[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656532":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":41,"studyPopulation":33,"armGroups":42,"interventions":57,"overallOfficials":81,"centralContacts":86,"locations":92,"responsibleParty":108,"collaborators":33,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":33,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":33,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":135,"overallStatus":143,"whyStopped":33,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator","Proportion of participants whose best overall response is complete response (CR) or partial response (PR) per RECIST 1.1. Tumor assessment (CT\u002FMRI or PET\u002FCT) is performed at baseline, after the first ablation, and every 8 weeks (±7 days) thereafter until disease progression, regardless of treatment continuation, and is evaluated by the investigator and by a senior radiologist. Analyzed in the full analysis set (all randomized participants, intention-to-treat).","From randomization until disease progression or end of study treatment, up to approximately 24 months",[14,18,22,25,29],{"measure":15,"description":16,"timeFrame":17},"Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator","Time from randomization to the first documented disease progression per RECIST 1.1 (regardless of treatment continuation) or death from any cause, whichever occurs first. Participants without an event are censored at the date of the last tumor assessment. Estimated by the Kaplan-Meier method and compared between arms by log-rank test.","From randomization to progression or death, up to approximately 28 months",{"measure":19,"description":20,"timeFrame":21},"Overall Survival (OS)","Time from randomization to death from any cause. Participants alive at the last follow-up are censored at the date last known alive. Estimated by the Kaplan-Meier method and compared between arms by log-rank test.","From randomization to death from any cause, up to approximately 28 months",{"measure":23,"description":24,"timeFrame":12},"Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by Investigator","Proportion of participants whose best overall response is CR, PR, or stable disease (SD) per RECIST 1.1.",{"measure":26,"description":27,"timeFrame":28},"Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator","Among participants with CR or PR, time from the first documented CR or PR to the first documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first.","From first documented response to progression or death, up to approximately 28 months",{"measure":30,"description":31,"timeFrame":32},"Incidence of Adverse Events (AEs) Per NCI CTCAE Version 5.0","Number and proportion of participants with treatment-emergent AEs, serious AEs, and treatment-related AEs, graded per NCI CTCAE v5.0.","From first study treatment until 30 days after the last dose of study treatment (or start of new anticancer therapy, whichever first), up to approximately 25 months",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"RANDOMIZED","PARALLEL","Participants are randomized 1:1 to local ablation plus systemic therapy or to systemic therapy alone.","TREATMENT",{"masking":40,"maskingDescription":33,"whoMasked":33},"NONE","Metachronous metastasis is defined as distant metastasis detected at least 6 months after curative treatment of the primary nasopharyngeal tumor. Eligible participants are randomized 1:1 to local ablation plus systemic therapy or systemic therapy alone.\n\nAblation is performed under CT guidance by two interventional radiologists; multiple lesions are treated in up to 3 sessions 3-4 weeks apart, and complete ablation is assessed by contrast-enhanced CT or PET\u002FCT 3-4 weeks after ablation.\n\nSystemic therapy in both arms consists of gemcitabine 1000 mg\u002Fm2 on days 1 and 8 plus cisplatin 80 mg\u002Fm2 on day 1 with a PD-1 inhibitor on day 1 every 3 weeks for 6 cycles, followed by PD-1 inhibitor maintenance every 3 weeks for up to 2 years. Tumor response is assessed per RECIST 1.1 every 8 weeks. Adverse events are graded per NCI CTCAE v5.0.\n\nThe sample size of 138 (69 per arm) provides 80% power at a two-sided alpha of 0.05 to detect an improvement in objective response rate from 70% to 90%, allowing for 10% dropout.",[43,52],{"label":44,"type":45,"description":46,"interventionNames":47},"Local ablation plus systemic therapy","EXPERIMENTAL","CT-guided percutaneous local ablation of all liver and\u002For lung oligometastases (single lesion in one session; multiple lesions in up to 3 sessions, 3-4 weeks apart), followed by gemcitabine plus cisplatin with a PD-1 inhibitor every 3 weeks for 6 cycles, then PD-1 inhibitor maintenance every 3 weeks for up to 2 years.",[48,49,50,51],"Procedure: CT-guided percutaneous local ablation","Drug: Gemcitabine","Drug: Cisplatin","Drug: PD-1 inhibitor",{"label":53,"type":54,"description":55,"interventionNames":56},"Systemic therapy alone","ACTIVE_COMPARATOR","Gemcitabine plus cisplatin with a PD-1 inhibitor every 3 weeks for 6 cycles, then PD-1 inhibitor maintenance every 3 weeks for up to 2 years.",[49,50,51],[58,63,68,72],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":33},"PROCEDURE","CT-guided percutaneous local ablation","Percutaneous thermal ablation of each liver and\u002For lung metastasis under CT guidance, performed by two interventional radiologists. The ablation needle is positioned in the center of the lesion and ablation parameters are set according to lesion size and location; ablation ends when the ablation zone covers the entire tumor with a safety margin. A single lesion is treated in one session; multiple lesions are treated in up to 3 sessions 3-4 weeks apart. Complete ablation is assessed by contrast-enhanced CT or PET\u002FCT 3-4 weeks after ablation. Ablation is scheduled at least 3 weeks apart from chemotherapy.",[44],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":33},"DRUG","Gemcitabine","1000 mg\u002Fm2 intravenously on days 1 and 8 of each 21-day cycle for 6 cycles.",[44,53],{"type":64,"name":69,"description":70,"armGroupLabels":71,"otherNames":33},"Cisplatin","80 mg\u002Fm2 intravenously on day 1 of each 21-day cycle for 6 cycles.",[44,53],{"type":64,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"PD-1 inhibitor","Any PD-1 inhibitor approved by the China NMPA for nasopharyngeal carcinoma, given intravenously at the labeled dose on day 1 of each 21-day cycle: 6 cycles together with chemotherapy, then maintenance every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent, death, or completion of 2 years of treatment.",[44,53],[77,78,79,80],"toripalimab","camrelizumab","tislelizumab","sintilimab",[82],{"name":83,"affiliation":84,"role":85},"Jinhua Huang, MD","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[87],{"name":88,"role":89,"phone":90,"phoneExt":33,"email":91},"Yi-Quan Jiang, MD","CONTACT","+86 20 87343272","jiangyq@sysucc.org.cn",[93],{"facility":94,"status":33,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060","China","CN",{"type":101,"coordinates":102},"Point",[103,104],113.25,23.11667,{"lat":104,"lon":103},[107],{"name":88,"role":89,"phone":90,"phoneExt":33,"email":91},{"type":85,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Huang Jinhua","Professor, Department of Minimally Invasive Interventional Therapy","100656532","phase-2-local-ablation-plus-systemic-therapy-for-metachronous-liver-andor-lung-oligometastases-from-nasopharyngeal-carcinoma-100656532",false,"NCT07824856","Local Ablation Plus Systemic Therapy for Metachronous Liver and\u002For Lung Oligometastases From Nasopharyngeal Carcinoma","Efficacy and Safety of Local Ablation Combined With Systemic Therapy for Metachronous Hepatic and\u002For Pulmonary Oligometastases From Nasopharyngeal Carcinoma: A Single-Center, Open-Label, Randomized Controlled Phase II Trial","Inclusion Criteria:\n\n* Written informed consent to participate in the trial\n* Age 18 to 75 years, any sex\n* Histologically or cytologically confirmed nasopharyngeal carcinoma, with clinically diagnosed liver and\u002For lung metastases\n* Primary nasopharyngeal tumor cured after curative treatment, with no lymph node metastasis and no metastases outside the liver and lung (metachronous metastasis: distant metastasis detected at least 6 months after curative treatment of the primary tumor)\n* No more than 5 liver and\u002For lung metastases, each 3 cm or smaller in diameter\n* Liver and\u002For lung metastases amenable to ablation\n* ECOG performance status 0 or 1\n* Adequate hematologic and organ function: absolute neutrophil count ≥1.5×10\\^9\u002FL; hemoglobin ≥70 g\u002FL; platelet count ≥50×10\\^9\u002FL; white blood cell count ≥3.0×10\\^9\u002FL; serum albumin ≥28 g\u002FL; total bilirubin ≤3.0 mg\u002FdL; AST and ALT ≤5×ULN; serum creatinine ≤1.5×ULN; INR ≤2.3 (without anticoagulant therapy)\n* No prior systemic therapy for metastatic disease (e.g., gemcitabine plus cisplatin chemotherapy or PD-1 inhibitor)\n\nExclusion Criteria:\n\n* History of hypersensitivity or intolerance to any study drug\n* Severe hepatic insufficiency, pulmonary fibrosis, or pulmonary hypertension\n* Poorly controlled infectious or radiation-induced inflammation around the lesion, skin infection at the puncture site, systemic infection, or fever \\>38.5 °C\n* Estimated life expectancy less than 3 months\n* Poorly controlled malignant pleural effusion\n* Clinically significant bleeding within 30 days before study entry\n* Uncorrectable coagulopathy or marked hematologic abnormality with evident bleeding tendency\n* Severe hepatic, renal, cardiac, pulmonary, or cerebral dysfunction; severe anemia, dehydration, or nutritional\u002Fmetabolic disturbance that cannot be corrected in the short term; left ventricular ejection fraction \\\u003C45%\n* History of congenital long QT syndrome, or corrected QT interval \\>480 ms (Fridericia)\n* Psychiatric disorder in an active episode\n* Poorly controlled hypertension: systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg\n* Urine protein ≥1 g\u002F24 h (participants with ≥1+ proteinuria on dipstick must have 24-hour urine protein measured); prior organ transplantation\n* Anticoagulant and\u002For antiplatelet therapy (except novel oral anticoagulants such as dabigatran and rivaroxaban) not discontinued for more than 5-7 days before ablation\n* Other malignancy within the previous 3 years or concurrently\n* Prior gemcitabine plus cisplatin chemotherapy or PD-1 inhibitor therapy\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for the trial","ALL","18 Years","75 Years",{"count":122,"type":123},138,"ESTIMATED","INTERVENTIONAL",[126],"PHASE2","This single-center, open-label, randomized phase II trial evaluates whether CT-guided local ablation of liver and\u002For lung oligometastases, added to systemic therapy, improves the objective response rate compared with systemic therapy alone in patients with metachronous liver and\u002For lung oligometastases (no more than 5 lesions, each 3 cm or smaller) from nasopharyngeal carcinoma.",[129,130,131,132,133,134],"Nasopharyngeal Carcinoma","Neoplasm Metastasis","Lung Metastases","Liver Metastases","Oligometastatic Disease","Ablation Techniques",[136,137,138,139,73,140,141,142],"local ablation","thermal ablation","oligometastases","metachronous metastasis","gemcitabine","cisplatin","nasopharyngeal carcinoma","NOT_YET_RECRUITING","2026-09-13",{"date":146,"type":147},"2026-09-17","ACTUAL",{"date":149,"type":123},"2026-10",{"date":151,"type":123},"2029-02",{"name":5,"class":6},1]