[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cholangiocarcinoma-resectable\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cholangiocarcinoma-resectable":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,65,92,118],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":39,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100627888","trace-btc-relation-of-biomarkers-and-patients-reported-quality-of-life-to-outcomes-in-patients-with-biliary-tract-cancer-a-real--world-cohort-100627888",false,"NCT07454486","TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort","TRACE-BTC","Inclusion Criteria:\n\n* Histopathologically verified biliary tract cancer (BTC) and\u002For Multidisciplinary Team (MDT) conference decision to define the patient as suffering from BTC.\n* Eligible for curative, adjuvant, or palliative oncological treatment.\n* Age ≥ 18 years.\n* Written and oral consent.\n\nExclusion Criteria:\n\n* Other malignant diseases within 5 years of BTC diagnosis, excluding early-stage non-melanoma skin cancer and carcinoma in situ of the cervix.\n* Conditions that prohibit blood sampling.\n* Known or suspected non-compliance.","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","5 Years","OBSERVATIONAL","Purpose of the Study:\n\nBile duct cancers are rare and aggressive. About 250 new cases are diagnosed each year in Denmark. These cancers are difficult to detect early, so only about 20% of patients can have surgery when diagnosed. Even after surgery, the cancer often returns, and chemotherapy only slightly reduces the risk of relapse.\n\nFor patients who cannot have surgery, treatments such as chemotherapy (sometimes combined with immunotherapy) can relieve symptoms and extend life, but their effect is limited. A small number of patients have specific genetic changes in their cancer that can be treated with targeted medicines.\n\nCurrently, doctors cannot predict which patients will benefit from treatment. Standard monitoring methods like CT scans are expensive, inconvenient, and sometimes unreliable because bile ducts are hard to see clearly on scans.\n\nBlood tests that detect cancer DNA in the blood (called circulating tumor DNA or ctDNA) and other biological markers may be a better way to monitor the disease and adjust treatment. These tests could help detect cancer recurrence earlier and determine whether treatment is working. Measuring patients' quality of life and symptoms over time may also help predict treatment benefit and evaluate effectiveness.\n\nThe goal of this study is to:\n\n* Investigate how biomarkers, including ctDNA, can predict disease course, detect relapse, and monitor treatment response.\n* Identify the best way to measure ctDNA in patients with bile duct cancer.\n* Examine whether patients' own reports of quality of life and symptoms can help assess treatment effect and prognosis.\n\nStudy Design and Procedures:\n\nThis is a prospective cohort study focusing on blood biomarkers and patient-reported symptoms and quality of life.\n\nParticipants agree to provide blood samples:\n\n* Before treatment\n* During treatment\n* During follow-up\n\nEach sample involves up to 40 ml of blood, with a maximum of 20 samples per patient.\n\nThe blood will be analyzed for:\n\n* ctDNA and genetic changes\n* Cancer-related markers\n* Inflammation markers\n* Immune system markers\n\nTumor tissue samples will also be examined to compare blood and tissue results. Full genome or exome sequencing will not be performed. Samples will be stored in a research biobank.\n\nFor patients with incurable disease, quality of life and symptom burden will be monitored repeatedly using Danish questionnaires.\n\nParticipants:\n\nThe study will include:\n\n* Up to 100 patients with potentially curable disease\n* Up to 200 patients with incurable disease\n\nTo participate, patients must:\n\n* Have confirmed bile duct cancer\n* Be eligible for curative, additional (adjuvant), or palliative treatment\n* Be over 18 years old\n* Provide written and verbal consent\n\nPatients cannot participate if they:\n\n* Had another cancer within the past 5 years (except early skin cancer or very early cervical cancer)\n* Cannot safely provide blood samples\n* Are unable to cooperate with study procedures\n\nRisks and Inconveniences:\n\nParticipants will have extra blood samples taken, usually during regular hospital visits. Possible side effects include mild soreness or small bruises at the needle site. The extra blood amount (40 ml per sample) is considered medically insignificant.\n\nParticipants will also spend time filling out questionnaires. The number and frequency of questions have been kept as low as possible while still providing meaningful data.\n\nFinancial Information:\n\nExtra costs for blood sampling, laboratory analysis, and data collection will be covered by external research funding managed by Aarhus University Hospital.\n\nThe researchers have no financial interest in the project. Patients will not receive financial compensation for participating.\n\nRecruitment and Consent:\n\nPotential participants are identified during routine clinical care. During a planned meeting with a doctor, patients receive written and verbal information about the study, including its purpose, risks, advantages, and disadvantages.\n\nThe conversation takes place in a calm and private setting. Patients may bring a support person. They have time to ask questions and at least 24 hours to consider participation.\n\nPatients can withdraw their consent at any time without affecting their treatment. Consent must be given before any study-related procedures begin.\n\nPublication of Results:\n\nThe results - whether positive or negative - will be presented at national and international conferences and submitted to peer-reviewed scientific journals.\n\nEthical Considerations:\n\nAll participants receive standard medical treatment. The risks and disadvantages are limited, and participants are unlikely to benefit directly from the study. However, the research may improve how biomarkers and patient-reported outcomes are used to predict prognosis and treatment response, potentially leading to better treatment for future patients with bile duct cancer.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38],"Biliary Tract Cancer (BTC)","Biliary Tract Cancer (CCA)","Gall Bladder Cancer","Biliary Tract Cancers (BTC)","Cholangiocarcinoma","Cholangiocarcinoma Non-resectable","Cholangiocarcinoma Resectable","Cholangiocarcinoma Metastatic","Cholangiocarcinoma of the Bile Duct","Cholangiocarcinoma, Extrahepatic","Cholangiocarcinoma, Hilar","Cholangiocarcinoma, Intrahepatic","Cholangiocarcinoma, Perihilar","Cholangiocarcinoma; Liver",[40,29,41,42,43,44,45,46,47,48,49,50,51],"Biliary Tract Neoplasms","Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Gallbladder Neoplasms","Circulating Tumor DNA","Liquid Biopsy","Minimal Residual Disease","Biomarkers, Tumor","Observational Study","Biobanking","DNA Methylation","Precision Oncology","NOT_YET_RECRUITING","2026-03-02",{"date":55,"type":56},"2026-03-06","ACTUAL",{"date":58,"type":20},"2026-03-15",{"date":60,"type":20},"2031-12-30",{"name":62,"class":63},"Aarhus University Hospital","OTHER",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":75,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":64},"100572187","phase-1-phase-iii-study-allogeneic-nk-cell-therapy-with-chemotherapy-for-post-surgery-pda-or-cholangiocarcinoma-patients-100572187","NCT06730009","Phase I\u002FII Study: Allogeneic NK-cell Therapy With Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients","A Dose-Finding Phase I Followed by a Phase II Study to Evaluate the Safety and Efficacy of Allogeneic NK-cell Combined With Chemotherapy in Patients With PDA or Cholangiocarcinoma After Surgery","Inclusion Criteria:\n\n1. Dated and signed informed consent.\n2. Either sex, aged older than 18 years old (inclusive) at date of consent.\n3. Subject with a macroscopic resection of the primary tumor and residual primary tumor that satisfies all of the items below according to the Union for International Cancer Control (UICC) histopathologic staging system:\n\n   * At or before the surgery, stage II or stage III.\n   * Local residual tumor classified as R0 or R1.\n   * Cytologic examination negative upon intraoperative peritoneal lavage.\n4. Histologically confirmed PDA or cholangiocarcinoma.\n5. Received curative resection within 12 weeks prior to screening visit and will receive adjuvant SLOG chemotherapy. Note: Subjects with cancer who had undergone surgery with or without prior neo-adjuvant therapy will be recruited.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.\n7. Subject with adequate hematology function at Visit 1:\n\n   * Total white blood cell (WBC) ≥ 3,000 cells\u002Fmm3.\n   * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3.\n   * Platelets ≥ 100,000 counts\u002Fmm3.\n   * Hemoglobin ≥ 9 g\u002FdL.\n   * International normalized ratio (INR) of prothrombin time within normal range. Note: Re-test for eligibility is allowed during the screening period.\n8. Subject with adequate hepatic and renal function at Visit 1:\n\n   * Serum creatinine ≤ 1.5× Upper Limit of Normal (ULN).\n   * Blood urea nitrogen (BUN) ≤ 1.5× ULN.\n   * Total bilirubin ≤ 1.5× ULN.\n   * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5× ULN.\n   * Alkaline phosphatase (ALP) ≤ 5× ULN.\n   * Albumin ≥ 3.0 g\u002FdL. Note: Re-test for eligibility is allowed during the screening period.\n9. Negative response in human immunodeficiency virus (HIV) and treponema pallidum (rapid plasma reagin \\[RPR\\]\u002Fvenereal disease research laboratory \\[VDRL\\] and treponema pallidum hemagglutination \\[TPHA\\]).\n10. Subject confirmed with past cytomegalovirus (CMV) infection in terms of having positive CMV immunoglobin G (CMV IgG).\n11. Subject with childbearing potential must agree to use at least two contraceptive precautions, one of which must be a condom or other adequate barrier method, from\n\n    * signing informed consent until 28 days after the last dose of investigational product (IP) administration.\n    * initiation of oxaliplatin treatment until at least 15 months (female) or 12 months (male) following the last dose.\n    * initiation of gemcitabine treatment until at least 6 months (female) or 3 months (male) following the last dose.\n12. Agree to be in compliance with clinical protocol-planned treatment. Note: Anti-virus treatment is allowed if active hepatitis B is presented.\n\nExclusion Criteria:\n\n1. Received any other investigational, anti-neoplastic medications, or immune cell therapy within 28 days prior to screening visit.\n2. Any prior history of malignant neoplasm, except:\n\n   1. Non-invasive, non-melanomatous skin cancer (including squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ), curatively treated with cryosurgery or surgical excision only.\n   2. Other primary malignant neoplasm diagnosed as disease free for more than 5 years.\n3. Immunocompromized, currently under immunosuppressive treatment for autoimmune disease, or have received systemic steroid of equivalent dosage higher than prednisolone 30 mg\u002Fday for more than 7 days within 14 days prior to Day 1.\n4. With known metastases.\n5. With ongoing acute diseases, or serious medical conditions within the past 2 years prior to screening, such as cardiovascular (e.g., New York Heart Association grade III or IV), hepatic (e.g., Child-Pugh Class C), psychiatric condition (e.g., alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject.\n6. Hypercoagulable state that may lead to clinically apparent thrombosis.\n7. With known hypersensitivity to aminoglycoside (e.g., streptomycin, gentamicin) or bacitracin.\n8. With known hypersensitivity to any of the components of Allogeneic Magicell-NK, including human serum albumin.\n9. With known hypersensitivity to any of the components of S-1, leucovorin, oxaliplatin, or gemcitabine.\n10. With any contraindication to S-1, leucovorin, oxaliplatin, or gemcitabine, including:\n\n    \\- Severe myelosuppression or myelosuppression that probably exacerbates.\n11. With symptomatic CMV disease.\n12. With any history of diagnosed or suspected cardiac arrhythmia or QT interval prolongation.\n13. Male subject with a corrected QT interval (QTc) ≥ 450 ms and female subject with a QTc ≥ 470 ms as determined by electrocardiogram (ECG) examination at screening.\n14. Received any drugs associated with QT prolongation within 28 days prior to the Screening Visit (refer to Appendix 3. Drugs Associated with QT Prolongation, including but not limited to the drug listed therein).\n15. Received brivudine or its analogs (e.g., sorivudine) or any live vaccines within 28 days prior to the Screening Visit.\n16. Female subject who is lactating or has positive serum or urine pregnancy test at screening.",{"count":73,"type":20},42,"INTERVENTIONAL",[76,77],"PHASE1","PHASE2","This is a phase I\u002FII study which intends to characterize the safety, tolerability, and preliminary efficacy of Allogeneic Magicell-NK infusion in PDA or cholangiocarcinoma patients after surgery. Subjects will receive a total of 6 intravenous (IV) infusions of the IP on the 11th day of each chemotherapy cycle. A total of 6 cycles of IP infusions are planned.\n\nThe phase I part of the study is a first-in-human phase I trial of Allogeneic Magicell-NK and is therefore designed in an open-label, dose-escalation manner. A standard 3+3 design will be employed to assess the safety profile of Allogeneic Magicell-NK and to determine the MTD\u002FMFD. Two dose cohorts are planned: the starting dose is 10 × 10\\^8 cells (Cohort 1), and escalates to 20 × 10\\^8 cells (Cohort 2).\n\nThe phase II part of the study is designed as an open-label, two-arm, randomized clinical trial comparing the combination of SLOG and Allogeneic Magicell-NK with SLOG alone when used as adjuvant therapy following resection for PDA or Cholangiocarcinoma. Approximately 30 subjects will be randomized at a 2:1 ratio between the two arms: Arm 1: SLOG and Allogeneic Magicell-NK (20 subjects); Arm 2: SLOG alone (10 subjects). Subjects will then receive 12 weeks of SLOG chemotherapy with or without Allogeneic Magicell-NK infusion.",[80,31],"Pancreatic Carcinoma Stage II","RECRUITING","2025-12-09",{"date":84,"type":56},"2025-12-17",{"date":86,"type":56},"2024-10-21",{"date":88,"type":20},"2029-08-31",{"name":90,"class":91},"Medigen Biotechnology Corporation","INDUSTRY",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":74,"phases":102,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":64},"100559829","phase-2-gemcitabinecisplatinnab-paclitaxel-and-rilvegostomig-in-resectable-icca-100559829","NCT06569225","Gemcitabine\u002FCisplatin\u002FNab-Paclitaxel and Rilvegostomig in Resectable iCCA","Perioperative Therapy With Gemcitabine\u002FCisplatin\u002FNab-Paclitaxel and Rilvegostomig for Patients With Resectable Intrahepatic Cholangiocarcinoma (iCCA) - A Phase II Trial","NEOLANGIO","Inclusion Criteria:\n\n1. Patient must be capable of providing written informed consent.\n2. Age \\>18 years at time of study entry\n3. Histologically proven intrahepatic cholangiocarcinoma\n4. Complete surgical resection of the tumor must be achievable\\*. Resection should include a portal lymphadenectomy as per standard of care.\n5. No prior cytotoxic, targeted or immune therapy\n6. Have provided archival tumor tissue sample or preferably freshly obtained biopsy of a tumor lesion not previously irradiated for mandatory pre-treatment evaluation (baseline).\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n8. Estimated life expectancy \\>3 months\n9. Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the infiltration of any adjacent organs or structures by CT or MRI, indicating an unresectable situation\n10. If underlying liver cirrhosis, Childs Pugh score of 5 or 6\n11. If underlying liver disease, ALBI grade ≤2†\n12. Patients with HBV infection, which is characterized by positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibodies (anti-HBcAb) with detectable HBV DNA (≥10 IU\u002Fml or above the limit of detection per local lab standard), must be treated with antiviral therapy, as per institutional practice, to ensure adequate viral suppression (HBV DNA ≤2000 IU\u002FmL) prior to study entry. Patients must remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication. Patients who test positive for anti-hepatitis B core (HBc) with undetectable HBV DNA (\\\u003C10 IU\u002Fml or under limit of detection per local lab standard) do not require anti-viral therapy prior to study entry. These subjects will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥10 IU\u002Fml or above the limit of detection per local lab standard). HBV DNA detectable subjects must initiate and remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication.\n13. Patients with HCV infection must have management of this disease per local institutional practice throughout the study. HCV diagnosis is characterized by the presence of detectable HCV ribonucleic acid (RNA) or anti-HCV antibody upon enrollment.\n14. Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients.\n15. Adequate normal organ and marrow function as defined below within screening period:\n\n    * Haemoglobin ≥9.0 g\u002FdL\n    * Absolute neutrophil count (ANC ≥1.0 × 109 \u002FL)\n    * Platelet count ≥100 × 109\u002FL\n    * Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). \\\u003C\\\u003CThis will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n    * AST (SGOT)\u002FALT (SGPT) ≤5 x institutional upper limit of normal.\n    * Measured creatinine clearance (CL) \\>50 mL\u002Fmin or Calculated creatinine clearance\n\n    CL\\>50 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:\n\n    Males:\n\n    Creatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg\u002FdL)\n\n    Females:\n\n    Creatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg\u002FdL)\n    * Albumin ≥2.8g\u002Fdl\n    * International normalized ratio ≤1.5 (for patients receiving Warfarin, please consult with the study physician)\n16. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\n    * Resectability is at the discretion of the investigators at each site but must be discussed at a multidisciplinary tumour board.\n\n      * based on albumin and bilirubin; ALBI score = (log10 bilirubin \\[umol\u002FL\\] x0.66) + (albumin \\[g\u002FL\\] x -0.0852). ALBI grade 1= score ≤ -2.60.\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled at time of study enrolment or where indicated:\n\n1. Locally unresectable tumor or metastatic disease:\n\n   1. Radiological evidence suggesting inability to resect with curative intent whilst maintaining adequate vascular inflow and outflow\n   2. Radiological evidence of direct invasion into adjacent organs.\n   3. Radiological evidence of extrahepatic metastatic disease (except regional lymph nodes - stations 9 and 12\n2. Contraindication to any of the study drugs\n3. Any concurrent chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment\n4. Are currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks or for a period of at least 5 half-lives of the respective drug\u002FIMP (whichever is longer) before screening and during Screening for this trial.\n5. Have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n6. Have a known additional malignancy that is progressing or has required active treatment within the past 2 years.\n\n   Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n7. Have active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n8. Have a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n9. Have an active infection requiring systemic therapy (exception: HBV and HCV infection).\n10. Have a history of Human Immunodeficiency Virus (HIV) (mandatory testing for HIV during screening is required).\n11. Have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n12. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of study treatment. Not engaging in sexual activity, per the patient's preferred and usual lifestyle, for the total duration of the treatment and 6 months after the last dose of study treatment is an acceptable practice.\n\n    Note: Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or not post menopausal.\n\n    Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n    * Women \\\u003C50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution.\n    * Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, or had chemotherapy-induced menopause with last menses \\>1 year ago.\n    * Women who are surgically sterile (i.e., bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) are eligible.\n\n    Highly effective methods of contraception, defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Note that some contraception methods are not considered highly effective (e.g., male or female condom with or without spermicide; female cap, diaphragm, or sponge with or without spermicide; non copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation is not the primary mode of action \\[excluding Cerazette\u002Fdesogestrel, which is considered highly effective\\]; and triphasic combined oral contraceptive pills). Serum levels of contraceptive hormones may be altered by concomitant use of other drugs. Therefore, drug interactions should always be considered when prescribing hormonal contraception; there could be a risk of contraceptive failure or other adverse effects.\n13. Legal incapacity or limited legal capacity.",{"count":101,"type":20},40,[77],"Biliary tract cancer is a highly aggressive and heterogeneous group of gastrointestinal cancers that arise from the intra- or extrahepatic bile ducts (CCA), or the gallbladder (GBC)(1-3). While it accounts for only 0.7% of all malignant tumors and 3% of all gastrointestinal malignancies in adults, both incidence and mortality are increasing. Biliary tract cancers usually present at an advanced stage, with only approximately 20% of patients being diagnosed with an early-stage disease (1, 2, 4). There is a high risk of recurrence post curative radical resection, with 60-70% of patients recurring within 5 years, with 5-year survival of around 25% (1, 2, 5). There is evidence for use of adjuvant chemotherapy with fluoropyrimidine- based regimens as per the BILCAP and ASCOT phase III trials \\[(5-7).However, despite advances in adjuvant treatment, recurrence rates after resection of BTC remain high even with adjuvant chemotherapy. For example, in the BILCAP study, 5-year RFS was reported as 33.9% (95% CI: 27.6 to 40.2) (1). Therefore, an unmet need exists to optimize peri-operative treatment to reduce recurrence and improve outcomes in patients with resectable BTC.",[31],[106,107,108],"CCA","Biliary cancer","Neo-adjuvant and adjuvant therapy","2024-08-21",{"date":111,"type":56},"2024-08-26",{"date":113,"type":20},"2024-12-15",{"date":115,"type":20},"2028-12-31",{"name":117,"class":63},"University Health Network, Toronto",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":74,"phases":128,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":138,"leadSponsor":140,"locationsCount":64},"100425804","neoadjuvant-pdt-in-the-treatment-of-cholangiocarcinoma-100425804","NCT04824742","Neoadjuvant PDT in the Treatment of Cholangiocarcinoma","A Prospective Randomized Controlled Study of Neoadjuvant PDT in the Treatment of Cholangiocarcinoma","Inclusion Criteria:\n\n* Patients with age between 18 to 75 years;\n* Patients'gender was not limited;\n* Patients with locally advanced cholangiocarcinoma who have a clear diagnosis of the primary disease and require surgical resection or potential surgical resection;\n* No history of radiotherapy and chemotherapy;\n* Willing to accept this clinical trial, sign informed consent and be able to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Women during pregnancy or breastfeeding, and those with mental illness;\n* Patients allergic to porphyrin drugs, porphyria;\n* Long-term use of glucocorticoids or autoimmune suppression;\n* Surgical contraindication, including:\n\nChild-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. End stage disease, complicated with biliary cirrhosis or portal hypertension.Patients with long- term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; Patients have the tendency or history of bleeding.","75 Years",{"count":127,"type":20},50,[129],"NA","For patients with locally advanced cholangiocarcinoma with resectable margins, patients who meet the selection criteria are randomly divided into two groups A and B. Group A: neoadjuvant PDT therapy combined with radical surgery; Group B: radical surgery. This study aims to explore the clinical effectiveness and safety of neoadjuvant photodynamic therapy for cholangiocarcinoma, as well as its role in destroying local tumors and enhancing systemic inflammation.",[31],[133],"Cholangiocarcinoma,Neoadjuvant therapy,Photodynamic therapy","2021-03-30",{"date":136,"type":56},"2021-04-01",{"date":136,"type":20},{"date":139,"type":20},"2028-04-01",{"name":141,"class":63},"First Affiliated Hospital Xi'an Jiaotong University"]