Colorectal Carcinoma","Advanced Gastric Carcinoma","Advanced Glioblastoma","Advanced Head and Neck Carcinoma","Advanced HER2 Positive Breast Carcinoma","Advanced Lung Carcinoma","Advanced Lung Small Cell Carcinoma","Advanced Malignant Germ Cell Tumor","Advanced Neuroendocrine Carcinoma","Advanced Ovarian Carcinoma","Advanced Pancreatic Carcinoma","Advanced Prostate Small Cell Neuroendocrine Carcinoma","Advanced Prostate Carcinoma","Hematopoietic and Lymphoid System Neoplasm","Multiple Myeloma","Myelodysplastic Syndrome","Advanced Basal Cell Carcinoma","Advanced Endometrial Carcinoma","Advanced Esophageal Carcinoma","Advanced Fallopian Tube Carcinoma","Advanced Liver Carcinoma","Advanced Lymphoma","Advanced Malignant Testicular Neoplasm","Advanced Melanoma","Advanced Merkel Cell Carcinoma","Advanced Penile Carcinoma","Advanced Primary Malignant Central Nervous System Neoplasm","Advanced Renal Cell Carcinoma","Advanced Sarcoma","Advanced Skin Squamous Cell Carcinoma","Advanced Urethral Carcinoma","Advanced Vaginal Carcinoma","Advanced Vulvar Carcinoma","Advanced Appendix Carcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","2026-04-15",{"date":136,"type":42},"2026-04-20",{"date":138,"type":42},"2023-08-23",{"date":140,"type":21},"2027-01-01",{"name":142,"class":79},"Mayo Clinic",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100549855","phase-1-phase-iii-trial-of-pemigatinib-in-combination-with-atezolizumab-and-bevacizumab-for-treatment-of-advanced-cholangiocarcinoma-with-fgfr2-fusion-100549855","NCT06439485","Phase I\u002FII Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion","Inclusion Criteria:\n\n* Ability to understand and willingness to sign informed consent.\n* Age ≥18 years.\n* Has histologically confirmed metastatic or advanced unresectable cholangiocarcinoma.\n* Has disease that is measurable per the RECIST v1.1.\n* Has at least one measurable target lesion.\n* Has FGFR2 fusion or rearrangement in tumor tissue, as determined by CLIA-validated genomic testing of a tumor tissue specimen (DNA-based or RNA-based).\n* Is refractory to, has demonstrated intolerance to, had received, or has refused access to, the 1st line systemic therapy including gemcitabine-based therapy with or without immunotherapy including durvalumab or pembrolizumab. Participants who discontinued available standard therapy due to toxicity must have continued evidence of measurable disease.\n* Has available a formalin-fixed, paraffin-embedded primary tumor sample.\n* Is able to take oral medication and to comply with protocol procedures and scheduled visits..\n* Has Eastern Cooperative Oncology Group performance status of 0 or 1\n* Has adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:\n* Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL (1000\u002FµL) without granulocyte colony-stimulating factor support\n* Platelet count ≥ 100 × 109\u002FL (100,000\u002FµL) without transfusion\n* Hemoglobin ≥ 90 g\u002FL (9 g\u002FdL), participants may be transfused to meet this criterion.\n* Aspartate amino transferate (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN), with the following exceptions:\n* Participants with documented liver metastases: AST and ALT ≤ 5 × ULN\n* Participants with documented liver or bone metastases: ALP ≤ 5 × ULN\n* Serum bilirubin ≤ 1.5 × ULN with the following exception:\n* Participants with known Gilbert disease: serum bilirubin ≤ 3 × ULN\n* Serum creatinine ≤ 1.5 × ULN\n* Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL)\n* For participants not receiving therapeutic anticoagulation: international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. For patients on anticoagulation, those on therapeutic anticoagulation over 2 weeks are eligible.\n* Has a negative human immunodeficiency virus (HIV) test at screening with the following exception: participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200 and have an undetectable viral load.\n* Has a negative hepatitis B surface antigen (HBsAg) test at screening (unless participant has chronic HBV on anti-viral therapy)\n* Has a negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening (unless patient has chronic HBV on anti-viral therapy)\n* The HBV DNA test will be performed only for participant who have a negative HBsAg test and a positive total HBcAb test.\n* Participants with chronic HBV on antiviral therapy or HCV participants who have completed curative anti-viral therapy can be included.\n* Contraception requirements for marketed Roche IMPs or NIMPs should be based on recommendations in the Summary of Product Characteristics or, if there is no Summary of Product Characteristics, national prescribing information. Length of time required for abstinence or use of contraceptives should take into account the reproductive toxicity profile, including genotoxicity and teratogenicity, the size of the molecule, and the number of doses. In the absence of specific delayed-toxicity concerns or safety hypotheses, the following guidelines should be used: Single-dose studies Small Molecules: 5 elimination half-lives or 14 days after the last dose, whichever is longer Large Molecules: 2 elimination half-lives or 28 days after the last dose, whichever is longer Multiple-dose studies Small Molecules: 5 elimination half-lives or 28 days after the last dose, whichever is longer Large Molecules: 2 elimination half-lives or 28 days after the last dose, whichever is longer Options for female contraception are based on the Clinical Trial Facilitation Group \"Recommendations related to contraception and pregnancy testing in clinical trials.\" Three options for female contraception are shown below.\n* For women of childbearing potential: agrees to remain abstinent (refrain from heterosexual intercourse) or to use contraceptive methods, and agrees to refrain from donating eggs, as defined below:\n* Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for 6 months after the final dose of atezolizumab\u002Fpemigatinib\u002Fbevacizumab. Women must refrain from donating eggs during this same period.\n* A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002F or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n* Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. Options for contraception in male patients with pregnant female partners and\u002F or with female partners of childbearing potential are based on the Clinical Trial Facilitation Group \"Recommendations related to contraception and pregnancy testing in clinical trials\" and the Roche White Paper regarding contraception for males in clinical trials. Atezolizumab does not require male contraception or condom use; guidelines below apply to other protocol-mandated study treatments.\n* For men: agrees to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agrees to refrain from donating sperm, as defined below:\n* With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of atezolizumab\u002Fpemigatinib\u002F bevacizumab to avoid exposing the embryo. Men must refrain from donating sperm during this same period.\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of preventing drug exposure.\n\nExclusion Criteria:\n\n* Received prior chemotherapy, biologic therapy, immunotherapy, or investigational agent within 3 weeks prior to initiation of study medications.\n* Had previous treatment with selective FGFR inhibitors including erdafitinib, infigratinib, or futibatinib.\n* Had prior therapy with any VEGFR-targeting agent targeting including bevacizumab, ramucirumab, pazopanib, lenvatinib, and other anti-angiogenesis inhibitors.\n* Has a history and\u002For has current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system, and lung. Exceptions include calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcifications-these are allowed.\n* Has corneal or retinal disorder\u002Fkeratopathy with current evidence of corneal or retinal disorder\u002Fkeratopathy including, but not limited to, bullous\u002F band keratopathy, inflammation, or ulceration, keratoconjunctivitis, or diabetic retinopathy, confirmed by ophthalmic physician. Participants with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study.\n* Are currently receiving or are planning to receive during participation in this study, treatment with any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Moderate CYP3A4 inhibitors are not prohibited but should be avoided. Medications that increase serum phosphorus and\u002For calcium concentration are prohibited. Medications associated with hyperphosphatemia and\u002For hypercalcemia adverse events are searchable in the Leximcomp Online Pharmacy \\& Formulary available on the Inside MD Anderson Clinical Tools SharePoint site. Participants are not permitted to receive enzyme-inducing anti-epileptic drugs, including carbamazepine, phenytoin, phenobarbital, and primidone.\n* Have consumed grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, Seville oranges or products containing juice of these fruits within 7 days prior to first dose of study drug.\n* Had a Grade 3-4 gastrointestinal bleed within 3 months prior to enrollment.\n* Has a history of deep vein thrombosis, pulmonary embolism, or any other thromboembolism, including portal venous thrombosis within 3 months prior to enrollment. Venous port or catheter thrombosis, incidental asymptomatic pulmonary embolism diagnosed on imaging studies, or superficial venous thrombosis are not considered significant and are allowed.\n* Has current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants (including direct oral anticoagulants); thrombolytic agents for therapeutic (as opposed to prophylactic) purpose; use of aspirin (\\> 325 mg\u002Fday); or use of clopidogrel (\\> 75 mg\u002Fday). Note: The use of full-dose oral or parenteral anticoagulants for therapeutic purpose is permitted as long as the INR and\u002For aPTT is within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the patient has been on a stable dose of anticoagulants for ≥ 2 weeks prior to initiation of study treatment. Prophylactic use of anticoagulants is allowed. However, the use of direct oral anticoagulant therapies such as dabigatran and rivaroxaban is not recommended due to bleeding risk.\n* Had significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, transient ischemic attack or cerebrovascular accident); unstable arrhythmia; or unstable angina significant cardiovascular disease within 6 months prior to enrollment.\n* Has a history of uncontrolled or poorly-controlled hypertension (\\>150 mmHg systolic or \\>100 mmHg diastolic).\n* Has a history of hypertensive crisis or hypertensive encephalopathy.\n* Had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.\n* Has undergone major surgery (including open biopsy, surgical resection, wound revision; or any other major surgery involving entry into a body cavity); or significant traumatic injury within 28 days prior to enrollment; or subcutaneous venous-access-device placement within 7 days prior to enrollment; or anticipates need for major surgical procedure, core biopsy, or other minor surgical procedures during the course of the study. o Note: Placement of a vascular access device should be at least 2 days prior to initiation of study treatment.\n* Is receiving chronic antiplatelet therapy, nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen), dipyridamole, clopidogrel, or similar agents. Once-daily aspirin use (≤325 mg\u002Fday) is allowed.\n* Has had significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization.\n* Has a history of central nervous system disease or evidence of this disease upon physical or neurological examination.\n* Has a history of Grade ≥ 2 hemoptysis (defined as ≥ 2.5 mL of bright red blood per episode) within 1 month prior to screening.\n* Has a history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation).\n* Has a history of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, or active GI bleeding within 6 months prior to randomization.\n* Has a history of leptomeningeal disease.\n* Has uncontrolled tumor-related pain.\n* Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Participants should have recovered from the effects of radiation. There is no required minimum recovery period.\n* Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy, if appropriate, prior to enrollment.\n* Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (at a frequency of at least once monthly) o Participants with indwelling catheters (e.g., PleurX®) are allowed. Has uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL, or corrected serum calcium \\> ULN).\n* Has current evidence of endocrine alterations of calcium\u002Fphosphate homeostasis, eg, parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, and other disorders.\n* Has elevated phosphorus or abnormal serum calcium, or phosphorus, or calcium-phosphorus product ≥ 55 mg2\u002FdL2:\n* Inorganic phosphorus \\> 1.02 × ULN Has active or a history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix 9 for full list), with the following exceptions:\n* Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study. Participants with controlled Type 1 diabetes mellitus (as determined by the treating physician) who are on an insulin regimen are eligible for the study.\n* Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n* Rash must cover \\\u003C 10% of body surface area\n* Disease is well controlled at baseline and requires only low-potency topical corticosteroids • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet-A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* Has a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis; or has evidence of active pneumonitis upon screening via computed tomography (CT) scan of the chest.\n* History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Has active tuberculosis.\n* Had a major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipates need for a major surgical procedure during the study.\n* Had a history of malignancy other than cholangiocarcinoma within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n* Had a severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n* Received treatment with therapeutic oral- or IV antibiotics within 2 weeks prior to initiation of study treatment.\n* Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Had a prior allogeneic stem cell or solid organ transplantation • Has any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the patient at high risk from treatment complications.\n* Received treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipates need for such a vaccine during treatment or within 5 months after the final dose of treatment. Receipt of SARS-CoV vaccine is allowed.\n* Received treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n* Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n* Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* Received treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, or anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipates a need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n* Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.\n* Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* Has a history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n* Has a known hypersensitivity to Chinese hamster ovary-cell products or to any component of the atezolizumab formulation.\n* Has a known allergy or hypersensitivity to any component of the pemigatinib, bevacizumab, or atezolizumab formulations.\n* Is pregnant or breastfeeding or intends to become pregnant during study treatment or within 6 months after the final dose of study treatment.\n* Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.\n* Has a history of hypovitaminosis D requiring supraphysiologic doses (eg, 50,000 UI\u002Fweekly) to replenish the deficiency. Vitamin D supplements are allowed.",{"count":150,"type":21},25,[61,24],"To learn if pemigatinib in combination with atezolizumab and bevacizumab can help to control cholangiocarcinoma.",[27,154],"FGFR2 Fusion","2026-01-13",{"date":157,"type":42},"2026-01-14",{"date":159,"type":42},"2024-11-19",{"date":161,"type":21},"2030-02-22",{"name":163,"class":79},"M.D. Anderson Cancer Center",1,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100618230","phase-3-efficacy-and-safety-of-tt-00420-tinengotinib-tablets-versus-chemotherapy-in-patients-with-advanced-intrahepatic-cholangiocarcinoma-harboring-fgfr2-fusionsrearrangements-or-mutations-100618230","NCT07328919","Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions\u002FRearrangements or Mutations","A Phase III, Randomized Controlled, Open-Label, Multicenter Clinical Study Evaluating the Efficacy and Safety of TT-00420 Tablets Versus Chemotherapy in Patients With Surgically Unresectable Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions\u002FRearrangements or Mutations, Who Have Progressed or Relapsed After Prior First-Line Systemic Therapy","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Histologically or cytologically confirmed intrahepatic cholangiocarcinoma.\n3. Subjects diagnosed with stage III or IV intrahepatic cholangiocarcinoma according to the American Joint Committee on Cancer (AJCC) 8th Edition (2018) staging system, and assessed by the investigator as not eligible for curative surgical resection.\n4. Subjects who have experienced recurrence or progression after receiving only one prior line of systemic chemotherapy combined with immunotherapy (PD-1\u002FPD-L1 inhibitor), with or without targeted therapy. Sequential immunotherapy following the completion of chemotherapy cycles is also considered part of the first-line combined regimen. First-line systemic chemotherapy is defined as gemcitabine\u002Fcapecitabine with or without a platinum-based agent.\n\n   Note: Recurrence within 6 months after completion of adjuvant or neoadjuvant therapy will be considered as a line of systemic therapy. Local treatments do not count as systemic therapy.\n5. The presence of FGFR2 gene fusion\u002Frearrangement or mutation must be confirmed by detection using tumor tissue samples provided by the patient and analyzed by a central laboratory.\n6. At least one radiographically measurable lesion must be present according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. ECOG ≤ 1.\n8. Subjects must have adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Subjects with a history of prior treatment with TT-00420 tablets.\n2. Subjects with a known severe allergic reaction to any agent in the study and for whom no alternative study treatment is available.\n3. Subjects receiving corticosteroid therapy for CNS metastases are also ineligible.\n4. Concurrent active malignancy requiring active treatment. Malignancies diagnosed \\>5 years ago without the need for treatment, as well as cured localized tumors such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid carcinoma, are allowed.\n5. Administration of other anti-tumor drugs prior to randomization with an interval of ≤ 5 half-lives or 14 days (whichever is shorter), or failure to recover from adverse events of prior therapies (except for adverse events of ≤ Grade 1, or ≤ Grade 2 events judged by the investigator as not constituting a safety risk).\n6. Prior radiation therapy (large-field radiotherapy within 4 weeks, or local palliative radiotherapy within 2 weeks, before randomization), or failure to recover from related adverse events, is excluded. However, initiation of the investigational drug during the washout period is permitted with sponsor approval, if the investigator believes it is in the subject's best interest based on a favorable benefit-risk assessment.\n7. Subjects who have undergone major surgery within 4 weeks prior to randomization, or who have not recovered from related adverse events (with the exception of ≤ Grade 1 events or non-risk Grade 2 events per investigator's judgment), are excluded.\n8. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and\u002For ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening).",{"count":173,"type":21},138,[175],"PHASE3","This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions\u002Frearrangements or mutations, who have experienced recurrence or progression after prior first-line systemic chemotherapy.",[178,27],"Intrahepatic Cholangiocarcinoma (Icc)","NOT_YET_RECRUITING","2025-12-26",{"date":182,"type":42},"2026-01-09",{"date":184,"type":21},"2026-01",{"date":186,"type":21},"2030-12-31",{"name":188,"class":49},"TransThera Sciences (Nanjing), Inc.",20,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":164},"100502519","phase-3-lenvatinib-tislelizumab-combined-with-gemcitabine-and-cisplatin-gplet-in-the-treatment-of-advanced-cholangiocarcinoma-100502519","NCT05823311","Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma","A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma","Inclusion Criteria:\n\n* Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.\n* Expected survival period \\> 12 weeks.\n* The World Health Organization (WHO) \u002F ECOG physical status (PS) was 0 or 1.\n* There was at least one target lesion that matched the RECIST 1.1 criteria at baseline.\n* Not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or\u002Fand PD-1 inhibitors.\n* Adequate organ and bone marrow function, defined as follows: Hemoglobin (Hb)≥9.0g\u002FdL; Neutrophils (ANC) ≥ 1.5\\* 10\\^9\u002FL; Platelet (Pt) ≥ 50\\*10\\^9\u002FL; ALT≤2.5×ULN（Normal upper limit); AST≤2.5×ULN.\n* Voluntary participation and signing of informed consent.\n\nExclusion Criteria:\n\n* Active or previously documented autoimmune disease or inflammatory disease.\n* Uncontrolled complications.\n* History of other primary malignancies.\n* Active infection.\n* Women who are pregnant or breastfeeding.\n* Patients with severe allergic history or specific constitution.\n* Researchers consider it inappropriate to participate in the test.","75 Years",{"count":199,"type":21},80,[175],"Cholangiocarcinoma (CCA) is a heterogeneous group of cancers arising from the epithelial cells of bile ducts. Because of highly aggressive malignancy, most of the patients are diagnosed at an advanced stage and lose the chance to undergo surgery.\n\nAs more effective and novel chemotherapy, targeted therapies, and immunotherapy become available, multiple treatments can be chosen for the patients with advanced CCA. Cytotoxic cell death during tumor chemotherapy triggers antigen release and induces strong anti-tumor effects of T cells. Tyrosine kinase inhibitors (TKI) can reduce the expression of PD-L1 and inhibit Treg cell infiltration, and together with immune checkpoint inhibitors, they can relieve tumor immunosuppressive microenvironment.\n\nTherefore, the study aims to investigate the safety and efficacy of Lenvatinib, Tislelizumab combined with Gemcitabine plus Cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.",[27],[204,205,206],"Lenvatinib","Tislelizumab","Gemcitabine and Cisplatin","2025-02-05",{"date":209,"type":42},"2025-02-10",{"date":211,"type":42},"2023-09-01",{"date":213,"type":21},"2027-12-31",{"name":215,"class":79},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":164},"100480136","phase-2-lenvatinib-tislelizumab-plus-gemcitabine-and-cisplatin-gplet-in-patients-with-advanced-cholangiocarcinoma-100480136","NCT05532059","Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma","A Phase Ⅱ, Open Label, Single-center Study of Lenvatinib and Tirelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma","Inclusion Criteria:\n\n* Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.\n* the world health organization (WHO)\u002FECOG physical state (PS) to 0 or 1.\n* at least 1 RECIST 1.1 standard target lesions.\n* not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or\u002Fand PD-1 inhibitors.\n* adequate organ and bone marrow function, defined as follows: 9.0 g\u002FdL or higher hemoglobin; neutrophil count 1.5 x 109 \u002F L; platelet count 100 x 109 \u002F L.\n\nExclusion Criteria:\n\n* Active or previously documented autoimmune disease or inflammatory disease.\n* Uncontrolled complications.\n* History of other primary malignancies.\n* Active infection.\n* Women who are pregnant or breastfeeding.","85 Years",{"count":225,"type":21},100,[24],"Cholangiocarcinoma (CCA) is a heterogeneous group of cancers arising from the epithelial cells of bile ducts. Because of highly aggressive malignancy, most of the patients are diagnosed at an advanced stage and lose the chance to undergo surgery. As more effective and novel chemotherapy, targeted therapies, and immunotherapy become available, multiple treatments can be chosen for the patients with advanced CCA. Cytotoxic cell death during tumor chemotherapy triggers antigen release and induces strong anti-tumor effects of T cells. Tyrosine kinase inhibitors (TKI) can reduce the expression of PD-L1 and inhibit Treg cell infiltration, and together with immune checkpoint inhibitors, they can relieve tumor immunosuppressive microenvironment. Therefore,we aim to investigate the safety and efficacy of lenvatinib, tislelizumab combined with gemcitabine plus cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.",[27],[230],"Lenvatinib; Gemcitabine and Cisplatin; Tislelizumab; Cholangiocarcinoma",{"date":209,"type":42},{"date":233,"type":42},"2022-01-31",{"date":235,"type":21},"2028-08-31",{"name":215,"class":79}]