[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572909":3},{"organization":4,"armGroups":7,"interventions":59,"overallOfficials":118,"centralContacts":122,"locations":131,"responsibleParty":161,"collaborators":65,"id":163,"slug":164,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":65,"eligibilityCriteria":169,"healthyVolunteers":165,"sex":170,"minAge":171,"maxAge":65,"enrollmentInfo":172,"targetDuration":65,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":65,"overallStatus":134,"whyStopped":65,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Tianjin Medical University Second Hospital","OTHER",[8,13,31,35,39,43,47,51,55],{"label":9,"type":6,"description":10,"interventionNames":11},"Monotherapy","In the OncoKB(Precision Oncology Knowledge Base) database, the gene alteration has a variant of clinical evidence in this tumor or other tumor types and is considered to be an interventional variant. Cohort-1may include different observation subgroups（dMMR\u002FMSI-H,TMB-H,NTRK fusion,RET-fusion,BRAF(p.V600E),KRAS(p.G12C),HER2(IHC,3+)）. For example, substudy-1: monotherapy\u002Fcombination therapy for patients with A1-relative. Substudy-x: monotherapy\u002Fcombination therapy for patients with Ax-relative.",[12],"Drug: Target Gene",{"label":14,"type":15,"description":16,"interventionNames":17},"Combination therapy-cohort1","EXPERIMENTAL","The characteristics of enrolled patients are the presence of two or more interventional or potential actionable targets(only TP53 alteration,MAP2K1 alteration,PMA pathway alteration,11q13 amplification,MET alteration).",[18,19,20,21,22,23,24,25,26,27,28,29,30,12],"Drug: Olaparib tablet","Drug: Temozolomide capsule","Drug: Anlotinib","Drug: Trametinib tablet","Drug: Dabrafenib","Drug: Vebreltinib Enteric Capsules","Drug: Alpelisib Pill","Drug: Sacituzumab Govitecan-Hziy 180 MG","Drug: Lenvatinib Capsules","Drug: Pazopanib Pill","Drug: Palbociclib Pill","Drug: Chidamide","Drug: PD-1\u002FPD-L1\u002FPD-1&CTLA4 inhibitor",{"label":32,"type":15,"description":33,"interventionNames":34},"Combination therapy-cohort2","The characteristics of enrolled patients are primary or secondary drug resistance during treatment.",[18,19,20,21,22,23,24,25,26,27,28,29,30,12],{"label":36,"type":15,"description":37,"interventionNames":38},"Olaparib+Anlotinib\u002FTemozolomide","The gene TP53 alteration that MTB combines with clinical practice and literature reports that can match targeted therapy is considered to be potential actionable targets.",[18,19,20],{"label":40,"type":15,"description":41,"interventionNames":42},"Trametinib±Vebreltinib","The gene MAP2K1 alteration that MTB combines with clinical practice and literature reports that can match targeted therapy is considered to be potential actionable targets.",[21,22],{"label":44,"type":15,"description":45,"interventionNames":46},"Alpelisib","The PMA(PI3K\u002FmTOR\u002FAKT ) pathway active alteration that MTB combines with clinical practice and literature reports that can match targeted therapy is considered to be potential actionable targets.This subgroup is not included in breast cancer patients.",[24],{"label":48,"type":15,"description":49,"interventionNames":50},"Palbociclib+Pazopanib","The gene alteration(Chromosome 11q13 amplification (CCND1, FGF3, FGF4, and FGF19)) that MTB combines with clinical practice and literature reports that can match targeted therapy is considered to be potential actionable targets.",[27,28],{"label":52,"type":15,"description":53,"interventionNames":54},"Vebreltinib","MET inhibitors have recently demonstrated clinical activity in patients with MET exon 14 (METex14)-skipping\u002FMET-amplification.",[23],{"label":56,"type":15,"description":57,"interventionNames":58},"Combination therapy group based on PD-1\u002FL1 immune checkpoint inhibitors","MTB combined with clinical practice and literature reports can not match the gene alteration of targeted therapy, which is considered as an irreversible gene alteration.This subgroup may use functional models (including but not limited to PDX(Patient-Derived Tumor Xenograft Model), organoids, etc.) for intervention therapy.",[26,29,30,12],[60,66,70,74,78,82,86,90,94,98,102,106,110,114],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"DRUG","Olaparib tablet","Usage and dosage: The recommended dosage is 200mg, twice a day, equivalent to a total daily dose of 400mg.The dosage for combined use will be adaptively adjusted by the researcher.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided(from the I-PREDICT study).",[14,32,36],null,{"type":61,"name":67,"description":68,"armGroupLabels":69,"otherNames":65},"Temozolomide capsule","Administration method and dosage: 75mg\u002Fm2, orally administered for 7 consecutive days, with a treatment cycle of every 21 days.The dosage for combined use will be adaptively adjusted by the researcher.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided.",[14,32,36],{"type":61,"name":71,"description":72,"armGroupLabels":73,"otherNames":65},"Anlotinib","Usage, dosage, and administration method: Take orally once a day before breakfast. Take the medication continuously for 2 weeks and stop taking it for 1 week, that is, 3 weeks (21 days) is one course of treatment. Until disease progression or intolerable toxic side effects occur.The dosage for combined use will be adaptively adjusted by the researcher.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided.",[14,32,36],{"type":61,"name":75,"description":76,"armGroupLabels":77,"otherNames":65},"Trametinib tablet","Usage, dosage, and administration method: The recommended dose is 2 mg, taken orally once a day with an interval of approximately 24 hours. The dose should be taken at least 1 hour before meals or 2 hours after meals. Do not take any missed doses of trametinib within 12 hours of taking the next dose.The dosage for combined use will be adaptively adjusted by the researcher.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided.",[14,32,40],{"type":61,"name":79,"description":80,"armGroupLabels":81,"otherNames":65},"Dabrafenib","Usage and dosage: Take 150mg orally twice a day, with an interval of about 12 hours.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided. When this product is used in combination with trametinib, it should be taken once a day at the same time, along with this product administered in the morning or evening.The dosage for combined use will be adaptively adjusted by the researcher.",[14,32,40],{"type":61,"name":83,"description":84,"armGroupLabels":85,"otherNames":65},"Vebreltinib Enteric Capsules","Usage and dosage: The recommended starting dose is 200 mg\u002Ftime, taken orally twice a day (once in the morning and once in the evening), until disease progression or intolerable toxicity occurs.The dosage for combined use will be adaptively adjusted by the researcher.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided.",[14,32,52],{"type":61,"name":87,"description":88,"armGroupLabels":89,"otherNames":65},"Alpelisib Pill","Usage and dosage: The recommended dosage is 300mg (two 150mg film tablets), taken once a day with food; Continue treatment until the disease worsens or unacceptable toxicity occurs.Administration method: Patients should take aspirin at approximately the same time every day and swallow the entire aspirin tablet (the tablet should not be chewed, crushed, or separated before swallowing).The dosage for combined use will be adaptively adjusted by the researcher.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided.",[44,14,32],{"type":61,"name":91,"description":92,"armGroupLabels":93,"otherNames":65},"Sacituzumab Govitecan-Hziy 180 MG","Usage and dosage: The recommended dosage is 10 mg\u002Fkg, administered intravenously every 21 days as a treatment cycle on the 1st and 8th days, and continued until disease progression or unacceptable toxicity occurs. The dosage of this product should not exceed 10 mg\u002Fkg.The dosage for combined use will be adaptively adjusted by the researcher.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided.",[14,32],{"type":61,"name":95,"description":96,"armGroupLabels":97,"otherNames":65},"Lenvatinib Capsules","Usage and dosage: For patients weighing less than 60kg, the recommended daily dose of lenvatinib is 8mg once a day; For patients weighing ≥ 60kg, the recommended daily dose of lenvatinib is 12mg once daily. Lunvatinib should be taken at a fixed time every day, on an empty stomach or with food.The dosage for combined use will be adaptively adjusted by the researcher.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided.",[56,14,32],{"type":61,"name":99,"description":100,"armGroupLabels":101,"otherNames":65},"Pazopanib Pill","Usage and dosage: In the safety introduction section, the initial dose of pazopanib is 400mg, and in the dose escalation queue, the dose of pazopanib is 600mg.The dosage for combined use will be adaptively adjusted by the researcher.\n\nAdministration method: Oral treatment once a day, with a cycle of 28 days.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided.",[14,32,48],{"type":61,"name":103,"description":104,"armGroupLabels":105,"otherNames":65},"Palbociclib Pill","Usage, dosage, and administration method: 100mg, orally administered once daily for 21 consecutive days, followed by a 7-day discontinuation; Every 28 days is a treatment cycle.The dosage for combined use will be adaptively adjusted by the researcher.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided.",[14,32,48],{"type":61,"name":107,"description":108,"armGroupLabels":109,"otherNames":65},"Chidamide","Usage and dosage: It is recommended to take 30mg (6 tablets) each time, twice a week, with an interval of no less than 3 days between each dose (such as Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.). It should be taken 30 minutes after breakfast.The dosage for combined use will be adaptively adjusted by the researcher.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided.",[56,14,32],{"type":61,"name":111,"description":112,"armGroupLabels":113,"otherNames":65},"PD-1\u002FPD-L1\u002FPD-1&CTLA4 inhibitor","Refer to the respective instructions for use, and the dosage for combined use will be adaptively adjusted by the researcher.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided.",[56,14,32],{"type":61,"name":115,"description":116,"armGroupLabels":117,"otherNames":65},"Target Gene","Granting CFDA or FDA approved drugs(off-label approved drugs) based on specific molecular characteristics.Essentially, for de novo combinations, we started patients at about 50% of the usual dose of each drug for two-drug combinations, and at about one-third of the dose of each drug for three-drug combinations. Patients then received escalating doses of drugs to tolerance, while being monitored closely by their treating physicians. Combinations of drugs with overlapping toxicities were avoided.",[56,14,32,9],[119],{"name":120,"affiliation":5,"role":121},"Haitao Wang, Ph.D","PRINCIPAL_INVESTIGATOR",[123,127],{"name":120,"role":124,"phone":125,"phoneExt":65,"email":126},"CONTACT","+86-022-88326385","peterrock2000@126.com",{"name":128,"role":124,"phone":129,"phoneExt":65,"email":130},"Jinhuan Wang, Ph.D","+86-022-88326610","wjhhappy2008@163.com",[132],{"facility":133,"status":134,"city":135,"state":136,"zip":137,"country":138,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":145,"contacts":146},"Tianjin Medical Unversity Second Hospital","RECRUITING","Tianjin","Tianjin Municipality","300211","China","CN",{"type":141,"coordinates":142},"Point",[143,144],117.17667,39.14222,{"lat":144,"lon":143},[147,150,154,155,157,159],{"name":148,"role":124,"phone":149,"phoneExt":65,"email":126},"Haitao Wang","+86-02288326610",{"name":151,"role":124,"phone":152,"phoneExt":65,"email":153},"Lili Wang","+86-13516108466","wangliliaigang@163.com",{"name":148,"role":121,"phone":65,"phoneExt":65,"email":65},{"name":151,"role":156,"phone":65,"phoneExt":65,"email":65},"SUB_INVESTIGATOR",{"name":158,"role":156,"phone":65,"phoneExt":65,"email":65},"Dingkun Hou",{"name":160,"role":156,"phone":65,"phoneExt":65,"email":65},"Jinhuan Wang",{"type":162,"investigatorFullName":65,"investigatorTitle":65,"investigatorAffiliation":65,"oldNameTitle":65,"oldOrganization":65},"SPONSOR","100572909","phase-2-precision-medicine-trial-based-on-molecular-matching-therapy-for-patients-with-standard-treatment-exhaustion-100572909",false,"NCT06739395","Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion","A Pan-Cancer Basket, Real World, Open-label, Multicenter Study on Molecular Matching Therapy Guided by Molecular Tumor Boards (MTB) for Pan Solid Tumor Patients With Standard Treatment Exhaustion","Inclusion Criteria:\n\n1. Recurrent or metastatic malignant solid tumors diagnosed by histology or cytology;\n2. ECOG score 0-4 (3-4 points only for patients with tumor burden);\n3. Those who fail or cannot tolerate standard treatment, or those who refuse standard treatment;\n4. At least one measurable lesion that meets the RECIST 1.1 standard;\n5. Expected survival period ≥ 3 months;\n6. Age ≥ 18 years old;\n7. Tumor tissue blocks with sufficient formalin fixed paraffin embedding (FFPE), or chest or ascites with cancer cells detected during treatment (not less than 200ml), or excised metastatic lymph nodes, or peripheral blood (approximately 5m1) can be used for genetic testing;\n8. Understand and voluntarily participate in this study, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients who have actively undergone or are currently participating in clinical trials for treatment;\n2. Serious or uncontrolled medical diseases (i.e. uncontrolled diabetes, chronic kidney disease, chronic lung disease or uncontrolled active infection, mental diseases\u002Fsocial conditions that limit the compliance with the research requirements) that the researchers think will confuse the research treatment response analysis;\n3. Pregnant or lactating patients, or any patients with fertility, have not taken appropriate pregnancy prevention measures.","ALL","18 Years",{"count":173,"type":174},300,"ESTIMATED","INTERVENTIONAL",[177],"PHASE2","The main purpose of this study is to explore the feasibility of selecting treatment plans based on genomic variations guided by MTB in patients with advanced refractory solid tumors.",[180,181],"Solid Tumor","Precision Medicine","2024-12-12",{"date":184,"type":185},"2024-12-18","ACTUAL",{"date":187,"type":185},"2024-11-01",{"date":189,"type":174},"2027-05-01",{"name":5,"class":6},1]