[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resistant-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resistant-cancer":134},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,57,78,110],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053502",false,"NCT06347068","Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells","Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer","Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:\n\n1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60% (see APPENDIX VI- Karnofsky Scale))\n4. Histologically confirmed TNBC (ER-, PR-, HER2-negative)\n\n   1. ER- and PR-negative: defined as \\\u003C 1% staining by immunohistochemistry (IHC)\n   2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \\\u003C 2.0\n\nExclusion Criteria:\n\n1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.\n2. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1","ALL","18 Years",{"count":18,"type":19},42,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed\u002Frefractory triple-negative breast cancer (TNBC).",[25,26,27,28],"Breast Cancer","Relapse","Resistant Cancer","Triple Negative Breast Cancer",[30,31],"cellular therapy","biologic therapy","RECRUITING","2026-07-09",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2024-06-27",{"date":40,"type":19},"2030-05",{"name":42,"class":43},"UNC Lineberger Comprehensive Cancer Center","OTHER",1,{"id":46,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":48,"briefSummary":23,"conditions":49,"keywords":50,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":55,"leadSponsor":56,"locationsCount":44},"100542761",{"count":18,"type":19},[22],[25,26,27,28],[30,31],"2026-06-23",{"date":53,"type":36},"2026-06-25",{"date":38,"type":36},{"date":40,"type":19},{"name":42,"class":43},{"id":58,"slug":4,"hasResults":10,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":20,"phases":65,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":44},"100528236","NCT06158139","Autologous CAR-T Cells Targeting B7-H3 in PDAC","A Phase I Study of Autologous CAR-T Cells Targeting the B7-H3 Antigen and Containing the Inducible Caspase 9 Safety Switch in Subjects With Refractory Pancreatic Ductal Adenocarcinoma (PDAC)","Inclusion Criteria:\n\n1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for releasing personal health information explained to, understood by, and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Eastern Cooperative Oncology Group of 0-1 Performance Status)\n4. Histological or cytological evidence\u002Fconfirmation of pancreatic ductal adenocarcinoma.\n5. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \\\u003C 1% failure rate for protection from pregnancy in the product label.\n6. Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the cell infusion therapy.\n\nExclusion Criteria:\n\n1. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n2. Subject is not willing and able to comply with study procedures based on the judgment of the investigator.",{"count":64,"type":19},27,[22],"The purpose of this gene therapy research study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9.CAR.B7-H3 T cells) in patients with pancreatic ductal adenocarcinoma that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration.",[68,26,27],"Pancreas Cancer",[30],"2026-06-05",{"date":72,"type":36},"2026-06-08",{"date":74,"type":36},"2024-07-18",{"date":76,"type":19},"2030-04",{"name":42,"class":43},{"id":79,"slug":4,"hasResults":10,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":20,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100634142","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.",{"count":84,"type":19},25,[86],"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.",[89,90,91,27],"HCC - Hepatocellular Carcinoma","TP53 Gene Mutation","Unresectable",[93,94,95,96,97,98,99],"Firsekibart","Tislelizumab","Lenvatinib","TP53-mutant hepatocellular carcinoma","Unresectable HCC","Advanced liver cancer","Single-arm study","NOT_YET_RECRUITING","2026-04-10",{"date":103,"type":36},"2026-04-17",{"date":105,"type":19},"2026-05",{"date":107,"type":19},"2027-06",{"name":109,"class":43},"Tongji Hospital",{"id":111,"slug":4,"hasResults":10,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":10,"sex":15,"minAge":116,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":44},"100507586","NCT05889312","Assessing Cancer Treatment Response to Therapy Using 18F-FSPG PET","Improving Response Assessment in Cancer by Measurement of Cellular Redox Status Using 18F-FSPG Positron Emission Tomography","Inclusion Criteria:\n\n1. Written informed consent\n2. Aged 16 or above\n3. Histologically confirmed HNSCC or NSCLC, who are treatment naïve and scheduled to commence standard of care treatment ((chemo)radiotherapy)\n4. Willingness and ability to comply with scheduled study visits and tests\n5. Confirmation of adequate function of all major organs and systems\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Concomitant uncontrolled medical conditions\n3. Participants likely to require palliative radiotherapy within the first 12 weeks of treatment\n4. Prognosis less than 3 months\n5. Previous anti-cancer treatment (only treatment naïve patients eligible for inclusion)","16 Years",{"count":118,"type":19},32,"OBSERVATIONAL","Prospective single centre non-randomised exploratory observational study to measure changes in tumour cellular redox status with 18F-FSPG PET in stage 3 non-small cell lung cancer (NSCLC) and stage 3 and 4 head and neck squamous cell cancer (HNSCC) at baseline and during standard of care treatment, and to compare this with 18F-FDG PET\u002FCT and RECIST 1.1 response at 12 weeks.",[122,123,27,124],"Cancer","Diagnosis","Response, Acute Phase","2025-04-02",{"date":127,"type":36},"2025-04-04",{"date":129,"type":36},"2025-02-19",{"date":131,"type":19},"2027-09",{"name":133,"class":43},"Guy's and St Thomas' NHS Foundation Trust",""]