[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tp53-gene-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tp53-gene-mutation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,73,104,127,158],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100634142","a-clinical-trial-of-firsekibart-tislelizumab-and-lenvatinib-in-patients-with-unresectable-tp53-mutated-hepatocellular-carcinoma-100634142",false,"NCT07535840","A Clinical Trial of Firsekibart, Tislelizumab, and Lenvatinib in Patients With Unresectable, TP53-Mutated Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Ability to understand and sign written informed consent prior to any study-related procedures.\n\nAge ≥18 years at the time of signing informed consent.\n\nHistologically or cytologically confirmed advanced or unresectable hepatocellular carcinoma (HCC).\n\nDocumented disease progression after prior systemic immunotherapy, including at least one PD-(L)1 inhibitor.\n\nConfirmed TP53 mutation in fresh liver tumor tissue by central laboratory testing.\n\nDetermined by liver tumor MDT to be unsuitable for curative surgery (R0 resection not feasible, insufficient normal liver volume, or other criteria).\n\nBCLC stage B or C.\n\nAt least one measurable lesion per RECIST v1.1 confirmed by BICR.\n\nECOG performance status 0-1.\n\nChild-Pugh class A within 7 days prior to randomization.\n\nAdequate organ and bone marrow function within 7 days prior to enrollment:\n\nANC ≥1.5×10\\^9\u002FL, Platelets ≥75×10\\^9\u002FL, HGB ≥9 g\u002FdL\n\nTBIL ≤2×ULN, ALT\u002FAST ≤5×ULN, Albumin ≥28 g\u002FL, ALP ≤5×ULN\n\nCreatinine ≤1.5×ULN or CCr ≥50 mL\u002Fmin, urine protein \\\u003C2+ (or 24-h urine protein \\\u003C1 g if baseline ≥2+)\n\nINR ≤2.3 or PT prolongation ≤6 sec\n\nExpected survival ≥12 weeks.\n\nWomen of childbearing potential and male participants with partners of childbearing potential must use effective contraception during treatment and for 6 months after last dose.\n\nAbility and willingness to comply with study procedures and visits.\n\nExclusion Criteria:\n\n* Candidates suitable for local curative therapy.\n\nMixed liver tumors containing sarcomatoid or intrahepatic cholangiocarcinoma components.\n\nHematologic malignancies.\n\nHistory of hepatic encephalopathy or prior liver transplantation.\n\nSymptomatic pleural effusion, ascites, or pericardial effusion requiring drainage; asymptomatic small effusions allowed.\n\nActive HBV (HBV DNA \\>2000 IU\u002FmL) or HCV (HCV RNA \\>10\\^3 copies\u002FmL) infection; co-infection HBsAg+\u002FHCV Ab+ excluded.\n\nCNS metastases.\n\nSignificant recent variceal bleeding (within 6 months).\n\nLife-threatening hemorrhagic events within 3 months.\n\nSignificant thromboembolic events within 6 months.\n\nUse of high-dose aspirin (\\>325 mg\u002Fday) or other platelet inhibitors within 2 weeks prior to first dose.\n\nUnresolved grade ≥2 toxicities from prior therapies (excluding hair loss or asymptomatic lab abnormalities).\n\nSymptomatic heart failure NYHA II-IV or LVEF \\\u003C50%.\n\nUncontrolled arrhythmias or congenital long QT syndrome, QTc \\>500 ms.\n\nActive bleeding disorders or on thrombolytic therapy.\n\nRecent history of gastrointestinal perforation, fistula, obstruction, or significant bowel disease.\n\nRadiotherapy within 3-7 weeks prior to first dose with residual toxicity.\n\nHistory of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced lung injury, or severe impaired lung function.\n\nActive tuberculosis or treatment for TB within 1 year.\n\nHIV infection or active, untreated syphilis.\n\nActive or uncontrolled severe infection within 4 weeks prior to first dose.\n\nActive autoimmune disease requiring systemic treatment within 2 years. Known primary immunodeficiency.\n\nUse of systemic immunosuppressants within 4 weeks prior to first dose (nasal\u002Finhaled steroids at physiologic dose allowed).\n\nReceipt of live attenuated vaccines within 4 weeks prior to first dose.\n\nMajor surgery within 4 weeks prior to first dose, or unhealed wounds. Minor procedures like IV lines excluded.\n\nUncontrolled metabolic disorders or organ\u002Fsystemic disease posing excess risk.\n\nHistory of other malignancy within 5 years, except curatively treated basal cell carcinoma, squamous cell carcinoma, or in situ carcinoma.\n\nKnown hypersensitivity to study drugs or formulation components.\n\nHistory of aortic dissection or visceral artery aneurysm.\n\nParticipation in another clinical trial within 4 weeks prior to first dose.\n\nPregnant or breastfeeding women.\n\nExtensive metastatic disease (≥5 lesions) or major vascular invasion.\n\nOther acute or chronic diseases, psychiatric conditions, or lab abnormalities deemed by investigator to increase risk or interfere with study.","ALL","18 Years",{"count":18,"type":19},25,"ESTIMATED","INTERVENTIONAL",[22],"NA","This study aims to evaluate the effectiveness and safety of a combination therapy with Fuxinqibai monoclonal antibody, Tislelizumab, and Lenvatinib in patients with advanced, unresectable TP53-mutated hepatocellular carcinoma (HCC) who have previously failed systemic immunotherapy.\n\nEligible patients will receive:\n\nFuxinqibai 200 mg IV every 3 weeks Tislelizumab 200 mg IV every 3 weeks Lenvatinib 8 mg (≤60 kg) or 12 mg (\\>60 kg) orally once daily Treatment will continue until disease progression, unacceptable toxicity, start of a new anticancer therapy, withdrawal of consent, or other protocol-defined reasons. Tumor response will be evaluated by RECIST v1.1 every 6 weeks, and confirmed after 4 weeks if response is observed.\n\nSafety will be monitored through adverse events and laboratory tests, graded according to NCI CTCAE v5.0. After treatment ends, patients will be followed every 6 weeks for tumor assessment and every 12 weeks for survival, until death, loss to follow-up, or withdrawal of consent.\n\nPrimary Objective: To assess the objective response rate (ORR) of the combination therapy.\n\nSecondary Objectives: To evaluate overall efficacy, safety, and explore potential biomarkers predicting treatment response.",[25,26,27,28],"HCC - Hepatocellular Carcinoma","TP53 Gene Mutation","Unresectable","Resistant Cancer",[30,31,32,33,34,35,36],"Firsekibart","Tislelizumab","Lenvatinib","TP53-mutant hepatocellular carcinoma","Unresectable HCC","Advanced liver cancer","Single-arm study","NOT_YET_RECRUITING","2026-04-10",{"date":40,"type":41},"2026-04-17","ACTUAL",{"date":43,"type":19},"2026-05",{"date":45,"type":19},"2027-06",{"name":47,"class":48},"Tongji Hospital","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":20,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100632236","phase-1-axatilimab-combined-with-decitabinevenetoclax-for-the-treatment-of-tp53-mutated-aml-100632236","NCT07511062","Axatilimab Combined With Decitabine\u002FVenetoclax for the Treatment of TP53-mutated AML","Axatilimab Combined With Decitabine\u002FVenetoclax for the Treatment of TP53-mutated\u002FDeleted AML Patients","Inclusion Criteria:\n\n* MDS\u002FAML or AML with a TP53 mutation or deletion, defined as:\n* greater than or equal to 10% AND (one of the following):\n* presence of a TP53 mutation\n* presence of a TP53 deletion by FISH\n* positive TP53 staining on IHC of diagnostic bone marrow\n* Either untreated or first salvage (primary refractory or first relapse)\n\nExclusion Criteria:\n\n* KPS \\\u003C60\n* active uncontrolled infection\n* history of HIV or active HBV or HBC infection\n* currently active second malignancy\n* calculated CrCl \\\u003C40mL\u002Fmin\n* AST and\u002For ALT and\u002For direct bilirubin \\>3x ULN\n* cardiac ejection fraction \\\u003C40% or history of uncontrolled cardiac arrhythmias\n* history of acute or chronic pancreatitis, history of myositis\n* known leukemia involvement of CNS\n* hematopoietic stem cell transplantation within 3 months of treatment start and\u002For persistent non-hematologic toxicities of Grade 2+ related to the transplant\n* active acute or chronic GVHD requiring immunosuppressive treatment",{"count":57,"type":19},32,[59],"PHASE1","Axatilimab combined with Decitabine\u002FVenetoclax for the treatment of TP53-mutated\u002Fdeleted AML patients",[62,26],"Acute Myeloid Leukemia","2026-03-31",{"date":65,"type":41},"2026-04-06",{"date":67,"type":19},"2026-08-01",{"date":69,"type":19},"2030-08-01",{"name":71,"class":48},"Northside Hospital, Inc.",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":81,"targetDuration":83,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100404078","li-fraumeni--tp53-lift-up-understanding-and-progress-100404078","NCT04541654","Li-Fraumeni & TP53 (LiFT UP): Understanding and Progress","Li-Fraumeni & TP53: Understanding and Progress (LiFT UP)","LiFT_UP","Inclusion Criteria:\n\n* Individuals with a TP53 pathogenic or likely pathogenic variant identified in blood or saliva,\n* Individuals with variants of uncertain significance in TP53 may be eligible at the PI's discretion,\n* Blood relatives of individuals with a TP53 variant, who may be presumed obligate carriers or healthy controls,\n* Individuals who meet Classic or Chompret LFS criteria whether or not they have a TP53 gene variant,\n* Individuals may enroll their deceased relatives in the study.\n* Individuals with a known TP53 variant that is not LFS, but rather ACE, CHIP, or mosaicism.\n* Individuals participating in other LFS studies can still enroll in LiFT UP. Investigators may be collaborators.\n\nExclusion Criteria:\n\n* Individuals who decline to sign consent\n* Individuals who are unable to give consent or assent and are without a designated healthcare proxy",{"count":82,"type":19},1500,"5 Years","OBSERVATIONAL","The purpose of this research study is to learn more about variants in the TP53 gene both associated with Li-Fraumeni Syndrome (LFS), a hereditary cancer risk condition, and TP53 variants found in the blood for other reasons (e.g. ACE\u002FCHIP and mosaicism).",[87,26,88,89,90],"Li-Fraumeni Syndrome","Hereditary Cancer Syndrome","Clonal Hematopoiesis","Mosaicism",[87,92,88,89,90],"TP53 Gene Mutation (Variant)","RECRUITING","2026-03-24",{"date":96,"type":41},"2026-03-27",{"date":98,"type":41},"2020-09-15",{"date":100,"type":19},"2032-12-31",{"name":102,"class":48},"Dana-Farber Cancer Institute",3,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":72},"100625227","germline-genetic-testing-of-the-tp53-gene-100625227","NCT07419893","Germline Genetic Testing of the TP53 Gene","Germline Genetic Testing of the TP53 Gene: Identification, Characterization, and Management of Patients and Families at High Risk of Cancer","Inclusion Criteria:\n\n* Have undergone at least one genetic counseling session at the Division of Cancer Prevention and Genetics of the IEO;\n* Have undergone germline TP53 genetic testing, regardless of the referral criteria for counseling and\u002For testing or the approach used;\n* Have provided written informed consent for participation in scientific research.\n\nExclusion Criteria:\n\n* Absence of signed informed consent for participation in scientific research.","90 Years",{"count":113,"type":19},1940,"This is a retrospective, observational, single-center study designed as a cohort analysis. The study population will include consecutive patients referred for genetic counseling and TP53 germline genetic testing between 2004 and 2025 at the Division of Cancer Prevention and Genetics of the IEO. The primary endpoint is to determine the overall detection rate of Pathological Variants (PVs) in the TP53 gene among individuals referred to the institute and the differences between the groups.",[26,116,117],"Multi-Gene Transcriptional Profiling","TP53 Gene Germline Mutation Carrier","2026-02-12",{"date":120,"type":41},"2026-02-19",{"date":122,"type":41},"2026-01-29",{"date":124,"type":19},"2031-01",{"name":126,"class":48},"European Institute of Oncology",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":20,"phases":136,"briefSummary":138,"conditions":139,"keywords":143,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":72},"100575892","phase-2-oral-ato-for-tp53-mutated-myeloid-malignancies-100575892","NCT06778187","Oral-ATO for TP53-mutated Myeloid Malignancies","A Phase 2 Study of Oral Arsenic Trioxide (Arsenol ®)-Based Low-intensity Treatment for Previously Untreated or Relapsed\u002FRefractory TP53-mutated Myeloid Malignancies","Inclusion Criteria:\n\n1. Willing and able to provide informed consent\n2. Age ≥18 years\n3. Diagnosis of acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS) or chronic myelonocytic leukaemia (CMML) by World Health Organization (WHO) 2022 criteria (1, 3)\n4. Presence of TP53 mutation\n5. Previously untreated patients for Cohort A (Treatment-naïve), or Patients failing 1 or more lines of prior treatment for Cohort B (Relapsed and Refractory)\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n7. Women of childbearing potential and fertile men must agree to use an approved method of contraception from Screening until 30 days after the last dose of oral arsenic trioxide, ascorbic acid, venetoclax and azacitidine\u002Fdecitabine\u002Foral-decitabine-cedazuridine.\n\nExclusion Criteria:\n\nInclusion Criteria\n\n1. Willing and able to provide informed consent\n2. Age ≥18 years\n3. Diagnosis of acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS) or chronic myelonocytic leukaemia (CMML) by World Health Organization (WHO) 2022 criteria (1, 3)\n4. Presence of TP53 mutation\n5. Previously untreated patients for Cohort A (Treatment-naïve), or Patients failing 1 or more lines of prior treatment for Cohort B (Relapsed and Refractory)\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n7. Women of childbearing potential and fertile men must agree to use an approved method of contraception from Screening until 30 days after the last dose of oral arsenic trioxide, ascorbic acid, venetoclax and azacitidine\u002Fdecitabine\u002Foral-decitabine-cedazuridine.\n\nExclusion Criteria\n\n1. Use of an investigational agent within 14 days of study treatment (or at least 7 half-lives of that agent, whichever is longer), prior to the first dose of oral arsenic trioxide\n2. Known hypersensitivity to arsenic trioxide, ascorbic acid, venetoclax or azacitidine\u002Fdecitabine\u002Foral-decitabine-cedazuridine or their excipients.\n3. Uncontrolled, active infection\n4. Major surgery within 4 weeks of starting the study drug, or not recovered from side effects of surgery\n5. Any other serious medical conditions that could compromise study participation, in the opinion of the investigator\n6. Known HIV infection or known, active hepatitis B or hepatitis C infection\n7. Concurrent second active and non-stable malignancy (patients with a concurrent second active but stable malignancy, i.e., non-melanoma skin cancers, are eligible)\n8. Known history of long QT syndrome (LQTS) or corrected QT interval by Fridericia formula (QTcF) ≥ 480 ms\n9. Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to hemolysis) as defined by any of the following local laboratory parameters:\n\n   1. Calculated glomerular filtration rate (GFR; using the Cockcroft-Gault equation or eGFR; using CKD-EPI) \\\u003C 40 mL\u002Fmin\n   2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x the local upper limit of normal\n10. Pregnant or lactating females, or females planning to become pregnant at any time during the study\n11. Unwilling or unable to comply with the study protocol",{"count":135,"type":19},30,[137],"PHASE2","This is an open-label, phase 2 study of oral arsenic trioxide (Arsenol ®) in combination with ascorbic acid and investigator choice of low-intensity therapy in patients with previously untreated or relapse\u002Frefractory TP53-mutated acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS), chronic myelomonocytic leukemia (CMML).",[62,140,141,26,142],"Myelodysplastic Neoplasm","Chronic Myelomonocytic Leukemia","Arsenic Trioxide",[144,145,146,147,148],"Acute myeloid leukemia","Myelodysplastic neoplasm","Chronic myelomonocytic leukemia","TP53 mutation","Oral arsenic trioxide","2025-06-05",{"date":151,"type":41},"2025-06-10",{"date":153,"type":41},"2025-02-07",{"date":155,"type":19},"2028-02",{"name":157,"class":48},"The University of Hong Kong",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":164,"minAge":16,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":167,"conditions":168,"keywords":172,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":4},"100556176","translational-study-of-mss-tp53-mutation-and-chromosome-instability-relationship-in-endometrial-carcinoma-100556176","NCT06521684","Translational Study of MSS, TP53 Mutation and Chromosome Instability Relationship in Endometrial Carcinoma","Inclusion Criteria:\n\n* willing to participate in the study and sign the informed consent\n* age ≥18 years old\n* researchers evaluated that it was suitable to participate in this translational study\n* Endometrial cancer was confirmed histologically\n* histopathological molecular classification was consistent with pMMR type and POLE wild type\n* The tumor tissue obtained by operation was the primary lesion\n\nExclusion Criteria:\n\n* Received chemotherapy within 14 days prior to sample collection, or received anti-tumor drug therapy such as radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, within 21 days prior to sample collection\n* previously treated with KIF18A inhibitors\n* researchers believed that the subjects were not suitable for the translational study for other reasons","FEMALE",{"count":166,"type":19},110,"The objective is to understand the relationship between TP53 mutation, MSS and chromosome instability in endometrial cancer and the effect on clinical prognosis.We will collect a small amount of tumor tissue samples. NGS panel detection and WGD\u002FAS analysis were performed on the tissue. Paracancer tissue was used as a negative control and relevant information in medical records during the operation. Then we will collect clinical diagnosis and disease information through telephone follow-up after the completion of the operation.",[169,26,170,171],"Endometrial Neoplasms","Chromosomal Instability","Microsatellite Stable Endometrial Carcinoma",[173,170,174,26,175],"Endometrial Cancer","microsatellite stability","Whole genome duplication","2024-07-22",{"date":178,"type":41},"2024-07-26",{"date":180,"type":19},"2024-09-01",{"date":182,"type":19},"2025-06-01",{"name":184,"class":48},"Peking Union Medical College Hospital"]