[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Cancer Institute, Naples\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":615},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,49,77,99,128,155,180,207,241,266,293,316,335,361,387,407,429,456,476,494,522,541,557,576,594],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100637890","early-phase-1-single-microdose-trial--cxcr4-pet-tracer---pharmacokinetics-and-pharmacodynamics-of-68gaga-r54-a-radiopharmaceutical-directed-toward-cxcr4-in-patients-with-advanced-solid-neoplasia-100637890",false,"NCT07577206","Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.","Inclusion Criteria:\n\n* Patients \\> 18 years\n* Patients with histological diagnosis of solid neoplasm (breast, lung, colon, ovary, pancreas) in advanced stages or multiple myeloma evaluated by PET\u002FCT with \\[18F\\]FDG carried out in the 3 months prior to enrollment. The neoplasm must express the CXCR4 receptor by immunohistochemistry\n* Patients with ECOG performance status 0-2, able to undergo the scheduled diagnostic procedure (PET\u002FCT with \\[68Ga\\]Ga-R54).\n* Patients with alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase \\\u003C3 x upper limit of reference range and total bilirubin \\\u003C2.0 mg\u002FdL\n* Patients with creatinine \\\u003C 1.5 x upper limit of reference range or 24-hour creatinine clearance \\> 50 mL\u002Fmin\n* Negative serum pregnancy test (b-hCG) for women of childbearing age before administration of \\[68Ga\\]Ga-R54).\n* Signature of informed consent indicating that the patient (or legal representative) has been informed of all aspects pertinent to the study\n* Willingness and ability to comply with scheduled visits, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n* Presence of active infections (e.g. requiring antibiotic therapy) or other serious concomitant illness, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study\n* Declared chronic active hepatitis (hepatitis B \u002F C)\n* Declared active autoimmune diseases\n* Recovery from major trauma including surgery within 4 weeks of study enrollment\n* Presence of neurodegenerative diseases\n* Pregnancy and\u002For breastfeeding\n* Any conditions that in the opinion of the investigator could hinder compliance with the study protocol\n* Patients who have not signed consent to participate in the study","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Phase 1, monocentric, open labeled, no profit \"Microdose\" trial. A single microdose of the new \\[68Ga\\]Ga-R54 PET radiopharmaceutical directed against CXCR4 will be injected into patients with advanced solid tumor or multiple myeloma to evaluate the binding.",[26,27],"Advanced Solid Tumor","Multiple Myeloma",[29,30,31,32,33,34,35],"\"Microdose\" trial","CXCR4","[68Ga]Ga-R54 PET radiopharmaceutical","pharmacokinetics","pharmacodynamics","advanced solid neoplasia","multiple myeloma","RECRUITING","2026-05-05",{"date":39,"type":40},"2026-05-11","ACTUAL",{"date":42,"type":40},"2025-01-24",{"date":44,"type":20},"2027-01",{"name":46,"class":47},"National Cancer Institute, Naples","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":48},"100609359","phase-2-simvastatin-efficacy-in-arid1a-mutated-advanced-gastroesophageal-carcinoma-treated-with-immunotherapy-100609359","NCT07213557","Simvastatin Efficacy in ARID1A Mutated Advanced gastroESophageal Carcinoma Treated With Immunotherapy","Randomized Phase 2 Study of Simvastatin in Patients With ARID1A Mutated Advanced Gastrooesophageal Carcinoma Treated With Nivolumab and Oxaliplatin- Based Chemotherapy as First-line Treatment (The ARES Trial)","Inclusion Criteria:\n\n1. Written informed consent to study procedures and to correlative studies.\n2. Aged ≥ 18.\n3. Histologically proven of gastrooesophageal carcinoma\n4. Diagnosis of advanced not operable or metastatic disease.\n5. HER2 negative and ARID1A mutated status at initial diagnosis.\n6. Available tumor tissue sample.\n7. No prior treatments (chemotherapy, radiation or surgery) for aGEC. Surgery for primary GEC tumor before starting treatment is allowed.\n8. Patient candidate to standard treatment with nivolumab and oxaliplatin-based chemotherapy as clinical practice (combined positive score ≥ 5).\n9. Eastern Cooperative Oncology Group (ECOG) Performance Status\n\n   ≤ 1 at study entry.\n10. Imaging-documented measurable disease, according to RECIST 1.1 criteria.\n11. Estimated life expectancy of more than 12 weeks.\n12. Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL and platelet count ≥ 100 x 109\u002FL and hemoglobin ≥ 9 g\u002FdL.\n13. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 5 X ULN.\n14. Adequate renal function: serum creatinine ≤ 1.5 mg\u002FdL OR creatinine clearance ≥ 60 mL\u002Fmin in males and ≥50 mL\u002Fmin in females (calculated according to Cockroft-Gault formula).\n15. Known dihydropyrimidine dehydrogenase (DPYD) activity is mandatory. The same criteria, except for the status of ARID1A, will be followed to select the 28 consecutive HER2-negative and ARID1A non mutated aGEC patients of observational cohort.\n\nExclusion Criteria:\n\n1. Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n2. Prior chemotherapy or any other medical treatment for aGEC (previous adjuvant chemotherapy is allowed if terminated \\> 12 months previously).\n3. Any contraindication to Nivolumab, simvastatin or oxaliplatin-based chemotherapy.\n4. Patients who have treatment with statins or fibrates or any medication for hypercholesterolemia.\n5. Major surgical intervention within 4 weeks prior to enrollment.\n6. Pregnancy and breast-feeding.\n7. Any brain metastasis.\n8. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.\n9. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form.\n10. Participation in any interventional drug or medical device study within 30 days prior to treatment start.\n11. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.\n12. Hypesensitivity to simvastatin.\n13. Acute hepatitis or chronic hepatitis.\n14. Personal or familial anamnesis of severe hepatopathy.\n15. Known coagulation disorders. The same criteria will be followed to select the 28 consecutive HER2-negative and ARID1A non mutated aGEC patients of observational cohort.",{"count":57,"type":20},84,[59],"PHASE2","The investigators hypothesize that simvastatin (SIM) may improve the efficacy of first- line Nivolumab and Oxaliplatin-based chemotherapy, extending progression-free survival (PFS) as compared with Nivolumab and chemotherapy alone in patients with HER2 negative and ARID1A mutated advanced gastrooesophageal carcinoma (aGEC).\n\nCorrelative mechanistic studies on tissue and blood samples, could help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach and adding new insight into the antitumor mechanism of the combination approach.",[62],"Advanced or Metastatic Gastrooesophageal Carcinoma",[64,65,66,67,68],"HER2 negative","ARID1A mutated","Simvastatin","gastrooesophageal carcinoma","liquid biopsy","2026-04-09",{"date":71,"type":40},"2026-04-14",{"date":73,"type":40},"2026-03-13",{"date":75,"type":20},"2028-05",{"name":46,"class":47},{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100502384","phase-2-valproic-acidsimvastatin-plus-gemcitabinenab-paclitaxel-based-regimens-in-untreated-metastatic-pancreatic-adenocarcinoma-patients-100502384","NCT05821556","Valproic Acid\u002FSimvastatin Plus Gemcitabine\u002FNab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients","Randomized Phase 2 Study of Valproic Acid combinEd With Simvastatin and Gemcitabine\u002FNab-paclitaxel-based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients (The VESPA Trial).","Inclusion Criteria:\n\n1. Written informed consent to study procedures and to correlative studies.\n2. Histologically or cytologically proven metastatic PDAC.\n3. No prior treatments (chemotherapy, radiation or surgery) for PDAC\n4. Either sex aged ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 at study entry.\n6. Imaging-documented measurable disease, according to RECIST 1.1 criteria.\n7. Known dihydropyrimidine dehydrogenase (DPD) activity is mandatory for patients enrolled in PAXG scheme.\n8. Adequate bone marrow haematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL AND platelet count ≥ 100 x 109\u002FL AND haemoglobin ≥ 9 g\u002FdL.\n9. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 in case of biliary stent) and aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 5 X ULN.\n10. Adequate renal function: serum creatinine ≤ 1.5 mg\u002FdL OR creatinine clearance ≥ 60 mL\u002Fmin in males and ≥50 mL\u002Fmin in females (calculated according to Cockroft-Gault formula).\n\nExclusion Criteria:\n\n1. Prior malignancy within one year. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n2. Prior chemotherapy or any other medical treatment for metastatic PDAC (previous adjuvant chemotherapy is allowed if terminated \\> 6 months previously).\n3. Patients who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid.\n4. Current use of statins or fibrates or any medication for hypercholesterolemia for any time during the 3 months before the study.\n5. Proven hypersensitivity to statins and to any component of the other medications used in the trial.\n6. Major surgical intervention within 4 weeks prior to enrollment;\n7. Pregnancy and breast-feeding.\n8. Brain metastasis.\n9. Hepatitis or any severe liver disorder.\n10. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.\n11. Patients with long QT-syndrome or QTc interval duration \\> 480 msec or concomitant medication with drugs prolonging QTc (see list in the appendix).\n12. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form.\n13. Participation in any interventional drug or medical device study within 30 days prior to treatment start.\n14. Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.\n15. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study and until 6 months after the last trial treatment.",{"count":85,"type":20},240,[59],"This is a proof-of-concept, Open label, randomized, multicentric, superiority phase-2 study.",[89],"Adenocarcinoma of the Pancreas",[91],"Metastatic",{"date":71,"type":40},{"date":94,"type":40},"2023-06-12",{"date":96,"type":20},"2027-06",{"name":46,"class":47},5,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":107,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":48},"100633131","phase-2-inavolisib-for-pik3ca-mutated-advanced-endometrial-cancer-mito-end-4-100633131","NCT07522697","Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: MITO END-4","Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: a Multicentric, Phase II, MITO END-4 Trial","MITO END-4","Inclusion Criteria:\n\n* Signed informed consent prior to any study specific procedures.\n* Female, age ≥ 18 years at time of signing informed consent.\n* Patients with histologically or cytologically confirmed diagnosis of advanced, recurrent or metastatic endometrial carcinoma (endometrioid, serous, clear cell, carcinosarcoma or mixed histology).\n* Biomarker eligibility: valid results from testing of tumor tissue documenting PIK3CA mutations listed below (a-m); however, activating PIK3CA mutations not listed may also be included, capped at 20% of the study population.\n\nH1047D\u002FI\u002FL\u002FN\u002FP\u002FQ\u002FR\u002FT\u002FY G1049A\u002FC\u002FD\u002FR\u002FS E545A\u002FD\u002FG\u002FK\u002FL\u002FQ\u002FR\u002FV E453A\u002FD\u002FG\u002FK\u002FQ\u002FV E542A\u002FD\u002FG\u002FK\u002FQ\u002FR\u002FV K111N\u002FR\u002FE Q546E\u002FH\u002FK\u002FL\u002FP\u002FR G106A\u002FD\u002FR\u002FS\u002FV N345D\u002FH\u002FI\u002FK\u002FS\u002FT\u002FY G118D C420R R88Q M1043I\u002FT\u002FV\n\n* Data from the reports indicating the pertinent PIK3CA mutation as well as the status of PTEN gene, and relative variant of allelic frequency (VAF) for each altered gene must be available upon enrollment. Local test results reported from tumor tissue should be from the patient's locally advanced or metastatic disease state whenever possible. Specifically, the detection of PIK3CAm combined with knowledge of PTEN molecular status is mandatory for the screening.\n* All patients are required to submit a paraffin embedded block from the primary surgery\u002Fbiopsy (chemotherapy - naive patients) and a freshly collected pre-treatment blood samples. A quality control analysis of samples will be performed by the Sponsor, before patient's enrollment. Only patients with adequate tumor sample will be enrolled.\n* Patients must have progressed after or during a platinum based-chemotherapy with or without immunotherapy in any setting. Specifically, patients receiving previous platinum-based chemotherapy in the neoadjuvant or adjuvant setting must have progressed within 6 months of last platinum therapy.\n* Patients must have received no more than 4 previous systemic therapy for endometrial cancer. Specifically, endocrine therapies, maintenance with PARP inhibitor or selinexor are not counted as a systemic line of therapy.\n* At least 1 measurable target lesion according to RECIST 1.1\n* Patients must have a life expectancy ≥ 16 weeks.\n* ECOG performance status of 0 to 1 within 28 days of enrollment.\n* Documented markers such as mismatch repair (MMR) status, hormone receptors (estrogen and progesterone receptors) and p53 status according to molecular or immunohistochemical classification of EC.\n* Patient must be able to take oral medications.\n* Patients must have normal organ and bone marrow function measured as defined below:\n\nHaemoglobin ≥ 9.0 g\u002FdL with no blood transfusion in the past 28 days Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) \u002F Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) (\\\u003C 3 x ULN if Gilbert's disease).\n\n* Patients must have creatinine clearance (CrCL) estimated of ≥30 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test: Estimated creatinine clearance = (140-age \\[years\\]) x weight (kg) \u002F a serum creatinine (mg\u002FdL) x 72 (x F) (where F=0.85 for females).\n\nThe recommended starting dosage of inavolisib for patients with moderate renal impairment (CrCL 30 to \\\u003C60 mL\u002Fmin) is 6 mg orally once daily.\n\nINR or PT aPTT\u002FPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (INR between 2.5 and 3.5 x ULN is permitted).\n\nFasting blood glucose ≤140 mg\u002FdL and HbA1c \\\u003C6.5%. Specifically, patients with Type 2 diabetes are eligible to enroll provided they meet the above criteria for fasting blood glucose and HbA1C and are on a stable dose of no more than one oral antidiabetic agent for ≥2 weeks prior to initiation of study treatment. The administration of insulin should not be counted as a 2nd agent.\n\n* Patients are eligible to participate only if they are not not pregnant or breastfeeding, and at least one of the following conditions applies.\n\n  1. Is not a Women of Childbearing Potential (WOCBP) A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).\n  2. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 1 weeks after the final dose of inavolisib. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.\n  3. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours before the first dose of study intervention.\n\nNote If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n* Endometrial tumors with the following histologies: squamous carcinomas, sarcomas.\n* Prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K\u002FAKT\u002FmTOR pathway.\n* Any history of Type 1 diabetes and Type 2 diabetics patients with fasting blood glucose \\>140 and HbA1C ≥6.5%, and\u002For those that require 2 or more anti-diabetic agents should be excluded.\n* Subjects known to be positive for Human Immunodeficiency Virus (HIV).\n* Patients with known active hepatitis (i.e. Hepatitis B or C)\n\n  1. Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible\n  2. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Patients unable to swallow orally administered medication and patients with gastrointestinal malabsorption or any other condition that may interfere with absorption of Inavolisib.\n* Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.\n* Major surgery within 28 days weeks of starting study treatment and patients must have recovered from any effects of major surgery. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.\n* Minor surgical procedures \\\u003C 7 days prior to first dose of study treatment.\n* Patients must have sufficiently recovered from surgery, including adequate wound healing.\n* Known untreated CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (i.e. without evidence of progression) for at least 4 weeks by repeat imaging (Note: The repeat imaging should be performed during study Screening.), clinically stable, and without requirement of steroid treatment for at least 14 days before the first dose of study intervention.\n* Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS).\n* Participation in another clinical study with an investigational drug product within 4 weeks before randomization.\n* Subjects who have not recovered adequately from any toxicity from other anti-cancer treatment regimens except for hot flashes, alopecia, and Grade 2 peripheral neuropathy.\n* Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, coronary heart disease, myocardial infarction, cerebrovascular accident\u002Fstroke within 12 months of the first dose of study drug, or cardiac arrhythmia associated with hemodynamic instability. Medically controlled arrhythmia would be permitted.\n* Congenital long QT syndrome or QT interval corrected through use of Fridericia's formula \\> 470 ms demonstrated by at least two ECGs \\>30 minutes apart, or family history of sudden unexplained death or long QT syndrome.\n* Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia).\n* Chronic corticosteroid therapy of ≥10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease.\n* Allergy or hypersensitivity to formulation components of inavolisib or any other drug under study.\n* Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1\n* Symptomatic active lung disease, including pneumonitis.\n* History of or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).\n* Patients currently receiving immunosuppressants for inflammatory bowel disease (e.g., sulfasalazine) are considered to have active disease and are therefore ineligible.\n* Any active bowel inflammation (including diverticulitis).\n* Any concurrent ocular or intraocular condition (e.g., diabetic retinopathy) that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition.\n* Active inflammatory (e.g., uveitis or vitritis) or infectious (e.g., eratitis, scleritis, or endophthalmitis) conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye.\n* Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, metabolic, or infectious disease) or any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that renders the patient at high risk from treatment complications.","FEMALE",{"count":109,"type":20},48,[59],"MITO END-4 is a prospective, single arm, multicentric phase II trial aiming to assess whether Inavolisib is effective in the treatment of advanced endometrial carcinoma with pathogenic PIK3CA mutation. Approximately 48 patients with PIK3CA mutation will be overall enrolled in the study.",[113],"Endometrial Cancer",[115,116,117,118],"endometrial cancer","PIK3CA","inavolisib","phase II trial","NOT_YET_RECRUITING","2026-04-08",{"date":122,"type":40},"2026-04-13",{"date":124,"type":20},"2026-05",{"date":126,"type":20},"2030-05",{"name":46,"class":47},{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":107,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":48},"100615306","phase-2-pembrolizumab-plus-lenvatinib-in-vulvar-cancer-patients-mito-vulva-01-100615306","NCT07290894","Pembrolizumab Plus Lenvatinib in Vulvar Cancer Patients: MITO VULVA-01","Pembrolizumab Plus Lenvatinib in Vulvar Cancer Patients: MITO VULVA-01 Study.","MITO VULVA-01","Inclusion Criteria:\n\nTarget subject population Inclusion Criteria\n\n1. Signed informed consent prior to any study specific procedure;\n2. Female, age ≥ 18 years at time of signing informed consent;\n3. Patients with histologically or cytologically confirmed unresectable squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva, defined as:\n\n   1. T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy (Cohort A) OR\n   2. recurrent or de novo metastatic chemotherapy-naive vulvar squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva, (Cohort B) OR\n   3. recurrent squamous cell carcinoma of the vulva after primary chemoradiation or patients with metastatic squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva in progression to a chemotherapy-based treatment (Cohort C)\n4. At least 1 measurable target lesion according to RECIST 1.1;\n5. Patients must have a life expectancy ≥ 16 weeks;\n6. ECOG performance status of 0 to 1;\n7. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤140\u002F90 mmHg at Screening and no change in antihypertensive medications within 1 week before the Cycle 1\u002FDay 1;\n8. Patient must provide formalin fixed paraffin embedded (FFPE), archival tumor samples, from primary tumor surgery or biopsy of primary tumor or metastases. The samples must be collected before any systemic treatment. (chemotherapy-naïve patients). A quality control analysis of samples will be performed before patient's enrollment. Only patients with adequate tumor samples will be enrolled.\n9. Patient must be able to take oral medications;\n10. Patients must have normal organ and bone marrow function measured as defined below:\n\n    * Haemoglobin ≥ 10.0 g\u002FdL with no blood transfusion in the past 28 days\n    * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL\n    * Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) \u002F Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN\n    * Patients must have creatinine clearance estimated of ≥51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test: Estimated creatinine clearance = (140-age \\[years\\]) x weight (kg)(x F)a serum creatinine (mg\u002FdL) x 72 (a where F=0.85 for females)\n11. INR or PT aPTT\u002FPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants;\n12. Patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n    1. Is not a Women of Childbearing Potential (WOCBP) or\n    2. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), as described in Appendix 1 during the intervention period and for at least 4 months post pembrolizumab or 30 days post lenvatinib, whichever occurs last. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention\n13. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention; Note: If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive;\n14. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.\n\nExclusion Criteria\n\n1. Patients with vulvar melanomas, sarcomas, vulvar Paget's disease, or basal cell carcinoma;\n2. Patients diagnosed with early-stage vulvar cancer that, according to the Investigator, can be treated with upfront curative surgery;\n3. Patients who have received any systemic anticancer therapy for vulvar cancer, anti-VEGF therapy, or any systemic investigational anticancer agent including radiotherapy (Cohort A and B); patients who have received any further systemic therapy for advanced disease after progression to a first-line platinum-based chemotherapy (Cohort C);\n4. Received a live vaccine or live attenuated within 30 days of planned start of study treatment (Cycle 1\u002FDay 1). Note: The killed virus vaccines (ie seasonal influenza vaccines for injection are allowed);\n5. Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula;\n6. Active infection (any infection requiring systemic treatment);\n7. Subjects known to be positive for Human Immunodeficiency Virus (HIV);\n8. Patients with known active hepatitis (i.e. Hepatitis B or C)\n\n   * Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible;\n   * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA;\n9. Subjects with a diagnosis of immunodeficiency or who are receiving systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medications;\n10. Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;\n11. Patients unable to swallow orally administered medication;\n12. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;\n13. Major surgery within 3 weeks of starting study treatment and patients must have recovered from any effects of major surgery;\n14. Breast feeding women;\n15. Known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks by repeat imaging (Note: The repeat imaging should be performed during study Screening.), clinically stable, and without requirement of steroid treatment for at least 14 days before the first dose of study intervention. Note: Participants with known untreated, asymptomatic brain metastases (ie, no neurological symptoms, no requirement for corticosteroids, no or minimal surrounding edema, and no lesion \\>1.5 cm) may participate but will require regular imaging of the brain as a site of disease;\n16. Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma\n17. Prolongation of QTcF interval to ≥480 msec;\n18. LVEF below of the institutional (or local laboratory), normal range, as determinated, by MUGA or ECHO;\n19. Participation in another clinical study with an investigational product during the last 3 months;\n20. Subjects who have not recovered adequately from any toxicity from other anti- cancer treatment regimens and\u002For complications from major surgery prior to starting therapy. Note: Withhold lenvatinib for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing;\n21. Significant cardiovascular impairment including: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, cerebro vascular accident\u002Fstroke, within 12 months of the first dose of study drug, or cardiac arrhythmia associated with hemodynamic instability. Medically controlled arrhytmia would be permitted;\n22. Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. Radiographic evidence of tumor invasion\u002Finfiltration of major blood vessels (e.g. carotid artery) or intratumoral cavitation. Note: The degree of major blood vessel should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy;\n23. Radiographic evidence of tumor invasion\u002Finfiltration of major blood vessels (e.g. carotid artery) or intratumoral cavitation. Note: The degree of major blood vessel should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy.\n24. History of arterial tromboembolism within 12 months of start the study;\n25. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug;\n26. Urine protein ≥1 g\u002F24 hours. Note: Participants with proteinuria ≥2+ (≥100 mg\u002FdL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria;\n27. GI malabsorption or any other condition that might affect the absorption of Lenvatinib;\n28. An allogenic tissue\u002Fsolid organ transplant;\n29. History of (noninfectious) pneumonitis\u002Finterstizial lung disease (ILD) that require steroids or current pneumonitis\u002F interstitial lung disease;\n30. Known psychiatric disorder or substance abuse that would interfere with participant ability to cooperate with the requirement of the study.\n31. Has received prior therapy with an anti-PD1, anti PD-L1 or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).",{"count":137,"type":20},80,[59],"MITO VULVA-1 is a prospective, single arm, multi-cohorts, phase II trial that aims to assess the activity and the safety of Lenvatinib plus Pembrolizumab in patients with vulvar cancer. 80 patients will be overall enrolled in the study.Three cohorts are planned",[141],"Vulva Cancer",[143,144,145,146],"vulvar cancer","pambrolizumab","lenvatinib","Phase II trial","2026-04-01",{"date":149,"type":40},"2026-04-02",{"date":151,"type":40},"2026-03-12",{"date":153,"type":20},"2031-10",{"name":46,"class":47},{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":177,"leadSponsor":179,"locationsCount":48},"100628306","phase-2-cannabis-extract-in-oncology-patients-for-the-treatment-of-tumor-related-symptom-burden-100628306","NCT07459920","Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden","Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden (CAPTURE)","CAPTURE","Inclusion Criteria:\n\n1. Written informed consent\n2. Individuals of any sex, gender, sexual orientation, and ethnicity aged 18 or over\n3. No previous use of Cannabis in the last 6 months\n4. Patients with advanced oncological neoplasia with a life expectancy of at least 6 months on active antineoplastic treatment and with a compromised quality of life defined by at least one of the following criteria:\n\n   1. presence of physical symptoms, such as moderate or severe pain, nausea, vomiting, loss of appetite\n   2. presence of psychological symptoms, such as anxiety, depression and insomnia\n5. ECOG ≤ 3\n6. ESAS-TSDS score ≥ 16\n7. Patients on stable therapy with \"Level II\" or Level III\" opioids according to the WHO analgesic scale and\u002For with adjuvants\n8. Women of childbearing age (Women Of Child Bearing Potential, WOCBP) are eligible for the study only if:\n\n   1. Negative pregnancy test\n   2. Willingness to use effective contraception (concurrent use of two methods with a Pearl Index \\\u003C 1%) during treatment and for at least 3 months after the last dose of the investigational product.\n9. Male participants with partners of childbearing potential must agree to use condoms (with spermicide, if available) in combination with an additional highly effective contraceptive method used by their partner, during treatment period and for at least 3 months after the last dose of the investigational product.\n\nExclusion Criteria:\n\n* 1\\. Inability to understand and complete the questionnaires required by the study 2. Known hypersensitivity\u002Fallergy to THC or CBD 3. Psychiatric illness related to schizophrenia\u002Fpsychosis 4. Personal history of any type of addiction 5. Pregnancy \u002F breastfeeding 6. PEG feeding 7. Any other medical condition that, in the opinion of the physician, would affect the participant's safety or ability to comply with the study protocol 8. Concurrent participation in other clinical studies started less than 30 days ago",{"count":164,"type":20},156,[59],"CAPTURE is a prospective, interventional, randomized, phase 2, double-blind, placebo-controlled study assessing the therapeutic add-on effect of the balanced THC\u002FCBD extract (Cannabis extract Avextra 10\u002F10 oral solution) on symptom burden in patients with advanced oncological disease receiving active treatment with WHO level II or III opioids and adjuvants therapies, compared to placebo, as measured by the Edmonton Symptom Assessment System Total Symptom Distress Score (ESAS-TSDS) at 8 weeks post randomization.",[168],"Advanced Malignant Solid Tumor",[170,171,172],"TUmor Related symptom burden","Oncology patients","balanced THC\u002FCBD extract","2026-03-03",{"date":175,"type":40},"2026-03-10",{"date":147,"type":20},{"date":178,"type":20},"2028-12-31",{"name":46,"class":47},{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":48},"100620172","financial-toxicity-in-patients-with-early-stage-breast-cancer-100620172","NCT07354165","Financial Toxicity in Patients With Early-stage Breast Cancer","Assessing Prevalence of Financial Burden and Impact of Cancer on Financial toxicIty in Patients With Early-stage Breast Cancer","VOICE - GIM36","Inclusion Criteria:\n\n* Signed informed consent form\n* Age \\> 18 years at the time of study entry\n* Histologically confirmed stage I-III invasive breast carcinoma before starting any systemic treatment.\n\nExclusion Criteria:\n\n* Stage IV invasive breast carcinoma\n* Major cognitive dysfunction or psychiatric disorders\n* Any previous systemic treatment for the current breast cancer",{"count":189,"type":20},864,"OBSERVATIONAL","Non-profit, multicenter, prospective, observational study. This study aims to evaluate whether the articulated treatment algorithm that is now possible for early-stage breast cancer patients does produce tangible changes of financial distress over the time and whether the determinants of financial distress change their relative weight over the time.",[193],"Breast Cancer",[195,196,197,198],"early breast cancer","financial toxicity","quality of life","PROFFIT questionnaire","2026-01-14",{"date":201,"type":40},"2026-01-21",{"date":203,"type":40},"2025-09-30",{"date":205,"type":20},"2034-09",{"name":46,"class":47},{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":219,"conditions":220,"keywords":227,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":48},"100617148","using-artificial-intelligence-to-guide-fluid-therapy-during-major-cancer-surgery-a-randomized-controlled-trial-100617148","NCT07314853","Using Artificial Intelligence to Guide Fluid Therapy During Major Cancer Surgery: A Randomized Controlled Trial","Fluid Optimization in Cancer Surgery With AI-Assisted Management - FOCUS-AFM Trial","FOCUS-AFM","Inclusion Criteria:\n\n* Age ≥ 18 years\n* American Society of Anesthesiologists (ASA) Physical Status II-IV\n* Undergoing major abdominal oncologic surgery (open or laparoscopic) with an expected duration \\>2 hours\n* Planned invasive arterial pressure monitoring\n* Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n* Significant arrhythmias (e.g., persistent atrial fibrillation)\n* Severe aortic stenosis\n* Emergency surgery\n* Sepsis\n* End-stage renal disease on dialysis\n* Pregnancy\n* Impossibility to cannulate the radial artery\n* Refusal to participate or refusal of data processing consent",{"count":216,"type":20},176,[218],"NA","The goal of this clinical trial is to learn if using artificial intelligence to guide intravenous fluid therapy during major cancer surgery can help keep blood pressure more stable compared with usual care in adult patients undergoing major cancer surgery. The main questions it aims to answer are:\n\n* Does artificial intelligence-guided fluid therapy reduce hypotensive events during surgery?\n* Does this approach improve recovery and reduce complications after major cancer surgery?\n\nResearchers will compare artificial intelligence-guided fluid therapy with standard fluid management to see if the artificial intelligence-guided approach provides better support during surgery.\n\nParticipants will:\n\n* Undergo major cancer surgery under general anesthesia\n* Receive either artificial intelligence-guided fluid management or standard fluid management during surgery\n* Be monitored during and after surgery as part of routine clinical care\n* Be followed after surgery to assess recovery and possible complications",[221,222,223,224,225,226],"Neoplasm","Cancer","Hemodynamic (MAP) Stability","Cancer Surgery","Artificial Intelligence (AI)","Fluid Therapy DURING SURGERY",[228,229,230,231,232],"randomized controlled trial","cancer","fluid balance","fluid therapy","artificial intelligence","2026-01-07",{"date":235,"type":40},"2026-01-09",{"date":237,"type":20},"2026-02",{"date":239,"type":20},"2029-02",{"name":46,"class":47},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":21,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":48},"100609360","phase-2-stream-2-second-line-treatment-with-regorafenib-in-advanced-ras-mutant-colorectal-cancer-100609360","NCT07213570","STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer","Regorafenib as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer: a Multicentre, Phase 2 Study","Inclusion Criteria:\n\n1. Written informed consent to study procedures and to correlative studies.\n2. Either sex aged ≥ 18.\n3. Histologically proven of colorectal adenocarcinoma.\n4. Diagnosis of metastatic disease.\n5. RAS mutant at initial diagnosis assessed at local centers according with a validated method defined by EMA and known MMR\u002FMSI status.\n6. Achieved a PFS in first line \\> 6 months with chemotherapy in combination to antiangiogenic treatment OR with one metastatic site at study entry\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry.\n8. Imaging-documented measurable disease, according to RECIST 1.1 criteria.\n9. Estimated life expectancy of more than 12 weeks\n10. Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL and platelet count ≥ 100 x 109\u002FL and hemoglobin ≥ 9 g\u002FdL.\n11. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 5 X ULN.\n12. Adequate renal function: serum creatinine ≤ 1.5 mg\u002FdL OR creatinine clearance ≥ 60 mL\u002Fmin in males and ≥50 mL\u002Fmin in females (calculated according to Cockroft-Gault formula).\n13. Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range.\n14. Known dihydropyrimidine dehydrogenase (DPYD) activity is mandatory. Additional analysis of polymorphisms uridine diphosphate-glycosyltransferase 1 (UGT1A1) enzyme is recommended but not mandatory.\n\nExclusion Criteria:\n\n1. Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n2. Any contraindication to regorafenib.\n3. Not received immunotherapy if dMMR or MSI-H.\n4. Major surgical intervention within 4 weeks prior to enrollment.\n5. Pregnancy and breast-feeding.\n6. Any brain metastasis.\n7. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.\n8. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form.\n9. Participation in any interventional drug or medical device study within 30 days prior to treatment start.\n10. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.\n11. Complete deficiency of activity of dihydropyrimidine dehydrogenase (DPYD)",{"count":249,"type":20},60,[59],"The investigators hypothesize that patients with mCRC RAS-mutant eligible for a second line treatment with good prognostic features, identified as single metastatic site, long progression free survival (PFS) in first line treatment, might benefit from a personalized approach, with less intensive treatment with regorafenib as part of a continuum-of-care strategy aimed at ensuring quality of life and extending survival.",[253],"Colorectal Cancer Metastatic",[255,68,256,257],"metastatic colorectal cancer","Regorafenib","RAS-mutation","2025-12-16",{"date":260,"type":40},"2025-12-17",{"date":262,"type":40},"2025-10-16",{"date":264,"type":20},"2027-04",{"name":46,"class":47},{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":21,"phases":276,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},"100570985","phase-2-valproic-acid-to-potentiate-anti-egfr-treatment-efficacy-and-preventrevert-resistance-in-colorectal-cancer-100570985","NCT06714357","ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent\u002FRevert Resistance in Colorectal Cancer","Randomized Phase 2 Study of Valproic Acid Combined With Rechallenge Anti-EGFR Based Regimen Regimens in Pretreated Patients With RAS\u002FBRAF Wild-type Metastatic Colorectal Cancer - VICTORIA Trial","VICTORIA","Inclusion Criteria (Study Part 1):\n\n1. Written informed consent to study procedures and to correlative studies.\n2. Either sex aged ≥ 18.\n3. Histologically proven of colorectal adenocarcinoma.\n4. Diagnosis of metastatic disease.\n5. RAS\u002FBRAF wild-type status at initial diagnosis assessed at local centers according with a validated method defined by EMA and known MMR\u002FMSI status\n6. RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type in liquid biopsy at study entry (according to central testing).\n7. Patient candidate to anti-EGFR rechallenge therapy with panitumumab and irinotecan as clinical practice; Efficacy of anti-EGFR drug in any line of treatment with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1) or stable disease ≥ 6 months and received a subsequent line of therapy upon progression.\n\n   a. Note. Patients must have received at least 2 lines of treatment. Previous treatment with regorafenib, trifluridine\u002Ftipiracile, trifluridine\u002Ftipiracile + bevacizumab or fruquintinib is allowed. Previous rechallenge with anti-EGFR MoAb is NOT allowed. Adjuvant treatment will be considered as one line of therapy in case of progression within 6 months from the last dose of treatment.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry.\n9. Imaging-documented measurable disease, according to RECIST 1.1 criteria.\n10. Estimated life expectancy of more than 12 weeks\n11. Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL and platelet count ≥ 100 x 109\u002FL and hemoglobin ≥ 9 g\u002FdL.\n12. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 5 X ULN.\n13. Adequate renal function: serum creatinine ≤ 1.5 mg\u002FdL OR creatinine clearance ≥ 60 mL\u002Fmin in males and ≥50 mL\u002Fmin in females (calculated according to Cockroft-Gault formula).\n14. Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range.\n\nExclusion Criteria (Study Part 1):\n\n1. Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n2. Any contraindication to panitumumab or irinotecan.\n3. Not received immunotherapy if dMMR or MSI-H.\n4. Patients who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid.\n5. Major surgical intervention within 4 weeks prior to enrollment.\n6. Pregnancy and breast-feeding.\n7. Any brain metastasis.\n8. Patients with long QT-syndrome or QTc interval duration \\> 480 msec or concomitant medication with drugs prolonging QTc .\n9. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.\n10. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form.\n11. Participation in any interventional drug or medical device study within 30 days prior to treatment start.\n12. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.\n13. History of interstitial pneumonitis or pulmonary fibrosis.\n14. History of corneal perforation or ulceration keratitis.\n15. Hypersensitivity to valproic acid or any of listed excipients.\n16. Acute hepatitis or chronic hepatitis.\n17. Personal or familial anamnesis of severe hepatopathy.\n18. History of Hepatic porphyria\n19. Known coagulation disorders.\n20. Known Polymerase-gamma (POLG) mitochondrial mutation (e.g. Alpers-Huttenlocher Syndrome).\n21. Known urea cycle disorders.\n\n    * Inclusion Criteria (Study Part 2):\n\n1\\. Have provided written informed consent to study procedures and to correlative studies.\n\n2\\. Enrolled in VICTORIA - Study Part 1 and randomized to ARM A (control arm) 3. Progressed to treatment within ARM A (control arm). 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry.\n\n5\\. Imaging-documented measurable disease, according to RECIST 1.1 criteria. 6. Estimated life expectancy of more than 12 weeks. 7. Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL and platelet count ≥ 100 x 109\u002FL and hemoglobin ≥ 9 g\u002FdL. 8. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 5 X ULN. 9. Adequate renal function: serum creatinine ≤ 1.5 mg\u002FdL OR creatinine clearance ≥ 60 mL\u002Fmin in males and ≥50 mL\u002Fmin in females (calculated according to Cockroft-Gault formula). 10. Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range.\n\n-Exclusion Criteria (Study Part 2):\n\n1. Did not receive a subsequent line of therapy upon progression to ARM A.\n2. Any brain metastasis.\n3. Pregnancy and breast-feeding.\n4. Serious Adverse events with panitumumab or irinotecan, leading to treatment interruption and discontinuation.\n5. Patients with long QT-syndrome or QTc interval duration \\> 480 msec or concomitant medication with drugs prolonging QTc\n6. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.\n7. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.",{"count":275,"type":20},130,[59],"The investigators hypothesize that the epigenetic agent valproic acid improve the activity of anti-EGFR agents, prevent and revert the emergence of EGFR resistance, in a rechallenge setting.\n\nCorrelative mechanistic studies on tissue and blood samples, liquid biopsies, could identify potential biomarkers of efficacy and help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach with a personalized anti- EGFR treatment strategy.",[253],[280,281,282,283,284,285],"Metastatic colorectal cancer","RAS\u002FBRAF wt","Liquid biopsy","Valproic Acid","anti-EGFR treatment","epigenetic reprogramming",{"date":260,"type":40},{"date":288,"type":40},"2025-03-12",{"date":290,"type":20},"2027-06-20",{"name":46,"class":47},8,{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":315},"100536882","the-oncocamp-study-100536882","NCT06270602","The ONCOCAMP Study","A Retrospective-prospective, Observational, Multicentric Study to Record Data From the ROC Platform and Monitor the ROC Performance","Inclusion Criteria:\n\n* signed informed consent\n* registration in the ROC platform",{"count":301,"type":20},15000,"The present study is a retrospective-prospective observational and multicentric study aiming to collect data relating to all patients included in the ROC platform. All ROC centers will be involved in the present study.",[304],"Oncology",[306,307],"Oncological Network","Multidisciplinary Oncology Groups",{"date":309,"type":40},"2025-12-22",{"date":311,"type":40},"2023-07-14",{"date":313,"type":20},"2026-07",{"name":46,"class":47},17,{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":323,"sex":107,"minAge":17,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":334},"100502051","selenoproteins-as-prognostic-markers-and-therapeutic-targets-in-breast-cancer-100502051","NCT05817227","Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.","Selebrec","Inclusion Criteria:\n\n* TNBC breast cancer patients, before any drug treatment\n* healthy women aged 25-60\n\nExclusion Criteria:\n\n* donors suffering from diabetes, hypertension, active infectious states, HIV infection, Hepatitis B or C, chronic inflammatory diseases, current or previous neoplasms, heart disease or drug treatment.",true,{"count":325,"type":20},300,"This is multicentric, spontaneous, observational, retrospective and prospective study.",[193],{"date":309,"type":40},{"date":330,"type":40},"2022-05-19",{"date":332,"type":20},"2027-11-19",{"name":46,"class":47},2,{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":344,"conditions":345,"keywords":347,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":334},"100613642","real-world-efficacy-and-safety-of-neoadjuvant-dostarlimab-in-patients-with-dmmrmsi-h-locally-advanced-rectal-cancer-100613642","NCT07269249","Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR\u002FMSI-H Locally Advanced Rectal Cancer","RW-NEDOS","Inclusion Criteria:\n\n* Signed informed consent form\n* Age \\> 18 years\n* Histologically confirmed stage II-III rectal cancer\n* dMMR\u002FMSI status assessed locally by Immunohistochemistry, next-generation sequencing or PCR\n\nFor the retrospective part of the study:\n\n* At least one dose of neoadjuvant dostarlimab from November 2023 (i.e. within the period of AIFA dostarlimab monitoring registry activation for the indication in rectal cancer, which is reimbursed according to the Italian law 648\u002F1996, GU n.252 as of 27\u002F10\u002F2023)\n* Eligible deceased or unreachable patients will also be included to avoid selection biases, in respect of the article 110 bis, paragraph 4 of the Italian Privacy Code (a Data Protection Impact Assessment will be produced and published on the Sponsor website before study initiation, and patients explicitly unwilling before death will be not included).\n\nFor the prospective part of the study:\n\n\\- Inclusion in the AIFA dostarlimab monitoring registry for the indication in rectal cancer, to receive dostarlimab according to the Italian law 648\u002F1996, GU n.252 as of 27\u002F10\u002F2023\n\nExclusion Criteria:\n\n* \\- Distant metastasis\n* Major cognitive dysfunction or psychiatric disorders\n* Any previous systemic or local treatment for rectal cancer\n* Dostarlimab received within an interventional clinical trial",{"count":343,"type":20},50,"This is an observational, retrospective-prospective, multicentre trial enrolling all patients included in the AIFA monitoring registry of Dostarlimab for the indication in rectal cancer. The aims of the study are to describe the clinical outcomes and safety of patients with dMMR\u002FMSI-H locally advanced rectal cancer (LARC) receiving neoadjuvant dostarlimab in the real-world setting.",[346],"Locally Advanced Rectal Cancer (LARC)",[348,349,350,351,352],"dostarlimab","mismatch repair-deficient LARC","real-world","retrospective-prospective study","neoadjuvant setting","2025-11-25",{"date":355,"type":40},"2025-12-08",{"date":357,"type":40},"2025-09-01",{"date":359,"type":20},"2027-12",{"name":46,"class":47},{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":107,"minAge":17,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":369,"conditions":370,"keywords":377,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":334},"100613529","contribution-of-oncovascular-surgery-in-the-treatment-of-gynecological-advanced-malignant-diseases-100613529","NCT07267780","Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.","The Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases: a Prospective and Retrospective Multicenter Study","Inclusion Criteria:\n\n\\- Retrospective Arm:\n\n1. Diagnosis of advanced or recurrent gynecologic cancer with vascular involvement requiring resection and\u002For reconstruction of major blood vessels, including:\n\n   * Ovarian carcinoma\n   * Cervical carcinoma\n   * Endometrial carcinoma\n   * Vulvar carcinoma\n   * Uterine or other types of sarcomas with vascular involvement\n2. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.\n3. Patients who underwent onco-vascular surgery for advanced or recurrent gynecologic cancers between January 1, 2017, and August 31, 2025.\n4. Data Protection Impact Assessment (DPIA) approved for the management of retrospective data. (Deceased or untraceable patients will also be included to avoid selection bias, in accordance with Article 110 bis, paragraph 4 of the Italian Privacy Code. A DPIA will be produced and published on the Sponsor's website before study initiation, and patients who explicitly objected before death will not be included.)\n\nProspective Arm:\n\n1. Age ≥18 years\n2. Patients eligible for onco-vascular surgery for advanced or recurrent gynecologic cancers with vascular involvement, including:\n\n   * Ovarian carcinoma\n   * Cervical carcinoma\n   * Endometrial carcinoma\n   * Vulvar carcinoma\n   * Uterine or other types of sarcomas\n3. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.\n4. Signed informed consent.\n\nExclusion Criteria:\n\n1. Patients younger than 18 years of age\n2. Patients with early-stage gynecologic cancers not eligible for onco-vascular surgery\n3. Patients undergoing vascular resection due to accidental injury of blood vessels not directly related to tumor infiltration.\n4. Patients who have previously undergone vascular surgery for reasons unrelated to the study, to avoid data overlap.",{"count":275,"type":20},"Multicenter ambispective observational study (prospective\u002Fretrospective)",[371,372,373,374,375,376],"Ovarian Carcinoma","Cervical Carcinoma","Endometrial Carcinoma","Vulvar Carcinoma","Uterine Sarcoma","Gynecologic Tumor",[378,379],"Advanced or recurrent gynecologic tumor","Vascular infiltration",{"date":381,"type":40},"2025-12-05",{"date":383,"type":20},"2025-12",{"date":385,"type":20},"2035-12",{"name":46,"class":47},{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":107,"minAge":17,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":406},"100595022","application-of-da-vinci-sp-for-endometrial-cancer-surgical-staging-100595022","NCT07027046","Application of da Vinci SP for Endometrial Cancer Surgical Staging","Application of da Vinci SP for Endometrial Cancer Surgical Staging: a Prospective Multicenter Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed endometrial carcinoma (including uterine carcinosarcoma)\n* Performance status (ECOG) 0 - 1\n* Patients undergoing staging surgery for endometrial cancer, including but not limited to robotic hysterectomy with bilateral salpingo-oophorectomy (ovarian preservation in selected patients is not an exclusion criterion) and possible sentinel lymph node biopsy\u002Fpelvic ± para-aortic lymphadenectomy\n* Signed informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients scheduled for an additional extra-genital surgical procedure during the staging surgery for endometrial carcinoma\n* Patients with anesthesiological contraindications to a minimally invasive approach\n* Synchronous tumor\n* Recurrence of endometrial carcinoma\n* Dementia or significantly altered mental status that may impair understanding and the ability to provide informed consent\n* Any reason that may interfere with regular follow-up, even if limited to the first 30 days post-surgery",{"count":395,"type":20},564,"Prospective Multicenter Observational Study The study involves the consecutive inclusion of every patient with endometrial cancer undergoing staging surgical treatment using a robotic approach with the da Vinci SP platform.",[113],"2025-09-18",{"date":400,"type":40},"2025-09-19",{"date":402,"type":40},"2025-04-03",{"date":404,"type":20},"2029-06",{"name":46,"class":47},3,{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":428},"100534256","identification-of-the-pathogenetic-mechanisms-underlying-squamous-cell-carcinomas-100534256","NCT06236464","Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas","Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas of the Anogenital Tract and of the Head-neck Region for the Development of Shared Therapeutic Strategies","Inclusion Criteria:\n\nPatients aged ≥ 18 years, candidates for surgical treatment for squamous cell carcinoma of the anus, uterine cervix, vulva, and head-neck region (including microinvasive and invasive carcinomas) who are capable of understanding and willing to sign the informed consent form. Prospective patients must provide written informed consent before any procedures.\n\nExclusion Criteria:\n\nPatients presenting any of the following criteria are not eligible for inclusion in this study. Exclusion criteria include:\n\n1. Metastatic neoplasia\n2. Treatment for other oncological pathologies\n3. Congenital or acquired immunosuppression (HIV, organ transplant, pharmacological)",{"count":415,"type":20},170,"This is a multicentric, retrospective, and prospective biomarker study.",[418,419],"Squamous Cell Carcinoma of the Head and Neck","Squamous Cell Carcinoma of the Anus","2025-07-24",{"date":422,"type":40},"2025-07-29",{"date":424,"type":40},"2023-09-25",{"date":426,"type":20},"2026-03",{"name":46,"class":47},4,{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":439,"conditions":440,"keywords":443,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":334},"100418247","pain-assessment-in-cancer-patients-by-machine-learning-pascale-100418247","NCT04726228","Pain ASsessment in CAncer Patients by Machine LEarning (PASCALE)","Home-Based Telemedicine for Automatic Pain Assessment in Cancer Patients: Dataset Creation and Development of Machine Learning Algorithms","PASCALE","Inclusion Criteria:\n\n* Patients aged \\> 18 years\n* Home care patients diagnosed with advanced cancer disease and life expectancy ≤ 1 year\n* Patients receiving treatment for cancer pain\n* Patients who have given their consent\n\nExclusion Criteria:\n\n* Patients aged \\\u003C 18 years\n* Willingness to sign the informed consent form (unable to read or write)\n* Cognitive deficit (e.g. Alzheimer disease or senile dementia)",{"count":438,"type":20},40,"In cancer patients, the integration between anticancer therapies and palliative care is of fundamental importance. In this context, telemedicine can improve the quality of life (QoL) of chronic patients through self-management and remote monitoring solutions. This approach can favor the effectiveness of the treatment and therapeutic adherence. Of note, telemedicine can also be applied to the management of cancer pain. In the advanced stages of cancer disease, pain is one of the most obvious and most disabling symptoms. Consequently, proper pain management has a significant impact on the QoL, the ability to withstand treatment, and the recovery of patients. On the other hand, given the complexity of cancer pain, the main obstacle to its proper management is the lack of adequate measurement methods. Although in recent years a great deal of effort has been made in the direction of automatic pain assessment, both concerning the creation of datasets and the development of classification algorithms, the literature is lacking regarding the automatic measurement of pain in the setting of cancer patients. Observation by experienced clinical staff and self-assessment by patients could be useful for obtaining the ground truth and, in turn, for training automatic pain recognition systems.",[304,441,442],"Cancer Pain","Quality of Life",[444,445,446,447,448,449,442],"Pain assessment","Machine Learning","Automatic Pain Assessment","Palliative Care","Telemedicine","Cancer pain",{"date":422,"type":40},{"date":452,"type":40},"2021-06-21",{"date":454,"type":20},"2025-10",{"name":46,"class":47},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":48},"100585652","molecular-based-selection-of-patients-with-head-and-neck-squamous-cell-carcinoma-biomarker-analysis-100585652","NCT06905145","Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis","Inclusion Criteria:\n\n1. Patients aged \\> 18 years\n2. Written informed consent approved by the competent Independent Ethics Committee\n3. Histopathological diagnosis of squamous cell carcinoma of the head and neck region originating from one of the following organs or structures: Oral cavity, oropharynx, larynx, hypopharynx\n4. Locally advanced stage: from T1N1M0 to T4N3M0\n5. Availability of a tissue sample from a biopsy performed according to clinical practice guidelines.\n\nExclusion Criteria:\n\n1. Recurrent\u002Fmetastatic disease\n2. Presence of a synchronous second tumor",{"count":463,"type":20},128,"This is an observational, prospective study enrolling patients who meet the inclusion criteria and provide consent for the use of biopsy samples collected as part of standard clinical practice. The analysis will focus on the following biomarkers: TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, and ERCC1.\n\nThese biomarkers will be examined in both observation groups.",[466,467],"Head and Neck Squamous Cell Carcinoma","Locally Advanced Stage","2025-03-25",{"date":470,"type":40},"2025-04-01",{"date":472,"type":40},"2024-05-03",{"date":474,"type":20},"2032-05",{"name":46,"class":47},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":483,"enrollmentInfo":484,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":493,"locationsCount":48},"100585661","tumor-antigen-discovery-for-innovative-cancer-immunotherapies-in-hcc-from-benchside-to-bedside-hepant-100585661","NCT06905262","Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: from Benchside to Bedside (HepAnt)","Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: from Benchside to Bedside (HepAnt) - Study of the Role of the Metagenome in Head and Neck Tumors Using Omics Techniques - HeNomics","Inclusion Criteria:\n\n* Histological diagnosis of primary HCC and other oncological pathology (Pascale Institute) or diagnosis of oncological pathology (without any exclusions) from an accredited medical-clinical facility (Fortore Mountain Community).\n* Age ≥18 years\n* Ability to give signed informed consent that includes compliance with the requirements and constraints listed in the informed consent form (ICF) and in this protocol.\n* In the case of paraffin-embedded samples obtained from the UOC of Pathological Anatomy and\u002For the Institute's Biological Bank, informed consent cannot be acquired, in accordance with the Provision of the Privacy Authority containing the requirements relating to the processing of special categories of data, pursuant to art. 21, paragraph 1 of Legislative Decree 10 August 2018, no. 101, published in the Official Journal - general series - no. 176 of 29\u002F07\u002F2019, point 5 \"Provisions relating to the processing of personal data carried out for scientific research purposes (gen. aut. n. 9\u002F2016)\" HEALTHY SUBJECTS\n* clinical history free from diagnosis of tumor or neoplastic pathology treated during life\n* Age ≥80 years\n* Ability to give signed informed consent that includes compliance with the requirements and constraints listed in the informed consent form (ICF) and in this protocol\n\nExclusion Criteria:\n\n* Current pathologies requiring antibiotic therapy\n* Diagnosis of pre-tumor pathology (in healthy subjects)","100 Years",{"count":485,"type":20},70,"Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: From Benchside to Bedside (HepAnt) - Study of the Role of the Metagenome in Head and Neck Tumors Using Omics Techniques (HeNomics).",[488],"Hepatocellular Carcinoma",{"date":470,"type":40},{"date":491,"type":40},"2023-01-02",{"date":203,"type":20},{"name":46,"class":47},{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":501,"enrollmentInfo":502,"targetDuration":4,"studyType":21,"phases":504,"briefSummary":505,"conditions":506,"keywords":509,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":48},"100584277","effectiveness-of-nurse-tele-consultation-on-the-quality-of-elective-colonoscopy-procedure-related-anxiety-and-financial-toxicity-100584277","NCT06887244","Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity","Evaluation of the Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity","Inclusion Criteria:\n\nSubjects eligible for outpatient pancolonoscopy:\n\n* for diagnostic purposes;\n* for screening purposes;\n* for post-polypectomy follow-up;\n* of both genders;\n* of all ethnicities;\n\nExclusion Criteria:\n\n* Patients under 18 years of age or over 80 years of age;\n* Patients on waiting lists with SHORT priority: the procedure to be provided within a short time (no more than 10 days);\n* Patients included in GOM pathways who undergo colonoscopy within 10 days;\n* Pregnancy;\n* Presence of known contraindications to bowel preparation;\n* Presence of known contraindications to performing pancolonoscopy;\n* Patients who have undergone colonic resection and\u002For have a colostomy\u002Fileostomy;\n* Patients with cognitive impairments;\n* Patients declared legally incompetent or unable to understand and make decisions;\n* Patients unable to provide informed consent.","80 Years",{"count":503,"type":20},534,[218],"This is a multicenter, non-pharmacological, experimental, prospective, randomized study, with two arms (1:1) in a single-blind design. The study aims to evaluate the effectiveness of a tele-consultation procedure in patients undergoing elective colonoscopy in terms of quality of the exam, anxiety procedure-related and financial toxicity.",[507,508],"Patient Satisfaction and Efficacy of Bowel-preparation","Colon Cancer Prevention",[510,511,512,196,513],"colonoscopy","tele-consultation procedure","colon cancer","anxiety procedure-related","2025-03-21",{"date":516,"type":40},"2025-03-26",{"date":518,"type":40},"2024-06-24",{"date":520,"type":20},"2026-05-31",{"name":46,"class":47},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":483,"enrollmentInfo":528,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":48},"100584095","multi-omic-approach-to-cancer-diagnosis-the-italian-network-of-excellence-for-advanced-diagnosis-innova-100584095","NCT06884878","Multi-omic Approach to Cancer Diagnosis: the Italian Network of Excellence for Advanced Diagnosis (INNOVA)","Inclusion Criteria:\n\n* Consent to participate in the study\n* Age \\>18 years\n* Performance status (PS) 0-1\n* Availability of biological samples for multi-omic profiling\n* Availability of radiological images for radiomic assessments\n* Patients with metastatic disease, i.e., stage IV (except for melanoma, where stage II\u002FIII patients eligible for adjuvant therapy may also be considered)\n* Patients eligible for targeted therapy and\u002For immunotherapy\n* Patients with aggressive neoplasms, including melanoma, non-small cell lung carcinoma (NSCLC), colon carcinoma (BRAF-mutated, MSI), triple-negative breast cancer, ovarian cancer, and cholangiocarcinoma.\n\nExclusion Criteria:\n\n* Previous line of immunotherapy or targeted therapy\n* Previous radiotherapy at the sites of the most recent diagnostic biopsy\n* Most recent diagnostic biopsy performed \\>24 months before enrollment\n* Absence of measurable lesions\n* Presence of active or untreated brain metastases or leptomeningeal carcinomatosis",{"count":529,"type":20},103,"The INNOVA project aims to create an advanced multidisciplinary diagnostic platform to support the Italian healthcare system and translational research. In this context, WP7, coordinated by the Pascale Institute and the focus of this study protocol, is responsible for developing a national platform for the multi-omic profiling of cancer patients eligible for precision medicine treatments, with the goal of supporting clinical decision-making.",[532],"Neoplasms","2025-03-19",{"date":535,"type":40},"2025-03-24",{"date":537,"type":40},"2024-10-08",{"date":539,"type":20},"2026-11",{"name":46,"class":47},{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":549,"conditions":550,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":48},"100584858","development-of-a-platform-for-the-clinical-implementation-of-precision-oncology-in-the-central-southern-regions-of-italy-coesit-100584858","NCT06894823","Development of a Platform for the Clinical Implementation of Precision Oncology in the Central-Southern Regions of Italy (COESIT)","Inclusion Criteria:\n\n* Cancer patients\n* Patients from the central-southern regions\n\nExclusion Criteria:\n\n\\-",{"count":548,"type":20},16000,"COESIT aims to establish a network of reference laboratories in the central-southern regions of Italy for the genetic and molecular characterization of tumors, with the goal of implementing precision and personalized oncology in clinical practice.",[221],{"date":468,"type":40},{"date":553,"type":40},"2024-12-10",{"date":555,"type":20},"2028-12",{"name":46,"class":47},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":323,"sex":107,"minAge":563,"maxAge":501,"enrollmentInfo":564,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":48},"100584784","assessment-of-the-effectiveness-of-the-metabolomic-approach-in-screening-for-endometrial-cancer-100584784","NCT06893861","Assessment of the Effectiveness of the Metabolomic Approach in Screening for Endometrial Cancer","Inclusion Criteria:\n\n1. Female sex\n2. Age between 50 and 80 years\n3. Willingness to participate in the study and signing of the informed consent\n4. Clinical condition of post-menopause\n\nExclusion Criteria:\n\n1. Previous hysterectomy\n2. Hormone replacement therapy\n3. Immunosuppressive therapy","50 Years",{"count":565,"type":20},3100,"The study involves the use of reagents or materials for diagnostic assessments that are not commercially available, specifically a metabolomic signature for screening endometrial carcinoma and\u002For other types of cancers, and follows a case-control design.\n\nThis study aims to achieve several objectives that contribute to evaluating the diagnostic potential of a specific \"metabolomic signature\" to be used for screening endometrial carcinoma. Specifically, the study seeks to assess the signature's discriminative ability in differentiating between benign endometrial neoplasms and neoplasms of different histological origins.",[568],"Endometrial Carcinoma (EC)","2025-03-18",{"date":468,"type":40},{"date":572,"type":40},"2023-07-06",{"date":574,"type":20},"2025-07",{"name":46,"class":47},{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":48},"100584203","spatial-radiomics-and-transcriptomics-to-the-discovery-of-the-cross-link-between-colon-cancer-and-chronic-kidney-disease-100584203","NCT06886282","Spatial RadiomIcs and TRanscriptomics to the DIscovery of the Cross-link Between Colon Cancer and ChrOnic Kidney Disease","SIRIO","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Life expectancy greater than 3 months \\*\\*\n* Histopathological diagnosis of colorectal cancer stage I or II according to the TNM (Tumor, Node, Metastasis) classification\n* Patients with tumors classified as T1-T3, N0, M0 (stage I-II) eligible for surgery\n* Ability to understand and sign the informed consent\n* Clinically stable patients with no significant changes in renal function or disease management in the weeks prior to enrollment \\*\\*\n\nFor the non-CKD group\n\n• Adequate liver, renal and bone marrow function (adequate levels of hemoglobin, platelets, creatinine and bilirubin)\n\nFor the CKD group\n\n* Confirmed diagnosis of chronic kidney disease according to the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines defined by a duration of at least three months with structural or functional abnormalities of the kidneys\n* BSA (Body Surface Area Area) eGFR≤60 ml\u002Fmin\u002F1.73 m2\n\nExclusion Criteria:\n\n* Recent episodes of acute renal failure\n* Kidney transplant, autoimmune diseases; inflammatory bowel diseases; other than oncological or oncohematological diseases of CRC\n* Recent therapies with steroids\u002Fimmunosuppressants and cardiovascular events (within 3 months of enrollment)\n* History of serious allergic reactions to iodinated contrast agents or gadolinium-based contrast agents\n* Recent or planned invasive or surgical treatments that could interfere with the study (within 3 months of enrollment)\n* Psychiatric disorders that could impair the patient's ability to follow study procedures or provide informed consent\n* Other types of concomitant or previous tumors in the previous 5 years of enrollment\n* Pregnant or breastfeeding women. Pregnancy status will be ascertained before enrollment by measuring Beta-hCG in urine (Pregnancy Test or urinary beta-HCG) or in blood (plasma beta-hCG).",{"count":137,"type":20},"The incidence of colorectal cancer (CRC) is higher in patients with chronic kidney disease (CKD) compared to general population. Causal factors have not been clarified so far, although some hypothesis could be formulated. Tumor microenvironment (TME) impacts cancer progression and is influenced by different chronic diseases associated with systemic inflammation. In our study, we aim to address this relevant issue by an in-deep characterization of TME in CKD patients with CRC undergoing surgery. This will provide genes expression directly on tumor tissues.\n\nOur network includes three high national relevance hospitals (INT IRCCS Pascale, AOU Vanvitelli and AOU Brotzu) and a Genetic Research Institute (Biogem Scarl). We will recruit two comparing groups of CRC patients eligible for surgical cancer resection: 1. Patients with I-II stage CRC alone, and 2. Patients with I-II stage CRC and CKD. Anthropological, clinical and laboratory tests data will be collected and organized in a database for epidemiological and descriptive analysis of the enrolled cohorts. Patients will be matched by age, gender and cancer stage and will be stratified by the estimated renal function (application of BSA eGFR formula by Janovitz T et al, J Clin Oncol, 2017). Patients will undergo preoperative high resolution abdominal MRI for high throughput accurate macroscopic assessment of TME by radiomic approach. During surgery, tumor tissue samples will be collected and promptly frozen at -80°C for subsequent analysis. CRC tissue samples will be analyzed combining spatially resolved and single-cell transcriptomic approach, providing a sensitive and unbiased lens for identifying the key mechanisms of the interplay between CRC and immune context, preserving their tissue architecture. Our study involves the usage of Visium Cytassist Spatial Gene Expression, a powerful tool based on in situ capturing methods, providing the whole transcriptome information from tissue sections.\n\nData collected by radiomics and tissue transcriptomics will undergo integrated analysis by a bioinformatic approach based on computational methods. TME will be macroscopically characterized on tumor images to map specific tissue areas of interest.\n\nBy spatial tumor sections analysis, initial segregation of non-malignant TME cells from malignant ones will be performed and then the identification of differentially expressed genes and pathways between the two groups of patients will be finalized.\n\nThese methodologies will allow the full characterization of CRC environment and will highlight possible differences between groups in TME macroscopic imaging features and gene expression. This will permit the discovery of possible specific tumor imaging-detected patterns and the associated molecular pathways specially promoted or deregulated in CKD patients with CRC. These evidences will enhance the value of possible prognostic parameters and the identification of early biomarkers of CRC and future development of targeted therapies. In the era of precision medicine, these goals appear relevant to address the increasing cost and social impact of both CRC and CKD.",[586],"Colorectal Cancer (CRC)",{"date":588,"type":40},"2025-03-20",{"date":590,"type":40},"2024-11-05",{"date":592,"type":20},"2026-08-31",{"name":46,"class":47},{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":21,"phases":603,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":614},"100542353","phase-2-neo-adjuvant-chemo-and-immunotherapy-in-the-pre-operative-treatment-of-locally-advanced-cholangiocarcinoma-100542353","NCT06341764","Neo-adjuvant Chemo and Immunotherapy in the Pre-operAtive Treatment of Locally Advanced CholangIOcarciNoma","Neo-adjuvant Chemo and Immunotherapy with Durvalumab (MEDI4736) and Tremelimumab (MEDI1123) in the Pre-operAtive Treatment of Locally Advanced CholangIOcarciNoma: an Exploratory and Translational Study.","Inclusion Criteria:\n\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union \\[EU\\] Data Privacy Directive in the EU) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n* Histologically or pathologically confirmed CCA\n* Age \\>18 years at time of study entry.\n* Eastern Cooperative Oncology Group (ECOG) 0 or 1.\n* Locally advanced disease (as assessed in multidisciplinary sessions).\n* Life expectancy of at least 16 weeks.\n* Body weight \\>30 kg\n* Adequate normal organ and marrow function as defined below: Haemoglobin ≥9.0 g\u002FdL\n* Absolute neutrophil count (ANC ≥1.5 × 109 \u002FL)\n* Platelet count ≥100 × 109\u002FL\n* Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n* AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN\n* Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine clearance CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.\n* At least 1 lesion that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to randomization.\n* No previous systemic or local treatments including radiation therapy, radiofrequency ablations, electro-chemotherapy.\n\nExclusion Criteria:\n\n* Any previous participation in another clinical interventional study.\n* Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n* History of allogenic organ transplantation.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, interstitial lung disease, etc.\\]). The following are exceptions to this criterion:\n\n  1. Patients with vitiligo or alopecia\n  2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  3. Any chronic skin condition that does not require systemic therapy\n  4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n  5. Patients with celiac disease controlled by diet alone\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, history of myocardial infarction within 12 months, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n* History of bowel obstruction, refractory ascites, or bowel perforation due to advanced disease within the past 3 months from start of study treatment.\n* Significant bleeding diathesis or coagulopathy. Serious, nonhealing wound, ulcer, or current healing fracture.\n* History of another primary malignancy except for\n\n  1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence\n  2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  3. Adequately treated carcinoma in situ without evidence of disease\n* History of leptomeningeal carcinomatosis\n* Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry.\n* History of active primary immunodeficiency.\n* Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection\n* Systemic corticosteroids at physiologic doses not to exceed \\\u003C\\\u003C10 mg\u002Fday\\>\\> of prednisone or its equivalent\n* Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.\n* Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or180 days after the last dose of durvalumab and tremelimumab combination therapy.\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.",{"count":602,"type":20},38,[59],"Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery.",[606],"Cholangiocarcinoma",{"date":608,"type":40},"2024-11-07",{"date":610,"type":40},"2023-09-01",{"date":612,"type":20},"2025-09",{"name":46,"class":47},6,""]