[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhai Wenlong\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"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":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100653709","phase-4-a-prospective-open-label-randomized-controlled-clinical-study-comparing-hepatic-arterial-infusion-chemotherapy-haic-with-capecitabine-as-adjuvant-therapy-after-radical-surgery-for-malignant-biliary-tract-tumors-100653709",false,"NCT07790445","A Prospective, Open-Label, Randomized Controlled Clinical Study Comparing Hepatic Arterial Infusion Chemotherapy (HAIC) With Capecitabine as Adjuvant Therapy After Radical Surgery for Malignant Biliary Tract Tumors","Inclusion Criteria:\n\n\\- Age ≥18 years, male or female;\n\nPathologically confirmed biliary malignancy (intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, gallbladder cancer, and distal cholangiocarcinoma), and had undergone curative surgery with negative surgical margins;\n\nNo history of other tumors, and no antitumor therapy received before or after surgery (including but not limited to chemotherapy, immunotherapy, radiotherapy, targeted therapy, etc.);\n\nECOG: 0-1;\n\nBaseline blood count tests and blood biochemistry must meet the following criteria: hemoglobin ≥80 g\u002FL; absolute neutrophil count ≥1.5×10\\^9\u002FL; platelet count ≥60×10\\^9\u002FL; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); total bilirubin ≤2 times ULN; serum creatinine ≤1.5 times ULN; albumin ≥30 g\u002FL; INR \\\u003C1.7 or PT prolongation not exceeding 4 seconds; serum creatinine less than 1.5 times the upper limit of normal;\n\nWomen of childbearing potential must agree to use contraception during the study and for 6 months after the study ends (e.g., intrauterine device, contraceptive pills, or condoms); a serum or urine pregnancy test must be negative within 7 days before enrollment, and they must not be breastfeeding; male participants must agree to use contraception during the study and for 6 months after the study ends;\n\nPatients with active hepatitis B virus (HBV) infection must begin anti-HBV treatment during the screening phase and be willing to receive antiviral treatment throughout the study; patients who are hepatitis C virus (HCV) RNA positive must receive antiviral treatment according to standard treatment guidelines and have liver function elevations no higher than CTCAE grade 1.\n\nSubjects voluntarily join this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Pregnancy or lactation;\n\nReceipt of antitumor drug therapy for cholangiocarcinoma before or after surgery;\n\nCardiac, pulmonary, or renal insufficiency, or severe hepatic insufficiency (Child-Pugh class C): severe cardiovascular and cerebrovascular disease (such as myocardial infarction within the past 6 months, unstable angina within the past 1 month, NYHA class III-IV heart failure, uncontrolled arrhythmia, or onset\u002Fworsening of congestive heart failure within the past 30 days). Severe respiratory disease (e.g., FEV1 1.8 mg\u002FdL (or \\>160 μmol\u002FL). Renal disease: chronic renal failure, MDRD ≥ stage III: GFR1.8 mg\u002FdL (or \\>160 μmol\u002FL) Uncontrolled active infection (e.g., severe suppurative cholangitis, sepsis), requiring intravenous antibiotics and hemodynamic instability. ⑤ ASA score \\>3; ⑥ BMI ≥35.;\n\nActive gastrointestinal bleeding, ulcer, or refractory ascites;\n\nDrug-uncontrolled hypertension, coagulation dysfunction, or severe portal hypertension;\n\nTumor recurrence within 1 month after surgery;\n\nHistory of other malignant tumors;\n\nReceipt of other clinical trial drugs within 28 days;\n\nThose deemed unsuitable for inclusion by the investigator.\n\nAllergy and contraindications: severe allergy to iodinated contrast media that cannot be relieved by premedication, or presence of contraindications to angiography.\n\nPostoperative pathology confirms non-biliary tract carcinoma.","ALL","18 Years",{"count":18,"type":19},90,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","3\\. Study Design 3.1.1 Study Site and Overall Population Overview This study is a prospective, open-label, randomized controlled clinical trial designed to observe and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy compared with capecitabine in the adjuvant treatment of malignant biliary tract tumors after radical surgery.\n\nThe study population consists of postoperative patients from the Hepatobiliary Surgery Department of our hospital, who are pathologically confirmed to have malignant biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and other subtypes, and who have completed radical resection (R0 or R1 resection), with postoperative pathology confirming no distant metastasis. Using a computer-generated random sequence, participants will be assigned in a 1:1 ratio to either the hepatic arterial infusion chemotherapy group or the capecitabine group. The study will use recurrence-free survival (RFS) as the primary efficacy endpoint, and plans to enroll approximately 90 patients with malignant biliary tract tumors after radical surgery. After giving informed consent and being screened as eligible, participants will receive the following regimens:\n\nHepatic arterial infusion chemotherapy group:\n\nOxaliplatin 40 mg\u002Fm2 will be infused on days 1-3 of each cycle over 2 hours, followed by continuous infusion of 5-fluorouracil 800 mg\u002Fm2 over a total of 22 hours. One cycle lasts 4 weeks. Treatment will continue for 3-4 consecutive cycles or until disease progression, intolerable toxicity, or withdrawal for other reasons.\n\nCapecitabine group:\n\nCapecitabine, 1250 mg\u002Fm2, orally, twice daily (once in the morning and once in the evening, equivalent to a total daily dose of 2500 mg\u002Fm2), administered from day 1 to day 14 of each 3-week cycle (d1-14, q3w; that is, 2 weeks of continuous treatment followed by 1 week off). One treatment cycle lasts 3 weeks, and a total of 8 cycles will be administered.",[25],"Malignant Biliary Tract Tumors","RECRUITING","2026-09-08",{"date":29,"type":30},"2026-09-11","ACTUAL",{"date":32,"type":30},"2026-07-30",{"date":34,"type":19},"2028-12-31",{"name":36,"class":37},"Zhai Wenlong","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":45,"enrollmentInfo":46,"targetDuration":4,"studyType":20,"phases":48,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":61,"locationsCount":38},"100653635","phase-4-a-prospective-single-arm-open-label-clinical-study-of-the-efficacy-and-safety-of-hepatic-arterial-infusion-chemotherapy-combined-with-targeted-therapy-and-a-pd-1-inhibitor-in-patients-with-postoperative-hepatocellular-carcinoma-and-microvascular-invasion-100653635","NCT07790419","A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Targeted Therapy and a PD-1 Inhibitor in Patients With Postoperative Hepatocellular Carcinoma and Microvascular Invasion","Inclusion Criteria:\n\n1. Age 18-80 years, male or female;\n2. Pathologically confirmed hepatocellular carcinoma, with complete resection of all tumor nodules and negative surgical margins;\n3. Microvascular invasion (MVI) grade ≥ 1\n4. No other history of tumors and no preoperative anticancer treatment.\n5. ECOG: 0-1;\n6. Baseline blood count tests and blood biochemistry must meet the following criteria:\n\n   Hemoglobin ≥80 g\u002FL;\n\n   Absolute neutrophil count ≥1.5×109\u002FL;\n\n   Platelet count ≥50×109\u002FL;\n\n   Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 times the upper limit of normal (ULN);\n\n   Total bilirubin ≤3 times ULN;\n\n   Serum creatinine ≤1.5 times ULN;\n\n   Albumin ≥28 g\u002FL; prothrombin time (PT) ≤19.5 s;\n\n   International normalized ratio (INR) ≤2.3\n7. Women of childbearing potential must agree to use contraception during the study and for 6 months after the study ends (e.g., intrauterine device, oral contraceptives, or condoms); serum or urine pregnancy test must be negative within 7 days before enrollment, and they must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study ends;\n8. Subjects voluntarily participate in this study, sign the informed consent form, are compliant, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Patients with any active autoimmune disease or a history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; patients whose childhood asthma has completely resolved and who require no intervention as adults may be included; asthma requiring bronchodilator intervention for medical management cannot be included);\n\n  2\\. Pregnancy or lactation;\n\n  3\\. Over 80 years old;\n\n  4\\. Prior systemic chemotherapy or radiotherapy;\n\n  5\\. Concomitant malignant pleural effusion or ascites;\n\n  6\\. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);\n\n  7\\. Concomitant infection requiring anti-infective treatment;\n\n  8\\. Concomitant peripheral nervous system disease or a history of significant psychiatric disease and central nervous system disease;\n\n  9\\. Diagnosis of other types of malignant tumors within 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix;\n\n  10\\. Uncorrectable coagulation disorders;\n\n  11\\. Significant ECG abnormalities or obvious clinical symptoms of heart disease, such as congestive heart failure (CHF), clinically significant coronary heart disease, difficult-to-control arrhythmias, and hypertension;\n\n  12\\. History of myocardial infarction within 12 months, or cardiac function class III or IV;\n\n  13\\. Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, uncontrolled diabetes, or other systemic diseases;\n\n  14\\. Individuals deemed unsuitable for inclusion by the investigator.","80 Years",{"count":47,"type":19},40,[22],"A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Targeted Therapy and a PD-1 Inhibitor in Patients with Postoperative Hepatocellular Carcinoma and Microvascular Invasion",[51],"Liver Cancer",[53],"HAIC","NOT_YET_RECRUITING","2026-08-24",{"date":57,"type":30},"2026-08-27",{"date":59,"type":19},"2026-08-30",{"date":34,"type":19},{"name":36,"class":37},""]