[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"narrow-margin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:narrow-margin":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,74,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100607289","phase-3-adjuvant-radiotherapy-of-sintilimab-versus-tace-for-hcc-100607289",false,"NCT07186621","Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC","Adjuvant Radiotherapy Combined With Sintilimab Versus Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma With Narrow Margins and High-Risk Features Following Resection: A Multi-center Phase III Randomized Controlled Trial","Inclusion Criteria:\n\n1. R0 resection of hepatocellular carcinoma (HCC) with a surgical margin \\\u003C1 cm (determined by postoperative pathology, surgical records, and imaging).\n2. Within 4 months after curative resection.\n3. High-Risk Recurrence Factors (at least one required in addition to narrow margin): (1) Microvascular invasion (MVI) positive, tumor thrombus, or satellite nodules (2) Preoperative AFP \\>400 ng\u002FmL (3) Tumor \\>5 cm with incomplete capsule\n4. ≥18 and ≤80 years old.\n5. ECOG score 0-1.\n6. Child-Pugh Class: A5, A6, or B7.\n7. Postoperative Contrast-enhanced MRI of the liver must be performed to exclude intrahepatic residual lesions.\n8. HBV DNA and HCV RNA status do not affect eligibility, but if HBV DNA positive and\u002For HCV RNA positive: ALT must be \\\u003C1.5× upper limit of normal (ULN). Antiviral therapy must be initiated.\n9. Liver Function Tests (LFTs): ALT ≤2.5× ULN (if HBV\u002FHCV positive, ALT ≤1.5× ULN). If ALT ≤1.5× ULN, AST ≤6× ULN (excluding AST elevation due to myocardial infarction). If ALT 1.5-2.5× ULN, AST ≤2.5× ULN.\n10. No significant ECG abnormalities and no severe cardiac dysfunction.\n11. Serum creatinine (CRE) and BUN ≤2.5× ULN.\n12. Hb≥80g\u002FL，ANC≥1.0×109 \u002FL，PLT≥40×109 \u002FL.\n13. Written informed consent obtained.\n\nExclusion Criteria:\n\n1. Vp3 or Vp4 portal vein tumor thrombus (PVTT) or Vv2\u002FVv3 inferior vena cava (IVC) tumor thrombus on preoperative imaging.\n2. Previous anti-HCC therapies, including but not limited to: targeted therapy (e.g., tyrosine kinase inhibitors), immune checkpoint inhibitors (e.g., PD-1\u002FPD-L1 inhibitors) or systemic chemotherapy\n3. Distant metastasis before randomization.\n4. Moderate to severe ascites unresponsive to medical management.\n5. History of other malignancies, except: carcinoma in situ，early-stage papillary thyroid cancer or basal cell carcinoma of the skin\n6. Previous radiotherapy involving the abdomen.\n7. Significant cardiac, renal, or other major organ dysfunction.\n8. Active Autoimmune Disease or Psychiatric Disorders.\n9. HIV Infection.\n10. Pregnant or breastfeeding women.\n11. Currently enrolled in another interventional clinical trial.","ALL","18 Years","80 Years",{"count":20,"type":21},286,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is an open-label, randomized controlled, multicenter, phase III clinical trial",[27,28,29,30,31],"Hepatocellular Carcinoma (HCC)","Radiotherapy, Adjuvant","Immune Checkpoint Inhibitor","TACE","Narrow Margin",[33,34,35,36,30],"hepatocellular carcinoma","radiotherapy","narrow margin","sintilimab","RECRUITING","2025-09-16",{"date":40,"type":41},"2025-09-22","ACTUAL",{"date":43,"type":41},"2025-07-10",{"date":45,"type":21},"2028-11-30",{"name":47,"class":48},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":49},"100597853","phase-2-a-prospective-phase-ii-study-of-postoperative-concurrent-chemoradiotherapy-in-patients-with-intrahepatic-cholangiocarcinoma-100597853","NCT07063888","A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma","A Prospective Phase II Study of Adjuvant Concurrent Chemoradiotherapy With Simultaneous Integrated Boost Following Hepatectomy for Intrahepatic Cholangiocarcinoma With Narrow Margin or Nodal Involvement","Inclusion Criteria:\n\n* Age \\> 18 years, \\\u003C 80 years\n* Patients with primary surgical treatment\n* Postoperative pathology confirmed intrahepatic cholangiocarcinoma\n* Postoperative pathology showing narrow resection margin (\\\u003C1cm) or positive lymph nodes\n* R0\u002FR1 resection\n* Postoperative Child-Pugh score A5-B7\n* Patients meeting either of the following conditions must undergo preoperative or pre-radiotherapy PET-CT to exclude distant metastasis or lymph node metastasis beyond the region from the lower esophagus to the aortic bifurcation\n\n  1. Lymph node metastasis accounting for \\>50% of dissected nodes\n  2. Lymph node metastasis involving the paracardial region or below the renal vein level\n* Postoperative contrast-enhanced liver MRI to exclude Intrahepatic satellite nodules\n* Recovery from surgery with Eastern Cooperative Oncology Group performance status score of 0-2\n* Estimated life expectancy \\>3 months\n\nExclusion Criteria:\n\n* History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix\n* Had prior abdominal irradiation\n* Had prior liver transplantation\n* Had serious myocardial disease or renal failure\n* Had moderate or severe ascites with obvious symptoms 4 months after surgery\n* Duration from surgery ≥ 4 months",{"count":58,"type":21},66,[60],"PHASE2","This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant concurrent chemoradiotherapy with simultaneous integrated boost following hepatectomy for intrahepatic cholangiocarcinoma with narrow margin (\\\u003C1cm) or nodal involvement. Eligibility patients will receive IMRT or VMAT. The prescription dose to high-risk area of tumor bed or positive lymph node was planned at 55-60Gy and the prescription dose to lymphatic drainage regions was planned at 40-45Gy in 20-25 fractions. During radiotherapy, patients will concurrently receive capecitabine (1600 mg\u002Fm² on days 1-14, every 21 days for 2 cycles). After radiotherapy, maintenance therapy with capecitabine will continue (2000 mg\u002Fm² on days 1-14, every 21 days for 6 cycles). For patients who cannot tolerate capecitabine, S-1 will be used as an alternative. The primary endpoint is 2-year recurrence-free survival. The secondary endpoints are 2-year overall survival, local-regional control rate and incidence of grade 3 or higher adverse events.",[63,64,31,65],"Intrahepatic Cholangiocarcinoma (Icc)","Adjuvant Chemoradiotherapy","Lymph Node Involvement","2025-07-11",{"date":68,"type":41},"2025-07-14",{"date":70,"type":41},"2025-05-16",{"date":72,"type":21},"2028-05-15",{"name":47,"class":48},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":49},"100531874","phase-2-phase-ii-study-of-adjuvant-sib-radiotherapy-following-narrow-margin-hepatectomy-in-patients-with-hcc-100531874","NCT06205472","Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.","Phase II Study of Adjuvant Simultaneously Integrated Boost Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.","Inclusion Criteria:\n\n* Pathological diagnosis of HCC after hepatectomy with narrow pathological margins (\\\u003C 1 cm)\n* Age \\> 18 years\n* Recovery from surgery with an Eastern Cooperative Oncology Group performance status score of 0 or 1\n* Child-Push Score: A5-A6\n* Estimated life expectancy \\> 3 months\n* No distant metastasis (M0)\n* Blood routine examination: Hb≥80g\u002FL, ANC≥1.0x10\\^9\u002FL, PLT≥50x10\\^9\u002FL\n* Hepatic function: alanine transaminase(ALT) and aspartate transaminase(AST) ≤1.5 times ULN; or ALT ≤ULN and AST ≤6 times ULN exclude possibility of heart disease\n* Renal function: creatinine(CRE) and blood urea nitrogen(BUN)≤1.5 times ULN\n* Voluntary to participate and sign informed consent\n\nExclusion Criteria:\n\n* History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix\n* Had prior abdominal irradiation\n* Had prior liver transplantation\n* Had serious myocardial disease or renal failure\n* Had moderate or severe ascites with obvious symptoms\n* Duration from surgery ≥ 3 months",{"count":82,"type":21},100,[60],"This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(\\\u003C1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.",[86,31,87],"Hepatocellular Carcinoma","Radiotherapy",[86,31,89],"Adjuvant Simultaneously Integrated Boost Radiotherapy","2024-01-11",{"date":92,"type":41},"2024-01-16",{"date":94,"type":21},"2024-01-26",{"date":96,"type":21},"2026-12-12",{"name":47,"class":48},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":49},"100485584","adjuvant-stereotactic-body-radiotherapy-sbrt-for-hepatocellular-carcinoma-after-hepatectomy-with-narrow-margin-a-prospective-multi-center-randomized-controlled-open-labelled-phase-iii-study-100485584","NCT05602974","Adjuvant Stereotactic Body Radiotherapy (SBRT) for Hepatocellular Carcinoma After Hepatectomy With Narrow Margin: a Prospective, Multi-center, Randomized Controlled, Open-labelled, Phase III Study","Adjuvant Stereotactic Body Radiotherapy (SBRT) for Hepatocellular Carcinoma After Hepatectomy With Narrow Margin: a Prospective, Multicenter, Randomized Controlled, Open-labelled, Phase III Study","Inclusion Criteria:\n\n1. Aged ≥18 years;\n2. Confirmed diagnosis of HCC. The diagnosis can be established radiographically by the criteria of the American Association for the Study of the Liver (AASLD), or by histologic diagnosis from the core biopsy;\n3. Pathologically confirmed as narrow margin (the shortest distance from the edge of the tumor to the surface of liver transection \\\u003C1cm) ;\n4. Child-Pugh class A and B7;\n5. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;\n6. Willing to provide tissue from an excisional biopsy of a tumor lesion;\n7. For patients with active HBV: HBV DNA \\\u003C 2000 IU\u002FmL during screening, and have initiated anti-HBV treatment at least 7 days prior to SBRT and willingness to continue anti-HBV treatment during the study;\n8. Adequate organ and marrow function as defined below:\n\n1)Marrow: absolute neutrophil count ≥1.5×109\u002FL; platelets ≥50×109\u002FL; hemoglobin ≥90g\u002FL; 2)Liver: total bilirubin ≤3× institutional upper limit of normal (ULN); AST(aspartate aminotransferase) or ALT(alanine aminotransferase) ≤ 5× institutional ULN; albumin ≥29g\u002FL; 3)Kidney: creatinine ≤ 1.5× institutional ULN or estimated glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 (according to the Cockcroft-Gault formula); 9. Women of childbearing potential must be willing to use a highly effective method of contraception for the course of the study through 30 days after radiotherapy. Female patient of childbearing potential should have a negative serum pregnancy test before 72h of her first treatment. Sexually active males must agree to use an adequate method of contraception starting with the treatment through 4 months after radiotherapy.\n\nExclusion Criteria:\n\n1. Have received radiotherapy for the area to be treated in the past;\n2. Severe bleeding tendency or coagulation dysfunction within the previous 6 months;\n3. Extrahepatic metastasis;\n4. Known history of active Bacillus Tuberculosis (TB)\n5. Known additional malignancy that is progressing or requires active treatment. 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.\n6. Active infection requiring systemic therapy;\n7. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy;\n8. Known psychiatric or substance abuse disorders ;\n9. Pregnant or breastfeeding;\n10. Known history of human immunodeficiency virus (HIV: HIV 1\u002F2 antibodies);\n11. Received a live vaccine within 30 days before radiotherapy.","75 Years",{"count":107,"type":21},140,[109],"NA","Hepatocellular carcinoma (HCC) is the sixth prevalent malignancy worldwide. Although surgical excision is considered the standard treatment for resectable HCC, a high rate of postoperative recurrence was observed after partial hepatectomy, with a marginal recurrence rate up to 30%. Narrow margin resection may be the most appropriate procedure for centrally located HCC or HCC located near liver capsule because the premise for survival is the conservation of more normal liver parenchyma. Unfortunately, narrow margin resection has been reported to contribute to poor survival outcomes. However, no adjuvant therapy after hepatectomy is generally considered to be effective in reducing post-operative recurrence.\n\nRadiotherapy (RT) has been well used in many solid malignant tumors as an (neo)adjuvant to surgical treatment, including HCC. SBRT has shown encouraging rates of local control for HCC. Compared with standard fractionation radiation, SBRT can achieve more precise delivery of high-dose radiation beams to the lesion, obtaining a much smaller target volume. Meanwhile, it could be finished in a short period which can bring more convenience to patients. Recently, several study and randomized controlled trials revealed the survival benefit of adjuvant RT (IMRT and SBRT) in patients with HCC. A large-sample and high-quality multi-center, randomized controlled, prospective study is warranted to further confirm the efficacy of adjuvant radiotherapy in patients with narrow margin resection, considering the small sample size of above-mentioned studies.",[86,31,112,113],"Adjuvant Stereotactic Body Radiotherapy","Hepatectomy",[115,116,112,113],"Hepatocellular carcinoma","Narrow margin","NOT_YET_RECRUITING","2023-02-16",{"date":120,"type":41},"2023-02-17",{"date":122,"type":21},"2023-03-01",{"date":124,"type":21},"2027-12-01",{"name":126,"class":48},"Second Affiliated Hospital, School of Medicine, Zhejiang University"]