[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653709":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":11,"studyPopulation":11,"armGroups":23,"interventions":36,"overallOfficials":11,"centralContacts":45,"locations":51,"responsibleParty":67,"collaborators":11,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":11,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":11,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":11,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"The First Affiliated Hospital of Zhengzhou University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival(PFS)",null,"From date of randonization until disease progerssion or death, assessad up to 12 months",{"measure":14,"description":15,"timeFrame":16},"Recurrence-free survival (RFS)","Time from surgery to the first documented recurrence or death from any cause.","From the date of surgery until the date of first documented recurrence or death from any cause, whichever came first, assessed up to 12 months.",{"allocation":18,"interventionModel":19,"interventionModelDescription":11,"primaryPurpose":20,"observationalModel":11,"timePerspective":11,"maskingInfo":21},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":22,"maskingDescription":11,"whoMasked":11},"NONE",[24,30],{"label":25,"type":26,"description":27,"interventionNames":28},"Capecitabine","ACTIVE_COMPARATOR","Participants will receive Capecitabine, 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 on Days 1 to 14 of each 3-week cycle (d1-14, q3w; i.e., 2 weeks on treatment followed by 1 week off). The treatment cycle is 3 weeks. Treatment will be continued for a total of 8 cycles.",[29],"Drug: Capecitabine",{"label":31,"type":32,"description":33,"interventionNames":34},"HAIC","EXPERIMENTAL","Participants will receive hepatic arterial infusion chemotherapy (HAIC) as follows: Oxaliplatin 40 mg\u002Fm2 will be infused over 2 hours on Days 1 to 3 of each cycle, followed by continuous infusion of 5-fluorouracil 800 mg\u002Fm2 for 22 hours. The treatment cycle is 4 weeks. Treatment will be continued for 3 to 4 cycles, or until disease progression, unacceptable toxicity, or withdrawal due to other reasons.",[35],"Drug: Oxaliplatin + 5-Fluorouracil\u002FLeucovorin",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"DRUG","Oxaliplatin + 5-Fluorouracil\u002FLeucovorin","On days 1-3 of each cycle, oxaliplatin 40 mg\u002Fm2 will be infused for 2 h, followed by continuous infusion of 5-fluorouracil 800 mg\u002Fm2 for a total of 22 h. One cycle lasts 4 weeks. Treatment will continue for 3-4 cycles",[31],{"type":38,"name":25,"description":43,"armGroupLabels":44,"otherNames":11},"Capecitabine, 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; i.e., 2 weeks on treatment followed by 1 week off). One treatment cycle lasts 3 weeks, for a total of 8 cycles",[25],[46],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Wenlong Zhai, MD","CONTACT","+86-371-66862231","ven0371@126.com",[52],{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Zhengzhou","Henan","450052","China","CN",{"type":60,"coordinates":61},"Point",[62,63],113.64861,34.75778,{"lat":63,"lon":62},[66],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Zhai Wenlong","Porfessor","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":80,"type":81},90,"ESTIMATED","INTERVENTIONAL",[84],"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.",[87],"Malignant Biliary Tract Tumors","2026-09-08",{"date":90,"type":91},"2026-09-11","ACTUAL",{"date":93,"type":91},"2026-07-30",{"date":95,"type":81},"2028-12-31",{"name":69,"class":6},1]