[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gallbladder-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gallbladder-cancer":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,100,140,241,269,291,317,349,375,393,417,445,465,490,514],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":77,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100210159","integrated-cancer-repository-for-cancer-research-100210159",false,"NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"ALL","19 Years","110 Years",{"count":21,"type":22},999999,"ESTIMATED","80 Years","OBSERVATIONAL","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Penile Cancer","Prostate Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Breast Cancer","Leukemia","Melanoma","Sarcoma","Unknown Primary Tumor","Multiple Myeloma","Ovarian Cancer","Endometrial Cancer","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[27,28,78,79,80,81,82,83,84,85,65,86,75,76],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor","RECRUITING","2026-06-25",{"date":90,"type":91},"2026-06-29","ACTUAL",{"date":93,"type":91},"2013-11-01",{"date":95,"type":22},"2099-12",{"name":97,"class":98},"University of Nebraska","OTHER",42,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":119,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100639462","phase-1-safety-and-efficacy-of-cd160-enhanced-autologous-antigen-specific-t-cells-btc-ag-t-in-advanced-biliary-tract-cancer-100639462","NCT07614061","Safety and Efficacy of CD160-Enhanced Autologous Antigen-Specific T-Cells (BTC-Ag-T) in Advanced Biliary Tract Cancer","A Phase I, Open-label Study to Evaluate the Safety and Efficacy of CD160-enhanced Autologous BTC-Ag-T Cells in Advanced Biliary Tract Malignancies","Major Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1\\. Age\n\n\\- Age ≥ 18 years at the time of signing informed consent. 2. Diagnosis\n\n* Histologically or cytologically confirmed biliary tract malignancy (intrahepatic, perihilar, or distal extrahepatic cholangiocarcinoma, or gallbladder cancer).\n\n  3\\. Disease status\n* Locally advanced unresectable or metastatic disease 4. Prior systemic therapy\n* Patients (including those with refractory BTC and those with postoperative recurrence) must have received prior gemcitabine-based chemotherapy in combination with a PD-1\u002FPD-L1 inhibitor.\n\n  5\\. Measurable disease\n* At least one measurable lesion per RECIST v1.1 at baseline imaging.\n* Sufficient viable tumor tissue from biopsy for antigen-presenting tumor cell (APTC) manufacturing 6. Adequate venous access and overall condition to tolerate leukapheresis. 7. Washout and lymphocyte recovery before leukapheresis 8. ECOG performance status 0 or 1 9. Organ function\n* Hematology (no growth-factor support or transfusion within 5 days of testing, unless otherwise stated): ANC ≥ 1.0 × 10⁹\u002FL; platelets ≥ 75 × 10⁹\u002FL; hemoglobin ≥ 8.0 g\u002FdL (transfusion to reach this threshold is permitted).\n* Hepatic: total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for documented Gilbert syndrome); AST and ALT ≤ 5.0 × ULN.\n* Renal: serum creatinine ≤ 1.5 × ULN, or estimated creatinine clearance (e.g., Cockcroft-Gault) ≥ 40 mL\u002Fmin.\n* Adequate cardiopulmonary reserve to tolerate lymphodepleting conditioning and cell infusion in the investigator's judgment.\n\n  10\\. Viral serology\n* No evidence of uncontrolled active viral infection.\n* HIV-1\u002F2 negative.\n* Hepatitis B: HBV DNA is negative.\n* Hepatitis C: HCV RNA is negative. 11. Contraception\n* Women of childbearing potential and men whose partners are of childbearing potential must agree to use highly effective contraception from the time of informed consent through at least 12 months after BTC-Ag-T infusion (or longer if required by local regulation).\n\n  12\\. Pregnancy status\n* Women of childbearing potential must have a negative serum or urine pregnancy test at screening.\n\n  13\\. Informed consent\n* Able to understand and willing to sign a written informed consent document, and willing to comply with study procedures.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded:\n\n1. Mixed\u002Fcombined hepatocellular-cholangiocarcinoma, ampullary carcinoma, and other histologies not consistent with BTC\n2. Prior allogeneic transplant or recent gene-modified cell therapy\n3. Active CNS metastases\n4. Patients with uncontrolled or high-risk active infection are excluded, including hepatitis B virus (HBV), hepatitis C virus (HCV), Epstein-Barr virus (EBV), and active tuberculosis (TB).\n5. Active autoimmune disease requiring systemic immunosuppression\n6. Significant cardiovascular disease\n7. Significant pulmonary disease\n8. Severe hepatic decompensation\n9. Active variceal bleeding, or recent life-threatening portal-hypertension complications that cannot be stably controlled.\n10. Another primary malignancy within the past 3 years, except: tumors treated with curative intent and at low risk of recurrence (e.g., adequately treated basal- or squamous-cell skin cancer, in-situ cervical cancer, or low-Gleason localized prostate cancer, occult thyroid carcinoma).\n11. Severe hypersensitivity.\n12. Pregnant or lactating women\n13. Concurrent participation in another interventional study\n14. Any other condition that, in the investigator's judgment, renders the patient unsuitable for enrollment.","18 Years",{"count":109,"type":22},18,"INTERVENTIONAL",[112],"PHASE1","BTC-Ag-T (ACH-AgT001) is an autologous experimental T-cell therapy designed for advanced biliary tract cancer. This is an open-label, single-arm Phase 1 study to evaluate the safety, tolerability, and preliminary efficacy of BTC-Ag-T in patients with advanced, unresectable, or metastatic biliary tract cancer who have failed standard-of-care therapy.",[115,116,117,118,38],"Biliary Tract Neoplasms","Cholangiocarcinoma, Intrahepatic","Cholangiocarcinoma, Extrahepatic","Cholangiocarcinoma, Perihilar",[120,121,122,123,124,125,126,127,128,129],"Adoptive T-cell therapy","Antigen-specific T cells","CD160","Autologous T cell therapy","Biliary tract cancer","Cholangiocarcinoma","APTC - antigen-presenting tumor cell","Lymphodepletion","Phase 1","Investigator-initiated trial","2026-05-28",{"date":132,"type":91},"2026-05-29",{"date":134,"type":22},"2026-05",{"date":136,"type":22},"2029-12",{"name":138,"class":98},"Shanghai Zhongshan Hospital",1,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":110,"phases":150,"briefSummary":152,"conditions":153,"keywords":226,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":139},"100432171","virtual-reality-for-gi-cancer-pain-to-improve-patient-reported-outcomes-100432171","NCT04907643","Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Inclusion Criteria:\n\n* Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period\n* Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible\n* Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments\n* Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible.\n* Have brain metastases\n* Have a prognosis of \\\u003C3 months from the time of enrollment per treating oncologist","99 Years",{"count":149,"type":22},360,[151],"NA","Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.\n\nTo address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.",[154,155,156,157,41,158,40,32,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,35,186,187,188,189,190,191,192,193,36,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,38,215,216,217,218,219,33,220,221,222,223,224,225],"Cancer Pain","Visceral Pain","Gastrointestinal Neoplasms","Cancer of Gastrointestinal Tract","Pancreas Cancer","Biliary Tract Cancer","Stomach Cancer","Rectum Cancer","Peritoneal Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Cancers - Anus","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Small Intestine","Small Intestine Cancer Stage III","Small Intestine Cancer Stage IV","Small Intestine Cancer, Recurrent","Pancreas Cancer, Stage III","Pancreas Cancer, Stage IV","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc","Liver Cancer Stage IV","Colon Cancer Stage III","Colon Cancer Stage IV","Stomach Cancer Stage III","Stomach Cancer Stage IV","Stomach Cancer Recurrent","Rectum Cancer, Recurrent","Gastrointestinal Cancers - Liver","Anal Cancer Stage III","Anal Cancer Stage IV","Anal Cancer Recurrent","Anal Cancer Metastatic","Anal Cancer, Stage IIIA","Anal Cancer, Stage IIIB","Appendix Cancer","Ampullary Cancer","Bile Duct Cancer Stage III","Bile Duct Cancer Stage IV","Bile Duct Cancer Stage IVA","Bile Duct Cancer Stage IVB","Bile Duct Cancer Recurrent","Carcinoid Tumor","Carcinoid Tumor of Pancreas","Carcinoid Tumor of Large Intestine","Carcinoid Tumor of GI System","Carcinoid Tumor of Colon","Carcinoid Tumor of Liver","Carcinoid Tumor of Cecum","Carcinoid Tumor of Ileum","Carcinoid Tumor of Rectum","Carcinoid Tumor of the Small Bowel","Carcinoid Tumor of the Stomach","Large Intestine Cancer","Esophagus Cancer","Esophagus Cancer, Stage III","Esophagus Cancer, Stage IV","Esophagus Cancer, Recurrent","Gallbladder Cancer Stage III","Gallbladder Cancer Stage IV","Gastric (Stomach) Cancer","Neuroendocrine Tumor","Peritoneum Cancer","Esophagus Cancer, Stage I","Esophagus Cancer, Stage II","Gallbladder Cancer Stage I","Gallbladder Cancer Stage II","Bile Duct Cancer Stage I","Bile Duct Cancer Stage II",[227,228,229,230,231],"Virtual Reality","VR","support","GI cancer","cancer pain","2026-02-18",{"date":234,"type":91},"2026-02-20",{"date":236,"type":91},"2021-10-05",{"date":238,"type":22},"2027-03-16",{"name":240,"class":98},"Cedars-Sinai Medical Center",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":110,"phases":250,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":268},"100604217","phase-2-trifluridinetipiracil--oxaliplatin-in-participants-with-advanced-or-metastatic-biliary-tract-cancer-100604217","NCT07146646","Trifluridine\u002FTipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer","A Phase II Trial of Trifluridine\u002FTipiracil Plus Oxaliplatin in Patients With Advanced or Metastatic Biliary Tract Cancer Following First-Line Therapy","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed biliary tract cancer (BTC) including cholangiocarcinoma and gallbladder carcinoma. Individuals with ampullary cancers will not be considered eligible. Cancer must be advanced stage or metastatic.\n* Participants must have received only one line of systemic therapy for advanced or metastatic BTCs.\n* Note: Individuals who have either progressed or are intolerant to the prior therapy can be included in this study.\n* Age \\>18 years on day of signing informed consent. Because no dosing or adverse event data are currently available on the use of FTD\u002FTPI in individuals ≤18 years of age, children are excluded from this study.\n* Performance status: ECOG performance status of 0 or 1.\n* At least one index lesion is measurable based on RECIST 1.1.\n* Participants must have organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelet count ≥75,000\u002FmcL\n  * AST (SGOT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases\n  * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases\n  * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with bilirubin levels \\>1.5 x ULN\n  * Serum Creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin for participants with creatinine levels \\>1.5 x ULN (Cockcroft-Gault method)\n* Participants must have recovered adequately from any major surgery, prior to starting therapy.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Agree to use adequate method of contraception.\n\nExclusion Criteria:\n\n* Participants receiving any other investigational agents.\n* Participant has received investigational therapy within 4 weeks or within 5 half-lives of the therapeutic agent (whichever is shorter).\n* Received more than one line of systemic therapy for bile duct cancer. Adjuvant therapy will not be counted as line of systemic therapy.\n* Receiving systemic steroid therapy (\\>10mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Prior treatment with FTD\u002FTPI or oxaliplatin.\n* Known additional malignancy that currently requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has already undergone potentially curative therapy.\n* Known central nervous system metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable without evidence of new or enlarging brain metastases and are not using steroids for at least 7 days prior to trial treatment.\n* Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (\\> 10 mg\u002Fday or equivalent of prednisone) or immunosuppressive agents. (thyroid disease and diabetes are allowed)\n* Interstitial lung disease or active, non-infectious pneumonitis.\n* Active infection requiring systemic antibiotics.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the individual's participation for the full duration of the trial, or is not in the best interest of the individual to participate, in the opinion of the treating investigator.\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the treating investigator.\n* Participants with uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations\u002Fsubstance abuse disorders that would limit compliance with study requirements.\n* Participants pregnant or breastfeeding expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 5 months after the last dose of trial treatment. Pregnant or breastfeeding women are excluded from this study because it is unknown if the combination of FTD\u002FTPI and oxaliplatin create the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug combination, breastfeeding should be discontinued if the mother is enrolled on this trial.",{"count":249,"type":22},27,[251],"PHASE2","Participants are eligible for this study who were treated for advanced biliary tract cancer (BTC) but the treatment either did not make the cancer better or is no longer working. The treatment for patients whose advanced BTC either did not make the cancer better or is no longer working is a combination of chemotherapy drugs called FOLFOX which consists of fluorouracil and oxaliplatin. Studies have shown that other treatments may work better to treat advanced BTC. In this study, investigators want to see if treating patients with the drug combination of trifluridine\u002Ftipiracil (FTD\u002FTPI) and another drug called oxaliplatin works better than FOLFOX for advanced BTC as second-line therapy. FTD\u002FTPI are pills that are taken by mouth, whereas oxaliplatin is given intravenously (by IV).",[159,115,125,38,254],"Gallbladder Carcinoma",[256,257,258],"Trifluridine\u002Ftipiracil","FTD\u002FTPI","Oxaliplatin","2026-02-17",{"date":261,"type":91},"2026-02-19",{"date":263,"type":91},"2025-12-01",{"date":265,"type":22},"2027-04",{"name":267,"class":98},"Case Comprehensive Cancer Center",2,{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":290},"100530894","eulat-eradicate-gbc-100530894","NCT06192719","EULAT Eradicate GBC","Establishment and Exploitation of a European-Latin American Research Consortium Towards Eradication of Preventable Gallbladder Cancer - EULAT Eradicate GBC","EULAT","Inclusion Criteria:\n\n1. Cohort A. Patients with gallbladder cancer or dysplasia, both before and after the start of their anticancer treatment.\n\n   Cohort B. Patients with cholelithiasis before cholecystectomy (only patients scheduled for cholecystectomy will be recruited)\n2. Diagnosis confirmed in accordance with standard protocols of the participating hospitals\n3. Men and women aged 18 or over\n\nExclusion Criteria:\n\n1. Any medical condition that present an unreasonable risk to the participant.\n2. Any psychiatric condition that interferes with understanding informed consent.",{"count":278,"type":22},15000,"Gallstones are relatively frequent in women and constitute one of the main risk factors for gallbladder cancer (GBC).\n\nCurrently, GBC diagnosis is mainly based on imaging (ultrasound or abdominal CT) associated with invasive examinations (biopsy and surgery), with no marker available to date to accurately predict risk and diagnose the disease early. The only curative treatment for GBC remains surgery with complete resection of tumors in early stages.\n\nGiven the aggressiveness of GBC and the very limited therapeutic options, as well as the possibility of preventing GBC by cholecystectomy during the 10 to 20 years required for the development of gallbladder tumors, it is imperative to develop effective and efficient prevention strategies based on a prioritization of interventions according to environmental and genetic-molecular risk factors.\n\nThe investigators aim to identify epidemiological factors linked to the development of GBC, and to identify, validate and functionally characterize genetic-molecular markers in blood, saliva, urine, bile and stool that allow risk prediction, early diagnosis and precision treatment of incidental tumors.",[38,281],"Gallstone Disease","2026-02-16",{"date":232,"type":91},{"date":285,"type":91},"2019-12-01",{"date":287,"type":22},"2028-12-31",{"name":289,"class":98},"Centre Paul Strauss",36,{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":110,"phases":301,"briefSummary":302,"conditions":303,"keywords":306,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":139},"100525544","stall-vs-sole-local-wound-infiltration-in-laparoscopic-cholecystectomy-100525544","NCT06123117","STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy","Single Transversus Abdominis Laparoscopy-guided Plane Block Combined With Local Trocar Site Ropivacaine Infiltration (STALL) vs Sole Local Wound Infiltration in LCC (Laparoscopic CholeCystectomy) - Double-blinded Randomized Controlled Trial.","STALL","Inclusion Criteria:\n\n* All patients scheduled for elective or emergency LCC, aged over 18 and able to give an informed consent.\n\nExclusion Criteria:\n\n* Age under 18 years, chronic daily opioid and\u002For pain tolerance \u002F pain threshold -modifying medication use (abuse), pregnancy, known allergy to local anesthetics, diagnosed severe coagulopathy and incapability to give informed consent for whatever reason.",{"count":300,"type":22},850,[151],"This trial is a prospective randomized superiority trial comparing sole ropivacaine based local trocar site infiltration to local infiltration combined with laparoscopic ropivacaine TAP block (STALL) in LCC.\n\nThere are only a few randomized trials comparing sole local anesthesia to additional laparoscopic TAP block in laparoscopic cholecystectomy and they have yet failed to show evidence in favor of TAP block.\n\nWe hypothesize STALL (Single Transversus Abdominis Laparoscopy-guided plane block combined with Local trocar site ropivacaine infiltration) is superior to local port site infiltration, provided that the sample size is sufficiently big.\n\nThe aim of this randomized study is to compare the efficacy of sole local anesthesia of trocar sites to STALL in LCC.",[304,305,38],"Cholelithiasis","Cholecystitis",[307],"laparoscopic transversus abdominis plane block","2025-09-10",{"date":310,"type":91},"2025-09-11",{"date":312,"type":91},"2024-01-16",{"date":314,"type":22},"2027-10",{"name":316,"class":98},"Helsinki University Central Hospital",{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":16,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":110,"phases":325,"briefSummary":326,"conditions":327,"keywords":332,"overallStatus":339,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":139},"100576631","proteomic-analysis-of-patients-undergoing-bariatric-surgery-100576631","NCT06787807","Proteomic Analysis of Patients Undergoing Bariatric Surgery","Inclusion Criteria:\n\n* patients over 18 years of age with a BMI above 35 kg\u002Fm² associated with comorbidity or BMI above 40 kg\u002Fm² without comorbidities,\n\nExclusion Criteria:\n\n* Patients with a previous history of cancer;\n* Underage patients\n* Patients with other diseases predisposing to the development of cancer: cirrhosis, ulcerative colitis, Barrett's esophagus, etc.\n* Patients who have previously undergone bariatric surgery;",{"count":324,"type":22},103,[151],"The expression of proteins in the blood of obese individuals is different from the expression of proteins in healthy individuals, and is also different in individuals after bariatric surgery. Therefore, this research aims to better understand protein expression in patients indicated for surgical treatment of obesity, evaluating the pre-operative and post-operative status. The objective of this research is to better understand protein expression in patients indicated for surgical treatment of obesity, evaluating the pre-operative and post-surgery status.",[328,32,28,30,27,39,329,72,40,38,48,330,46,70,331,65,71],"Obesity","Potmenopausal Breast Cancer","Ovarian","Meningioma",[333,334,335,336,337,338],"obesity","cancer","bariatric surgery","proteomics","biomarkers","mass spectrometry","NOT_YET_RECRUITING","2025-01-16",{"date":342,"type":91},"2025-01-22",{"date":344,"type":22},"2025-06-10",{"date":346,"type":22},"2025-12",{"name":348,"class":98},"Universidade Federal de Pernambuco",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":147,"enrollmentInfo":356,"targetDuration":4,"studyType":110,"phases":358,"briefSummary":360,"conditions":361,"keywords":362,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":139},"100503327","phase-2-addition-of-everolimus-to-standard-of-care-in-carcinoma-gallbladder-100503327","NCT05833815","Addition of Everolimus to Standard of Care in Carcinoma Gallbladder","A Randomized Controlled, Open Labeled, Two Arm, Study of Addition of Everolimus to Standard of Care in Carcinoma Gallbladder","Inclusion Criteria:\n\n* Histological proof of cancer with stage III inoperable or Stage IV metastatic disease without any prior treatment.\n* Patients with histologic proof of metastatic gallbladder carcinoma who have not had previous treatment for metastatic disease or who received gemcitabine\u002Fcapecitabine with or without platinum\\>= 6 months ago as part of adjuvant therapy\n* Absolute neutrophil count (ANC) \\>= 1500\u002FuL\n* Platelet (PLT) \\>= 100,000\u002FuL\n* Total bilirubin =\\\u003C 3mg\u002Fdl for gemcitabine and any value for Capecitabine\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 2.5 x upper limit of normal (ULN) (=\\\u003C 5x ULN in patients with liver metastases)\n* Creatinine =\\\u003C 1.5 x Institutional ULN\n* Alkaline phosphatase =\\\u003C 5 x Institutional ULN\n* Haemoglobin (Hgb) \\>= 8.0 g\u002FdL\n* International normalized ratio (INR) and Partial thromboplastin time (PTT) =\\\u003C 3.0 x ULN (anticoagulation is allowed if target INR =\\\u003C 3.0 x ULN on a stable dose of warfarin or on a stable dose of low-molecular-weight \\[LMW\\] heparin for \\> 2 weeks at time of registration)\n* Fasting serum glucose \\\u003C 1.5 x ULN\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n* Ability to provide informed consent\n* Willingness to return for follow up\n* Life expectancy \\>= 12 weeks\n* Women of childbearing potential only: Negative serum pregnancy test done =\\\u003C 7 days prior to registration.\n\nExclusion Criteria:\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Clinically significant cardiac disease, especially history of myocardial infarction =\\\u003C 6 months, or congestive heart failure (New York Heart Association \\[NYHA\\] classification III or IV) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Patients taking strong inhibitors or inducers of CYP3A4\n* Prior therapy with everolimus\n* Any of the following prior therapies:\n\n  * Chemotherapy =\\\u003C 4 weeks prior to registration\n  * Immunotherapy =\\\u003C 4 weeks prior to registration\n  * Biological therapy =\\\u003C 4 weeks prior to registration\n  * Radiation therapy =\\\u003C 4 weeks prior to registration\n  * Radiation to \\> 25% of bone marrow prior to registration\n* Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment\n* CNS metastases brain or leptomeningeal metastases that are not stable for at least 4 weeks prior to registration based on imaging, clinical assessment, and use of steroids\n* Pregnant women\n* Nursing women\n* Men or women of childbearing potential who are unwilling to employ adequate contraception\n* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational 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* Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive\n* Current active other malignancy, Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)\n* Severely impaired lung function (i.e., forced expiratory volume in one second \\[FEV1\\] \\\u003C 1 liter)\n* Received immunization with attenuated live vaccines =\\\u003C 7 days prior to study entry or during study period; close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus; examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid, SARS CoV2 vaccines\n* Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C); A detailed assessment of Hepatitis B\u002FC medical history and risk factors will be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and\u002For confirmation of prior HBV\u002FHCV infection.",{"count":357,"type":22},56,[251,359],"PHASE3","Gallbladder cancer (GBC) is the most common malignant tumour of the biliary tract. It is also the most aggressive cancer of the biliary tract with the shortest median survival from the time of diagnosis. Currently, radical resection is the most effective strategy to potentially cure GBC. Chemotherapy and radiotherapy have been employed as adjuvant and palliative setting, however, the overall survival is still dismal. This study aim to evaluate the addition of Everolimus in addition to standard of care in gallbladder cancer.",[38],[363,364,365],"everolimus","mToR inhibitors","chemotherapy","2024-08-09",{"date":368,"type":91},"2024-08-13",{"date":370,"type":91},"2022-11-01",{"date":372,"type":22},"2024-12-30",{"name":374,"class":98},"Banaras Hindu University",{"id":376,"slug":377,"hasResults":11,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":147,"enrollmentInfo":382,"targetDuration":384,"studyType":24,"phases":4,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":139},"100470322","ngs-in-gallbladder-cancer-and-response-to-treatment-100470322","NCT05404347","NGS in Gallbladder Cancer and Response to Treatment","Genetic Mutations and Response to Treatment in Gallbladder Cancer: A Hospital Based Cohort Study","Inclusion Criteria:\n\n* Treatment naïve patients with histologically proven carcinoma of the gallbladder.\n\nExclusion Criteria:\n\n* No histological evidence of malignancy\n* Pregnant and lactating women",{"count":383,"type":22},100,"5 Years","Evidence suggests distinct models of molecular and pathologic progression, and a growing body of genetics data points to a heterogeneous collection of underlying mutations in key oncogenes and tumor suppressor genes. Although tumor genetics have been used to tailor individual treatment regimens and guide clinical decision making in other cancers, these principles have not been applied in gallbladder malignancy. Recent clinical trials with targeted therapies seem promising, although the relationships between subsets of patients with positive responses to therapy and tumor genetics remain unexplored.",[38],{"date":368,"type":91},{"date":389,"type":91},"2018-01-01",{"date":391,"type":22},"2026-12-31",{"name":374,"class":98},{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":23,"enrollmentInfo":400,"targetDuration":4,"studyType":110,"phases":402,"briefSummary":403,"conditions":404,"keywords":405,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":139},"100279682","the-effect-in-wedge-resection-and-ivbv-resection-of-the-liver-for-gallbladder-cancer-100279682","NCT02920554","The Effect in Wedge Resection and IVb\u002FV Resection of the Liver for Gallbladder Cancer","The Effect in Wedge Resection and IVb\u002FV Resection of the Liver for Gallbladder Cancer Operation: Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with T2 or T3 gallbladder cancer on preoperative CT exam\n* Patients who are pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy\n\nExclusion Criteria:\n\n* Peritoneal seeding or distant metastasis\n* Impossible to resect the cancer radically\n* Pathologically diagnosed to other malignancy such as adenosquamous carcinoma, sarcoma, etc.\n* R1 or R2 resection were pathologically diagnosed.",{"count":401,"type":22},88,[151],"The extent of hepatic resection for gallbladder cancer can be done from a wedge resection to 4b\u002F5 bisegmentectomy. This study aims to compare the recurrence rates and survival rates between wedge resection group and bisegmentectomy group. Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy were enrolled. All patients are randomly assigned to wedge resection or bisegmentectomy group. Number of patients in each group is 44. Primary endpoint is recurrence-free-survival rates and overall survival rates.",[38],[406,407],"gallbladder cancer","bisegmentectomy","2024-05-20",{"date":410,"type":91},"2024-05-22",{"date":412,"type":4},"2014-07",{"date":414,"type":22},"2030-12",{"name":416,"class":98},"Saint Vincent's Hospital, Korea",{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":424,"enrollmentInfo":425,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":427,"conditions":428,"keywords":431,"overallStatus":339,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":4},"100537309","construction-of-multicenter-retrospective-registry-cohort-database-for-gallbladder-cancer-100537309","NCT06276153","Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer","CRGGCext","Inclusion Criteria:\n\n* Sign informed consent, have good compliance, and be willing to accept follow-up and provide blood samples\n* Age 18-74 years old, gender is not limited\n* Clinical diagnosis of gallbladder cancer, including unoperated patients preliminarily diagnosed as gallbladder cancer according to the results of imaging examinations and laboratory tests, or pathological examination of patients treated with surgery confirmed as malignant tumors of the gallbladder.\n* The primary tumor is located in gallbladder floor, gallbladder body, gallbladder neck or gallbladder duct.\n* Karnofsky performance score greater than 50.\n\nExclusion Criteria:\n\n* Patients with gallbladder cancer, gallbladder cancer foci are not primary lesions.\n* Patients with gallbladder cancer, combined with serious central nervous system diseases, respiratory diseases, autoimmune diseases, chronic renal insufficiency and other diseases, long-term use of immunosuppressants, combined with serious uncontrolled infections.\n* Patients with gallbladder cancer, who also have active cardiovascular and cerebrovascular diseases, have cerebrovascular accidents, myocardial infarction, unstable angina pectoris, or grade II. or above congestive heart failure according to the standards of the New York Heart Association, and require serious arrhythmias requiring drug treatment.\n* Patients with gallbladder cancer, women of childbearing age who have a positive blood pregnancy test or have not had a pregnancy test, pregnant or breastfeeding women.\n* The patient is participating in other therapeutic clinical trials where treatment measures cannot be clarified or treatment information cannot be collected .","74 Years",{"count":426,"type":22},5000,"The aim of the study is to establishing a standardized clinical information database for patients with malignant tumors of gallbaldder. Based on the database, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy.",[429,38,430],"Biliary Tract Diseases","Gallbladder Neoplasms",[406,432,433,434,435],"gallbladder neoplasms","cohort study","registry cohort","biliary tract neoplasms","2024-02-25",{"date":438,"type":91},"2024-02-28",{"date":440,"type":22},"2024-03-01",{"date":442,"type":22},"2029-02-28",{"name":444,"class":98},"RenJi Hospital",{"id":446,"slug":447,"hasResults":11,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":452,"targetDuration":454,"studyType":24,"phases":4,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":463,"locationsCount":139},"100334684","the-relationship-between-triceps-skinfold-and-overall-survival-of-pancreas-bile-duct-gallbladder-cancer-100334684","NCT03637569","The Relationship Between Triceps Skinfold and Overall Survival of Pancreas, Bile Duct, Gallbladder Cancer","The Relationship Between Triceps Skinfold and Overall Survival of Pancreatic Cancer, Cholangiocarcinoma and Gallbladder Cancer.","Inclusion Criteria:\n\n* Newly diagnosed pancreatic, bile duct or gallbladder cancer patients, undergoing therapeutic management (including surgery, chemotherapy or palliative care).\n* Age above 18 years old\n\nExclusion Criteria:\n\n* Other malignant disease\n* Underlying intestinal disease that cause absorprtion disorder\n* Underlying psychiatric disorder such as eating disorder (bulimia, anorexia)",{"count":453,"type":22},1000,"2 Years","In this study, the investigators aim to demonstration of relationship between triceps skinfold thickness and overall survival of pancreatic cancer, cholangiocarcinoma and GB cancer.",[158,125,38],"2023-08-24",{"date":459,"type":91},"2023-08-25",{"date":461,"type":91},"2018-04-01",{"date":391,"type":22},{"name":464,"class":98},"Samsung Medical Center",{"id":466,"slug":467,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":424,"enrollmentInfo":472,"targetDuration":454,"studyType":24,"phases":4,"briefSummary":474,"conditions":475,"keywords":479,"overallStatus":339,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":4},"100508172","the-construction-of-clinical-database-and-multiomics-biobank-based-on-a-multicentral-prospective-cohort-of-benign-and-malignant-biliary-tract-diseases-100508172","NCT05896956","The Construction of Clinical Database and Multiomics Biobank Based on a Multicentral Prospective Cohort of Benign and Malignant Biliary Tract Diseases","The Construction of Clinical Database and Multiomics Biobank Based on a Multicentral Prospective Cohort of Benign and Malignant Biliary Tract Diseases 胆道系统良恶性肿瘤前瞻性登记队列数据库与多组学生物样本库建设","Inclusion Criteria:\n\n1. Sign informed consent, have good compliance, and be willing to accept follow-up and provide blood samples.\n2. Age 18-74 years old, gender is not limited.\n3. Clinical diagnosis of benign and malignant tumors of the biliary system, including unoperated patients preliminarily diagnosed as benign and malignant tumors of the biliary tract according to the results of imaging examinations and laboratory tests, or pathological examination of patients treated with surgery confirmed as benign and malignant tumors of the gallbladder.\n4. The primary tumor is located in the extrahepatic bile duct, intrahepatic bile duct, gallbladder floor, gallbladder body, gallbladder neck or gallbladder duct.\n5. Karnofsky performance score greater than 50.\n\nExclusion Criteria:\n\n1. Patients with biliary malignant tumors, biliary malignant tumor foci are not primary lesions.\n2. Patients with biliary malignant tumors, combined with serious central nervous system diseases, respiratory diseases, autoimmune diseases, chronic renal insufficiency and other diseases, long-term use of immunosuppressants, combined with serious uncontrolled infections.\n3. Patients with biliary malignant tumors, who also have active cardiovascular and cerebrovascular diseases, have cerebrovascular accidents, myocardial infarction, unstable angina pectoris, or grade II. or above congestive heart failure according to the standards of the New York Heart Association, and require serious arrhythmias requiring drug treatment.\n4. Patients with biliary malignant tumors, women of childbearing age who have a positive blood pregnancy test or have not had a pregnancy test, pregnant or breastfeeding women.\n5. The patient is participating in other therapeutic clinical trials where treatment measures cannot be clarified or treatment information cannot be collected.",{"count":473,"type":22},500,"The aim of the study is to establishing a standardized biobank and a clinical information database for patients with benign and malignant tumors of the biliary system. With follow-up plans and advanced multiomics technology, a multiomics database for patients with benign and malignant tumors of the biliary tract will be further established. Based on the above work, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy based on multiomics characteristics and molecular typing of biliary tract tumors.",[429,38,476,477,115,478],"Extrahepatic Bile Duct Cancer","Intrahepatic Cholangiocarcinoma","Gall Stone",[480,406,435,481,433],"biliary tract diseases","biliary tract cancer","2023-06-01",{"date":484,"type":91},"2023-06-09",{"date":486,"type":22},"2023-07-01",{"date":488,"type":22},"2027-06-30",{"name":444,"class":98},{"id":491,"slug":492,"hasResults":11,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":497,"enrollmentInfo":498,"targetDuration":4,"studyType":110,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":139},"100497445","phase-2-combination-of-gemcitabine-albumin-paclitaxel--sintilimab-and-bevacizumab-in-unresectable-gallbladder-cancer-100497445","NCT05757336","Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer","Explore the Efficacy and Safety of Sintilimab Plus Bevacizumab Combined With Gemcitabine and Albumin-paclitaxel (AG Regimen) in First-line Treatment of Initial Unresectable Gallbladder Cancer: a Phase II Clinical Study","Inclusion Criteria:\n\n1\\. Before the implementation of any trial-related procedures, sign a written informed consent 2. Male or female ≥18 years old, ≤75 years old 3. Gallbladder carcinoma confirmed by histology or cytology 4. No previous systemic anti-tumor therapy (radiotherapy, chemotherapy, targeted or immunotherapy, etc.) 5. Expected survival time \\> 3 months 6. At least 1 measurable lesion according to RECIST1.1 criteria 7. ECOG PS score of 0-1 8. Sufficient organ function, the subject needs to meet the following laboratory indicators:\n\n1. Absolute value of neutrophils (ANC) ≥ 1.5x109\u002FL and platelets ≥ 90×109\u002FL without using granulocyte colony-stimulating factor in the past 14 days;\n2. Hemoglobin \\> 9g\u002FdL without blood transfusion or use of erythropoietin in the past 21 days;\n3. Total bilirubin ≤ 3 × upper limit of normal (ULN);\n4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN (patients with liver metastases are allowed ALT or AST ≤5×ULN);\n5. Alkaline phosphatase (AKP) ≤2.5×ULN\n6. Creatinine clearance rate (calculated using the Cockcroft-Gault formula) ≥ 50 ml\u002Fmin;\n7. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;\n8. Normal thyroid function, defined as thyroid-stimulating hormone (TSH ≤ 10) within the normal range; thyroid dysfunction without clinical significance after thyroid hormone supplementation can also be included.\n9. Myocardial enzyme spectrum is within the normal range (such as simple laboratory abnormalities that are judged by the investigator to have no clinical significance are also allowed to enter the group); 9. For female subjects of childbearing age, they should receive a urine or serum pregnancy test within 3 days before receiving the first study drug administration (day 1 of cycle 1) and the result is negative. If the urine pregnancy test result cannot be confirmed negative, a blood pregnancy test will be ordered. Women of non-reproductive age are defined as postmenopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy 10. If there is a risk of pregnancy, all subjects (regardless of male or female) need to use contraceptive measures with an annual failure rate of less than 1% during the entire treatment period until 120 days after the last study drug administration\n\nExclusion Criteria:\n\n1. Other malignant diseases outside the biliary tract diagnosed within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, and\u002For radically resected carcinoma in situ, radically cured thyroid papillary carcinoma can also be included after surgery);\n2. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first administration;\n3. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) occurred before the first dose. Replacement therapies (eg, thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy. Known history of primary immunodeficiency. Only patients with autoimmune antibody positive need to confirm whether there is an autoimmune disease according to the investigator's judgment;\n4. Active hemoptysis (spitting up at least 2.5ml or 1\u002F2 teaspoon of fresh blood) within 3 months before the first study drug administration, and active gastrointestinal bleeding within 3 months before administration;\n5. Imaging shows tumor invasion\u002Finfiltration of large blood vessels or bleeding tendency assessed by researchers or radiologists;\n6. Received major surgical treatment within 4 weeks before the first study drug administration (except for surgery for biopsy);\n7. Severe unhealed wound ulcers or fractures;\n8. Current or recent (within 10 days before receiving the first dose of the study drug) use of aspirin (\\>325mg\u002Fday) or other non-steroidal anti-inflammatory drugs known to inhibit platelet function for 10 consecutive days;\n9. Current or recent (within 10 days before receiving the first dose of study drug) treatment with full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days Note: The prophylactic use of small doses of anticoagulants is allowed: on the premise that the international normalized ratio (INR) of prothrombin time is ≤1.5, small doses of warfarin (≤1 mg\u002Fd) and low doses of heparin are allowed for prophylactic purposes (≤12,000 U\u002Fd) or low-dose aspirin (≤100mg\u002Fd);\n10. Have hereditary bleeding tendency or coagulation disorder, or history of thrombosis;\n11. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other routes of topical glucocorticoid) or any other form of immunosuppressive therapy within 4 weeks before the first dose of the study Note: Physiological doses of glucocorticoids are permitted (≤10 mg\u002Fday of prednisone or equivalent)\n12. There is clinically uncontrollable pleural effusion\u002Fabdominal effusion (patients who do not need drainage or stop drainage for 3 days without significant increase in effusion can be enrolled)\n13. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation\n14. Those who are known to be allergic to active ingredients or excipients of the study drug sintilimab, bevacizumab, gemcitabine hydrochloride for injection, paclitaxel for injection (albumin-bound type)\n15. Has not recovered adequately from any intervention-induced toxicity and\u002For complications (ie, ≤ Grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiating treatment\n16. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1\u002F2 antibody positive)\n17. Untreated active hepatitis B (defined as HBsAg positive and detection of HBV-DNA copy number greater than the upper limit of normal value of the laboratory laboratory of the research center)\n\nNote: Hepatitis B subjects who meet the following criteria can also be enrolled:\n\n1. If the HBV viral load before the first administration is \\\u003C2.5×103 copies\u002Fml (500 IU\u002Fml), the subject should receive anti-HBV treatment during the entire study treatment period\n2. For subjects whose anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load are less than the upper limit of normal value in the laboratory department of the research center, they do not need to receive preventive anti-HBV treatment, but they need to be closely monitored. Monitoring for viral reactivation 18. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the lower limit of detection) 19. Except for those who have received live attenuated vaccines within 4 weeks before the first dose of the new crown vaccine 20. Pregnant or lactating women 21. Esophageal or gastric variceal bleeding events caused by portal hypertension in the past 6 months; known severe (G3) varices in endoscopy within 3 months before the first administration; evidence of portal hypertension (including Imaging examination revealed that the length of splenomegaly exceeds 10 cm and the platelets are less than 100×109\u002FL), and the researchers evaluated the risk of bleeding as high 22. Any life-threatening bleeding events occurred in the past 3 months, including the need for blood transfusion therapy, surgery or local therapy, continuous drug therapy 23. Arterial and venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious history of thromboembolism. Implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, unless the thrombus is stabilized after conventional anticoagulant therapy 24. History of gastrointestinal perforation and\u002For fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colon resection or extensive small bowel resection, complicated by chronic diarrhea) within the past 6 months , Crohn's disease, ulcerative colitis, or long-term chronic diarrhea; 25. Presence of any serious or uncontrolled systemic disease, such as:\n\n1\\) Resting ECG has significant abnormalities in rhythm, conduction or morphology, and the symptoms are severe and uncontrollable, such as complete left bundle branch block, heart block above second degree, ventricular arrhythmia or with fast ventricular rate atrial fibrillation 2) Unstable angina, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure 3) Any arterial thrombosis, embolism or ischemia occurred within 6 months before the selected treatment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, etc.; 4) Received major surgical operations (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within 4 weeks before the first administration. Received tissue biopsy or other minor surgical procedures within 7 days before the first dose, except for venipuncture for intravenous infusion 5) Unsatisfactory blood pressure control (systolic blood pressure \\> 140 mmHg and\u002For diastolic blood pressure \\> 90 mmHg) 6) Active tuberculosis 7) Active or uncontrolled infection requiring systemic therapy 8) Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction 9) Liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis 10) Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10mmol\u002FL) 11) Urine routine prompts urine protein ≥ ++, and confirmed 24-hour urine protein quantity \\> 1.0 g; 12) Patients with mental disorders who cannot cooperate with treatment 26. Medical history or disease evidence that may interfere with the test results, prevent the subject from participating in the whole study, abnormal treatment or laboratory test values, or other situations that the investigator believes are not suitable for enrollment. The investigator believes that there are other potential risks t","75 Years",{"count":499,"type":22},50,[251],"Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Objective response rate via investigator, Safety; Secondary endpoints: disease control rate, disease-free survival, overall survival, and proportion of acceptable radical resection of primary lesions; Main characteristics of enrolled patients: Patients with initially unresectable gallbladder cancer; Interventions: Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab; Sample size: Using Simon's two-stage design, 15 patients in the first stage, and if more than 4pts response, enlarge the sample size to 45 patients in total; Treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal; Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 9 weeks of treatment, up to surgical treatment or disease progression; Safety evaluation: Evaluate adverse reactions according to CTCAE 5.0; Follow up: every 90 days (±7 days) until the subject died, lost follow-up or the end of the study.",[38,503,504],"Initially Unresectable","the First Line Treatment","2023-02-24",{"date":507,"type":91},"2023-03-07",{"date":509,"type":91},"2022-12-22",{"date":511,"type":22},"2026-12-22",{"name":513,"class":98},"Lu Wang, MD, PhD",{"id":515,"slug":516,"hasResults":11,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":523,"conditions":524,"keywords":525,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":139},"100453427","identification-of-new-biomarkers-for-patients-with-cholangiocarcinoma-and-gallbladder-cancer-100453427","NCT05184400","Identification of New Biomarkers for Patients With Cholangiocarcinoma and Gallbladder Cancer","Identification of New Biomarkers for Patients With Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer) - do They Provide New Information Regarding Diagnosis, Treatment Efficacy, Side Effects, or Prognosis?","CHOCA","Inclusion Criteria:\n\n* Histological or cytological diagnosis of BTC\n* Patients referred for treatment of BTC\n* Signed informed consent\n\nExclusion Criteria:\n\n* None",{"count":473,"type":22},"No validated biomarkers exist that can identify patients with biliary tract cancer at an early stage or predict treatment outcomes. The objective of the present study is to find diagnostic, prognostic and predictive biomarkers.",[159,125,38],[526,527,528,529,530],"Prospective observational open cohort study","Biomarkers","Diagnostics","Prognostics","Prediction of treatment efficacy","2021-12-21",{"date":533,"type":91},"2022-01-11",{"date":535,"type":91},"2015-01-01",{"date":537,"type":22},"2030-12-31",{"name":539,"class":98},"Herlev and Gentofte Hospital"]