[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-biliary-tract-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-biliary-tract-carcinoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,75,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100597728","phase-3-trastuzumab-plus-chemotherapy-vs-chemotherapy-alone-in-first-line-her2-positive-advanced-biliary-tract-cancer-patients-100597728",false,"NCT07062263","Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients","Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients - a Randomized Non-blinded Two-arm Phase III Prospective Clinical Trial (TAB-2 Study).","TAB-2","Inclusion Criteria:\n\nHistologically confirmed adenocarcinoma of the biliary tract, with the following specifications -\n\n1. Biliary tract cancers include gallbladder cancer, intrahepatic cholangiocarcinoma, and perihilar cholangiocarcinoma.\n2. HER2-positive by IHC or FISH\n3. Age \\>=18 years.\n4. ECOG performance status 0 - 2.\n5. Unresectable or metastatic cancer.\n6. Patient does not have any contraindications to receive chemotherapy or trastuzumab.\n7. Adequate hematological, hepatic, and renal function parameters- Hematological- Hb\\> 80 g\u002FL, ANC ≥ 1.5 x 109\u002FL, platelets ≥ 100 x 109\u002FL. Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST\u002FALT ≤ 5 x ULN, alkaline phosphatase ≤ 6 x upper limit normal (ULN) S. albumin ≥ 30 g\u002FL.\n\n   Renal function- Creatinine ≤ 1.5 ULN, Creatinine clearance \\>= 30 mL\u002Fmin.\n8. Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography, ejection fraction (EF) \\>=50% or above the lower limit of normal. ECG with no clinically relevant abnormalities.\n9. Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.\n10. Subjects must provide written informed consent prior to the performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up assessments and procedures.\n11. Subjects who have received adjuvant chemotherapy will be considered eligible provided that therapy is completed more than 12 months before study enrollment. Patients who have received radiation therapy and surgery will also be eligible provided the interventions have been completed 3 and 2 weeks, respectively, before enrolment in the study.\n12. Negative serum pregnancy test (if applicable) and willing for adequate contraception.\n13. At least one measurable disease according to RECIST criteria.\n14. Life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n1. Distal cholangiocarcinoma\n2. Known hypersensitivity or contraindications against gemcitabine, cisplatin, Nab- paclitaxel, or trastuzumab.\n3. Clinically significant active coronary heart disease, cardiomyopathy, or congestive heart failure, NYHA III-IV.\n4. Clinically significant valvular defect.\n5. Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.\n6. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.\n7. Baseline neuropathy \\> NCI Grade I.\n8. Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.\n9. Received prior chemotherapy within 1 year.\n10. Any active ILD\u002F history of lung illness requiring bronchodilator drugs.\n11. Patients with prior chemotherapy for metastatic disease will be ineligible for enrollment in the study.","ALL","18 Years","99 Years",{"count":21,"type":22},220,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a randomized, open-label, two-arm, Phase III clinical trial evaluating the efficacy and safety of trastuzumab plus chemotherapy versus chemotherapy alone as first-line treatment in patients with HER2-positive advanced or metastatic biliary tract cancers (BTC). HER2-positive BTCs represent a molecular subset of these rare cancers, associated with poor prognosis and limited treatment options.\n\nEligible patients with histologically confirmed HER2-positive (IHC 3+ or IHC 2+ with FISH amplification) unresectable or metastatic biliary tract adenocarcinoma-including gallbladder cancer, intrahepatic, and perihilar cholangiocarcinoma-will be randomized in a 1:1 ratio. Participants in the intervention arm (Arm A) will receive either gemcitabine and cisplatin with or without nab-paclitaxel plus trastuzumab, while those in the control arm (Arm B) will receive chemotherapy alone (gemcitabine + cisplatin with or without nab-paclitaxel). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or death.\n\nThe primary endpoint is 6-month progression-free survival (PFS). Secondary endpoints include overall survival (OS), response rate (RR), quality of life (QOL), and adverse event (AE) profiles. The study aims to enroll 196 patients across a single center in India over a period of 5 years, with an additional 6-month follow-up. This trial builds on earlier Phase II findings suggesting improved outcomes with trastuzumab in HER2-positive BTC and aims to provide the first randomized evidence for the benefit of HER2-targeted therapy in this setting.",[28,29,30,31,32],"Biliary Tract Cancer","HER2-positive Cancer","Advanced Cancer","Unresectable Biliary Tract Carcinoma","Metastatic Biliary Tract Carcinoma","RECRUITING","2025-07-02",{"date":36,"type":37},"2025-07-14","ACTUAL",{"date":39,"type":37},"2023-07-21",{"date":41,"type":22},"2029-07-31",{"name":43,"class":44},"Tata Memorial Centre","OTHER",6,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100526527","phase-2-tripegfilgrastim-trial-to-reduce-the-risk-of-severe-neutropenia-in-patients-with-unresectable-pancreaticobiliary-cancers-100526527","NCT06135896","Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers","An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers","Dulastin","Inclusion Criteria:\n\n* Patients aged at least 19 years old, diagnosed with unresectable pancreaticobiliary cancer, and scheduled to receive chemotherapy using nal-IRI\u002F5-FU\u002FLV combination chemotherapy\n\nExclusion Criteria:\n\n* Patients who refuse to sign the consent form Patients who have previously experienced severe neutropenia during chemotherapy","19 Years",{"count":56,"type":22},98,[58],"PHASE2","* Clinical trial phase: Phase 2\n* Intervention model: Control group\n* Group allocation: Randomized controlled trial\n* Research perspective: Prospective study\n* Participating centers: Multicenter study\n* Definition of the intervention period: Based on the RECIST 1.1 guidelines, patients will receive treatment until dropout due to disease progression or unacceptable toxicity related to the trial drug. Patients will be followed up with to assess survival every 2 months until either death or the end of the trial, whichever is first.\n* The intervention period is from the date of IRB approval to December 31st, 2025\n* The follow-up duration is one year, and the statistical analysis duration is six months\n* The total research period is from the date of IRB approval to June 30th, 2026",[61,62,31],"Unresectable Pancreatic Cancer","Unresectable Bile Duct Carcinoma",[61,62,31],"2025-06-15",{"date":66,"type":37},"2025-06-18",{"date":68,"type":37},"2024-01-16",{"date":70,"type":22},"2026-06-30",{"name":72,"class":73},"National Cancer Center, Korea","OTHER_GOV",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":74},"100573703","phase-2-adebrelimab-combined-with-apatinib-and-gemcitabine-and-cisplatin-gp-first-line-treatment-for-unresectable-biliary-tract-carcinoma-100573703","NCT06749730","Adebrelimab Combined with Apatinib and Gemcitabine and Cisplatin (GP) First-line Treatment for Unresectable Biliary Tract Carcinoma","A Prospective, Single Arm Study of Adebrelimab Combined with Apatinib and Gemcitabine and Cisplatin (GP) First-line Treatment for Unresectable Biliary Tract Carcinoma","Inclusion Criteria:\n\n* 1.Age range from 18 to 80 years old, regardless of gender;\n* 2.Histologically confirmed, unresectable advanced or metastatic BTC including cholangiocarcinoma (intrahepatic or extrahepatic), gallbladder carcinoma.\n* 3\\. Patients who have not received systematic treatment for BTC in the past .\n* 4.At least one measurable lesion (according to RECIST v1.1 requirements).\n* 5.ECOG PS: 0-1 points;\n* 6.Expected survival time ≥ 12 weeks;\n* 7\\. The main organs are functioning normally and meet the following requirements White blood cell count ≥ 3.0× 10 9\u002FL; Hb ≥ 90 g\u002Fl; Absolute neutrophil count ≥ 1.5× 10 9\u002FL; Platelet count ≥ 100× 10 9\u002FL; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤ 2.5 times the upper limit of normal limit (ULN); Total bilirubin ≤ 2 times of ≤ULN; Serum creatinine ≤ 1.5 times of ≤ULN; Albumin ≥ 30 g\u002Fl;\n* 8\\. Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 14 days prior to enrollment, and voluntarily use appropriate methods of contraception during observation and within 8 weeks after the last administration of study medication; For males, surgical sterilization should be performed, or appropriate methods of contraception should be agreed upon during observation and within 8 weeks after the last administration of study medication;\n* 9\\. The subjects voluntarily joined this study, signed an informed consent form, and cooperated with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Histologically diagnosed as neuroendocrine carcinoma;\n* 2\\. People who are allergic to adebelizumab, apatinib, gemcitabine, cisplatin or their auxiliary materials;\n* 3\\. Systemic treatment in the past;\n* 4\\. Pleural effusion, pericardial effusion or ascites accompanied by clinical symptoms and judged by the researcher to require frequent drainage;\n* 5\\. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);\n* 6\\. Active or uncontrollable serious infection (≥ CTCAE grade 5.02 infection), including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia, and unexplained fever \\> 38.5℃ before the first administration;\n* 7\\. Liver cirrhosis and active hepatitis; Hepatitis B reference: HBsAg positive, and HBV DNA exceeds the upper limit of normal value (1000 copies \u002Fml or 500 IU\u002Fml); Patients with hepatitis B virus (HBV) infection or cured HBV infection in the past (defined as the existence of hepatitis B core antibody \\[HBcAb\\] and the absence of HBsAg, and those with normal HBV DNA value during the screening period can be included; Hepatitis C reference: HCV antibody is positive, and the detection value of HCV virus titer exceeds the upper limit of normal value \u002FHCV RNA or HCV Ab detection indicates acute and chronic infection;\n* 8\\. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;\n* 9.Within 5 years, the subject has other malignant tumors in the past or at the same time and needs active treatment (except for fully treated basal cell or squamous cell skin cancer, cervical carcinoma in situ and breast cancer in situ, if the estimated 5-year survival rate is more than 90%);\n* 10\\. There is an uncorrectable coagulation disorder;\n* 11\\. Severe liver diseases (such as liver cirrhosis), kidney diseases, respiratory diseases, uncontrollable diabetes or other types of systemic diseases.\n* 12\\. Patients whose imaging shows that the tumor has invaded important blood vessels or who are judged by the researchers to be very likely to invade important blood vessels and cause fatal bleeding during the follow-up study;\n* 13\\. Active autoimmune disease or immunodeficiency, or the following medical history, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc.) shall not be included. The following exceptions are made: patients with a history of autoimmune hypothyroidism but receiving thyroid hormone replacement therapy can be included in the study. Patients with type 1 diabetes whose blood sugar has been controlled after insulin administration can participate in this study.\n* 14, Within 14 days prior to signing the informed consent form, use immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dose\\>10mg\u002Fday prednisone or other therapeutic hormones)\n* 15.Arterial\u002Fvenous thrombosis events occurred within 6 months before the first administration, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral embolism, etc.), deep venous thrombosis and pulmonary embolism;\n* 16.The researcher judges digestive tract diseases or conditions that may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis or active bleeding of unresectable digestive tract tumors, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the researcher, with various factors that affect oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);\n* 17.Individuals with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg)\n* 18.Surgery (except biopsy) was performed within 28 days before being enrolled in this study, or the surgical incision was not completely healed;\n* 19.Have received any other experimental drug treatment or participated in other intervention research within 4 weeks before signing the informed consent form;\n* 20.Pregnant (pregnancy test positive before medication) or breast-feeding women;\n* 21.According to the researcher's judgment, that is not suitable for patients in the group;","80 Years",{"count":84,"type":22},63,[58],"This study is designed to combine anti-angiogenic drugs on the basis of PD-L1+ gemcitabine\u002Fcisplatin, hoping to further improve the curative effect of advanced BTC treatment and provide more choices for first-line treatment of BTC in China.",[31],"2024-12-24",{"date":90,"type":37},"2024-12-27",{"date":92,"type":37},"2024-04-01",{"date":94,"type":22},"2027-06",{"name":96,"class":73},"Henan Cancer Hospital",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100566544","phase-2-endoscopic-retrograde-cholangiopancreatography-with-radiofrequency-ablation-ercp-rfa-combined-with-envafolimab-and-surufatinib-sequential-therapy-for-unresectable-biliary-tract-carcinoma-100566544","NCT06656559","Endoscopic Retrograde Cholangiopancreatography With Radiofrequency Ablation (ERCP-RFA) Combined With Envafolimab and Surufatinib Sequential Therapy for Unresectable Biliary Tract Carcinoma","Endoscopic Retrograde Cholangiopancreatography With Radiofrequency Ablation (ERCP-RFA) Combined With Envafolimab and Surufatinib Sequential Therapy for Unresectable Biliary Tract Carcinoma: A Prospective, Single-Arm, Single-Center Phase II Clinical Study","Inclusion Criteria:\n\n* Sign written informed consent.;\n* 18-79 years of age (at the time of signing the informed consent);\n* Patients with confirmed diagnosis of biliary tract tumors by histopathologic examination;\n* Patients have received no previous local treatment or any systemic treatment, and have been considered unsuitable for radical therapies\n* Patients assessed by the investigator as unsuitable for or refusing chemotherapy\n* At least one measurable lesion (≥10 mm long diameter on CT scan for tumor lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria);\n* ECOG score: 0-1;\n* Expected survival ≥ 12 weeks;\n* Vital organ function in accordance with the following requirements (excluding any blood components and cell growth factors within 14 days): 1) blood routine: neutrophils ≥ 1.5 × 10\\^9\u002FL platelet count ≥ 60 × 10\\^9\u002FL hemoglobin ≥ 90 g\u002FL; 2) liver and kidney function: serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml\u002Fmin (Cockcroft-Gault formula); total bilirubin (TBIL) ≤ 1.5 times ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 ULN (≤ 5ULN if liver function abnormalities are due to liver metastases); urine protein \\\u003C 2 +; if urine protein ≥ 2 +,24-hour urine protein must show protein ≤ 1g;\n* Normal coagulation, no active bleeding and thrombosis disease 1) international normalized ratio INR ≤ 1.5 × ULN; 2) partial thromboplastin time APTT ≤ 1.5 × ULN; 3) prothrombin time PT ≤ 1.5 × ULN;\n* Non-surgically sterilized or female patients of childbearing age who need to use a medically recognized contraceptive (such as an intrauterine device, contraceptive pills or condom) during study treatment and within 3 months after the end of study treatment; non-surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 7 days before study enrollment; and must be non-lactating; non-surgically sterilized or male patients of childbearing age who need to agree to use a medically recognized contraceptive during study treatment and within 3 months after the end of study treatment with their spouses.\n* Willing and able to be followed up until death or end of study or study termination.\n\nExclusion Criteria:\n\n* History of other malignancies (except basal cell carcinoma of the skin and\u002For carcinoma in situ of the cervix after radical surgery).\n* Previous treatment with other immune checkpoints; the subject known to have a prior allergy to macromolecular protein preparations;\n* Presence of any active autoimmune disease or history of autoimmune disease in the subject;\n* Subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppression (dose \\>10mg\u002Fday prednisone or other equipotent hormone) and who continue to be on it within 2 weeks prior to enrollment.\n* Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;\n* Patients with poorly controlled cardiac clinical symptoms or diseases such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;\n* Subjects with active infection or unexplained fever \\>38.5 degrees Celsius during screening and prior to the first dose (if the subject had fever due to the tumor, as determined by the investigator, he could be enrolled);\n* Previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.;\n* Subjects with congenital or acquired immune deficiency (e.g., HIV-infected individuals)\n* Subjects who have had a live bacterial vaccine or live attenuated vaccine vaccine within 4 weeks prior to the first dose of study treatment.\n* Subject has a known history of psychiatric drug abuse, alcoholism, or drug abuse;\n* Patients who cannot be administered orally\n* The subject had received treatment with traditional Chinese medicine within 2 weeks before the first treatment\n* ECOG score: ≥2\n* Patients with any other diseases, dysfunction caused by metastatic lesions, or suspected disease found by physical examination, indicating possible contraindications to the use of the investigational drug or putting the patients at high risk of treatment-related complications.","79 Years",{"count":106,"type":22},30,[58],"The sequential treatment strategy of ERCP-RFA combined with envafolimab and surufatinib proposed in this study aims to maximally inhibit the progression of unresectable biliary tract tumors through the combined application of multiple therapeutic modalities. ERCP-RFA, as a local treatment, first reduces the tumor burden and alleviates biliary obstruction through physical ablation. Subsequently, Envafolimab enables the body to more effectively identify and attack the remaining tumor cells by activating the immune system. Finally, Surufatinib as a targeted drug, further controls the growth and spread of tumors by inhibiting tumor angiogenesis and cell proliferation. The potential advantage of this combined treatment lies in the complementary effects of different therapeutic modalities.",[31],"NOT_YET_RECRUITING","2024-10-23",{"date":113,"type":37},"2024-10-24",{"date":115,"type":22},"2024-10",{"date":117,"type":22},"2026-08",{"name":119,"class":44},"Tianjin Medical University Cancer Institute and Hospital"]