[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chemotherapy-effect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chemotherapy-effect":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,55,0,25,[9,41,70,101,135,158,185,213,241,259,281,303,325,356,382,414,425,456,486,514,541,572,600,632,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053549","predicting-postoperative-chemotherapy-efficacy-in-patients-with-esophageal-squamous-cell-carcinoma-100053549",false,"NCT06490003","Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma","Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma by Biopsy Specimens.","Inclusion Criteria:\n\n1. Patients who had histologically confirmed esophageal squamous cell carcinoma.\n2. Patients who had undergone chemotherapy.\n3. Patients receiving initial chemotherapy\n4. Written informed consent following full study information is provided to the patient.\n\nExclusion Criteria:\n\n1. Patients for whom a preoperative biopsy sample cannot be obtained\n2. Patients who cannot assess at 2 months later after chemotherapy.\n3. Patients with multiple cancers.","ALL","20 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","Esophageal cancer remains a disease with a poor prognosis. Chemotherapy is an important part of its treatment, but there are cases in which chemotherapy is ineffective. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective group.",[25,26,27],"Esophageal Squamous Cell Carcinoma","Chemotherapy Effect","DNA Methylation","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2004-06-01",{"date":36,"type":21},"2028-06-18",{"name":38,"class":39},"City of Hope Medical Center","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":40},"100555278","phase-2-perioperative-oxaliplatin-with-s-1-combined-h-pylori-eradication-in-the-management-of-locally-advanced-gastric-cancer-100555278","NCT06510010","Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer","Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Adenocarcinoma of the Gastric and Oesophagogastric Junction: an Open-label, Prospective, Multicenter, Randomised, Phase 2 Trial.","Inclusion Criteria:\n\n1. have been fully informed about the study and voluntarily signed the informed consent form (ICF);\n2. Gastroscopy pathology confirmed locally advanced adenocarcinoma of the gastric and oesophagogastric junction (Siewert type I-III);\n3. Clinical (enhanced CT, enhanced MRI, or PET-CT) staging at the time of diagnosis: cT3\u002F4a Nx or T2 N2\u002F3, M0 (The American Joint Committee on Cancer 8th edition):\n4. The present H. Pylori infection at the time of diagnosis is determined by one of the following 3 items: ① Positive gastric mucosal tissue rapid urease test (RUT), tissue section staining, or bacterial culture for any of the 3 items. Positive 13C or 14C-urea breath test (UBT). ③ Positive helicobacter pylori stool antigen (HpSA) tests (clinically validated monoclonal antibody method). Positive serum H. Pylori antibody test (clinically proven reagent with high accuracy) suggests previous infection, and those who have never been treated can be considered as having current infection;\n5. Sex is not limited and age is 18-75 years old;\n6. Eastern Cooperative Oncology Group (ECOG) score 0-1;\n7. Organ function permits major abdominal surgery;\n8. Expected survival ≥ 6 months;\n9. Laboratory test values must meet the following criteria within 7 days prior to enrollment:\n\n   1. whole-body cryotherapy\u002Fcryostimulation (WBC) \\> 4.0 × 10\\^9\u002FL and \\\u003C 15 × 10\\^9\u002FL, ANC \\> 1.5 × 10\\^9\u002FL, Hb ≥ 75 g\u002FL, PLT ≥ 100 × 10\\^9\u002FL;\n   2. Serum bilirubin ≤ 1.5 x high limit of normal, aspartate transaminase (AST), alanine aminotransferase (ALT) ≤ 2.5 x high limit of normal;\n   3. Creatinine ≤ 1.5 x high limit of normal or creatinine clearance rate \\> 60 ml\u002Fmin;\n   4. international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × Upper limit of normal ( ULN ) only for subjects not receiving anticoagulation; subjects receiving anticoagulation should be on a stable dose;\n10. Ability to cooperate with the appropriate endoscopic, laboratory and imaging tests for this protocol;\n11. Females of childbearing potential (including females who are menopausal due to chemo-menopause or other medical reasons) must agree to use contraception for a period of at least 6 months from the time of signing the Informed Consent Form to at least 6 months after the last dose of study treatment or concomitant chemotherapy, whichever is later. Females must also agree to refrain from breastfeeding for a period of at least 6 months from the time of signing the informed consent to the time of the last administration of the study drug or concomitant chemotherapy, whichever is later; males must agree to use contraception for a period of at least 6 months from the time of administration of the test drug to the time of the last administration of the test drug or concomitant chemotherapy, whichever is later.\n\nExclusion Criteria:\n\n1. Stage IV or unresectable gastric or gastroesophageal junction cancer as determined by the investigator;\n2. Other active malignancies within 5 years or concurrently.\n3. Patients who are preparing for or have previously received organ or bone marrow transplantation;\n4. Myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women) within 6 months prior to the first dose (QTc interval is calculated by the Fridericia formula);\n5. Presence of New York Heart Association (NYHA) class III-IV cardiac insufficiency or cardiac ultrasound: LVEF (left ventricular ejection fraction) \\\u003C 50%;\n6. Presence of active pulmonary tuberculosis by history or CT, or patients with a history of active pulmonary tuberculosis within 1 year prior to enrollment, or patients with a history of active pulmonary tuberculosis more than 1 year prior but without regular treatment;\n7. Presence of a known active or suspected autoimmune disease. The exception is those who are in a stable state of that disease at the time of enrollment (not requiring systemic immunosuppression therapy);\n8. Received a live vaccine within 28 days prior to the first dose; except inactivated viral vaccines for seasonal influenza;\n9. Patients requiring treatment with systemic corticosteroids (\\> 10 mg\u002Fday prednisone efficacy dose) or other immunosuppressive drugs within 14 days prior to first dose or during the study period. However, enrollment is permitted if patients are allowed to be treated with topical topical or inhaled steroids, or adrenal hormone replacement therapy at doses ≤ 10 mg\u002Fday prednisone efficacy dose in the absence of active autoimmune disease;\n10. Undergoing treatment in another clinical study or scheduled to begin treatment in this study less than 14 days from the end of treatment in the previous clinical study;\n11. Known history of severe allergy to any study drug excipients;\n12. known history of psychotropic pharmaceuticals abuse or drug addiction; patients who have stopped drinking alcohol can be enrolled;\n13. Presence of patients with conditions that may increase the risk of study medication, or other severe, acute and chronic medical conditions that, in the judgment of the investigator, make participation in a clinical study unsuitable.","18 Years","75 Years",{"count":51,"type":21},180,"INTERVENTIONAL",[54],"PHASE2","This study focuses on patients with H. pylori-positive resectable locally advanced adenocarcinoma of the gastric and oesophagogastric junction. It evaluates the perioperative oxaliplatin with S-1 (SOX) combined H. pylori eradication versus oxaliplatin with S-1 in the management of H. pylori-positive locally advanced adenocarcinoma of the gastric and oesophagogastric junction (cT3\u002F4a Nx or T2 N2\u002F3, M0) , assessing their values and advantages.",[26],[58,59,60],"H. Pylori Eradication","Perioperative chemotherapy","Locally Advanced Gastric Cancer","2026-06-08",{"date":63,"type":32},"2026-06-10",{"date":65,"type":32},"2024-12-31",{"date":67,"type":21},"2027-07-31",{"name":69,"class":39},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":52,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":40},"100636146","phase-4-study-of-the-effectiveness-and-safety-of-daunorubicin-idarubicin--silibinin-in-treating-newly-diagnosed-aml-non-m3-100636146","NCT07561892","Study of the Effectiveness and Safety of Daunorubicin \u002FIdarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3).","Prospective Randomized Study of the Effectiveness and Safety of Chemotherapy Protocols Containing Daunorubicin \u002FIdarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3)","AML","Inclusion Criteria:\n\n1. Newly diagnosed acute leukemia(non-M3)confirmed according to the 2018 WHO classification criteria for the diagnosis and classification of acute leukemia;\n2. Suitable for standard chemotherapy regimens containing idarubicin\u002Fdaunorubicin;\n3. Patients with an expected survival time of at least 3 months as determined by the investigator;\n4. Voluntarily agree to participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. History of other malignant tumors concurrently or previously diagnosed malignancies not under control;\n2. Participation in other clinical trials within one month prior to screening;\n3. Presence of uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases, or other such conditions;\n4. Other uncontrolled diseases that the investigator considers inappropriate for inclusion;\n5. Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol;\n6. Pregnant or breastfeeding women;\n7. History of liver cirrhosis, or current active liver disease or biliary disease;\n8. HIV-positive individuals;\n9. Any other conditions that, in the investigator's judgment, may prevent the subject from completing the study or pose significant risk to the subject.","65 Years",{"count":80,"type":21},100,[82],"PHASE4","Silibinin is the major active component of silymarin, a commonly used hepatoprotective agent. It stabilizes hepatocyte membranes, preserves cellular integrity, and accelerates DNA synthesis in liver cells. Clinically, it is widely used in the treatment of chronic persistent hepatitis, chronic active hepatitis, early-stage liver cirrhosis, and hepatotoxicity. Moreover, it has been reported to inhibit the growth and differentiation of various cancer cells, including hepatocellular carcinoma, prostate cancer, breast cancer, and cervical cancer.\n\nBased on these preclinical findings, we aim to evaluate the efficacy and safety of combining silybinin with the standard first-line idarubicin\u002Fdaunorubicin-based regimen in the treatment of newly diagnosed acute leukemia(non-M3)in a clinical setting.",[85,86,26],"Acute Myeloid Leukemia","Newly Diagnosed",[76,88,89,90,91],"newly diagnosed","Silybin","daunorubicin","Idarubicin","2026-04-27",{"date":94,"type":32},"2026-05-01",{"date":96,"type":32},"2022-04-01",{"date":98,"type":21},"2026-12-31",{"name":100,"class":39},"Fujian Medical University Union Hospital",{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":52,"phases":112,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100584654","massage-impact-on-sleep-in-pediatric-oncology-100584654","NCT06892158","Massage Impact on Sleep in Pediatric Oncology","Massage Impact on Sleep in Hospitalization for Pediatric Oncology and Stem Cell Transplant Patients","Inclusion Criteria:\n\n1. Diagnosis of cancer, such as acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (rALL) OR admitted to receive autologous or allogeneic HSCT for any indication\n2. Expected to be an inpatient for at least 21 days\n3. Aged 12 to 21 years at enrollment.\n4. Inpatient at Children's National or Children's Hospital of Philadelphia (CHOP).\n\nExclusion Criteria:\n\n1. Cognitive impairment sufficient to preclude completing questionnaires appropriately\n2. Insufficient knowledge of English or Spanish that would prohibit completing the study instruments\n3. Previous enrollment","12 Years","21 Years",{"count":111,"type":21},70,[113],"NA","This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).",[116,117,26,85,118,119],"Cancer","Pediatric Cancer","Acute Lymphoblastic Leukemia, Pediatric","Hematopoietic Stem Cell Transplantation (HSCT)",[121,122,123,124],"Stem cell transplant (SCT)","Decreased sleep efficiency","Pediatric cancer diagnosis","Circadian activity rhythm (CAR)","2026-04-13",{"date":127,"type":32},"2026-04-15",{"date":129,"type":32},"2025-01-23",{"date":131,"type":21},"2028-07",{"name":133,"class":39},"Children's Hospital of Philadelphia",2,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":52,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":40},"100540158","phase-2-hai-floxuridine-or-sirt-combined-with-gemox-for-patients-with-intra-hepatic-cholangiocarcinoma-not-amenable-to-resection-tomcat-100540158","NCT06313203","HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)","Trans-arterial Treatment of Patients With Intra-hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)","TOMCAT","Inclusion Criteria:\n\n1. Intra-hepatic cholangiocarcinoma. Diagnosis confirmed by biopsy, cytology or previous resection.\n2. Not amenable for upfront resection. Defined as:\n\n   1. A tumour that is technically not resectable with R0 margins (i.e. where resection will not yield an FLR of sufficient size and function) without reconstruction of portal or liver vein, or artery.\n   2. Any multifocality (more than one tumour) irrespective of distance between assumed primary and other lesions\n   3. Recurrent tumour following resection\n   4. Radiologically or cytology-proven malignant regional lymph nodes\n3. Disease confined to the liver or associated with limited, resectable porta hepatis lymph node metastases\n4. Radiologically measurable disease with at least one lesion \\> 2 cm in greatest diameter\n5. Physical performance score WHO\u002FECOG stage 0\u002F1\n6. Age \\> 18 years\n7. Assumed ability to tolerate at least one full cycle of GemOx\n8. For eligibility to HAI-FUDR\u002FDEX treatment, patients must be willing and able to go to Oslo every fortnight\n9. Women of childbearing age and potential must be willing to use highly effective contraception during the study and for a period after the study, as defined in this protocol. Male patients or male patients who have female partners of childbearing age and potential must be willing to use highly effective contraception during the study and for a period after the study, as defined in this protocol. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n\nExclusion Criteria:\n\n1. Any non-liver malignant deposit (except for resectable, hilar lymph nodes)\n2. Serum bilirubin, creatinine or INR outside of normal range\n3. Haemoglobin \\\u003C 7 g\u002FdL and thrombocytes \\\u003C 75 × 109\u002FL\n4. Liver failure (if cirrhosis, Child-Pugh B or C)\n5. Clinical evidence of portal hypertension (non-surgically related ascites, gastro-oesophageal varices, portal vein thrombosis)\n6. History of peripheral neuropathy\n7. More than 70 % of liver consisting of tumour\n8. History of other malignancy past three years except localized\u002Fearly stage cancer that has been adequately resected.\n9. Pregnant or lactating women\n10. Expected life expectancy less than three months.\n11. Inability to comply with study routines or follow-up procedures\n12. Inability to read and comprehend Norwegian\n13. Arterial anatomy unsuited for SIRT or HAI, respectively\n14. Any reason why, in the view of the investigators, the patient should not be included",{"count":144,"type":21},39,[54],"Patients with intrahepatic cholangiocarcinoma (IHC) have relatively aggressive tumors, and the prognosis for most of these patients is dismal. Surgery is the only option that can offer potential cure, but only an estimated 20-25 % are amenable to resection. Down-staging conventional chemotherapy has a relatively low response rate (\\\u003C 50 %). Patients will be included into the respective treatment arms based on their tumour characteristics and disease stage, but also based on their ability\u002Fpreferences, as HAI-FUDR\u002FDEX requires going to Oslo every fortnight for the duration of the treatment and SIRT has some limitations regarding tumour distribution.\n\nData from the MSKCC has suggested a clinically relevant benefit from adding intrahepatic chemotherapy to systemic therapy. HAI-FUDR\u002FDEX is not approved in Norway and can only be evaluated in a protocolized trial. Given the risk of distant disease progression with IHC, the addition of conventional systemic chemotherapy makes good clinical sense, and data from MSKCC supports this approach. SIRT is another modality also applied trans-arterially and directly into the tumour. This treatment is approved in Norway and available in Bergen and in Oslo. It is far less cumbersome to deliver and maintain than HAI-FUDR\u002FDEX. The efficacy and safety of the two treatment groups, HAI-FUDR\u002FDEX and SIRT, will be compared in a parallel cohort (non-randomized) design",[148,26],"Intrahepatic Cholangiocarcinoma","2026-01-29",{"date":151,"type":32},"2026-02-02",{"date":153,"type":32},"2024-02-13",{"date":155,"type":21},"2034-01",{"name":157,"class":39},"Oslo University Hospital",{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":166,"minAge":48,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":52,"phases":169,"briefSummary":170,"conditions":171,"keywords":175,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":40},"100418114","improving-cognitive-function-through-high-intensity-interval-training-in-breast-cancer-patients-undergoing-chemotherapy-100418114","NCT04724499","Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy","Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)","CLARITY","Inclusion Criteria:\n\n* Written informed consent prior to any study-related procedures\n* Women newly diagnosed (Stage I-III) breast cancer.\n* Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease\n* The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.\n* Will receive (neo)adjuvant chemotherapy\n* Speak English\n* Able to provide physician clearance to participate in the exercise program\n* Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)\n* Have not experienced a weight reduction ≥10% within the past 6 months\n* Currently participate in less than 60 minutes of structured exercise\u002Fweek\n* Does not smoke (no smoking during previous 12 months)\n* Willing to travel to DFCI for assessments (54 visits total for those who elect the exercise group with on campus training session, 6 visits for those that elect the exercise at home option, 6 visits for those assigned to the control group)\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease\n* Patients with other active malignancies are ineligible for this study.\n* Patients with metastatic disease\n* Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies\n* Participates in more than 60 minutes of structured exercise\u002Fweek\n* Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise\n* Have a pacemaker or any implantable device that are not MRI safe; the BWH\u002FDFCI Standard MRI screening form\n* Is unable to travel to DFCI\n* Patients who are pregnant\n* Patients with claustrophobia\n* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.","FEMALE",{"count":168,"type":21},30,[113],"The purpose of this research is to determine whether a 16-week high intensity interval training (HIIT) exercise program will improve brain health among women undergoing chemotherapy and also improve cardiovascular (heart) function.\n\nThe names of the study interventions involved in this study are\u002Fis:\n\n* High-Intensity Interval Training (HIIT)",[172,26,173,174],"Breast Cancer","Exercise Therapy","Cognitive Change",[172,26,173,174],"2026-01-20",{"date":178,"type":32},"2026-01-22",{"date":180,"type":32},"2021-07-14",{"date":182,"type":21},"2027-04-01",{"name":184,"class":39},"Dana-Farber Cancer Institute",{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":17,"minAge":193,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":52,"phases":197,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":4},"100621578","photobiomodulation-in-the-prevention-and-management-of-oral-mucositis-in-children-100621578","NCT07372443","Photobiomodulation in the Prevention and Management of Oral Mucositis in Children","Usefulness of Photobio-modulation in the Prevention and Management of Oral Mucositis in Pediatric Patients Undergoing Antineoplastic Treatment: Randomized Clinical Trial","PBMOM-PEDMX","Inclusion Criteria:\n\nPrevention Arm - Inclusion Criteria\n\n* Age 4 to 17 years\n* Histopathologic diagnosis of malignant neoplasm: leukemia, lymphoma, or solid tumor of the head and neck.\n* Within days 1-3 of the start of any chemotherapy cycle; for leukemia patients, in consolidation phase as defined by protocol.\n* No signs of oral mucositis at enrollment.\n* Availability and willingness to attend scheduled photobiomodulation (PBM) application sessions.\n* Parent\u002Flegal guardian signed informed consent and child assent when applicable (≥ 8 years).\n* No documented primary immunodeficiency.\n* No severe concomitant systemic infection or medical condition that, in the investigator's judgment, contraindicates participation.\n* No PBM treatment within 14 days prior to enrollment.\n* No history of adverse reactions to light therapies or known photosensitivity.\n* No history of seizure disorder or diagnosis of epilepsy.\n\nTreatment Arm - Inclusion Criteria\n\n* Age 4 to 17 years\n* Histopathologic diagnosis of malignant neoplasm: leukemia, lymphoma, or solid tumor of the head and neck.\n* Currently receiving chemotherapy (any cycle of the regimen).\n* Presence of oral mucositis of any grade during chemotherapy, identified within the first 3 days from onset of the mucositis episode.\n* Parent\u002Flegal guardian signed informed consent and child assent when applicable (≥ 8 years).\n* No documented primary immunodeficiency.\n* No severe concomitant systemic infection or medical condition that, in the investigator's judgment, contraindicates participation.\n* No photobiomodulation (PBM) treatment within 14 days prior to enrollment.\n* No history of adverse reactions to light therapies or known photosensitivity.\n* No history of seizure disorder or diagnosis of epilepsy.\n\nExclusion Criteria:\n\n* Documented primary immunodeficiency.\n* Severe concomitant systemic infection or unstable medical condition.\n* PBM treatment within 14 days prior to enrollment.\n* Known photosensitivity or prior adverse reaction to light therapy.\n* History of seizures or epilepsy.\n* Any condition that, in the investigator's opinion, would interfere with study participation or safety.\n\nParticipant Withdrawal Criteria\n\n* Attendance to fewer than 80% of scheduled treatment sessions.\n* Any adverse event or persistent discomfort attributed to PBM that leads the participant or guardian to decline further intervention.\n* Withdrawal of consent by parent\u002Fguardian or assent withdrawal by participant when applicable.\n* Development of a new medical condition that, per investigator judgment, contraindicates continuation.","4 Years","17 Years",{"count":196,"type":21},49,[113],"Oral mucositis (OM) is a frequent, debilitating complication in pediatric oncology that impairs quality of life, nutrition, hydration, and treatment adherence. This randomized, prospective, single blind trial in Mexico will evaluate photobiomodulation (PBM) versus a conventional bioadhesive gel for prevention and treatment of antineoplastic therapy-induced OM in children aged 4-17 with leukemia, lymphoma, or head and neck tumors. A total of 49 participants will be enrolled. The study has two components: (1) Treatment - parallel comparison of PBM versus bioadhesive gel for established OM; (2) Prevention - crossover design in which patients receive both interventions across successive chemotherapy cycles. PBM will be delivered with a 660 nm device, 40 mW, 10 J\u002Fcm². The primary outcome is OM grade by the WHO scale assessed on days 7, 11, 14, and 21. Expected results include reduced OM incidence, severity, duration, and pain with favorable safety and tolerability, supporting standardized PBM protocols in pediatric oncology in Mexico.",[200,26,117],"Oral Mucositis",[202],"Photobiomodulation","NOT_YET_RECRUITING","2026-01-19",{"date":206,"type":32},"2026-01-28",{"date":208,"type":21},"2026-01",{"date":210,"type":21},"2027-08",{"name":212,"class":39},"Universidad de Guanajuato",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":52,"phases":222,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":40},"100425581","phase-3-neoadjuvant-treatment-modalities-in-esophageal-cancer-100425581","NCT04821843","Neoadjuvant Treatment Modalities in Esophageal Cancer","Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer","Inclusion Criteria:\n\n* ≥18 years；\n* Esophageal or Esophagogastric cancer；\n* Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa (AJCC 8th)；\n* Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；\n* ECOG PS score: 0\\~1；\n* Estimated survival time ≥3 months；\n* Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g\u002FL ;Leukocytes: greater than or equal to 4,000 G\u002FL; Neutrophil: greater than or equal to 2,000 G\u002FL; Platelets: greater than or equal to 100,000\u002Fmm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml\u002Fmin; AST\u002FALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit；\n* Informed consent；\n\nExclusion Criteria:\n\n* With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc；\n* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer；\n* Existing active infection such as active tuberculosis and hepatitis；\n* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia；\n* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin；\n* Participation in other clinical trials currently or within 4 weeks of selection；\n* Pregnant or lactating females；\n* Absence of medical records.",{"count":221,"type":21},2000,[223],"PHASE3","Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1\u002FPD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.",[226,26,227,228,229,230,231],"Esophageal Cancer","Chemoradiation","Surgery","Targeted Therapy","Immunotherapy","Esophagogastric Juction Cancer","2026-01-18",{"date":234,"type":32},"2026-01-21",{"date":236,"type":32},"2002-01-01",{"date":238,"type":21},"2030-12-31",{"name":240,"class":39},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":52,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":256,"leadSponsor":257,"locationsCount":258},"100425577","phase-3-chemoradiotherapy-in-esophageal-or-esophagogastric-junction-cancer-100425577","NCT04821778","Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer","Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer","Inclusion Criteria:\n\n* ≥18 years；\n* Esophageal or Esophagogastric cancer；\n* Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa(AJCC 8th)；\n* Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；\n* ECOG PS score: 0\\~1；\n* Estimated survival time ≥3 months；\n* Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g\u002FL ;Leukocytes: greater than or equal to 4,000 G\u002FL; Neutrophil: greater than or equal to 2,000 G\u002FL; Platelets: greater than or equal to 100,000\u002Fmm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml\u002Fmin; AST\u002FALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit；\n* Informed consent；\n\nExclusion Criteria:\n\n* With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc；\n* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer；\n* Existing active infection such as active tuberculosis and hepatitis；\n* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia；\n* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin；\n* Participation in other clinical trials currently or within 4 weeks of selection；\n* Pregnant or lactating females；\n* Absence of medical records.",{"count":221,"type":21},[223],"Definitive chemoradiotherapy is the standard of care in unresectable esophageal or esophagogastric cancer. A multidisciplinary approach, including chemotherapy and radiotherapy, is important for these patients. Morerover, molecular targeting agents does not show clear efficacy in EC up to now. Nowadays, the pace of development of cancer immunotherapies is accelerating. Clinical evidence of the efficacy of immune checkpoint inhibitors and adoptive immunotherapies herald the onset of a new era in cancer immunotherapy. There have also been recent developments to provide a promising frontier in extending the use of immunotherpay or targeting agents to radiotherapy. The purpose of this study was to explore the optimal treatment modalities including PD-1\u002FPD-L1 antibody or targeted drug for patients with unresectable esophageal or esophagogastric junction cancer.",[252,253,227,229,230,26],"Esophagus Cancer","Esophagogastric Junction Cancer",{"date":234,"type":32},{"date":236,"type":32},{"date":238,"type":21},{"name":240,"class":39},5,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":52,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":40},"100489187","anxiolytic-effects-of-socio-aesthetics-in-cancer-patients-undergoing-chemotherapy-100489187","NCT05649852","Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy","Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy (PASITHEA)","PASITHEA","Inclusion Criteria:\n\n* Patient with cancer treated with adjuvant chemotherapy with an interval of 14 or 21 days for the first 3 cycles;\n* Chemotherapy naïve patient;\n* Patient speaking and understanding French and able to complete the questionnaires;\n* Patient having been informed and having signed an informed consent form to participate in the study.\n\nExclusion Criteria:\n\n* Patient who has already benefited from socio-aesthetic care;\n* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);\n* Patient unable to understand the information related to the study (linguistic, psychological, cognitive reasons, etc.);\n* Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;\n* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;\n* Patient not benefiting from a social security scheme.",{"count":268,"type":21},192,[113],"The purpose of the study is to assess the average of the \"State Anxiety\" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)",[26],"2026-01-13",{"date":274,"type":32},"2026-01-15",{"date":276,"type":32},"2023-03-23",{"date":278,"type":21},"2027-06-30",{"name":280,"class":39},"GCS Ramsay Santé pour l'Enseignement et la Recherche",{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":52,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":40},"100613531","phase-3-camrelizumab-and-apatinib-with-or-without-folfox-chemotherapy-for-advanced-hcc-100613531","NCT07267806","Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC","Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy as First-Line Treatment for Advanced Hepatocellular Carcinoma (HCC): A Randomized, Controlled, Open-Label, Multicenter Phase III.","Inclusion Criteria:\n\n1. Patients volunteered to participate in this study and signed informed consent;\n2. ≥18 years old, male and female;\n3. Before treatment, it was confirmed by histopathology or cytology, or clinically diagnosed as hepatomegaly.Patients with Hepatocellular Carcinoma, HCC);\n4. BCLC stage B or C hepatocellular carcinoma, which is not suitable for curative surgical or local therapies, or has progressed after such treatments.\n5. Local therapy (including but not limited to surgery, radiation therapy, transarterial chemoembolization \\[TACE\\], hepatic arterial infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) must have been completed at least 4 weeks prior to the baseline radiographic scan (with the exception of palliative radiotherapy, for which a 2-week interval is sufficient).\"\n6. Has not received any systemic treatment for HCC.\n7. According to RECIST 1.1 standard, patients have at least one measurable lesion (CT\u002FMRI scan long diameter ≥10mm or CT\u002FMRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);\n8. Child-pugh liver function grading: Grade A or Grade Better B (≤7 points)\n9. ECOG PS score 0-2;\n10. Expected survival ≥ 12 weeks;\n11. Major organ functions are basically normal and meet the following requirements (within 7 days before starting the study treatment):\n\n    1. Complete blood count: absolute neutrophil count ≥ 1.5\\*10\\^9\u002FL, platelets (PLT) ≥ 75\\*10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL;\n    2. Blood biochemistry: albumin ≥ 25 g\u002FL; total bilirubin ≤ 3.0 × upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 5 × ULN; creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CrCl) \\> 50 mL\u002Fmin.\n    3. International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) no more than 6 seconds above the normal control range;\n    4. Urine protein \\\u003C2 (if urine protein ≥2, a 24-hour urine protein quantification can be performed; 24-hour urine protein \\\u003C1.0 g is allowed for inclusion).\n12. Patients with active hepatitis B virus (HBV) infection must receive anti-HBV therapy prior to initiating study treatment and be willing to continue antiviral therapy throughout the study; hepatitis C virus (HCV) RNA-positive patients must receive antiviral therapy according to local standard treatment guidelines with liver function not exceeding CTCAE grade 1 elevation.\n13. Women of childbearing potential should have a negative serum or urine pregnancy test within 7 days prior to study enrollment, must not be breastfeeding, and must agree to use contraception during the study and for 6 months after the study; men must agree to use contraception during the study and for 6 months after the study.\n\n    \\-\n\nExclusion Criteria:\n\n1. Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, and fibrolamellar carcinoma; having other active malignancies within the past 5 years or simultaneously, excluding HCC. Successfully treated localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included.\n2. Patients who are preparing for or have previously undergone organ or allogeneic hematopoietic stem cell transplantation;\n3. Patients with clinical symptoms of moderate to severe ascites that require therapeutic puncture or drainage; uncontrolled pleural effusion or pericardial effusion of moderate amount or more;\n4. Patients with a history of gastrointestinal bleeding within 6 months before the start of the study treatment or a clear tendency for gastrointestinal bleeding, such as: high-risk or severe esophageal and gastric varices, localized active gastrointestinal ulcer lesions, or persistent positive fecal occult blood;\n5. Patients who have had abdominal fistulas, gastrointestinal perforation, or intra-abdominal abscesses within 6 months before the start of the study treatment;\n6. Patients with known hereditary or acquired bleeding disorders (such as coagulation dysfunction) or thrombophilia.\n7. Currently using or having recently used (within 10 days before the start of the study treatment) aspirin \\[\\>325 mg\u002Fday (maximum antiplatelet dose)\\] or dipyridamole, ticlopidine, clopidogrel, and cilostazol;\n8. Occurrence of thrombotic or embolic events within 6 months before the start of the study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary .embolism).\n9. Uncontrolled cardiac clinical symptoms or conditions, such as:\n\n   1. Heart failure of NYHA class II or above;\n   2. Unstable angina;\n   3. Myocardial infarction occurring within the past year;\n   4. Clinically significant supraventricular or ventricular arrhythmias requiring medical intervention;\n   5. Patients with hypertension whose condition is poorly controlled by medication and who are assessed by a doctor to be at high risk when using apatinib;\n10. Suffering from hypertension that cannot be well controlled with antihypertensive medication (systolic ≥140 mmHg or diastolic ≥90 mmHg); history of hypertensive crises or hypertensive encephalopathy;\n11. Major vascular disease occurring within 6 months prior to the start of study treatment (e.g., an aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis);\n12. Severe, non-healing, or dehisced wounds, as well as active ulcers or untreated fractures;\n13. Undergoing major surgery (except for diagnosis) within 4 weeks before the start of study treatment or anticipated need for major surgery during the study period;\n14. Inability to swallow pills, malabsorption syndrome, or any condition affecting gastrointestinal absorption;\n15. History of intestinal obstruction and\u002For clinical signs or symptoms of gastrointestinal obstruction within 6 months before starting study treatment;\n16. Evidence of intra-abdominal gas that cannot be explained by puncture or recent surgery;\n17. Past or present central nervous system metastases; 18. History of hepatic encephalopathy.\n18. Currently accompanied by interstitial pneumonia or interstitial lung disease, or with a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or other conditions that may interfere with the assessment and management of immune-related lung toxicity, such as pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or severely impaired lung function; active tuberculosis;\n19. Currently accompanied by interstitial pneumonia or interstitial lung disease, or with a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or other conditions that may interfere with the assessment and management of immune-related lung toxicity, such as pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or severely impaired lung function; active tuberculosis;\n20. Subjects with active autoimmune diseases or a history of autoimmune diseases that may relapse (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[subjects whose condition can be controlled solely with hormone replacement therapy may be included\\]); subjects with skin diseases that do not require systemic treatment such as vitiligo, psoriasis, or alopecia, subjects with type 1 diabetes controlled with insulin therapy, or subjects whose childhood asthma has fully resolved and require no intervention as adults may be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included.\n21. Use of immunosuppressants or systemic steroid therapy within 14 days prior to the start of study treatment to achieve immunosuppression (dose \\>10 mg\u002Fday of prednisone or other equivalent steroids);\n22. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications; oral or intravenous therapeutic antibiotics within 2 weeks prior to the start of study treatment (patients receiving prophylactic antibiotics are eligible for the study, such as for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease);\n23. Congenital or acquired immunodeficiency (e.g., HIV infection);\n24. Coinfection with hepatitis B and hepatitis C;\n25. Prior treatment with other anti-PD-1 antibodies or other PD-1\u002FPD-L1 targeted immunotherapies, or prior treatment with apatinib;\n26. Vaccination with live attenuated vaccines within 28 days prior to the start of study treatment, or anticipated need for such vaccines during camrelizumab treatment or within 60 days after the last dose of camrelizumab;\n27. Treatment with other investigational drugs within 28 days prior to the start of study treatment.\n28. According to the researcher's judgment, the patient has other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe illnesses (including psychiatric disorders) requiring combined treatment, significant abnormalities in laboratory tests, or family or social factors that could affect the patient's safety.",{"count":289,"type":21},326,[223],"This is a multi-center randomized phase III clinical study of first-line Camrelizumab and Apatinib with or without intravenous FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma (HCC).",[293,26],"Hepato Cellular Carcinoma (HCC)","2025-12-08",{"date":296,"type":32},"2025-12-16",{"date":298,"type":32},"2025-10-31",{"date":300,"type":21},"2032-10",{"name":302,"class":39},"Linhui Peng",{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":310,"targetDuration":4,"studyType":52,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":40},"100529317","phase-3-infusional-folfox-plus-camrelizumab-and-apatinib-vs-haic-folfox-plus-camrelizumab-and-apatinib-for-advanced-hcc-100529317","NCT06172205","Infusional FOLFOX Plus Camrelizumab and Apatinib vs HAIC-FOLFOX Plus Camrelizumab and Apatinib for Advanced HCC","Infusional FOLFOX Plus Camrelizumab and Apatinib Versus HAIC-FOLFOX Plus Camrelizumab and Apatinib for Hepatocellular Carcinoma of BCLC C Stage: A Multi-center Randomized Phase III Trial","Inclusion Criteria:\n\n1. Age 18-75, male or female;\n2. The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to BCLC stage C.\n3. Child-pugh liver function grading: Grade A or B\n4. Did not received any type of other first-line drugs such as Sorafenib\n5. According to RECIST 1.1 standard, patients have at least one measurable lesion (CT\u002FMRI scan long diameter ≥10mm or CT\u002FMRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);\n6. ECOG PS score 0-2;\n7. Expected survival ≥ 12 weeks;\n8. The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days): Blood routine:White blood cells count ≥3.0×10\\^9\u002FL Platelet count ≥70×10\\^9\u002FL Hemoglobin ≥80g\u002FL(without blood transfusion); Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN); Total bilirubin (TBIL) ≤ 3 times the upper limit of normal value (ULN); AST or ALT levels ≤ 3 times the upper limit of normal value (ULN)\n9. Subjects with HBV or HCV infection should receive anti-virus treatment without interfron.\n10. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within six months of the end of medication;Patients with negative serum or urine pregnancy tests within 7 days prior to study inclusion and who must be non-lactating, and males should agree to use contraceptives during the study period and for 6 months after the end of the study period.\n11. Patients volunteered to participate in this study and signed informed consent; Subjects have good compliance and cooperate with the follow-up.\n\nExclusion Criteria:\n\n1. Have received immunotherapeutic drugs or interferon in the past.\n2. Severe allergic reaction to other monoclonal antibodies, immunotherapy or chemotherapy.\n3. Female subjects with pregnancy or on feeding.\n4. Patients with congenital or acquired immune deficiencies.\n5. Abnormal coagulation function (INR\\>2.0, PT\\>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin\n6. The patient has suffered from other malignant tumors at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ)\n7. The patient has active infection, fever of unknown origin within 7 days (CTCAE\\>2)\n8. Patients with congenital or acquired immune deficiencies.\n9. Severe coagulation dysfunction (INR \\> 2.0, PT \\> 16s), with a significant tendency to bleed (including but not limited to vomiting blood or passing blood in stool daily within the past 3 months);\n10. Moderate to severe ascites with clinical symptoms that require therapeutic puncture or drainage, or Child-Pugh score \\> 2 (except for cases where imaging shows only a small amount of ascites without clinical symptoms); uncontrolled or moderate to large pleural effusion or pericardial effusion;\n11. Patients are to be excluded if they have a history of gastrointestinal bleeding within 6 months prior to the start of the study treatment, or have a definite tendency for gastrointestinal bleeding, including but not limited to: bleeding-risk or severe esophageal\u002Fgastric varices, locally active ulcerative lesions, or persistently positive fecal occult blood tests.\n12. Occurrence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the start of study treatment;\n13. Occurrence of thrombotic or embolic events within 6 months prior to the start of study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, cerebrovascular abnormalities, cerebral aneurysm), pulmonary embolism, etc.;\n14. Major vascular disease within 6 months prior to the start of study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis); severe, unhealed, or dehisced wounds, as well as active ulcers or untreated fractures; Criteria for Discontinuation of Study Treatment\n15. Previous or current presence of central nervous system metastases;\n16. Individuals with a history of substance abuse of psychiatric medications who are unable to quit, or those with mental disorders; or those with brain metastases or hepatic encephalopathy;\n17. According to the judgment of the investigator, the patients with factors that may affect the results of the study or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) need to be treated together, severe laboratory abnormalities, accompanied by family or social factors, which will affect the safety of patients",{"count":311,"type":21},262,[223],"This is a multi-center randomized phase III clinical study of first-line intravenous FOLFOX plus Camrelizumab and apatinib versus HAIC-FOLFOX plus Camrelizumab and apatinib for BCLC C stage hepatocellular carcinoma.",[315,26],"BCLC Stage C Hepatocellular Carcinoma","2025-11-25",{"date":318,"type":32},"2025-12-03",{"date":320,"type":32},"2023-07-01",{"date":322,"type":21},"2029-07-31",{"name":324,"class":39},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":332,"sex":166,"minAge":48,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":52,"phases":336,"briefSummary":337,"conditions":338,"keywords":342,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":40},"100505660","improve-cancer-related-cognitive-impairment-100505660","NCT05864274","Improve Cancer-related Cognitive Impairment","Using a Novel Mobile Cognitive Training Application to Improve Cancer-related Cognitive Impairment in Gynecologic Oncology Patients","Inclusion criteria are:\n\n* newly diagnosed gynecologic malignancy (uterine, cervical, ovarian, primary peritoneal, vulvar, or vaginal) and undergoing chemotherapy\n* own a smartphone or tablet with ability to download cognitive training application\n* and age \\>21 years old\n\nExclusion criteria include:\n\n* medical diagnosis of dementia\n* significant underlying mental diagnoses for which they are on more than 1 medication for (patients with depression or anxiety on single-agent therapy will be able to participate\n* age \\\u003C21",true,"90 Years",{"count":335,"type":21},64,[113],"Cancer-related cognitive impairment (CRCI), also known as \"chemobrain,\" is the cognitive decline that negatively impacts the majority of cancer patients undergoing chemotherapy, radiation, and\u002For hormonal treatments. This application focuses on evaluating if using a cognitive mobile training application can decrease the impact of CRCI in gynecologic oncology patients through a multidisciplinary approach with patients undergoing assessments by our neurocognitive team.",[339,26,340,341],"Gynecologic Cancer","Chemo-brain","Cancer-related Cognitive Difficulties",[343,344,345,346],"CHEMOTHERAPY SIDE EFFECTS","GYNECOLOGIC CANCERS","CHEMO-BRAIN","CANCER-RELATED COGNITIVE IMPAIRMENT","2025-11-18",{"date":349,"type":32},"2025-11-24",{"date":351,"type":32},"2024-09-01",{"date":353,"type":21},"2027-08-01",{"name":355,"class":39},"University of Alabama at Birmingham",{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":52,"phases":364,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":4},"100601285","phase-2-efficacy-and-safety-of-lm-302-combined-with-gemcitabine-cldn-182-positive-unresectable-locally-advanced-or-metastatic-pancreatic-cancer-100601285","NCT07108504","Efficacy and Safety of LM-302 Combined With Gemcitabine CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer","An Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of LM-302 Combined With Gemcitabine as Second-line Treatment for CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n1. Capable of providing written informed consent, understanding and complying with study requirements. Willing to participate after full disclosure of the study's purpose, procedures, potential risks, and benefits, and must sign the informed consent form before any study-related procedures.\n2. Age ≥18 years old.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks before the first dose.\n4. Expected survival ≥3 months.\n5. Histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) not amenable to curative treatment.\n6. Must have experienced disease progression or intolerance to first-line standard therapy containing 5-FU (fluorouracil) (radiologically confirmed).\n7. At least one measurable lesion per RECIST v1.1.\n8. Must provide 5-7 unstained slides from archived (within 3 years) or fresh tumor tissue for CLDN18.2 and other biomarker testing. CLDN18.2 positivity defined as: Moderate-to-high staining intensity (2+\\~3+) in ≥50% of tumor cells, as assessed by central laboratory IHC (immunohistochemistry).\n9. Adequate Organ Function (within 7 days before first dose) Bone marrow function: Platelets (PLT) ≥90 × 10⁹\u002FL; Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL; Hemoglobin ≥9 g\u002FdL (no erythropoietin \\[EPO\\], G-CSF, or GM-CSF support within 14 days, and no transfusions within 7 days prior to treatment) Coagulation: INR ≤1.5; APTT ≤1.5 × ULN Liver function: Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome); AST\u002FALT ≤2.5 × ULN (≤5 × ULN if liver metastases present); Serum albumin (ALB) ≥28 g\u002FL Renal function: Serum creatinine ≤1.5 × ULN; Creatinine clearance (CrCl) ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula) Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%; QTcF interval ≤470 ms\n10. Females of childbearing potential and males with fertile partners must agree to use highly effective contraception from 7 days before the first dose until 6 months after the last dose.\n11. Able to communicate effectively with investigators and comply with all study requirements.\n\nExclusion Criteria:\n\n1. Previous treatment with gemcitabine or nab-paclitaxel.\n2. Received any investigational drug or therapy within 28 days before the first dose of the study drug.\n3. Recent Anticancer Therapy (within 21 days before the first dose, except for): Palliative radiotherapy (e.g., for bone metastasis pain control) within 14 days. Oral drugs (e.g., fluoropyrimidines, small-molecule targeted agents) within 14 days or 5 half-lives (whichever is longer). Traditional Chinese medicine with anticancer indications within 14 days. Nitrosoureas or mitomycin C within 42 days. Therapeutic radiopharmaceuticals within 56 days.\n4. Residual Toxicities from Prior Therapy Adverse reactions from prior anticancer therapy have not recovered to CTCAE v5.0 Grade ≤1 (except for non-safety risks, such as alopecia, chronic radiotherapy toxicities ≤Grade 2, or lymphopenia).\n5. Poorly Controlled Tumor-Related Pain Patients requiring analgesics must be on a stable dose before study entry.\n6. Active or Untreated CNS Metastases Excludes those with previously treated, stable brain metastases (confirmed by imaging ≥4 weeks before the first dose, no new neurological symptoms, and no progression).\n7. Proteinuria Urine protein ≥3+, or 2+ with 24-hour urine protein \\>1 g.\n8. Recent Life-Threatening Hemorrhage Any major bleeding event within 3 months before the first dose.\n9. High-Risk Esophageal\u002FGastric Varices Requires endoscopic evaluation within 3 months before the first dose if there is a history of variceal bleeding.\n10. Severe Liver Dysfunction Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B\u002FC cirrhosis.\n11. Uncontrolled Third-Space Fluid Accumulation Clinically significant ascites\u002Fpleural effusion requiring repeated drainage, recent intervention (within 14 days), or causing complications (e.g., bowel obstruction).\n12. Tumor Invasion of Critical Structures Encasement of major vessels (aorta, SVC, etc.) or risk of fistula formation (e.g., tracheoesophageal, pleuroesophageal).\n13. History of GI Perforation\u002FFistula Within 6 months before the first dose.\n14. Bowel Obstruction\u002FPerforation Risk Complete\u002Fincomplete intestinal obstruction or high perforation risk within 3 months before the first dose.\n15. Hypersensitivity to Antibody-Based Therapies History of ≥Grade 3 infusion reactions to monoclonal\u002Fbispecific antibodies, ≥Grade 3 immune-related AEs from prior immunotherapy, or discontinuation due to severe immune toxicity.\n16. Recent Systemic Corticosteroid Use ≥10 mg\u002Fday prednisone (or equivalent) for \\>7 days within 2 weeks before the first dose (topical\u002Focular\u002Finhaled steroids allowed).\n17. Active Autoimmune Disease Includes but not limited to: Autoimmune hepatitis, SLE, rheumatoid arthritis, myasthenia gravis, multiple sclerosis. Exceptions: Stable hypothyroidism on hormone replacement, vitiligo, or psoriasis not requiring systemic therapy.\n18. Inflammatory Bowel Disease (IBD) Active or history of Crohn's disease, ulcerative colitis, or chronic diarrhea.\n19. Interstitial Lung Disease (ILD) Current or prior ILD requiring systemic corticosteroids.\n20. Peripheral Neuropathy ≥Grade 2 sensory\u002Fmotor neuropathy at screening.\n21. Allergy to MMAE-Based ADCs Known ≥Grade 3 hypersensitivity to antibody-drug conjugates containing monomethyl auristatin E (MMAE).\n22. Prior CLDN18.2-Targeted Therapy Any previous treatment targeting claudin 18.2 (CLDN18.2).\n23. Strong CYP3A4 Modifiers Use of strong inhibitors\u002Finducers within 14 days before the first dose.\n24. Live Vaccination Received live\u002Flive-attenuated vaccines within 28 days (e.g., MMR, varicella, BCG, yellow fever). Allowed: Inactivated\u002FmRNA COVID-19 vaccines, seasonal flu shots (non-nasal).\n25. Therapeutic Anticoagulation Current use of heparin\u002Fwarfarin (except prophylactic low-dose therapy).\n26. Major Surgery\u002FTrauma Undergone major surgery or invasive procedures within 28 days, or with unhealed wounds\u002Ffractures.\n27. Severe Cardiovascular Disease Includes: Uncontrolled arrhythmias (e.g., ventricular tachycardia, AV block ≥Grade 2). Thromboembolism requiring anticoagulation. NYHA Class III\u002FIV heart failure. Acute coronary syndrome, stroke, or ≥Grade 3 CV events within 6 months. Uncontrolled hypertension.\n28. Active Infection Severe infections (e.g., sepsis, pneumonia) within 4 weeks, or ongoing systemic antibiotics within 2 weeks (except HBV\u002FHCV antiviral therapy).\n29. Immunodeficiency History of primary\u002Fsecondary immunodeficiency, organ transplant, or stem cell transplant (unless no immunosuppression needed).\n30. Chronic Viral Infections HIV-positive; Active HBV\u002FHCV (exceptions): HBsAg+ if HBV DNA \\\u003C500 IU\u002FmL or undetectable; HCV Ab+ if HCV RNA negative.\n31. Active Tuberculosis (TB) Must be ruled out clinically if suspected.\n32. Other Malignancies Concurrent or history of other cancers within 5 years, except: Cured non-melanoma skin cancer, bladder CIS, low-risk prostate cancer (stage ≤T2a, Gleason ≤6, PSA ≤10 ng\u002FmL), or cervical\u002Fbreast CIS.\n33. Pregnancy\u002FLactation Positive pregnancy test within 7 days or breastfeeding.\n34. Psychiatric Disorders Conditions affecting compliance or safety judgment.\n35. Non-Cancer-Related Systemic Illness Severe comorbidities (e.g., leukemoid reaction (WBC \\>20×10⁹\u002FL), cachexia (\\>15% weight loss in 3 months).\n36. Investigator's Discretion Any other condition deemed unsuitable for study participation.",{"count":168,"type":21},[54],"The goal of this clinical trial is to evaluate the efficacy and safety of LM-302 combined with gemcitabine as a second-line treatment for CLDN 18.2-positive unresectable locally advanced or metastatic pancreatic cancer.\n\nThe main questions it aim to answer:\n\n1. Does LM-302 plus gemcitabine improve the objective response rate (ORR, per RECIST 1.1) compared to historical controls?\n2. What is the safety and tolerability profile of this combination therapy?\n\nParticipants will receive:\n\n1. Gemcitabine (1000 mg\u002Fm² IV on Days 1, 8, and 15) in 4-week cycles, and LM-302 (1.8 mg\u002Fkg IV on Day 1) in 2-week cycles,\n2. Undergo regular tumor imaging (CT\u002FMRI) and safety assessments;\n3. Provide blood samples for biomarker and pharmacokinetic analyses.",[367,26],"Pancreatic Cancer",[369,370,371,372],"pancreatic adenocarcinoma","CLDN18.2","LM302","Gemcitabine","2025-08-06",{"date":375,"type":32},"2025-08-07",{"date":377,"type":21},"2025-08-10",{"date":379,"type":21},"2028-08-10",{"name":381,"class":39},"Shanghai Zhongshan Hospital",{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":390,"enrollmentInfo":391,"targetDuration":392,"studyType":22,"phases":4,"briefSummary":393,"conditions":394,"keywords":399,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":134},"100497317","on-treatment-biomarkers-in-metastatic-colorectal-cancer-for-life-100497317","NCT05755672","On-treatment Biomarkers in Metastatic Colorectal Cancer for Life","On-treatment Biomarkers in Metastatic Colorectal Cancer for Life: The On-CALL Study","On-CALL","Inclusion Criteria:\n\n* Clinical diagnosis of synchronous metastatic colorectal cancer, planned cancer treatment with curative intent at the Skåne University Hospital\n\nExclusion Criteria:\n\n* Not accepting the study inclusion terms (informed consent not obtained)\n* Age below or above the age limit","110 Years",{"count":80,"type":21},"10 Years","By virtue of an increased strategic use of cytotoxic and biological agents, and more options for locoregional treatment, the survival of patients with metastatic colorectal cancer (mCRC) has improved considerably in the past decades. The personalized approach to systemic treatment is further aided by the use of complementary molecular biomarkers. However, the evolutionary dynamics of mCRC, a disease harnessed by multiple adaptive genetic alterations towards its final stages, poses a particular challenge to single-sample biomarker analyses and standardized linear treatment protocols. The aim of the On-treatment biomarkers in metastatic ColorectAL cancer for Life (On-CALL) study is to generate further knowledge on the evolutionary progression of mCRC during treatment, and to elucidate the mechanisms underlying the therapeutic failure still seen in a substantial number of patients.\n\nThe On-CALL study is a prospective, single-arm observational study. All patients diagnosed with synchronous mCRC treated with curative intent at Skåne University Hospital will be invited to participate. Clinical and histopathological data will be compiled at study entry. An individual tissue microarray block with samples from resected primary tumours and metastases representing the full extent of the tumour spread will be constructed for each patient. Blood samples will be drawn for biomarker analyses at multiple time points prior to, during and after systemic treatment. DNA sequencing of tumour tissue and circulating tumour DNA (ctDNA) will be performed to define the spatial clonal landscape in primary tumours and metastases, as well as over time.",[395,26,396,397,398],"Metastatic Colorectal Cancer","Peritoneal Metastases","Liver Metastasis Colon Cancer","Lung Metastases",[400,401,402,403,404],"Metastatic colorectal cancer","Chemotherapy","Targeted therapy","Tumor heterogeneity","Tumor evolution","2025-07-14",{"date":407,"type":32},"2025-07-17",{"date":409,"type":32},"2023-03-01",{"date":411,"type":21},"2033-03",{"name":413,"class":39},"Region Skane",{"id":415,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":417,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":422,"leadSponsor":424,"locationsCount":40},"100553739",{"count":20,"type":21},[25,26,27],"2025-07-09",{"date":420,"type":32},"2025-07-11",{"date":34,"type":32},{"date":423,"type":21},"2026-06-18",{"name":38,"class":39},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":166,"minAge":48,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":52,"phases":435,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":40},"100415841","quality-of-life-improvement-during-chemotherapy-100415841","NCT04694885","Quality of Life Improvement During Chemotherapy","Quality of Life Improvement of Breast Cancer Patients During Chemotherapy With Structured Psychological Interventions","QoLMa","Inclusion Criteria:\n\n* Minimum Age 18 years\n* Female\n* Primary breast cancer\n* Receiving neo-adjuvant or adjuvant chemotherapy\n\nExclusion Criteria:\n\n* Verbal or cognitive deficits that are not compatible with outpatient psychotherapy\n* Not consenting patients and vulnerable persons\n* Psychological disorders that prevent patients from participating in the study (e.g. psychotic disorder)\n* acute suicidality",{"count":434,"type":21},62,[113],"This study is a randomized controlled trial, taking place at the University Hospital Basel (CH). It aims at the alleviation of breast cancer patients' life quality during chemotherapy.\n\nThe intervention group will participate in 10 sessions of structured hypnotherapy during the course of chemotherapy in addition to the standard of care. The control group will have access to the standard of care without any additional treatment. The main goal of the study is to investigate whether quality of life is higher among patients in the intervention group. Additionally, it will be analyzed if the interventions have a positive effect on chemotherapy side effects, symptoms of anxiety and depression and the immune system. Finally, the relative dose intensity (RDI) as well as treatment schedule adherence will be assessed.\n\nThere are no risks to be expected from the intervention itself. In the case of positive findings, the standard of psycho-oncological care can be updated by integrating structured hypnotherapeutic interventions into the treatment of patients with breast cancer.",[438,26],"Breast Cancer Female",[440,401,441,442,443,444,445,446,447],"Breast cancer","Hypnotherapy","Hypnosis","Quality of life","Anxiety","Depression","Immunity","Dose-response effect","2025-07-08",{"date":418,"type":32},{"date":451,"type":32},"2021-07-31",{"date":453,"type":21},"2026-12-30",{"name":455,"class":39},"Christian Schwegler",{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":465,"conditions":466,"keywords":472,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":40},"100440369","cognitive-impairment-in-colorectal-cancer-patients-receiving-cytotoxic-chemotherapy-100440369","NCT05014399","Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy","Chemo Brain","Inclusion Criteria:\n\n* Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) prior to study-specific screening procedures. Must be able to provide study-specific informed consent prior to study entry.\n* A histologically-confirmed colorectal tumor\n* Patients who will be treated with cytotoxic chemotherapies including Capecitabine, Oxaliplatin, 5 fluorouracil, and Irinotecan are eligible.\n* Patients must not have received cytotoxic chemotherapy previous to enrollment.\n\nExclusion Criteria:\n\n* Prior administration of anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents\n* Patients having mental incompetence as assessed by study PI, which would hinder completion of the surveys\n* Pregnant or breastfeeding\n* Any known brain metastases\n* Non-English speaking patients\n* Patients who have been diagnosed with any neuro-cognitive disorder including traumatic brain injuries, Alzheimer's disease, Parkinson's disease, Huntington's disease, and Creutzfeldt-Jakob disease.\n* Patients deemed inappropriate to participate in this study by the study PI or coordinator will be excluded.",{"count":464,"type":21},60,"The purpose of this research study is to see how the brain changes in patients receiving chemotherapy (cytotoxic drug) treatment for colon or rectal cancer at Parkview Cancer Institute. This information will be used to identify helpful tests to diagnose individuals at risk for developing difficulties with thinking and memory due to their cancer treatments.",[467,468,469,174,340,470,26,471],"Neoplasm, Colorectal","Cognitive Impairment","Cognitive Dysfunction","Chemo Fog","Cognitive Decline",[473,474,475,476,468,461],"Palliative Care","Palliative Oncology","Supportive Care","Supportive Oncology","2025-06-06",{"date":479,"type":32},"2025-06-11",{"date":481,"type":32},"2021-09-20",{"date":483,"type":21},"2031-10",{"name":485,"class":39},"Joseph McCollom",{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":496,"conditions":497,"keywords":501,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":258},"100588683","a-new-clinical-pathway-for-personalized-management-of-borderline-resectable-and-locally-advanced-pancreatic-cancer-100588683","NCT06944587","A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer","A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer - Norwegian Pancreatic Cancer Trial-3 (NORPACT 3)","NORPACT-3","Inclusion Criteria:\n\n* Borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2021) (Appendix 3)\n* Nx, M0 (UICC 8th version, 2016)\n* Cytological or histological confirmation of adenocarcinoma\n* Age \\>18 year\n* Considered able to receive primary chemotherapy and possible surgery\n* Written informed consent\n\nExclusion Criteria:\n\n* Co-morbidity or performance status precluding primary chemotherapy\n* Co-morbidity or performance status precluding pancreatectomy\n* Female patients in child-bearing age not using adequate contraception, pregnant or lactating women\n* Mental or physical disorders that could interfere with treatment of with the provision of informed consent\n* Any reason why, in the opinion of the investigator, the patient should not participate",{"count":495,"type":21},400,"NORPACT-3 is a nationwide, Norwegian single arm prospective study that evaluates the resectability rates and survival in patients with borderline resectable and locally advanced pancreatic cancer who received primary chemotherapy. Eligible patients are treated with primary chemotherapy possibly followed by surgical exploration and resection. All Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The assignment of the medical intervention is not at the discretion of the investigator, but follow the national Norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up. The primary aim is a national resection rate of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy, with adequate overall survival and morbidity\u002Fmortality (after resection median overall survival of 24 months, 1 year survival 80%, and 5 year survival \\>20% + 90 day postoperative mortality ≤5%, 90-day postoperative major morbidity (Clavien Dindo grade 3) ≤40%).",[498,499,500,26],"Locally Advanced Pancreatic Cancer","Borderline Resectable Pancreatic Cancer","Pancreatectomy",[502,503,499,498,500,26,504,505],"Primary chemotherapy","Resection rate","FDG PET-CT","ctDNA","2025-04-17",{"date":508,"type":32},"2025-04-25",{"date":510,"type":32},"2024-12-03",{"date":512,"type":21},"2028-12-31",{"name":157,"class":39},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":17,"minAge":521,"maxAge":48,"enrollmentInfo":522,"targetDuration":4,"studyType":52,"phases":524,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":40},"100556461","effect-of-sodium-bicarbonate-saline-and-black-mulberry-syrup-on-degree-of-oral-mucositis-in-children-receiving-chemotherapy-100556461","NCT06525402","Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemotherapy","The Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on The Degree of Oral Mucositis in Children Receiving Chemotherapy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* The willingness of the family and the child to participate in the study\n* Parent and child have separately informed written consent form\n* Be between 6-18 years old\n* Receiving chemotherapy and being hospitalized for chemotherapy treatment\n* Being fed orally\n\nExclusion Criteria:\n\n* Oral mucositis in the first intraoral evaluation\n* Having diabetes\n* Receiving radiotherapy\n* Having a surgical procedure in the mouth and jaw area\n* Receiving steroid therapy during chemotherapy treatment\n* Using a method other than the methods used in the study to protect the oral mucous membrane throughout the study","6 Years",{"count":523,"type":21},54,[113],"This study was planned as a randomized controlled experimental study in order to compare the effects of oral care with saline and black mulberry syrup in addition to sodium bicarbonate on oral mucositis level in children aged 6-18 years receiving chemotherapy.",[200,26],[528,529,530,200,401,531],"Sodium Bicarbonate","Saline","Black Mulberry Syrup","Children","2025-03-23",{"date":534,"type":32},"2025-03-26",{"date":536,"type":32},"2025-01-30",{"date":538,"type":21},"2025-12-31",{"name":540,"class":39},"Burdur Mehmet Akif Ersoy University",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":52,"phases":550,"briefSummary":551,"conditions":552,"keywords":556,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":569,"leadSponsor":570,"locationsCount":40},"100582462","the-effect-of-immersive-virtual-reality-and-relaxing-videos-on-lung-cancer-patients-100582462","NCT06863623","The Effect of Immersive Virtual Reality and Relaxing Videos on Lung Cancer Patients","The Effect of Immersive Virtual Reality and Relaxing Videos on Symptom Severity, Distress and Quality of Life in Patients With Lung Cancer Undergoing Chemotherapy","Inclusion Criteria:\n\n* are over 18 years old,\n* diagnosed with lung cancer,\n* will receive chemotherapy for the first time,\n* will receive at least 2 cycles of chemotherapy treatment\n* agree to participate in the study,\n\nExclusion Criteria:\n\n* Having a cognitive and psychiatric disorder and diagnosis,\n* Having brain metastasis or chronic disease related to the head-brain region,\n* Having vision-hearing problems,\n* Having epilepsy, vertigo, chronic severe headache, dizziness problems,\n* Having a history of virtual reality, simulator or motion sickness,\n* Having\u002Fdeclaring that he\u002Fshe has open area, underwater, specific animal phobia,\n* Do not agree to participate in the study",{"count":549,"type":21},90,[113],"Lung cancer is one of the types of cancer with a high incidence and mortality rate in the world and in our country. Frequently used protocols in the chemotherapy treatment of lung cancer are the Platine-based drugs. The main side effects of this chemotherapy protocols are nausea, vomiting, neutropenia and fatigue. The side effects of cancer and chemotherapy cause patients to experience distress and their quality of life is adversely affected. Some non-pharmacological methods such as meditation, breathing exercises, and massage can be used to manage the symptoms experienced by patients due to chemotherapy for supportive care. One of these methods is the virtual reality applications. In addition, audio-visual (video) therapy methods are other methods that can be used in the symptom management of these patients. In this study, the effect of interactive\u002Fimersive virtual reality intervention and relaxant video intervention on symptom severity, distress level and quality of life of patients diagnosed with lung cancer will be evaluated. Patients will be assigned to 3 groups: virtual reality intervention group (VR), relaxant video application group (RV) and control group (CG) by stratified randomization according to the disease stage and dryg type. During the chemotherapy treatment, the patients will take interactive\u002Fimmersibe virtual reality (VR group) or relaxant video application (RV group) consisting of nature-themed scenarios. The interventions will be done 2 times and about 20 minutes in the first day of each chemotherapy cycles, in total 2 cycles. The control group will receive routine nursing care. Research data will be collected at different intervals during the chemotherapy course with the Patient Information Form (only once), the Edmonton Symptom Diagnosis Scale, the NCCN Distress Thermometer, the European Cancer Treatment and Organization Committee Quality of Life Scale and the Patient Follow-up Form and will be analyzed with the IBM SPSS v.23 program.",[553,26,554,555],"Lung Cancer","Distress, Emotional","Quality of Life (QOL)",[557,558,559,560,561,562,563,564],"cancer","chemotherapy","immersive","virtual reality","lung cancer","quality of life","symptom","side-effect","2025-03-10",{"date":567,"type":32},"2025-03-13",{"date":351,"type":32},{"date":538,"type":21},{"name":571,"class":39},"Hacettepe University",{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":108,"maxAge":578,"enrollmentInfo":579,"targetDuration":4,"studyType":52,"phases":581,"briefSummary":582,"conditions":583,"keywords":588,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":40},"100555887","prevalence-of-long-term-dental-effects-of-chemotherapy-in-childhood-cancer-survivors-diagnosed-with-cancer-before-the-age-of-10-100555887","NCT06517927","Prevalence of Long-term Dental Effects of Chemotherapy in Childhood Cancer Survivors Diagnosed With Cancer Before the Age of 10","Inclusion Criteria:\n\n* age below 10 at cancer diagnosis (for the CCS group).\n* Chemotherapy must have been used to treat the patient (For the CCS group).\n* The patient is 12 years old or older at the time of the follow-up appointment of the present study\n\nExclusion Criteria:\n\n* A patient who was diagnosed and treated after 10 years old.\n* Patient below 12 years old at time of study recruitment\n* Patients with syndrome or diseases that involve teeth impairment\\*\n* Pregnant patient\n* Refusal or inaptitude to undergo dental and radiographic examination","36 Years",{"count":580,"type":21},142,[113],"To date, there are no methods for assessing the risk of oral developmental defects that could predict long-term adverse effects in childhood cancer survivors. Having such a method at our disposal would enable us to better assess the risk to develop those defects and will help us provide new prevention and treatment strategies to ensure a healthy oral development.\n\nThe aims of this study are :\n\n* Assess the caries risk in childhood cancer survivors compared with a control group.\n* Assess the dental development defects risk in childhood cancer survivors compared with a control group.",[26,584,585,586,587],"Dental Caries","Malocclusion","Childhood Cancer","Tooth Defect",[589,590],"Childhood cancer survivors","Dental defect","2024-11-15",{"date":593,"type":32},"2024-11-19",{"date":595,"type":32},"2024-05-03",{"date":597,"type":21},"2026-05-03",{"name":599,"class":39},"Cliniques universitaires Saint-Luc- Université Catholique de Louvain",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":52,"phases":610,"briefSummary":611,"conditions":612,"keywords":615,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":630,"locationsCount":40},"100481821","phase-2-metronomic-temozolomide-in-unfit-nens-patients-metronomic-temozolomide-in-unfit-patients-with-advanced-neuroendocrine-neoplasms-nens-mete-study-100481821","NCT05554003","Metronomic Temozolomide in Unfit NENs Patients Metronomic Temozolomide in Unfit Patients With Advanced Neuroendocrine Neoplasms (NENs): MeTe Study","An Italian Multicenter Phase II Trial of Metronomic Temozolomide in Unfit Patients With Advanced Neuroendocrine Neoplasms (NENs): MeTe Study","MeTe","Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. Histologically proven diagnosis of low grade GEP-NENs (including morphology and ki67 in accordance with WHO 2019 classification), bronchial carcinoids (in accordance with the Travis classification), low grade of unknown primary sites NENs.\n3. Advanced disease (unresectable locally advanced or metastatic).\n4. ECOG performance status 2 and\u002For moderate medullary impairment (at least one of the following criteria: Hb concentration \\\u003C10-8 gr\u002Fdl; WBC \\\u003C3000-2000\u002Fmm3; platelets \\\u003C75000-50000\u002Fmm3; neutrophil count \\\u003C1500-1000\u002Fmm3); renal failure (eGFR o CrCl 30-59 ml\u002Fmin - G2) and\u002For moderate liver failure (Child B 7-9) and\u002For severe comorbidities and\u002For \\> 3 prior systemic antitumor therapies (apart from SSA).\n\n   For all the parameters other than the above mentioned criteria n° 4 consider the following criteria (that must be associated with at least one of those above): absolute neutrophil count of ≥1.5×109\u002FL, platelet count of ≥100×109\u002FL, haemoglobin ≥9 g\u002FdL, serum total bilirubin \\\u003C1.5 times the upper limit of normal (ULN) alanine aminotransferase (ALT), AST, or alkaline phosphatase levels ≤2.5 times the ULN (if known liver metastases ALT, AST, and ALP ≤3× the ULN), serum creatinine \\\u003C1.5 times ULN or creatinine clearance ≥60 mL\u002Fmin as estimated by the Cockcroft-Gault formula\n5. Functioning\u002Fnon functioning.\n6. Morphological progressive disease (CT scan or MRI).\n7. Recovery from toxicities related to any prior treatments, adequate wash-out period from previous treatments.\n8. Ability to swallow pills.\n9. Fertile men should agree to use effective contraceptive methods up to 6 months after the last temozolomide intake and should be informed about the possible irreversible infertility related to temozolomide intake.\n\nExclusion Criteria:\n\n1. Patients pretreated with temozolomide.\n2. Are Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 28 days 2 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential; WOCBP childbearing potential who are nursing or are pregnant or do not agree to submit to pregnancy testing required by this protocol\n3. Patients that did not sign written informed consent prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law\n4. Knowed active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and\u002For HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and\u002For known Human Immunodeficiency Virus (HIV) carrier.\n5. Patients treated with systemic therapies (chemotherapy, interferon-alpha, somatostatin analogues, molecular target therapies) within 1 month prior to screening visit\n6. Hypersensitivity to the active substance or to any of the excipients, hypersensitivity to dacarbazine (DTIC), known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery and stable for at least 3 months before study entry, pregnant or lactating females, patients on chronic treatment with valproic acid",{"count":609,"type":21},46,[54],"Study design and rationale: Neuroendocrine neoplasms (NENs ) represent a heterogeneous group of malignancies, which differ in terms of behavio r and prognosis. Most of t hem are advanced at diagnosis t herefore systemic treatment is proposed. While over the last years many advanced have been made especially in terms of molecular targeted therapies (MTA) like everolimus and sunitinib, chemotherapy i n NENs still represents a controversial question. Temozolomide has been reported to be active alone or in combination with other drugs in neuroendocrine neoplasms (NENs) from different origin. So far there is not universal agreement on the right setting an d way of administration of this therapy. Objective: This is a multicentric phase II prospective interventional study to evaluate the clinical features of patients, who are judged unfit for systemic treatments, consecutively treated with a metronomic Temozolomide chemotherapy schedule in Italian centers with expertise in NEN and to explore also the methylation status of O6-methylguanine-DNA-methyltransferase (MGMT) and the polymorphism of thymidylate synthase (TS) by pyrosequencing in those patients of which tissues were available. This study will allow a better understanding of the role of metronomic temozolomide chemotherapy in NENs patients and help clinicians in answering some of the outstanding questions on their management. Method: Prospective analysis of clinical data of patients unfit for chemotherapy consecutively treated with metronomic temozolomide regimen in Italian centers with expertise in clinical and research NEN activity, for one year from the start of the accrual. Planning of study: Data from NENs patients of any age treated at these centers will be retrieved by searching the hospital information system and analysed. Eligible study population: Patients with histological diagnosis of low grade advanced NEN treated unfit for systemic treatments, for one year from the start of the accrual. Endpoints and evaluation parameters:\n\nDescription of efficacy and toxicity of Temozolomide regimen in patients with advanced NENs with different primary sites unfit for systemic treatment and explored the pote ntial correlation with clinical\u002Fbiological factors.",[613,614,26],"Neuroendocrine Tumors","Frailty",[616,617,618,619,620,401,621,622,623,624],"Temozolomide","Neuroendocrine tumors","NETs","NENs","Unfit","Metronomic","Advanced","Phase II","Open label",{"date":626,"type":32},"2024-11-18",{"date":628,"type":32},"2022-01-14",{"date":65,"type":21},{"name":631,"class":39},"European Institute of Oncology",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":332,"sex":166,"minAge":48,"maxAge":640,"enrollmentInfo":641,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":642,"conditions":643,"keywords":646,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":4},"100568655","studying-the-senescent-t-cell-features-and-its-relationship-with-the-chemotherapy-efficacy-in-young-tnbc-100568655","NCT06684054","Studying the Senescent T Cell Features and Its Relationship with the Chemotherapy Efficacy in Young TNBC","Study of the Features of Senescent T Lymphocytes Induced by Chemotherapy and Its Relationship with the Efficacy of Neoadjuvant Chemotherapy in Young Triple-negative Breast Cancer Patients, a Single-center, Observational Study.","STFREiYTNBC","Inclusion Criteria:\n\n1. Female, age≤40 years old,\n2. Invasive breast cancer confirmed by pathology, immunohistochemistry showed TNBC (ER-, PR-, HER2-),\n3. Indications for neoadjuvant chemotherapy according to guidelines: tumor diameter \\> 2cm or with axillary lymph node metastasis or desiring breast-conserving surgery but should obtain negative surgical margins through neoadjuvant chemotherapy.\n\nExclusion Criteria:\n\n1. Stage IV patients or a history of other malignancies,\n2. Having microbial infection or autoimmune disease have not been cured or having HBV, HIV infection,\n3. Having surgery 3 months before enrollment,\n4. Patients with insufficient clinicopathological data,\n5. Does not meet the indications for neoadjuvant chemotherapy or is unwilling to cooperate.","40 Years",{"count":168,"type":21},"The goal of this observational study is to learn about the features of senescent T lymphocytes induced by chemotherapy and its relationship with the efficacy of neoadjuvant chemotherapy in young triple-negative breast cancer (TNBC) patients.\n\nThe main questions it aims to answer are:\n\n* What are the senescent features of peripheral T lymphocytes in young TNBC patients receiving neoadjuvant chemotherapy and the relationship with the efficacy of neoadjuvant chemotherapy?\n* What is the relationship between senescent T cells and adverse events, DFS and tumor infiltrating lymphocytes?\n\n  1. Participants will receive 6 cycles of docetaxel + adriamycin\u002Fepirubicin + cyclophosphamide (TEC\u002FTAC) neoadjuvant chemotherapy, and radical mastectomy after chemotherapy.\n\n2.5ml peripheral venous blood will be collected before chemotherapy, after 2 cycles of chemotherapy, before surgery, and six months after surgery.\n\n3.Clinicopathological data, chemotherapy-related adverse events and prognostic information of patients should be collected during the study.",[644,26,645],"T-Cell Dysfunction","Adverse Events",[647,648,558],"breast cancer","senescence","2024-11-10",{"date":651,"type":32},"2024-11-12",{"date":653,"type":21},"2025-01-01",{"date":655,"type":21},"2027-12-31",{"name":657,"class":39},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":665,"targetDuration":4,"studyType":52,"phases":667,"briefSummary":668,"conditions":669,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":40},"100471885","drug-sensitivity-detection-of-micro-tumor-ptc-to-guide-postoperative-adjuvant-treatment-strategy-of-colorectal-cancer-100471885","NCT05424692","Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy of Colorectal Cancer","Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) Combined with Tumor Whole Exon (WES) Sequencing Technology to Guide Postoperative Adjuvant Treatment Strategy and Prognosis of Colorectal Cancer","Inclusion Criteria:\n\n* Age 18 \\~ 75 years old, regardless of gender\n* Patients with colorectal cancer diagnosed by histopathology or cytology\n* Colorectal cancer patients who need adjuvant therapy after radical surgery and have not received neoadjuvant therapy\n* Having at least one assessable tumor focus\n* ECoG physical condition score ≤ 2 points\n* Voluntarily participate and sign informed consent\n\nExclusion Criteria:\n\n* Patients diagnosed with metastasis\n* Patients who cannot obtain tumor samples\n* Pregnant and lactating women\n* Patients with poor compliance\n* Patients with severe cardiovascular and cerebrovascular complications who cannot receive adjuvant treatment\n* Patients with other malignant tumors\n* Suffering from serious mental and nervous system diseases\n* The researchers believe that patients should not be selected for this study",{"count":666,"type":21},200,[113],"The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. The completion of this study will provide real-world data support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.",[670,671,26,672,673],"Colon Cancer","Rectal Cancer","PTC","Exon Mutation","2024-11-01",{"date":676,"type":32},"2024-11-04",{"date":678,"type":32},"2021-09-01",{"date":680,"type":21},"2027-09-01",{"name":682,"class":39},"Peking Union Medical College Hospital"]