[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-biliary-tract-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-biliary-tract-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,69,91,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100613368","phase-3-a-study-to-select-a-dose-regimen-part-a-and-to-investigate-overall-survival-part-b-with-nanvuranlat-compared-with-physicians-best-choice-in-participants-aged-18-years-or-older-with-biliary-tract-cancer-100613368",false,"NCT07265674","A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer","A Phase 3, Multicenter, Randomized, Open-label, Study Evaluating the Efficacy and Safety of Nanvuranlat in Patients With Previously Treated Advanced Biliary Tract Cancer","Beacon-BTC","Inclusion Criteria:\n\n\\- Individuals are eligible to be included in the study only if all of the following criteria apply:\n\n1. At least 18 years of age inclusive at the time of signing the informed consent.\n2. Provides informed written consent according to local laws or regulations.\n3. Able and willing to comply with scheduled visits, treatment plans, procedures, and laboratory tests, including peripheral blood and urine sampling during the study.\n4. Willing to participate in LAT1 testing and NAT2 and transporter genotyping. Note: For LAT1 testing, if the participant does not have archival tissue and a fresh biopsy is not in the best interest of the participant, they will still be eligible for the trial.\n5. Cancer must be metastatic, locally advanced and unresectable, or not amenable to treatment with local therapies that could offer a reasonable likelihood of clinical benefit.\n6. Histologic or cytologic diagnosis of BTC.\n7. Has BTC that is classified as either an IHC, EHC, or GBC based on surgical, clinical, or laparoscopic findings and\u002For radiological imaging (eg, CT, MRI).\n8. Has received 1 prior appropriate platinum (cisplatin, carboplatin, or oxaliplatin)-based therapy for advanced disease (locally advanced or metastatic) with or without a mAb targeting PD-1 or PD-L1.\n\n   1. Disease progression during or within 6 months of neoadjuvant or adjuvant treatment with a platinum-containing regimen will count as having received 1 prior regimen.\n   2. If a patient has a mutation\u002Ffusion of IDH1, FGFR2 or NTRK, or an amplified, mutated, or overexpressed form of HER2, or a recognized aberration in a validated \"driver\" of BTC, and was treated with an appropriate targeted agent, or the patient's tumor was determined to be MSI-H and an appropriate PD-1\u002FPD-L1 mAb was administered, the targeted therapy or immunotherapy will NOT count as a separate line of treatment.\n9. ECOG PS of 0 or 1.\n10. Expected life expectancy of at least 90 days after the first day of treatment as per the site Investigator.\n11. At least 1 measurable lesion by RECIST v1.1 based on imaging (eg, CT, MRI) performed within 28 days prior to initiation of study intervention. Those who have received prior local therapy, including but not limited to embolization, chemoembolization, radiation therapy, and\u002For other appropriate ablative procedures to a measurable lesion that is within the treatment and shown ≥ 20% growth in size since posttreatment assessment.\n12. Resolution to ≤ Grade 1 by the NCI CTCAE v 5.0 (or higher) of all clinically significant toxic effects of prior chemotherapy or other treatments, except for alopecia and peripheral neuropathy (these must have resolved to ≤ Grade 2). If medical therapy is required for the treatment of a laboratory abnormality, the dose and laboratory value(s) should be stable.\n13. Adequate hematologic function:\n\n    1. ANC ≥ 1.5 × 109\u002FL. Myeloid growth factors must not have been administered within 7 days before the participant's first dose of study intervention.\n    2. Hemoglobin ≥ 8.5 g\u002FdL and no RBC transfusions during the 14 days before the participant's first dose of study intervention.\n    3. Platelet count ≥ 100 × 109\u002FL and no platelet transfusions during the 14 days before the participant's first dose of study intervention.\n14. Adequate baseline organ function, as demonstrated by the following:\n\n    1. eGFR ≥ 50 mL\u002Fmin as estimated by CKD-EPI 2021.\n    2. Bilirubin ≤ 2 × ULN (local institution).\n    3. AST and ALT ≤ 5 × ULN (local institution).\n15. Adequate coagulation function as defined by INR ≤ 1.5 OR a PT ≤ 1.5 × ULN AND an aPTT ≤ 1.5 × ULN if not receiving anticoagulation therapy. Note: Participants may receive subtherapeutic doses of warfarin while on study to maintain patency of venous devices but not with therapeutic doses of warfarin. Participants may be treated with low-molecular weight heparin.\n16. Women of childbearing potential must be willing to use a highly effective method of contraception throughout the study and study follow up or for at least 9 months after the last dose of study intervention. Note: A woman is of nonchildbearing potential if she meets 1 of the following criteria: a) postmenopausal with at least 12 months of spontaneous amenorrhea; b) has had a bilateral oophorectomy; or c) has had a hysterectomy. Highly effective methods of contraception include:\n\n    * Abstinence from sexual activity.\n    * Hormonal contraception (eg, injection, implant, pill, patch, or vaginal ring as available in each country) associated with inhibition of ovulation (both estrogen and progestogen and progestogen only) in use for at least 30 days before administration of study intervention.\n    * Intrauterine device in use for at least 30 days before administration of study intervention.\n    * Intrauterine hormone-releasing system in use for at least 30 days before administration of study intervention.\n    * Bilateral tubal occlusion\u002Fligation at least 6 months before administration of study intervention.\n    * Partner who has been vasectomized at least 6 months before administration of study intervention.\n17. Males and their female partners must use a highly effective method of birth control if female partner(s) is of childbearing potential, and males must not donate sperm during the study and for 9 months after the last dose of study intervention.\n\nExclusion Criteria:\n\n* Individuals will be excluded from study participation if they meet any of the following criteria:\n\n  1. Received systemic therapy or an investigational agent before washing out, as follows:\n\n     1. \\\u003C 2 weeks prior to Cycle 1 Day 1 for systemic non-immune-based therapy\n     2. \\\u003C 3 weeks prior to Cycle 1 Day 1 for immune-based therapy\n     3. ≤ 5 half-lives or 3 weeks (whichever is longer) prior to Cycle 1 Day 1 for an investigational agent\n  2. Received radiotherapy to metastatic sites within 2 weeks of Cycle 1 Day 1. Patients must have recovered from all radiation-related toxicities and not require corticosteroids. A 1 week washout is permitted for palliative radiation with a limited port ≤ 2 weeks of radiotherapy to non-CNS disease.\n  3. Underwent hepatic radiation, chemoembolization, or radiofrequency ablation \\\u003C 4 weeks prior to Cycle 1 Day 1.\n  4. Underwent major surgery \\\u003C 3 weeks before Screening and has not recovered adequately from the procedure and\u002For any complications from the surgery prior to starting study intervention.\n  5. Known active CNS metastases and\u002For carcinomatous meningitis. Those with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of PD for at least 4 weeks by repeat imaging), clinically stable, and without requirement of corticosteroid treatment for at least 14 days prior to first dose of study intervention. For those with a history of CNS involvement, repeat imaging should be performed during study screening. However, CNS imaging is not required prior to study entry unless there is clinical suspicion of CNS involvement.\n  6. Clinically significant cardiovascular disease (eg, uncontrolled or any New York Heart Association Class 3 or 4 heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).\n  7. Resting QTcF \\> 470 msec at screening.\n  8. An additional active malignancy that is progressing or has required active treatment within the past 3 years. Cases involving a past cancer history with substantial potential for recurrence must be discussed with the Medical Monitor before study entry. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia, breast cancer, and melanoma in situ), organ-confined prostate cancer with no evidence of PD.\n  9. Require strong inhibitors of P-gp, BCRP, OATP1B1, OATP1B3, OATP1A2, and OAT3 transporters unless they can be transferred to other medications within ≥ 5 half-lives of treatment.\n  10. Require sensitive substrates of OATP1B1 and OATP1B3 unless they can be transferred to other medications within ≥ 5 half-lives of treatment.\n  11. Known positive status for HIV, has not been treated with established appropriate antiretroviral therapy for at least 4 weeks, and has a hydrophobic interaction chromatography viral load \\\u003C 400 copies\u002FmL and a CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FµL prior to enrollment. No HIV testing is required unless mandated by local health authority.\n  12. Active or chronic HBV and active (not cured) HCV. Participants who are HBV carriers without active disease (HBV DNA titer \\\u003C 1000 copies\u002FmL or 200 IU\u002FmL) or cured HCV (negative HCV RNA test) with confirmed viral clearance that are not receiving ongoing treatment and without residual chronic liver disease may be enrolled.\n  13. An uncontrolled intercurrent illness including, but not limited to medical illness; uncontrolled infection requiring therapy; psychiatric illness; alcohol or drug dependence; social situations or a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator or Medical Monitor.\n  14. Requires therapeutic doses of warfarin (ie, requires monitoring). A washout period of 7 days before administration of a participant's first dose of study intervention is required for those in whom therapeutic doses of warfarin are discontinued. Note: Warfarin at a low daily dose to maintain patency for indwelling venous catheters is allowed. Low-molecular weight heparin and direct-acting oral anticoagulants, according to the inclusion requirements pertaining to coagulation test results, are allowed.\n  15. Clinically significant edema or intracavitary fluid collections (eg, ascites, pleural effusion, pericardial effusions) resulting in moderate symptoms and\u002For requiring frequent drainage.\n  16. Previously developed shock, anaphylaxis, or renal disorder due to SBECD.\n  17. WOCBP who is pregnant, lactating, or discontinued lactation \\\u003C 12 weeks prior to Screening, or who plans to become pregnant or initiate lactation during the study.\n  18. Known reaction or contraindication to any component of study intervention (ie, oxaliplatin, leucovorin \\[including levoleucovorin\\], and 5-FU \\[FOLFOX\\] and irinotecan, leucovorin, and 5-FU \\[FOLFIRI\\]).\n  19. Known DPD deficiency. Screening for DPD deficiency is not mandated but should be considered in subjects who have had severe toxicity due to fluoropyrimidine-based therapy in the past.","ALL","18 Years",{"count":20,"type":21},480,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is designed to 1) select a dose regimen for continued development and 2) evaluate nanvuranlat versus Physicians Best Choice (PBC) (FOLFOX, FOLFIRI, or Best Supportive Care (BSC)) in participants aged 18 years and over with BTC. Participants enrolling in Part A the trial will be randomly assigned to receive 1 of 3 nanvuranlat dose regimens or PBC. In Part B, participants will be randomly assigned to receive nanvuranlat or PBC. Participants will receive treatment every 2 weeks for as long as they do not experience safety issues, or their cancer gets worse, and the study doctor feels they should stop treatment. Health measurements including physical examinations, vital signs, ECGs, and safety laboratory tests will be performed to monitor safety, and tumor imaging will be performed to monitor cancer response to treatment. Other exploratory makers will be measured to better understand how nanvuranlat works.",[27,28],"Advanced Biliary Tract Cancer","Biliary Tract Cancer (BTC)",[30,31,32],"Intrahepatic cholangiocarcinoma (IHC)","Extrahepatic cholangiocarcinoma (EHC)","Gallbladder carcinoma (GBC)","RECRUITING","2026-06-29",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2026-05-11",{"date":41,"type":21},"2027-10",{"name":43,"class":44},"J-Pharma Co., Ltd.","INDUSTRY",18,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100610595","phase-3-a-phase-iii-study-of-shr-8068-in-combination-with-adebrelimab-and-platinum-containing-chemotherapy-versus-durvalumab-in-combination-with-platinum-containing-chemotherapy-as-first-line-treatment-for-advanced-biliary-tract-cancer-btc-100610595","NCT07229625","A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)","A Phase III, Randomized, Controlled, Open-Label, Multicenter Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-Line Treatment for Advanced Biliary Tract Cancer (BTC)","Inclusion Criteria:\n\n1. Locally advanced or recurrent\u002Fmetastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;\n2. No previous systemic anti-tumor treatment has been received;\n3. At least one measurable lesion that complies with the RECIST v1.1 standard;\n4. ECOG PS score: 0-1 point;\n5. The expected survival period is ≥ 3 months;\n6. Good organ function level;\n7. Negative blood pregnancy (for women of childbearing age) and not in the lactation period, adhering to efficient contraceptive requirements;\n8. Patients voluntarily joined this study and signed informed consent.\n\nExclusion Criteria:\n\n1. Other pathological types of cholangiocarcinoma other than adenocarcinoma;\n2. Malignant tumor of the ampulla;\n3. Have had or concurrently suffered from other malignant tumors;\n4. Those with concurrent biliary obstruction and at risk of biliary tract infection;\n5. Those with any active or known autoimmune diseases.","75 Years",{"count":55,"type":21},604,[24],"This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.",[27],"2026-01-27",{"date":61,"type":37},"2026-01-28",{"date":63,"type":37},"2026-01-21",{"date":65,"type":21},"2029-12",{"name":67,"class":44},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":68},"100591260","phase-2-a-study-of-bl-b01d1pd-1pd-l1-monoclonal-antibody-in-patients-with-advanced-biliary-tract-cancer-100591260","NCT06978114","A Study of BL-B01D1+PD-1\u002FPD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer","A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1+PD-1\u002FPD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n1. Sign the informed consent form voluntarily and follow the protocol requirements;\n2. Gender is not limited;\n3. Age ≥18 years old and ≤75 years old;\n4. Expected survival time ≥3 months;\n5. Patients with advanced biliary tract cancer confirmed by histology or cytology;\n6. Patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for PD-L1 testing and other testing;\n7. At least one measurable lesion meeting the RECIST v1.1 definition was required;\n8. ECOG score 0-1;\n9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;\n10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. Organ function level must meet the requirements;\n12. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n13. Urinary protein ≤2+ or ≤1000mg\u002F24h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Patients with active central nervous system metastases;\n2. Who had participated in any other clinical trial within 4 weeks before the trial dose;\n3. Received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug;\n4. Had undergone major surgery (investigator-defined) within 4 weeks before the first dose;\n5. Had received immunotherapy and developed grade ≥3 irAE or grade ≥2 immune-related myocarditis;\n6. Use of immunomodulatory drugs within 14 days before the first dose of study drug;\n7. Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before the study administration;\n8. Pulmonary disease grade ≥3 according to NCI-CTCAE v5.0; A history of ILD\u002Fpulmonary inflammation requiring steroid treatment;\n9. Severe systemic infection occurred within 4 weeks before screening;\n10. Patients at risk for active autoimmune disease or with a history of autoimmune disease;\n11. Other malignant tumors within 5 years before the first dose;\n12. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;\n13. Poorly controlled hypertension by two antihypertensive drugs with different mechanisms;\n14. Diabetic patients with poor glycemic control;\n15. Had a history of severe cardiovascular and cerebrovascular diseases;\n16. Previous history of autologous or allogeneic stem cell, bone marrow or organ transplantation;\n17. Subjects with clinically significant bleeding or significant bleeding tendency within the preceding 4 weeks were screened;\n18. Patients with massive or symptomatic effusions or poorly controlled effusions;\n19. Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large arteries or invaded the pericardium and heart;\n20. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;\n21. Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;\n22. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of the trial drug;\n23. The cumulative dose of anthracyclines \\> 360 mg\u002Fm2 in previous (new) adjuvant therapy;\n24. Pregnant or lactating women;\n25. Who have a history of psychotropic drug abuse and cannot quit or have mental disorders;\n26. The investigator did not consider it appropriate to apply other criteria for participation in the trial.",{"count":77,"type":21},46,[79],"PHASE2","This study is a clinical study to explore the efficacy and safety of BL-B01D1+PD-1\u002FPD-L1 monoclonal antibody in patients with advanced biliary tract cancer.",[27],"2025-07-01",{"date":84,"type":37},"2025-07-02",{"date":86,"type":37},"2025-06-10",{"date":88,"type":21},"2027-12",{"name":90,"class":44},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":68},"100592066","gemcis-plus-pd-1pd-l1-inhibitor-in-advanced-biliary-tract-cancer-efficacy-and-immune-microenvironment-btc-im-1-100592066","NCT06988592","GemCis Plus PD-1\u002FPD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1）","A Prospective, Non-interventional Study of Gemcitabine\u002FCisplatin Combined With PD-1\u002FPD-L1 Inhibitor as First-line Treatment in Treatment-naïve Advanced Biliary Tract Cancer Patients: Efficacy and Immune Microenvironment Dynamics","BTC-IM-1","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed unresectable\u002Fmetastatic cholangiocarcinoma (intrahepatic, extrahepatic, or gallbladder).\n* No prior systemic anticancer therapy (chemotherapy, targeted therapy, or immunotherapy).\n* Planned to receive GemCis+PD-1\u002FPD-L1 inhibitor as standard first-line treatment.\n* ≥1 measurable lesion per RECIST 1.1.\n* ECOG performance status 0-1.\n* Adequate organ function:\n\n  * ANC ≥1.5 × 10⁹\u002FL, platelets ≥100 × 10⁹\u002FL, hemoglobin ≥9 g\u002FdL.\n  * Total bilirubin ≤1.5 × ULN, AST\u002FALT ≤3 × ULN (≤5 × ULN if liver metastases).\n  * Creatinine ≤1.5 × ULN or CrCl ≥60 mL\u002Fmin.\n* Willing to provide archival\u002Ffresh tumor tissue and peripheral blood samples.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Prior systemic therapy.\n* Active autoimmune disease requiring immunosuppression.\n* Active infection requiring IV antibiotics.\n* HIV-positive or active HBV\u002FHCV infection (HBsAg+ with HBV DNA ≥2000 IU\u002FmL; HCV RNA+).\n* Symptomatic CNS metastases.\n* Pregnancy\u002Flactation.\n* Any condition compromising protocol compliance or data interpretation per investigator.",{"count":100,"type":21},100,"OBSERVATIONAL","To evaluate the efficacy and immune microenvironment changes in treatment-naïve advanced biliary tract cancer (BTC) patients receiving first-line standard therapy with gemcitabine\u002Fcisplatin (GemCis) combined with PD-1\u002FPD-L1 inhibitors.",[27],"2025-05-22",{"date":106,"type":37},"2025-05-29",{"date":108,"type":37},"2025-05-23",{"date":110,"type":21},"2027-12-30",{"name":112,"class":113},"Fudan University","OTHER",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":68},"100570562","phase-2-phase--clinical-study-of-surufatinib-combined-with-gemcitabine-and-cisplatin-plus-durvalumabpembrolizumab-regimen-in-the-treatment-of-advanced-biliary-tract-cancer-100570562","NCT06708858","Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab\u002FPembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n1. Patients with biliary tract cancer who are clearly diagnosed by pathology, are unable to undergo radical surgery or have local\u002Fdistant metastasis (allowing surgical treatment after successful transformation).\n2. Have at least 1 lesion that can be measured according to RECIST v1.1 (more than 1cm on CT or MRI).\n3. Have not received systematic anti-tumor therapy before.\n4. Expected survival greater than 3 months;\n5. Age 18-75 years old, male and female;\n6. Body weight \\> 40kg;\n7. ECOG 0-1\n8. Total peripheral blood white blood cells \\> 2×109\u002FL;\n9. Bone marrow reserve and liver and kidney function (as demonstrated by the following laboratory tests prior to initial treatment) :\n\n   Neutrophil absolute value ≥ 1,000\u002Fmm3; Hemoglobin \\> 8g\u002FdL; Platelet count \\> 80,000\u002Fmm3; Glutamic pyruvic transaminase\u002Fglutamic oxalacetic transaminase \\\u003C 3×ULN; Serum creatinine \\\u003C 3×ULN. Total bilirubin level \\\u003C 3×ULN.\n10. No obvious genetic disease;\n11. Liver function child-pugh A ;\n12. Women of childbearing age (15 to 49 years) must undergo a pregnancy test with a negative result within 7 days before starting treatment and have effective contraception within 120 days after the last cycle of treatment.\n13. The previous treatment for the tumor has ended for at least 4 weeks, and the adverse reactions of the previous treatment have basically recovered (according to the CTCAE5.0 standard ≤ Grade 1, except hair loss).\n14. Voluntarily enrolled in the group and signed informed consent, followed the experimental treatment plan and visit plan, and could cooperate to observe adverse events and efficacy.\n\nExclusion Criteria:\n\n1. Join another clinical study at the same time, unless it is during the follow-up period of an observational (non-interventional) or supportive care clinical study or interventional study.\n2. Obstructive jaundice (bilirubin \\> 1.5 ULN) with inadequate biliary drainage.\n3. Absolute neutrophil count (ANC) \\\u003C1×109\u002FL or platelet \\\u003C80×109\u002FL or hemoglobin \\\u003C 8g\u002FdL (based on the normal value of the clinical trial center)\n4. Serum total bilirubin was 5 times higher than the upper limit of the normal reference range;\n5. ALT, AST or ALP above 5 times the upper limit of the normal reference range;\n6. Known active central nervous system metastatic and\u002For cancerous meningitis; Patients with previously treated BMS may participate provided they are stable (there is no evidence of imaging progression at least 4 weeks before the first dose of trial treatment, and any neurological symptoms have returned to baseline levels), there is no evidence of new or expanded BMS, and there is no evidence of new or expanded BMS. And no use of hormones greater than 10mg prednisone per day or equivalent for at least 14 days prior to trial treatment.\n7. Toxicity of previous anticancer treatment has not returned to grade 0 or 1 level (except hair loss);\n8. Uncontrolled mass pleural effusion or massive ascites\n9. Organ failure; Heart: Grade III and grade IV; Liver: reached Child-Pugh liver function grade B and C; Kidney: renal failure and uremia stage; Lungs: Symptoms of severe respiratory failure; Brain: A person with a disorder of consciousness.\n10. History of heart disease:\n\n1\\) Patients with pre-existing arrhythmias with prolonged PR, QTc and\u002For QRS; 2) Acute myocardial infarction or congestive heart failure within 6 months; 3) Patients with long QT syndrome; 4) Patients who have been treated with antiarrhythmic drugs (e.g. quinidine IA, amiodarone III, sotalol); 11. Patients who have undergone major surgery within 4 weeks prior to the start of study treatment, or who expect to undergo major surgery (other than surgery for diagnostic purposes) during the study period; 12.HIV antibody positive, or have other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation; 13. Uncontrolled co-morbidity, including but not limited to persistent or active infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease with diarrhea, or mental illness\u002Fsocial conditions, will limit compliance with study requirements. Substantially increases the risk of developing AEs or impairs a patient's ability to give written informed consent.\n\n14\\. Patients with a history of Parkinson's disease or epilepsy, or who had a history of transient ischemic attacks, stroke, or traumatic brain injury with disturbance of consciousness in the 12 months prior to the study; 15. CTCAE2 grade infection that does not respond to treatment or CTCAE grade \\> 2 active clinically serious infection.\n\n16\\. Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection who require treatment.\n\n17\\. Known or suspected prior allergy or hypersensitivity to any investigational drug or to any investigational drug excipient (duvaliumab, Sofantinib, Pabolizumab).\n\n18\\. Chronic diseases requiring immunological agents or hormone therapy; 19. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 20. Participated in a non-anti-PD1 \u002FL1 antibody based clinical trial within the past 30 days.\n\n21\\. Patients with rare heritability should not participate in this clinical study.\n\nExit criteria\n\nIf any of the following events occur, the patient must withdraw from the study:\n\n1. Patient voluntary withdrawal\n2. Ineligibility discovered after enrollment\n3. Poor compliance, failure to adhere to the protocol\n4. Occurrence of adverse events (AE) or serious adverse events (SAE) where the investigator determines or the patient and family prefer not to continue treatment\n5. Pregnancy\n6. Inability to complete treatment according to the protocol after adjustment for grade 3\u002F4 adverse events\n7. Unforeseen, intolerable adverse reactions\n8. Medical or ethical reasons impacting the continuation of the study",{"count":121,"type":21},35,[79],"This phase II trial studies how well gemcitabine, cisplatin and durvalumab\u002FPembrolizumab and surufatinib work in treating participants with advanced Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Whether if adding surufatinib to a standard of care can bring addition benefit needs to be explored.",[27],"2024-11-26",{"date":127,"type":37},"2024-11-27",{"date":129,"type":37},"2024-08-15",{"date":131,"type":21},"2027-07",{"name":133,"class":113},"Dai, Guanghai"]