[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-tract-cancer-btc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-tract-cancer-btc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,46,76,102,128,165,186,222,249,279,305,334,378,402,426,451,472,499,519,539],{"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":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100642405","phase-2-becotatug-vedotin-plus-pucotenlimab-for-advanced-biliary-tract-cancer-phase-ii-100642405","NCT07649980","Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II","Becotatug Vedotin Combined With Pucotenlimab in First-Line Treatment-Failed Advanced Biliary Tract Carcinoma: A Phase II Exploratory Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female.\n2. Histologically or cytologically confirmed advanced biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC); recurrent biliary tract cancer is also eligible.\n3. EGFR expression positive by immunohistochemistry (IHC) (+, ++, or +++).\n4. Failed at least one line of standard systemic therapy.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Life expectancy ≥ 3 months.\n7. At least one measurable lesion per RECIST v1.1 on CT or MRI.\n8. Child-Pugh class A or B (\\\u003C7 points).\n9. Adequate organ function as defined below:\n\n   * Hematologic: Hemoglobin (Hb) ≥ 90 g\u002FL; white blood cell count (WBC) ≥ lower limit of normal (LLN); absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelet count ≥ 100 × 10⁹\u002FL.\n   * Renal: Serum creatinine ≤ 1.5 × upper limit of normal (ULN); creatinine clearance (CrCl) ≥ 55 mL\u002Fmin.\n   * Hepatic: Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (or ≤ 3 × ULN for total bilirubin and ≤ 5 × ULN for ALT\u002FAST in patients with intrahepatic cholangiocarcinoma or liver metastases).\n   * Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; partial thromboplastin time (PTT) within normal range.\n10. No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or fever (\\>38°C) not attributable to cancer.\n11. Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment, must not be breastfeeding, and must agree to use effective contraception during the study and for 6 months after the last dose. Male participants must agree to use effective contraception during the study and for 6 months after the last dose.\n12. Expected to have good compliance with protocol-specified follow-up for efficacy and safety assessments.\n13. Able to understand the study and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosis of another primary malignancy within 5 years prior to enrollment, except for adequately treated carcinoma in situ or basal cell carcinoma of the skin.\n2. EGFR expression negative by IHC.\n3. Known central nervous system (CNS) metastases or carcinomatous meningitis, unless clinically stable for ≥ 4 weeks after radiotherapy or surgery and asymptomatic.\n4. Psychiatric or neurological disorders that compromise the ability to comply with study procedures.\n5. Prior treatment with MMAE-containing antibody-drug conjugate (ADC) therapy.\n6. Planned or previous organ or bone marrow transplantation.\n7. Active or history of autoimmune disease requiring systemic immunosuppressive therapy.\n8. Receipt of live vaccine within 30 days prior to first dose. Inactivated seasonal influenza vaccines are allowed.\n9. Uncontrolled cardiac conditions or symptoms.\n10. Active infection or fever (unless clearly attributable to tumor).\n11. History or evidence of interstitial lung disease or active non-infectious pneumonitis.\n12. Any other condition that makes the patient unsuitable for enrollment, including but not limited to: immunodeficiency; active tuberculosis; hepatitis B (eligible if HBV-DNA \\\u003C 500 IU\u002FmL with normal liver function after antiviral therapy); hepatitis C virus (HCV) infection; uncorrectable electrolyte disturbances; uncontrolled pericardial effusion, pleural effusion, or ascites.\n13. Known hypersensitivity to any component of the study drugs.\n14. Use of systemic immunosuppressive agents or corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) within 14 days prior to enrollment.\n15. Receipt of radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment.\n16. Participation in another interventional clinical trial within 4 weeks prior to enrollment.\n17. Pregnancy or breastfeeding.\n18. Any other condition that, in the investigator's judgment, makes the patient inappropriate for study participation.",{"count":54,"type":21},30,[56],"PHASE2","Biliary tract carcinoma (BTC), including cholangiocarcinoma and gallbladder cancer, is a highly aggressive digestive system malignancy with limited treatment options after failure of first-line standard chemotherapy.\n\nThis open-label, single-arm, Phase II exploratory study aims to evaluate the efficacy and safety of Becotatug Vedotin combined with Pucotenlimab in patients with EGFR-positive advanced BTC who have failed first-line therapy. Participants will receive the combination regimen until the occurrence of disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator's decision to discontinue treatment, or study termination, whichever occurs first.The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.",[28,59],"EGFR-positive Advanced Biliary Tract Carcinoma",[61,62,63,64,65],"Becotatug Vedotin","Pucotenlimab","EGFR-ADC","PD-1","Second-line","NOT_YET_RECRUITING","2026-06-10",{"date":69,"type":37},"2026-06-16",{"date":36,"type":21},{"date":72,"type":21},"2029-12-31",{"name":74,"class":75},"HuiKai Li","OTHER",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100563891","phase-3-d07001-softgel-capsules-and-capecitabine-combination-therapy-in-patients-with-advanced-biliary-tract-cancer-100563891","NCT06622057","D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer","Phase III, Randomized, Double-blind Study of Combination Therapy With D07001-Softgel Capsules and Capecitabine vs Placebo and Capecitabine in Patients With Advanced BTC After Failed on Gemcitabine, Platin, and FOLFOX or Irinotecan Regimens","Inclusion Criteria:\n\n1. Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.\n2. Participant aged at least 18 years at the time of consent.\n3. Participant has histopathological or cytologic diagnosis of unresectable, locally advanced or metastatic BTC (cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma).\n4. Participant has measurable disease as assessed by central review by RECIST v1.1.\n5. Participant must have failed on a gemcitabine + cisplatin-based chemotherapy, regardless of whether an immune checkpoint inhibitor, such as durvalumab or pembrolizumab, or S-1 (tegafur, gimeracil, and oteracil potassium), was also administered. Oxaliplatin or carboplatin may be substituted for cisplatin when renal or auditory function is of concern. Participants also have failed (disease progression or intolerance) on, or refused FOLFOX chemotherapy, including modified FOLFOX variants, or failed on irinotecan + fluorouracil-based chemotherapy.\n6. Participants with tumors expressing the following biomarkers may be enrolled even if they have not previously received FOLFOX but have received appropriate targeted therapies until disease progression or intolerance: fibroblast growth factor receptors (FGFR) aberrations, microsatellite instability biomarker\u002Fdeficient DNA mismatch repair, Tumor Mutation Burden-high, or mutations in isocitrate dehydrogenase, BRAF, HER2, NTRK, RET, or KRAS G12C.\n7. Participant has ECOG PS of 0-2.\n8. Participant's life expectancy is ≥12 weeks.\n9. Participant has adequate bone marrow function, demonstrated by:\n\n   1. Absolute neutrophil count ≥1500 cell\u002Fmm3.\n   2. Platelet count ≥85,000 cells\u002Fmm3.\n   3. Hemoglobin ≥9 g\u002FdL.\n10. Participant has adequate liver function, demonstrated by:\n\n    1. Aspartate transaminase and alanine transaminase ≤2.5 × upper limit of normal (ULN), or ≤5.0 × ULN in the case of liver lesions.\n    2. Total bilirubin ≤1.5 × ULN.\n    3. Albumin ≥3.0 g\u002FdL.\n    4. International normalized ratio \\\u003C1.5.\n11. Participant has adequate renal function, demonstrated by creatinine clearance ≥ 45 mL\u002Fmin calculated by Cockcroft-Gault formula or estimated glomerular filtration rate ≥ 45 mL\u002Fmin\u002F1.73 m2 by the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine equation.\n12. No clinically significant abnormalities in coagulation results.\n13. Participant is eligible to participate if not pregnant (as demonstrated by serum pregnancy testing at Screening), not breastfeeding, and at least 1 of the following conditions applies:\n\n    1. Not of childbearing potential (CBP). Participants of non-childbearing potential are defined as those with functioning ovaries with a documented history of tubal ligation or hysterectomy or who are postmenopausal, as defined by 12 months of spontaneous amenorrhea with an appropriate clinical profile, e.g., age appropriate, \\>45 years, in the absence of hormone replacement therapy. If necessary, a blood sample for follicle stimulating hormone will be obtained to confirm postmenopausal status.\n    2. A participant of CBP who is sexually active with a partner who could impregnate them agrees to use a highly effective form of contraception during the study and for at least 6 months after the EOS intervention.\n14. Participants with partners of childbearing potential whom they could impregnate must agree to use contraception during the study and for 3 months after the EOS intervention.\n15. Participants who are able to donate sperm must refrain from sperm donation during the study and for 3 months after the EOS intervention.\n16. Participant is willing to comply with the protocol-required visit schedule and visit requirements.\n17. More than 14 days have elapsed between the participant completing a prior line of chemotherapy or targeted therapy, and enrollment. More than 28 days have elapsed between the participant receiving concurrent radiotherapy (CCRT) and enrollment\n\nExclusion Criteria:\n\n1. Participant has a diagnosis of active malignancy other than BTC within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent.\n2. Participant discontinued prior gemcitabine due to pulmonary or hepatic toxicity or hemolytic uremic syndrome, hypersensitivity, allergic reaction, or intolerance.\n3. Participant had a prior unanticipated severe reaction to capecitabine or metabolites or to fluoropyrimidine therapy.\n4. Participant received treatment with brivudine, sorivudine, or its chemically related analogs ≤28 days prior to the date of enrollment.\n5. Participant is currently receiving flucytosine treatment.\n6. Participant has residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted).\n7. Participant has any gastrointestinal disorder or prior gastrointestinal surgery that would significantly impede absorption of an oral agent, such as gastrectomy, Crohn's disease, ulcerative colitis, or short gut syndrome.\n8. Participant has known brain or leptomeningeal metastases.\n9. Participant had major surgery or definitive ablation-intent (excluding palliative radiotherapy for bone metastasis) radiation therapy within the past 28 days.\n10. Participant has any active disease or condition that would not permit compliance with the protocol.\n11. Participant has clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, New York Heart Association Grade 2 or greater), or uncontrolled serious cardiac arrhythmia.\n12. Participant has documented cerebrovascular disease.\n13. Participant has a seizure disorder not controlled with medication (based on Investigator's decision).\n14. Participant has received an investigational agent within 28 days of enrollment.\n15. Participant has an uncontrolled active viral, bacterial, or systemic fungal infection.\n16. Participants with positive hepatitis B surface antigen (HBsAg) or positive hepatitis C virus antibody (anti-HCV) and detectable hepatitis B virus (HBV) DNA ≥2000 copies\u002FmL or hepatitis C virus (HCV) RNA above the institutional lower limit of quantification are excluded. Participants with resolved HBV infection (negative HBsAg and positive hepatitis B core antibody \\[anti-HBc\\]) are eligible if HBV DNA is \\\u003C2000 copies\u002FmL. Participants with positive anti-HCV antibody must have completed curative antiviral therapy and have undetectable HCV RNA by PCR to be eligible.\n17. Has positive human immunodeficiency virus antibody.\n18. Participant has received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks before Screening.\n19. Participant has a history of drug or alcohol abuse within the year before signing the informed consent form.\n20. Participant has any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in or compliance with the clinical trial.",{"count":84,"type":21},195,[24],"The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS).\n\nEligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.",[28],[89,90,91,92],"BTC","cholangiocarcinoma","Biliary Tract Cancer","third-line","2026-06-09",{"date":95,"type":37},"2026-06-11",{"date":93,"type":37},{"date":98,"type":21},"2027-12-31",{"name":100,"class":44},"InnoPharmax Inc.",2,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100642862","phase-2-efficacy-and-safety-of-sbrt-plus-gemcitabine-cisplatin-and-sintilimab-as-first-line-treatment-for-unresectable-biliary-tract-cancer-100642862","NCT07638501","Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment for Unresectable Biliary Tract Cancer","Evaluation of the Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) Combined With Gemcitabine, Cisplatin, and Sintilimab as First-Line Therapy for Unresectable Biliary Tract Cancer: A Prospective, Multicenter, Randomized Controlled Study","Inclusion Criteria:\n\n1. Patients voluntarily provide written informed consent, with authorization obtained from the patient or legal representative prior to any protocol-related procedures.\n2. Age ≥ 18 years and ≤ 75 years; both female and male\n3. Histologically or cytologically confirmed, unresectable advanced or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.\n4. No prior systemic anti-tumor treatment for BTC. Patients who developed recurrent disease \\>6 months after surgery with curative intent and, if given, \\>6 months after the completion of neo\u002Fadjuvant therapy (chemotherapy and\u002For radiation) will be eligible.\n5. At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.\n6. ECOG performance status of 0 or 1.\n7. Life expectancy ≥12 weeks.\n8. Adequate organ and bone marrow function within 14 days prior to initiation of study treatment, defined as follows:\n\n   a.Hematology (without transfusion, granulocyte colony-stimulating factor \\[G-CSF\\], or other correction treatment within 14 days prior to screening): i.Hemoglobin \\[HB\\] ≥ 90 g\u002FL; ii.Absolute neutrophil count \\[ANC\\] ≥ 1.5 × 109\u002FL; iii.platelet count (PLT) ≥ 75 × 109\u002FL b.Biochemistry Examination (without albumin infusion within 14 days prior to screening): i.Total bilirubin (TBIL) ≤ 2 × upper limit of normal (ULN) (for patients with Gilbert's syndrome, ≤ 3 × ULN) ii.alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN; iii.serum creatinine (Cr) ≤ 1.5 × ULN or clearance of creatinine (CCr) ≥ 50 mL\u002Fmin (Cockcroft-Gault formula);\n   * Male: Creatinine clearance rate = \\[(140 - age) × weight\\] \u002F (72 × serum Cr)\n   * Female: Creatinine clearance rate= \\[(140 - age) × weight\\] \u002F (72 × serum Cr) × 0.85 (Weight unit: kg; serum Cr unit: mg\u002FdL)\n9. Patients with evidence of hepatitis B virus (HBV) infection, defined as detectable HBV DNA (≥10 IU\u002FmL or above the lower limit of detection according to local laboratory standards) and positive HBsAg and\u002For anti-HBc, must receive antiviral therapy prior to study drug administration in accordance with institutional practice to ensure adequate viral suppression. Antiviral therapy must be continued throughout the study period and for at least 6 months after the last dose of study treatment. Patients who are anti-HBc positive but HBV DNA negative (\\\u003C10 IU\u002FmL or below the lower limit of detection according to local laboratory standards) are not required to receive antiviral therapy unless HBV DNA rises to ≥10 IU\u002FmL or exceeds the local lower limit of detection during study treatment.\n10. Female patients of childbearing age must have a documented negative urine or serum pregnancy test within 7 days prior to the first dose. If the urine test result is inconclusive, a serum test must be performed, and the serum result will be considered definitive. Female patients of childbearing age who have sexual intercourse with non-sterilized male partners must agree to take effective contraceptive measures throughout the treatment and 120 days after the last dose.\n11. Male patients with female sexual partners of childbearing age must agree to take effective contraceptive measures throughout the treatment and 120 days after the last dose. The decision to discontinue contraception beyond this time frame should be discussed with the investigator.\n12. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed rare biliary tract tumors, including ampullary cancer, neuroendocrine tumors, sarcoma, or mucinous cystic neoplasms.\n2. Other active malignancy within the past 5 years or concurrent, except adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.\n3. History of carcinomatous meningitis or brain metastases.\n4. Known hypersensitivity or allergic reaction to any study drug or any excipient therein.\n5. Participation in another investigational drug clinical trial within the past 3 months or concurrent enrollment in another clinical study, unless observational, non-interventional, or follow-up phase of an interventional study.\n6. Uncontrolled concurrent illness, including but not limited to moderate to severe ascites, uncontrolled or moderate-to-large pleural or pericardial effusion, uncontrolled acute or chronic pancreatitis, active hemorrhagic disorder, or severe chronic gastrointestinal disease associated with diarrhea.\n7. History of allogeneic organ or allogeneic bone marrow transplantation.\n8. History of significant cardiovascular or cerebrovascular disease, including:\n\n   1. congestive heart failure (NYHA Class ≥II), unstable angina, myocardial infarction, uncontrolled arrhythmia, or cerebrovascular accident within 12 months prior to first dose;\n   2. left ventricular ejection fraction \\\u003C50%;\n   3. corrected QT interval (QTc) \\>480 ms (Fridericia formula);\n   4. poorly controlled hypertension (systolic ≥150 mmHg or diastolic ≥100 mmHg based on ≥2 measurements);\n   5. history of hypertensive crisis or hypertensive encephalopathy.\n9. Active autoimmune disease within 2 years prior to first dose or history of autoimmune disease with potential for relapse, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (except hypothyroidism controlled by hormone replacement therapy).\n10. Prior anti-cancer therapy-related adverse events not recovered to Grade ≤1 or baseline, with Grade ≤2 neuropathy possibly eligible per investigator assessment.\n11. Active infection, including tuberculosis or human immunodeficiency virus (HIV).\n12. Diagnosis of immunodeficiency, or chronic systemic steroid therapy (daily dose \\>10 mg prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to first dose of study intervention.\n13. History of gastrointestinal bleeding within 6 months prior to study treatment, documented predisposition to gastrointestinal hemorrhage, or known hereditary or acquired bleeding (e.g., coagulopathy) or thrombotic tendency.\n14. Major surgery (excluding biopsy) with incomplete recovery from surgery or surgical complications, or incomplete wound healing, prior to start of study intervention, or anticipated need for major surgery during the study period.\n15. Receipt of live attenuated vaccine within 28 days prior to first dose of study intervention, or anticipated need for live attenuated vaccine during study treatment or within 60 days after last dose.\n16. Any other condition judged by the investigator to potentially interfere with study outcomes or lead to premature study termination, including alcohol or drug abuse, severe comorbidity requiring concomitant therapy (including psychiatric illness), severe laboratory abnormality, or family or social factors affecting patient safety or data collection.","75 Years",{"count":111,"type":21},123,[56],"According to current clinical guidelines, first-line treatment for advanced biliary tract cancer (BTC) is the gemcitabine plus cisplatin (GC) regimen combined with immunotherapy, which has been shown to improve patient outcomes. Additionally, the combination of radiotherapy and immunotherapy may synergistically enhance antitumor efficacy. Therefore, this study aims to assess the efficacy and safety of first-line treatment with radiotherapy in combination with sintilimab and gemcitabine\u002Fcisplatin versus sintilimab in combination with gemcitabine\u002Fcisplatin in patients with previously untreated, unresectable locally advanced or metastatic BTC.",[28],[116,117,118],"First-line Therapy","Stereotactic Body Radiotherapy (SBRT)","Immunotherapy","2026-06-04",{"date":67,"type":37},{"date":122,"type":21},"2026-06-15",{"date":124,"type":21},"2029-06-15",{"name":126,"class":75},"Eastern Hepatobiliary Surgery Hospital",1,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":134,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":162,"locationsCount":164},"100608130","phase-1-a-phase-11b-study-of-st-01156-a-small-molecule-rbm39-degrader-in-patients-with-advanced-solid-malignancies-100608130","NCT07197554","A Phase 1\u002F1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\n* Age ≥ 18 years on the day of signing the consent form, except for adolescents with Ewing Sarcoma or other malignancies for which there is a biological rationale to support participation, in which case the participant is ≥ 16 years old.\n* Has a metastatic or locally advanced and unresectable solid tumor.\n* Has at least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* Has an ECOG performance status ≤ 2 at screening.\n* Has adequate organ function as defined in the protocol.\n\nExclusion Criteria:\n\n* Has received prior radiotherapy within 2 weeks of treatment.\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate, provided they are radiologically stable\n* Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days or 5 half-lives, whichever is shorter.\n* Had major surgery within 28 days before study therapy administration\n* Has toxicities from previous anticancer therapies that have not resolved to baseline levels, with the exception of alopecia and peripheral neuropathy.\n* Has previously received a RBM39 inhibitor\u002Fdegrader.","16 Years",{"count":136,"type":21},171,[138],"PHASE1","A Phase 1\u002F1B Study of ST-01156 in Patients with Advanced Solid Malignancies",[141,142,143,28],"Advanced Solid Tumors","Ewing Sarcoma","Hepatocellular Carcinoma (HCC)",[145,146,147,148,149,150,151,152,153,154,155],"cancer","solid tumors","RBM39","RBM39 degrader","metastatic solid malignancies","Ewing sarcoma","Hepatocellular carcinoma","HCC","Biliary tract carcinoma","endometrial carcinoma","Adolescents","2026-05-30",{"date":158,"type":37},"2026-06-02",{"date":160,"type":37},"2025-12-01",{"date":72,"type":21},{"name":163,"class":44},"SEED Therapeutics, Inc.",6,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":182,"leadSponsor":184,"locationsCount":4},"100638451","phase-4-a-single-arm-multicenter-clinical-study-of-iparomlimab-and-toripalimab-in-combination-with-bevacizumab-and-chemotherapy-as-first-line-treatment-for-advanced-biliary-tract-cancer-100638451","NCT07619235","A Single-arm, Multicenter Clinical Study of Iparomlimab and Toripalimab in Combination With Bevacizumab and Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer","A Study of Iparomlimab and Toripalimab in Combination With Bevacizumab and Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n* Informed Consent: Patients voluntarily join this study and sign the informed consent form.\n* Age: 18 to 75 years old, male or female.\n* Histologically or cytologically confirmed, unresectable locally advanced or metastatic biliary tract cancer (BTC), including cholangiocarcinoma (intrahepatic and extrahepatic) and gallbladder carcinoma.\n* No prior systemic anti-tumor therapy for locally advanced or metastatic BTC.\n* At least one measurable lesion according to RECIST v1.1 that is suitable for accurate repeated measurement. Lesions previously irradiated or brain metastases are not eligible as target lesions.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n* Adequate organ function\n* For HBsAg positive subjects: HBV DNA must be \\\u003C 2000 IU\u002FmL (or \\\u003C 10⁴ copies\u002FmL), and effective antiviral therapy (e.g., Entecavir, Tenofovir, TAF, or Tenofovir Amibufenamide) must be administered throughout the study.\n\nSubjects with a history of HCV infection but negative HCV RNA PCR results may be considered uninfected.\n\n* Female subjects of childbearing potential must have a negative urine or serum pregnancy test (if urine test is not definitively negative, a serum test is required).\n* Willingness to use highly effective contraceptive measures during the study and for 3 months after the last dose.\n* Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other requirements of the study.\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed small cell carcinoma, neuroendocrine tumors, lymphoma, sarcoma, colloid carcinoma, adenosquamous carcinoma, squamous cell carcinoma, mucinous intraductal papillary neoplasm, mucinous cystic neoplasms, or other rare pathological types of biliary tract tumors.\n* Brain Metastases: History of brain metastases or presence of active brain metastases.\n* Vascular Invasion \\& Bleeding Risk: Imaging at screening shows tumor invasion or encasement (\\>180 degrees) of major blood vessels; or the tumor presents with significant necrosis or cavitation, and the investigator judges that enrollment poses a high risk of bleeding.\n* Cardiac Disease: Uncontrolled cardiac clinical symptoms or diseases, including but not limited to:\n\n  1. Cardiac insufficiency classified as Class II or higher according to the New York Heart Association (NYHA) criteria, or Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% on echocardiography;\n  2. Unstable angina pectoris;\n  3. Myocardial infarction within 1 year prior to study entry;\n  4. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;\n  5. QTc interval \\> 450 ms (male) or \\> 470 ms (female) (QTc calculated using the Fridericia formula; if abnormal, repeat ECG three times at 2-minute intervals and use the average value).\n* Autoimmune Disease: Active autoimmune disease or a history of autoimmune disease likely to recur (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism \\[patients controlled solely by hormone replacement therapy are not excluded\\]).\n* Esophageal\u002FGastric Varices: History of esophageal or gastric variceal bleeding due to portal hypertension within 6 months prior to the first dose; known severe varices on endoscopy within 3 months prior to the first dose; or evidence of portal hypertension (including splenomegaly on imaging) with high bleeding risk assessed by the investigator (including moderate-to-severe esophageal\u002Fgastric varices with bleeding risk, local active gastrointestinal ulcers, and persistent positive fecal occult blood tests). Endoscopy is required to exclude patients with \"red color signs.\" Patients with a history of \"red color signs\" are excluded.\n* Hemorrhage: Any life-threatening bleeding event within 3 months prior to the first dose, including events requiring blood transfusion, surgery, local therapy, or continuous medication.\n* Systemic Immunosuppression: Use of systemic corticosteroids or other immunosuppressive therapies for active autoimmune diseases within the past 2 years. Note: Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment.\n* Inflammatory Bowel Disease: Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or chronic diarrhea.\n* Transplantation: History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Pneumonitis\u002FILD: Previous or current history of non-infectious pneumonitis\u002Finterstitial lung disease requiring systemic glucocorticoid therapy.\n\nSurgery: Major surgical procedure or severe trauma within 30 days prior to the first dose, or planned major surgery within 30 days after the first dose (as determined by the investigator); minor local surgery within 3 days prior to the first dose (excluding peripherally inserted central catheter \\[PICC\\] line placement and implantable venous port insertion).\n\n* Infection: Severe active infection judged by the investigator.\n* Pregnancy: Pregnant women or those planning to become pregnant during the study period.\n* Prior Trials: Participation in another drug clinical trial within 12 months prior to enrollment.\n* Other: Other conditions deemed unsuitable for enrollment by the investigator.",{"count":173,"type":21},32,[175],"PHASE4","This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of Iparomlimab and Toripalimab (QL1706) in combination with bevacizumab and chemotherapy as first-line treatment for patients with advanced biliary tract cancer",[28],"2026-05-24",{"date":180,"type":37},"2026-06-01",{"date":36,"type":21},{"date":183,"type":21},"2028-12-31",{"name":185,"class":75},"Xianglin Yuan",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":204,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":45},"100595891","phase-1-aventine-1-study-of-avzo-1418-as-a-single-agent-and-in-combination-therapy-in-patients-with-locally-advanced-or-metastatic-solid-tumors-avzo-1418-1001-100595891","NCT07038343","AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)","A Phase 1\u002F2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria\n\n* Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \\> 3 months.\n* Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic malignancies for tumor types of preferred indications:\n\n  o Locally advanced or metastatic epithelial solid tumors (as specified in the protocol).\n* Measurable disease as assessed by Investigator using RECIST v1.1.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable.\n* Other protocol-defined Inclusion criteria apply.\n\nKey Exclusion Criteria\n\n* Uncontrolled hypertension.\n* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.\n* History of drug-induced interstitial lung disease (ILD).\n* History of any serious cardiovascular condition.\n* Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.\n* History of a solid organ transplant.\n* Other protocol-defined Exclusion criteria apply.",{"count":20,"type":21},[138,56],"This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.",[197,198,199,200,201,28,202,203],"Solid Tumor Cancer","Locally Advanced","Metastatic Solid Tumors","Lung Cancers","Epithelial Tumor","Urothelial Cancer","Nasopharyngeal Cancers",[205,206,198,207,208,91,202,209,210,211,89,212,213],"Solid Tumors","Metastatic","Lung Cancer","Epithelial Solid Tumors","SCLC","HER3","EGFR","Small Cell Lung Cancer","NSCLC",{"date":215,"type":37},"2026-05-13",{"date":217,"type":37},"2025-06-04",{"date":219,"type":21},"2030-12",{"name":221,"class":44},"Avenzo Therapeutics, Inc.",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":234,"conditions":235,"keywords":236,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":101},"100628791","haic-plus-systemic-therapy-as-de-escalation-therapy-strategy-for-biliary-tract-cancer-100628791","NCT07466238","HAIC Plus Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer","HAIC Combined With Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer: A Conceptual Study","Inclusion Criteria:\n\n* Age: 18-80 years, both genders.\n* Diagnosis of biliary tract cancer (including intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, and gallbladder cancer) and confirmed by histopathological or cytopathological examination.\n* Without distant metastasis or limited distant metastasis\n* Treatment-naive.\n* ECOG PS score \\\u003C 2.\n* Child-Pugh score: Class A or B (≤7).\n* Normal major organ function, meeting the following standards:(1) Blood routine examination:A. Hb≥90 g\u002FL;B. ANC≥1.5×10\\^9\u002FL;C. PLT≥75×10\\^9\u002FL;(2) Biochemical examination:A. ALB ≥30g\u002FL;B. ALT and AST\\\u003C5×ULN;C. TBiL ≤5×ULN;D. Creatinine ≤1.5×ULN;(3) Coagulation function:A. International normalized ratio (INR) ≤1.5×ULN;B. Activated partial thromboplastin time (APTT) ≤1.5×ULN.\n\nExclusion Criteria:\n\n* Coexistent or synchronous malignancies.\n* Distal cholangiocarcinoma.\n* Allergic to contrast agents or oxaliplatin.\n* Pregnant or lactating women.\n* Multiple extrahepatic metastases or combined malignant pleural and peritoneal effusions.\n* History of organ transplantation.\n* With infections requiring anti-infection treatment.\n* Severe and irreparable coagulation dysfunction.","80 Years",{"count":231,"type":21},40,[233],"NA","Biliary tract cancer (BTC), including cholangiocarcinoma and gallbladder cancer (GBC), is a group of malignancies with highly heterogeneous, highly aggressiveness, and poor prognosis. Surgery is recognized as the only curative treatment for BTC, however, only about 20% BTC patients are eligible for curative resection since most patients with BTC are diagnosed at an advanced stage. The median overall survival (OS) in patients with unresectable BTC is typically less than 6 months. For patients with unresectable BTC, gemcitabine plus cisplatin (GemCis) had been recommended as the standard first-line treatment for many years. However, the objective response rate (ORR) of this regimen is only 26.1%, and the survival benefit remains limited, with a median OS of less than one year.\n\nIn recent years, two phase III trials (TOPAZ-1 and KEYNOTE-966) have demonstrated that combining immune checkpoint inhibitors (durvalumab or pembrolizumab) with the GemCis regimen could further prolong survival in patients with BTC, achieving a median OS of 12.9 months and 12.7 months, respectively. Based on this evidence, many guidelines worldwide had recommended GemCis plus durvalumab or pembrolizumab as the preferred standard first-line treatment for patients with unresectable BTC. However, survival benefits from this combination therapy remain relatively limited, and tumor response is suboptimal, with an ORR of only 26.7%-29%.\n\nHepatic arterial infusion chemotherapy (HAIC) enables continuous infusion of chemotherapeutic agents via the hepatic artery, significantly increasing local drug concentration at the tumor site, maximizing antitumor efficacy, and achieving a higher ORR (50%-60%) with substantial reduction in tumor burden. In recent years, HAIC has been increasingly used in the treatment of unresectable BTC, with its efficacy supported by many clinical studies.\n\nFirstly, HAIC provides survival benefits comparable to surgery in patients with multifocal intrahepatic cholangiocarcinoma (iCCA), and significantly outperforms systemic therapy. In 2022, a retrospective study enrolled 141 patients who received HAIC and 178 patients who underwent surgical resection from 12 centers. The results showed the median OS was 20.3 months in the HAIC group and 18.9 months in the resection group (P = 0.32), indicating comparable survival outcomes between HAIC and surgery. Given the risks of post-hepatectomy complications, HAIC may serve as an effective alternative treatment strategy for multifocal iCCA. Furthermore, for locally advanced unresectable iCCA, the results in a study in 2024 comparing HAIC with GemCis regimen chemotherapy revealed that although patients in the HAIC group had a higher tumor burden (proportion of multifocal disease: 73.4% vs. 55.3%, P = 0.023), the median OS in HAIC group remained significantly superior to that in the GemCis group (27.7 months vs. 11.8 months, P \\\u003C 0.001).\n\nSecondly, HAIC has also been demonstrated to be effective in treating perihilar cholangiocarcinoma (pCCA). In 2017, a single-arm, prospective phase II trial conducted in our center showed HAIC with oxaliplatin and fluorouracil yielded an ORR of 67.6%, a median progression-free survival (PFS) of 12.2 months, and a median OS of 20.5 months in treating perihilar cholangiocarcinoma (pCCA).\n\nFurthermore, HAIC also has clinical potential in treating advanced GBC. In 2021, a retrospectively study in our center enrolled 26 patients with advanced GBC who received HAIC with oxaliplatin and fluorouracil, of whom 23.1% had failed prior systemic therapy and 34.6% had contraindications to systemic treatment. The results showed that HAIC achieved a median PFS of 10 months and a median OS of 13.5 months, with an ORR of 69.2% and a disease control rate (DCR) of 92.3%.\n\nIn recent years, many studies have demonstrated that HAIC combined with systemic therapy could yield significant survival benefits in patients with unresectable BTC. A phase II clinical trial in 2022 evaluated the efficacy of HAIC with floxuridine plus systemic gemcitabine and oxaliplatin (GEMOX) in unresectable iCCA. The results showed that the combination therapy achieved a median PFS of 11.8 months and a median OS of 25 months, with a 6-month DCR of 84%, and 58% of patients achieved partial response (PR). Additionally, the association of benefit of combining HAIC with systemic chemotherapy and stage of BTC has been reported, and that patients with locally advanced cholangiocarcinoma may not derive such benefit from this combination. In 2025, a phase II clinical trial conducted in our center evaluated the efficacy and safety of HAIC (bevacizumab, oxaliplatin, and fluorouracil) combined with toripalimab as a first-line treatment for unresectable BTC. The results showed a median PFS of 13.2 months and a median OS of 19 months, with an ORR as high as 84.38%. Some patients achieved successful conversion resection following this combination therapy, and postoperative pathology confirmed pathological complete res",[28],[237,238,239],"biliary tract cancer","hepatic arterial infusion chemotherapy","systemic therapy","2026-05-05",{"date":242,"type":37},"2026-05-08",{"date":244,"type":37},"2026-03-31",{"date":246,"type":21},"2029-03-31",{"name":248,"class":75},"Peking University",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":134,"maxAge":4,"enrollmentInfo":256,"targetDuration":258,"studyType":259,"phases":4,"briefSummary":260,"conditions":261,"keywords":268,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":127},"100608807","in-depth-characterisation-of-biliary-strictures-and-hepato-pancreato-biliary-focal-lesions-for-development-of-new-technologies-to-tackle-hepato-pancreato-biliary-cancers-100608807","NCT07206355","In-Depth Characterisation of Biliary Strictures and Hepato-Pancreato-Biliary Focal Lesions for Development of New Technologies to Tackle Hepato-Pancreato-Biliary Cancers","Map HPB","Inclusion Criteria:\n\n* Aged 16 years and over\n* Ability to provide informed consent to participate in the study\n* Patients attending Nottingham University Hospitals NHS Trust (NUH) as part of standard clinical care for either:\n\n  * the diagnosis and treatment of suspected biliary stricture or any focal lesion in the Hepato-Pancreato-Biliary (HPB) tract (clinically \u002F radiologically) including liver or pancreatic lesion or pancreatic cyst\n  * surgical resection treatment of liver, pancreas, or gall bladder including Whipple Procedure (pancreaticoduodenectomy surgery), gall bladder resection (cholecystectomy), hepatic resection\n\nExclusion Criteria: No exclusion criteria",{"count":257,"type":21},160,"5 Years","OBSERVATIONAL","Hepato-Pancreato-Biliary (HPB) cancers originating in the liver, bile ducts, pancreas, and gall bladder represent a rising global health challenge, with incidence doubling in the UK over the past decade. Cholangiocarcinoma (CCA) and pancreatic cancer are particularly aggressive, often detected late due to non-specific symptoms and difficulties in sampling or imaging. In the UK, CCA affects around 3,000 people annually, with only 13% surviving 3 years, while pancreatic cancer has a 5-year survival of 8.3%. Diagnosis is complicated by the anatomical narrowness of the bile duct and the similarity between malignant and benign strictures. Standard imaging often cannot distinguish between inflammation and cancer, while tissue sampling is challenging, paucicellular, and limited in sensitivity, necessitating repeated biopsies. Yet, accurate characterisation is critical as NICE now recommends targeted therapies (FGFR2, NTRK, MSI-H\u002FdMMR, IDH1 mutations) that require molecular profiling.\n\nBoth CCA and PDAC display high heterogeneity, further complicating treatment. Emerging approaches such as Raman spectroscopy can map malignant tissues by detecting vibrational energy shifts, but require further validation due to weak signals. For focal or cystic HPB lesions not well visualised by conventional imaging, novel modalities like ultra-thin endoscopes with scattering\u002Fabsorption imaging are being developed for improved early diagnosis.\n\nManagement of biliary obstruction frequently involves stenting to restore bile flow, essential for palliation and pre-treatment optimization. However, stent failure from tumour ingrowth, displacement, or erosion remains common, and evidence for best stent use is limited. Novel approaches, including drug-eluting coatings and nanoparticle-mediated wireless treatment delivery, are being investigated.\n\nTo overcome diagnostic and therapeutic barriers, flexible snake-like robotic systems with navigation, sampling, spectroscopy, and treatment capabilities are being developed. These devices, alongside ultra-thin endoscopes and integrated Raman spectroscopy, aim to characterise strictures, generate 3D imaging in ex-vivo HPB tissue, and permit targeted ablation. Parallel work will explore molecular and fluid-based biomarkers (blood, bile, cyst fluid) to support minimally invasive diagnosis and monitoring.\n\nThrough integration of engineering, molecular diagnostics, and device innovation, this transdisciplinary research programme (UKRI and MRC funded) seeks to transform early detection, accurate diagnosis, and novel treatment of HPB cancers, thereby improving outcomes in CCA, pancreatic malignancy, and other clinically similar biliary disorders.\n\nAim:\n\nTo provide a detailed understanding of the characteristics (including clinical and molecular) of liver and pancreatic biliary focal lesions (inflammatory and cancerous) and create a bioresource of liver, pancreas, gallbladder and biliary tract associated tissue and fluids (biopsies, brushings, resected tissues, bile and cyst fluid and blood samples) in order to develop innovative tools for accurate diagnosis and treatment.\n\nStudy Configuration: Prospective Longitudinal Cohort study Setting: Secondary care centre, Nottingham University Hospitals NHS Trust. (NUH).\n\nCo-ordinated by the NIHR Nottingham Biomedical Research Centre Description of interventions: This is an observational study involving collecting tissue or body fluids (such as bile or pancreatic cyst fluid) during clinical care in addition to collection of blood samples (for DNA, serum and plasma) and data collection.\n\nSurplus tissue residual to the requirements for standard care will be stored and used. Additional tissue samples and body fluid samples collected for research at time of clinical investigations will not be increasing the risk of the clinical procedure.\n\nBlood samples will be collected from patients at the time of enrolment in the study. These may be collected before and\u002F or after diagnosis is secured.\n\nDuration of study: Overall duration: 60 months Outcome measures: - To report the proportion of patients where adequate tissue could be retrieved from HPB biopsy to come to definitive diagnosis using standard of care.\n\n* To report the proportion of patients where adequate tissue could be retrieved from biopsy to perform molecular characterisation of HPB samples, beyond standard cyto\u002Fhistology, using advanced optical-spatial technologies currently under development.\n* To report the proportion of patients where definitive diagnosis of mucinous cystic neoplasm could be made in patients with pancreatic cyst using standard care\n* To report the proportion of patients where molecular characterisation beyond standard cyto\u002Fhistology could be made in patients with pancreatic cyst using exploratory new technologies under development through ex-vivo experiments\n* To report the correlation between Raman Spectroscopy and standard cyto\u002Fhistology for identification of cancer in HPB samples",[28,262,263,264,265,266,267],"Biliary Tract Cancer (CCA)","Cholangiocarcinoma","Cholangiocarcinoma Cancer","Cholangio Carcinoma","Pancreatic Cancer","Pancreatic Cyst",[237,266,267,269,28,263],"Pancreatic lesions","2026-04-28",{"date":272,"type":37},"2026-04-29",{"date":274,"type":37},"2026-01-25",{"date":276,"type":21},"2030-09-30",{"name":278,"class":75},"University of Nottingham",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":4},"100632612","a-comprehensive-biomarker-evaluation-in-biliary-tract-cancer-100632612","NCT07515950","A COMPREHENSIVE BIOMARKER EVALUATION IN BILIARY TRACT CANCER","REVEAL-BTC","Inclusion Criteria:\n\n1. Written informed consent for the use of clinical data and tissue samples is available. (The use of data and samples without consent is only possible if exemption is granted by the corresponding Institutional Review Board - IRB).\n2. Histologically confirmed diagnosis of biliary tract cancer (including gallbladder carcinoma \\[GBC\\] or cholangiocarcinoma \\[CCA\\]), regardless of disease stage.\n3. Diagnosis must have been established within the last 15 years prior to Study initiation.\n4. Availability of archival formalin-fixed paraffin-embedded (FFPE) tumor tissue sample, collected prior to Study inclusion at any disease stage (e.g., during surgery or in the advanced setting). For patients with de novo metastatic disease or early stage primary tumors undergoing surgery, the tissue must have been obtained before the initiation of any systemic therapy (e.g. chemotherapy) or radiotherapy. For patients with recurrent disease undergoing a new biopsy, previous treatments are allowed.\n5. Availability and accessibility of basic clinical information and survival data on medical records.\n\nExclusion Criteria:\n\n1. Unavailability or inadequate quality (e.g., insufficient tumor content, degraded tissue) of archival FFPE tumor tissue samples for the planned immunohistochemical analysis.\n2. Missing or incomplete basic clinical and\u002For survival data in the medical record.",{"count":287,"type":21},244,"The REVEAL-BTC Study will analyze 5 biomarkes in samples of participants who in the past 15 year have been diagnosed with any stage of biliary tract cancer. The expression levels of the biomarkers will be correlated with clinical outcomes in the participants, which will lead to better patient stratification that will help guide the use of targeted therapies in the future.",[28],[291,292,293,294,295,296],"Biliary tract cancer","CLDN18.2","TROP2","B7-H4","HER-2","PD-L1",{"date":298,"type":37},"2026-04-07",{"date":300,"type":21},"2026-07",{"date":302,"type":21},"2027-07",{"name":304,"class":75},"MedSIR",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":22,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"100431646","phase-1-study-of-tj033721-givastomig-in-subjects-with-advanced-or-metastatic-solid-tumors-100431646","NCT04900818","Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors","A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nPart 1 - Monotherapy Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options.\n\nPart 2 - Combination Therapy Subjects with treatment naïve locally advanced, unresectable or metastatic gastric, GEJ, esophageal adenocarcinoma;\n\nPart 3: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma;\n\nPart 4: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed biliary tract cancer.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function\n* Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)\n\nFor dose expansion and Part 2, Part 3, Part 4 Combination subjects:\n\n• Must have CLDN18.2-positive tumor expression\n\nExclusion Criteria\n\n* Prior exposure to CLDN18.2 -targeted therapy\n* Prior exposure to 4-1BB agonists\n* Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ\n* Known active or chronic Hepatitis B or Hepatitis C, other hepatitides\n* Unstable\u002Factive ulcer or digestive tract bleeding within 6 weeks\n* Active autoimmune disease requiring systemic treatment within the past 2 years\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;\n* New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, severe\u002Funstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) in the previous 6 months\n* Diagnosis of immunodeficiency such as known active HIV\n* Any active infection requiring parenteral treatment\n\nFor Part 2, 3, 4 Combination subjects:\n\n• Prior treatment with anti-PD-1 or PD-L1 agent",{"count":313,"type":21},330,[138],"This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.",[317,318,319,320,321,322,323,28],"Solid Tumor","Advanced Cancer","Metastatic Cancer","Gastric Cancer","Gastroesophageal Junction Carcinoma","Esophageal Adenocarcinoma","PDAC - Pancreatic Ductal Adenocarcinoma","2026-03-03",{"date":326,"type":37},"2026-03-05",{"date":328,"type":37},"2021-06-29",{"date":330,"type":21},"2027-12",{"name":332,"class":44},"I-Mab Biopharma US Limited",21,{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":258,"studyType":259,"phases":4,"briefSummary":343,"conditions":344,"keywords":356,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":127},"100627888","trace-btc-relation-of-biomarkers-and-patients-reported-quality-of-life-to-outcomes-in-patients-with-biliary-tract-cancer-a-real--world-cohort-100627888","NCT07454486","TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort","TRACE-BTC","Inclusion Criteria:\n\n* Histopathologically verified biliary tract cancer (BTC) and\u002For Multidisciplinary Team (MDT) conference decision to define the patient as suffering from BTC.\n* Eligible for curative, adjuvant, or palliative oncological treatment.\n* Age ≥ 18 years.\n* Written and oral consent.\n\nExclusion Criteria:\n\n* Other malignant diseases within 5 years of BTC diagnosis, excluding early-stage non-melanoma skin cancer and carcinoma in situ of the cervix.\n* Conditions that prohibit blood sampling.\n* Known or suspected non-compliance.",{"count":342,"type":21},300,"Purpose of the Study:\n\nBile duct cancers are rare and aggressive. About 250 new cases are diagnosed each year in Denmark. These cancers are difficult to detect early, so only about 20% of patients can have surgery when diagnosed. Even after surgery, the cancer often returns, and chemotherapy only slightly reduces the risk of relapse.\n\nFor patients who cannot have surgery, treatments such as chemotherapy (sometimes combined with immunotherapy) can relieve symptoms and extend life, but their effect is limited. A small number of patients have specific genetic changes in their cancer that can be treated with targeted medicines.\n\nCurrently, doctors cannot predict which patients will benefit from treatment. Standard monitoring methods like CT scans are expensive, inconvenient, and sometimes unreliable because bile ducts are hard to see clearly on scans.\n\nBlood tests that detect cancer DNA in the blood (called circulating tumor DNA or ctDNA) and other biological markers may be a better way to monitor the disease and adjust treatment. These tests could help detect cancer recurrence earlier and determine whether treatment is working. Measuring patients' quality of life and symptoms over time may also help predict treatment benefit and evaluate effectiveness.\n\nThe goal of this study is to:\n\n* Investigate how biomarkers, including ctDNA, can predict disease course, detect relapse, and monitor treatment response.\n* Identify the best way to measure ctDNA in patients with bile duct cancer.\n* Examine whether patients' own reports of quality of life and symptoms can help assess treatment effect and prognosis.\n\nStudy Design and Procedures:\n\nThis is a prospective cohort study focusing on blood biomarkers and patient-reported symptoms and quality of life.\n\nParticipants agree to provide blood samples:\n\n* Before treatment\n* During treatment\n* During follow-up\n\nEach sample involves up to 40 ml of blood, with a maximum of 20 samples per patient.\n\nThe blood will be analyzed for:\n\n* ctDNA and genetic changes\n* Cancer-related markers\n* Inflammation markers\n* Immune system markers\n\nTumor tissue samples will also be examined to compare blood and tissue results. Full genome or exome sequencing will not be performed. Samples will be stored in a research biobank.\n\nFor patients with incurable disease, quality of life and symptom burden will be monitored repeatedly using Danish questionnaires.\n\nParticipants:\n\nThe study will include:\n\n* Up to 100 patients with potentially curable disease\n* Up to 200 patients with incurable disease\n\nTo participate, patients must:\n\n* Have confirmed bile duct cancer\n* Be eligible for curative, additional (adjuvant), or palliative treatment\n* Be over 18 years old\n* Provide written and verbal consent\n\nPatients cannot participate if they:\n\n* Had another cancer within the past 5 years (except early skin cancer or very early cervical cancer)\n* Cannot safely provide blood samples\n* Are unable to cooperate with study procedures\n\nRisks and Inconveniences:\n\nParticipants will have extra blood samples taken, usually during regular hospital visits. Possible side effects include mild soreness or small bruises at the needle site. The extra blood amount (40 ml per sample) is considered medically insignificant.\n\nParticipants will also spend time filling out questionnaires. The number and frequency of questions have been kept as low as possible while still providing meaningful data.\n\nFinancial Information:\n\nExtra costs for blood sampling, laboratory analysis, and data collection will be covered by external research funding managed by Aarhus University Hospital.\n\nThe researchers have no financial interest in the project. Patients will not receive financial compensation for participating.\n\nRecruitment and Consent:\n\nPotential participants are identified during routine clinical care. During a planned meeting with a doctor, patients receive written and verbal information about the study, including its purpose, risks, advantages, and disadvantages.\n\nThe conversation takes place in a calm and private setting. Patients may bring a support person. They have time to ask questions and at least 24 hours to consider participation.\n\nPatients can withdraw their consent at any time without affecting their treatment. Consent must be given before any study-related procedures begin.\n\nPublication of Results:\n\nThe results - whether positive or negative - will be presented at national and international conferences and submitted to peer-reviewed scientific journals.\n\nEthical Considerations:\n\nAll participants receive standard medical treatment. The risks and disadvantages are limited, and participants are unlikely to benefit directly from the study. However, the research may improve how biomarkers and patient-reported outcomes are used to predict prognosis and treatment response, potentially leading to better treatment for future patients with bile duct cancer.",[28,262,345,346,263,347,348,349,350,351,352,353,354,355],"Gall Bladder Cancer","Biliary Tract Cancers (BTC)","Cholangiocarcinoma Non-resectable","Cholangiocarcinoma Resectable","Cholangiocarcinoma Metastatic","Cholangiocarcinoma of the Bile Duct","Cholangiocarcinoma, Extrahepatic","Cholangiocarcinoma, Hilar","Cholangiocarcinoma, Intrahepatic","Cholangiocarcinoma, Perihilar","Cholangiocarcinoma; Liver",[357,263,358,359,360,361,362,363,364,365,366,367,368],"Biliary Tract Neoplasms","Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Gallbladder Neoplasms","Circulating Tumor DNA","Liquid Biopsy","Minimal Residual Disease","Biomarkers, Tumor","Observational Study","Biobanking","DNA Methylation","Precision Oncology","2026-03-02",{"date":371,"type":37},"2026-03-06",{"date":373,"type":21},"2026-03-15",{"date":375,"type":21},"2031-12-30",{"name":377,"class":75},"Aarhus University Hospital",{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100626565","phase-2-testing-mitazalimab-in-combination-with-standard-chemotherapy-in-immunotherapy-resistant-advanced-biliary-tract-cancers-100626565","NCT07437287","Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers","Countering Immunotherapy Resistance With Novel Combinations in Advanced Biliary Tract Cancers","CROCOBIL","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Histologically-proven intrahepatic cholangiocarcinoma, extrahepatic (perihilar\u002Fdistal) cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded)\n3. Measurable tumor according to RECIST v1.1 classification\n4. Non-resectable or metastatic disease or recurrent after surgery (if recurrence more than 6 months after adjuvant treatment stop)\n5. Participants having received a standard first-line treatment (CISGEM + durvalumab or pembrolizumab) and eligible for second- or third-line treatment with FOLFOX. Participant could have received a previous targeted therapy in case of targetable alteration, but only one line of chemotherapy is permitted.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Adequate bone marrow reserve, normal renal and liver functions:\n\n   * Neutrophil count ≥ 1500\u002Fmm³\n   * Platelet count ≥ 150 000\u002Fmm³\n   * Hemoglobin ≥ 10 g\u002Fdl\n   * Estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n   * Total bilirubin \\\u003C 1.5 x ULN (after biliary stent placement in case of biliary obstruction)\n8. No dihydropyrimidine dehydrogenase deficiency, as assessed by pre-treatment uracil blood level ≤ 16 ng\u002FmL\n9. Women of childbearing potential must have a negative serum or urine pregnancy test done within 7 days before randomization.\n10. Participants must agree to use adequate contraception methods for the duration of study treatment and for within 15 months for women and 12 months for men after completing treatment.\n11. Participants must be affiliated to a Social Security System (or equivalent).\n12. Participant must have signed a written informed consent prior to any trial specific procedures. When the participant is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the participant's consent.\n13. Participants must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures.\n14. Have archival tumor tissue sample that has been identified and confirmed as available\n15. Participant having consented for a new tumor biopsy at inclusion for ancillary studies (participants with non-contributory new biopsy may still be included in the study).\n\nExclusion Criteria:\n\n1. Participants having received previous treatment with fluoropyrimidine, oxaliplatin or CD40 agonist, except for capecitabine given as adjuvant treatment (if last administered \\> 6 months).\n2. Concurrent malignancy (other than BTC), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 3 years or more and are deemed at negligible risk for recurrence, are eligible for the trial\n3. Known CNS metastases or carcinomatous meningitis\n4. History of chronic diarrhea, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction\n5. History of myocardial infarction within 12 months of the first administration of mitazalimab, uncontrolled angina pectoris, unstable cardiac arrhythmias, or congestive heart failure of New York Heart Association class II or greater\n6. QTc \\>450 msec\n7. Known history of HIV, hepatitis B or active hepatitis C infection\n8. Toxicities from first-line treatment not resolved to Grade ≤ 1 (according to NCI-CTCAE v6.0) before randomization with the exception of alopecia\n9. Contraindication to mitazalimab or to FOLFOX regimen, or their excipients\n10. Prior toxicities of grade ≥ 3 with durvalumab or pembrolizumab (except from vitiligo, alopecia, hypothyroidism, adrenal insufficiency and diabetes) or other immune-related toxicities that led to definitive discontinuation\n11. Has received attenuated vaccine within 28 days before the first dose of study treatment\n12. Any condition which in the Investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the protocol (including uncontrolled comorbidities, active infections or untreated central nervous system metastases)\n13. Participation in another therapeutic trial within the 30 days prior to randomization\n14. Pregnant women or women who are breast-feeding\n15. Participant unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons\n16. Individual deprived of liberty or placed under protective custody or guardianship.",{"count":257,"type":21},[56,24],"The goal of this clinical trial is to etablish whether adding Mitazalimab to standard chemotherapy is more effective than standard chemotherapy alone in people with advanced bile duct cancer. It will also learn about the safety of Mitazalimab.\n\nThe main questions it aims to answer are:\n\n* Does the addition of Mitazalimab enhance efficacy?\n* What medical problems do participants have when taking Mitazalimab + mFOLFOX?\n\nParticipants will:\n\n* Take drug mFOLFOX every two weeks until disease progression or mFOLFOX every two weeks plus mitazalimab in addition to mFOLFOX, with a first injection 7 days before the first mFOLFOX chemotherapy and then 3 days after the start of each mFOLFOX cycle.\n* Visit the clinic once every 2 weeks for checkups and tests\n* Have a radiological assessment every 8 weeks during treatment. After stopping treatment, participants will be monitored at the hospital every 8 weeks if no progression is observed, or every 12 weeks after disease progression.",[28],[91,391,392],"Mitazalimab","Resistance to immunotherapy","2026-02-20",{"date":395,"type":37},"2026-02-27",{"date":300,"type":21},{"date":398,"type":21},"2031-10",{"name":400,"class":75},"UNICANCER",22,{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":425},"100476358","phase-1-spevatamig-pt886-as-monotherapy-or-in-combination-with-chemo-andor-ici-for-the-treatment-of-patients-with-advanced-gastric-gastroesophageal-junction-pancreatic-ductal-or-biliary-tract-carcinomas-the-twinpeak-study-100476358","NCT05482893","Spevatamig (PT886) as Monotherapy or in Combination With Chemo and\u002For ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)","A Phase 1\u002F2, Open-Label, Dose Escalation and Expansion Study With PT886 (Spevatamig) Followed by a Multi-cohorT Study in Patients With Advanced GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, and\u002For an Immune ChecKpoint Inhibitor. The TWINPEAK Study","Key Inclusion Criteria\n\n1. 18 years or older and able to sign informed consent and comply with the protocol.\n2. Measurable disease as defined by RECIST V1.1 criteria for solid tumors.\n3. 3\\. Part A and Part B: Histologically or cytologically confirmed unresectable advanced or metastatic solid gastric, gastroesophageal junction (GEJ), biliary tract or pancreatic carcinomas previously treated for advanced (metastatic or unresectable) disease or for which treatment is not available or not tolerated.\n\n   Part C, Cohort C1: 2L m\u002Fa GC\u002FGEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. Patients who are HER2 positive are eligible.\n\n   Part C, Cohort C2: 1L m\u002Fa PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane).\n\n   Part C, Cohort C3: 1L m\u002Fa PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX\u002FmFFX.\n\n   Cohort C4: Patients with m\u002Fa BTC who have progressed on 1L SOC chemotherapy (GemCis) ± ICI and are eligible for 2L SOC FOLFOX treatment.\n\n   Cohort C5: Patients with m\u002Fa HER2 negative GC\u002FGEJC and present a PD-L1 CPS score of \\\u003C1%, who are treatment naïve for their m\u002Fa disease and eligible for treatment with SOC chemotherapy (mFOLFOX6 or CAPOX).\n\n   Part D, Cohort D2: Patients with m\u002Fa GC\u002FGEJ-C, that have progressed under 1L SOC chemotherapy, and zolbetuximab, will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab).\n\n   Part D, Cohort D3: 2L or 3L m\u002Fa GC\u002FGEJ-C patients will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab).\n\n   Part D, Cohort D4: 1L HER2 negative m\u002Fa GC\u002FGEJ-C patients will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab).\n4. Biopsies:\n\n   Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably fresh biopsy or if not possible, archival tissue) to be assessed for CLDN18.2 expression and other biomarkers.\n\n   Parts C and D: Patients must present with ≥ 10%; ≥ 2+ CLDN18.2 positive TC in their tumor tissue.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ function confirmed at screening and within 72 hours of initiating treatment.\n\nKey Exclusion Criteria\n\nPatients are excluded from the study if any of the following criteria apply:\n\n1. Women who are pregnant or lactating.\n2. Women of child-bearing potential (WOCBP) who do not use adequate birth control.\n3. Has an active autoimmune disease that has required systemic treatment in the past 2 years.\n4. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to study treatment.\n5. Patients with a history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or have a history of interstitial lung disease. History of COVID-19 pneumonia with fibrotic changes.\n6. Patients with untreated brain or central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain\u002FCNS metastases).\n7. Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents. For Part D, Cohort D2, prior treatment with zolbetuximab is allowed.\n8. Impaired cardiac function or significant diseases.\n9. Prior hemolytic anemia or Evans Syndrome in the last 3 months.\n10. Active gastric perforation, pyloric obstruction, complete biliary obstruction, complete or incomplete intestinal obstruction requiring clinical intervention, or pleural effusion or peritoneal effusion requiring clinical intervention.\n11. Patients who have experienced any thromboembolic event such as deep vein thrombosis (DVT) or pulmonary embolism in the past 6 months.\n\nAdditional inclusion and exclusion criteria will apply.",{"count":410,"type":21},258,[138,56],"This is a first-in-human, Phase 1\u002F2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Spevatamig (PT886). Patients with the following tumor types will be eligible for screening: unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, biliary tract carcinoma (BTC) and pancreatic ductal adenocarcinoma (PDAC).",[414,415,28],"Gastric or Gastroesophageal Junction Adenocarcinoma","Pancreatic Ductal Adenocarcinoma","2025-10-31",{"date":418,"type":37},"2025-11-04",{"date":420,"type":37},"2023-03-15",{"date":422,"type":21},"2028-04",{"name":424,"class":44},"Phanes Therapeutics",11,{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":449,"locationsCount":127},"100606005","yueju-pill-combined-with-standard-therapy-in-advanced-biliary-tract-cancer-100606005","NCT07169916","Yueju Pill Combined With Standard Therapy In Advanced Biliary Tract Cancer","Effect of Yueju Pill Combined With Standard Therapy on Quality of Life and Treatment Efficacy in Patients With Advanced Biliary Tract Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial","YJ-BTC","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be enrolled in this study:\n\n1. No gender restriction, age ≥18 years, and expected survival ≥3 months;\n2. ECOG Performance Status (PS) of 0-1;\n3. Child-Pugh class A;\n4. Histologically confirmed diagnosis of advanced biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, or gallbladder cancer;\n5. At least one measurable lesion according to RECIST v1.1 criteria;\n6. Planned to receive or currently receiving guideline-based, chemotherapy-centered systemic first- or second-line therapy;\n7. Presence of mild to moderate anxiety or depressive symptoms (PHQ-9 or GAD-7 score of 5-14);\n8. Adequate major organ function, including:\n\n   1. Hematology (no blood transfusion or hematopoietic growth factors within 14 days): Hb ≥90 g\u002FL, ANC ≥1.5×10⁹\u002FL, PLT ≥90×10⁹\u002FL, WBC ≥3.0×10⁹\u002FL;\n   2. Biochemistry: TBIL ≤1.5×ULN (≤2×ULN if liver metastases); ALT and AST ≤2.5×ULN (≤5×ULN if liver metastases); serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin; plasma albumin ≥30 g\u002FL;\n   3. Coagulation: INR and PT ≤1.5×ULN, APTT ≤1.5×ULN;\n   4. Cardiac function: LVEF ≥50%, QTcF ≤450 msec (male) or ≤470 msec (female);\n   5. Urine protein ≤2+, and if \\>2+, 24-hour urine protein must be ≤1.0 g;\n9. Not pregnant or breastfeeding, and subjects of childbearing potential must use effective contraception during treatment and for 3 months after treatment;\n10. Voluntary participation with signed informed consent, good compliance, and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will not be eligible for this study:\n\n1. Histological types of ampullary cancer, hepatocellular carcinoma, mixed-type liver cancer, or other malignancies not originating from bile duct cells;\n2. History of or concurrent malignancy at other sites;\n3. Severe anxiety or depression (PHQ-9 or GAD-7 score ≥15), currently receiving antidepressant or anti-anxiety medication, or history of substance abuse, alcoholism, or drug abuse;\n4. Currently using other traditional Chinese medicine compound interventions;\n5. Known allergy to monoclonal antibodies, anti-angiogenic drugs, gemcitabine, platinum drugs, or components of Chinese medicine;\n6. Uncontrolled severe comorbidities, including:\n\n   1. Congestive heart failure;\n   2. Difficult-to-control hypertension;\n   3. Angina or arrhythmias;\n   4. Interstitial lung disease or active pulmonary tuberculosis;\n   5. HBV DNA \\>2000 copies\u002FmL or HCV RNA \\>1000 IU\u002FmL after antiviral therapy;\n   6. Known HIV positive or diagnosed with acquired immunodeficiency syndrome (AIDS);\n   7. Clinically significant gastroesophageal variceal bleeding within 3 months prior to enrollment, or known bleeding tendency;\n   8. Coagulation abnormalities (PT \\>14 sec), bleeding tendency, or currently receiving anticoagulant\u002Fthrombolytic therapy;\n   9. Known or suspected active autoimmune disease, or requiring long-term systemic immunosuppressive therapy or corticosteroids;\n7. Other factors that, in the investigator's judgment, may affect patient safety or trial compliance (e.g., severe laboratory abnormalities, psychiatric disorders, lack of family or social support).",{"count":435,"type":21},210,[233],"This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the impact of Yueju Pill on quality of life and treatment efficacy in patients with advanced biliary tract cancer (BTC) receiving standard therapy.",[28],[91,440,441,442],"Yueju Pill","Quality of Life","Treatment Efficacy","2025-09-05",{"date":445,"type":37},"2025-09-12",{"date":447,"type":21},"2025-09-01",{"date":98,"type":21},{"name":450,"class":75},"Fudan University",{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":459,"targetDuration":4,"studyType":22,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":470,"locationsCount":127},"100605183","phase-2-paclitaxel-micelle-later-line-combined-immunotherapy-for-biliary-tract-cancer-100605183","NCT07159204","Paclitaxel mIcelle Later-line cOmbined immunoTherapy for Biliary Tract Cancer","The Paclitaxel Polymer Micellar Based Combined Immunotherapy for the Posterior Line Treatment of Advanced Bile Tract Cancer","PILOT-BTC","Inclusion Criteria:\n\n* The subjects voluntarily participated in the study and agreed to sign the written informed consent, with good compliance and follow-up, and were at least 18 years old at the time of signing the informed consent, regardless of gender.\n* Patients with advanced biliary carcinoma diagnosed by imaging and histology as unresectable, recurrent, locally advanced, or with metastatic lesions are defined as stage IIIA or above according to the AJCC-8 staging system, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer. No more than 2 organs metastasized, including liver, lung, bone, and brain.\n* Radical surgery\u002Flocal treatment, including focal excision, ablation, transcatheter arterial chemoembolization, hepatic arterial infusion chemotherapy, and radiotherapy, is not appropriate for at least 4 weeks prior to baseline assessment, or for disease progression thereafter. All acute toxic effects during local treatment must be ≤CTCAE5.0 grade 1.\n* Patients were intolerant or failed for ≥1 month after first-line systemic therapy, required palliative care, and patient adverse events were controlled (NCI-CTCAE≤ Grade I).\n* At least one measurable lesion (a spiral CT scan of a measurable lesion ≥10mm or an enlarged lymph node ≥15mm, as required by RECIst version 1.1).\n* The ECOG score in the first week of enrollment was 0-1. Survival was expected to be ≥3 months as assessed by the investigators.\n* Active hepatitis B and C patients are required to receive relevant antiviral therapy, HBV-DNA \\\u003C 2000 IU\u002Fml (\\\u003C 104 copies \u002Fml), and have received anti-HBV therapy for at least 14 days prior to study entry and continue treatment during treatment. HCV RNA-positive patients must receive antiviral therapy according to standard local treatment guidelines and have liver function within CTCAE grade 1 elevation.\n* Hematology and organ function are adequate, based on the following laboratory results obtained within 14 days prior to initiation of investigational therapy (unless otherwise indicated)\n* Any clinically significant biliary obstruction should be resolved before randomization.\n* Adequate renal function: creatinine ≤1.5×ULN, or creatinine clearance \\>50mL\u002Fmin\n* Women who are fertile: agree to abstain from sex (abstain from heterosexual intercourse) or use a contraceptive method with an annual contraceptive failure rate of \\\u003C 1% during treatment and for at least 6 months after the last dose.\n* Men: agree to abstain from sex (no heterosexual intercourse) or use contraception, and agree not to donate sperm.\n\nExclusion Criteria:\n\n* Those who have previously received treatment with immune checkpoint inhibitors, lenvatinib or paclitaxel, or are known to be allergic to or intolerant to immune checkpoint inhibitors, lenvatinib or paclitaxel and their components\n* Any systemic anti-tumor treatment received within the three months prior to participating in the study, including but not limited to intravenous infusion and\u002For oral chemotherapy, targeted drugs, antibody drugs and traditional Chinese medicines with known anti-cancer effects.\n* The patient is undergoing approved or under-development systemic anti-cancer therapies, including chemotherapy, biological immunotherapy, targeted therapy, or traditional Chinese medicine therapy with clear indications. Treatment is allowed 4 weeks before randomization.\n* The histopathological results show a mixture of liver cancer, squamous cell carcinoma or sarcoma cell components, or ampullary carcinoma.\n* Accompanied by other malignant tumors, but having had other uncured malignant tumors in the past (within 5 years) or simultaneously.\n* Significant digestive tract diseases: Pre-existing or existing grade 3 or above digestive tract fistula or non-digestive tract fistula as per CTCAE 5.0 criteria. There is evidence or history of bleeding mechanism disorders such as a history of gastrointestinal bleeding within the last 6 months, or a clear tendency of gastrointestinal bleeding, or a gastrointestinal bleeding event of grade ≥3 (CTCAE 5.0).\n* Cardiovascular and cerebrovascular diseases with significant clinical significance Including but not limited to having experienced acute myocardial infarction, severe\u002Funstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment, congestive heart failure, arrhythmia requiring treatment, hypertension that has not been well controlled after antihypertensive drug treatment, and a history of thromboembolism (including stroke and\u002For transient ischemic attack) within the last 6 months.\n* Liver and kidney insufficiency: Liver insufficiency: Characterized by jaundice, ascites and\u002For bilirubin \\>3×ULN. Renal insufficiency: Creatinine ratio \\>3.5g\u002F24 hours, urine routine showing urine protein ≥++ or confirmed 24-hour urine protein quantification \\> 1.0g, or renal failure requiring hemodialysis or peritoneal dialysis, etc. Having received treatment with a potent CYP3A4 inhibitor within 7 days before participating in the study, or having received treatment with a potent CYP3A4 inducer within 12 days before participating in the study.\n* Have active autoimmune diseases or a history of autoimmune diseases or are at risk of immune diseases: Have suffered from active, known or suspected autoimmune diseases in the past two years, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, etc. Be ready or have previously received organ or allogeneic bone marrow transplantation. Alternative therapy is not considered a form of systemic treatment for participants who may have their vital organ functions affected or who have already\u002Fmay need systemic immunosuppressive therapy. This clinical trial allows patients with type 1 diabetes, hypothyroidism with only hormone replacement, skin diseases that do not require systemic treatment, or those who will not relapse without external triggers to participate.\n* Neurological disorders: Known or untreated brain metastases, or patients with epilepsy requiring drug treatment. Known active central nervous system metastases and\u002For cancerous meningitis. Subjects with previously treated brain metastases but stable brain metastasis disease (no evidence of progression on imaging at least four weeks before the first trial treatment and any neurological symptoms have returned to baseline) can participate, without evidence of new or expanded brain metastases, and without steroid use for at least 7 days before the trial treatment. However, cancerous meningitis is not included. Regardless of clinical stability, it is excluded.\n* Infectious disease: Persistent infection with grade \\>2 (CTCAE 5.0). A known history of active tuberculosis (Mycobacterium tuberculosis). A known history of human immunodeficiency virus (HIV) infection.",{"count":460,"type":21},100,[56],"After the standard first-line treatment, the treatment regimen was adjusted to a paclitaxel polymer micellar-based immunotherapy combination regimen",[28],"2025-08-28",{"date":466,"type":37},"2025-09-08",{"date":468,"type":37},"2023-01-01",{"date":36,"type":21},{"name":471,"class":75},"Peking Union Medical College Hospital",{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":479,"targetDuration":4,"studyType":22,"phases":481,"briefSummary":482,"conditions":483,"keywords":484,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":4},"100602861","phase-2-trastuzumab-rezetecan-combined-with-pertuzumab-and-iparomlimab-and-tuvonralimab-for-biliary-tract-cancer-100602861","NCT07129018","Trastuzumab Rezetecan Combined With Pertuzumab and Iparomlimab and Tuvonralimab for Biliary Tract Cancer","A Prospective, Open-Label, Multicenter Phase II Clinical Study of Trastuzumab Rezetecan Combined With Pertuzumab and Iparomlimab and Tuvonralimab as First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Biliary Tract Cancer","Inclusion Criteria:\n\n1. Patients must voluntarily participate in the trial, provide fully informed consent with signed written documentation, and demonstrate good compliance.\n2. Age between 18 and 75 years (inclusive), calculated as of the day of signing the informed consent form; both male and female patients are eligible.\n3. Patients must have histologically or cytologically confirmed locally advanced or metastatic biliary tract cancer, including: Cholangiocarcinoma (intrahepatic or extrahepatic) and Gallbladder carcinoma\n4. HER2 Expression Criteria: HER2 Overexpression: IHC 3+ OR IHC 2+ with FISH-positive (gene amplification); HER2 Moderate\u002FLow Expression: Moderate: IHC 2+ with FISH-negative (no gene amplification) Low: IHC 1+ (any level of HER2 staining)\n5. Patients must not have received prior systemic anti-tumor therapy for advanced disease. Prior neoadjuvant\u002Fadjuvant chemotherapy and\u002For radiotherapy is permitted, provided ≥6 months have elapsed between the last dose and disease recurrence.\n6. Patients must have at least one measurable lesion meeting RECIST v1.1 criteria, and the lesion must be suitable for repeated accurate measurements.\n7. ECOG performance status of 0 or 1;\n8. estimated life expectancy ≥12 weeks;\n9. Adequate organ and bone marrow function meeting all criteria below (within 14 days prior to treatment initiation): 1. Hematological Tests \\*(No transfusion, G-CSF use, or corrective medication within 14 days before screening)\\* Hemoglobin (Hb) ≥90 g\u002FL Absolute Neutrophil Count (ANC) ≥1.5 × 10\\\u003Csup\\>9\\\u003C\u002Fsup\\>\u002FL Platelets (PLT) ≥75 × 10\\\u003Csup\\>9\\\u003C\u002Fsup\\>\u002FL 2. Biochemical Tests (No albumin infusion within 14 days before screening) Total Bilirubin (TBIL) ≤2 × ULN Gilbert's syndrome: ≤3 × ULN ALT\u002FAST ≤3.0 × ULN Liver metastasis: ≤5 × ULN Serum Creatinine (Cr) ≤1.5 × ULN OR Creatinine Clearance (CrCl) ≥50 mL\u002Fmin (Cockcroft-Gault formula);\n10. Patients with detectable HBV DNA levels (≥10 IU\u002FmL or above the lower limit of quantification per local laboratory assays) who are HBV-infected (HBsAg-positive and\u002For anti-HBc-positive) must receive antiviral therapy prior to treatment initiation according to institutional practice to achieve sufficient viral suppression. Antiviral therapy must be maintained throughout the study and for 6 months after the last dose of study treatment. Patients with positive anti-HBc but undetectable HBV DNA (\\\u003C10 IU\u002FmL or below the lower limit of quantification per local laboratory assays) do not require antiviral prophylaxis unless HBV DNA exceeds 10 IU\u002FmL or reaches detectable levels during treatment monitoring.\n11. Childbearing potential females: Negative pregnancy test (urine\u002Fserum) within 7 days pre-dose (serum result definitive if urine inconclusive). Sexually active with non-sterilized males: Use acceptable contraception from screening until 120 days post-last dose.\n12. Non-sterilized males sexually active with childbearing-potential partners: Use effective contraception from screening until 120 days post-last dose. Discontinuation post-120 days requires investigator discussion.\n13. Subjects must comply with visits, treatment, lab tests, and study requirements.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed ampullary carcinoma, small cell carcinoma, neuroendocrine tumors, sarcoma, mucinous cystic neoplasms, or other rare biliary tract malignancies.\n2. Active other malignancies within 5 years or concurrently.\n3. History of leptomeningeal disease, brain metastases, or current brain metastases.\n4. Participation in other investigational drug trials within the past 3 months, or concurrent enrollment in another interventional clinical trial (observational\u002Fnon-interventional studies or follow-up phases allowed).\n5. Any condition deemed by the investigator to compromise safety or compliance, including: Uncontrolled systemic diseases (e.g., severe hypertension, moderate\u002Fsevere symptomatic ascites) Uncontrolled\u002Fmoderate-or-greater pleural\u002Fpericardial effusion Acute\u002Fchronic uncontrolled pancreatitis Active bleeding disorders, infections, or ILD\u002Finterstitial lung disease Severe chronic GI disorders with diarrhea Psychiatric illness\u002Fsocial circumstances affecting compliance History of allogeneic organ or bone marrow transplantation.\n6. Within 12 months prior: NYHA Class ≥II congestive heart failure Unstable angina, myocardial infarction Poorly controlled arrhythmia or cerebrovascular accident LVEF \\\u003C50% by echocardiogram QTc \\>480 ms (Fridericia method; average of 3 measurements if abnormal) Uncontrolled hypertension (SBP≥150 mmHg and\u002For DBP≥100 mmHg, average of ≥2 readings) History of hypertensive crisis or encephalopathy.\n7. Active autoimmune disease within 2 years or history of recurrent autoimmune disease (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyper\u002Fhypothyroidism). (Except hypothyroidism controlled by hormone replacement)\n8. Previous treatment with HER2-targeted agents, HER2-ADCs, or immunotherapy (e.g., checkpoint inhibitors\u002Fagonists, cell therapy). Therapeutic cancer vaccines excluded.\n9. Prior anti-tumor therapy toxicities not recovered to CTCAE v5.0 Grade ≤1 (alopecia\u002Flab abnormalities meeting inclusion criteria allowed per investigator).\n10. Unexplained intra-abdominal gas unrelated to recent surgery\u002Fparacentesis.\n11. Abdominal complications within 6 months: Abdominal fistula, gastrointestinal perforation, or abscess；Tumor invasion of adjacent organs (e.g., aorta, trachea) with high bleeding\u002Ffistula risk.\n12. Immunodeficiency (e.g., HIV infection) or history of organ transplantation.\n13. Active tuberculosis (TB): Active TB within 1 year prior to enrollment；Untreated active TB history \\>1 year prior.\n14. Bleeding\u002Fthrombotic risks: Gastrointestinal bleeding within 6 months or high bleeding tendency；Known hereditary\u002Facquired bleeding disorders or thrombophilia.\n15. Surgical history: Major surgery within 4 weeks prior (excluding biopsies) or unhealed surgical wounds ；Planned major surgery during the study；Minor traumatic surgery within 7 days prior；\n16. Severe\u002Funhealed wounds, active ulcers, or untreated fractures.\n17. CNS metastases (past or present).\n18. Live attenuated vaccines: Administered within 28 days before the first study dose; Planned use during the study or within 60 days after the last dose.\n19. Other exclusionary factors per investigator judgment (e.g., substance abuse, severe comorbidities, abnormal lab values, psychosocial circumstances).",{"count":480,"type":21},63,[56],"Based on unmet clinical needs, relevant research backgrounds, and scientific evidence, it is planned to conduct a prospective, dual-cohort exploratory study. The aim of this study is to explore the efficacy and safety of ricartuzumab combined with pertuzumab and epalrestat-vorolizumab in the first-line treatment of HER2-expressing locally advanced or metastatic biliary tract cancer. It is expected to provide more treatment options for biliary tract cancer patients, optimize treatment strategies, and improve patients' long-term survival rates.",[28,116],[485,486,487,488,489],"Iparomlimab and Tuvonralimab","Pertuzumab","Trastuzumab-rezetecan","HER2-expressing","biliarytract cancer (BTC)","2025-08-18",{"date":492,"type":37},"2025-08-19",{"date":494,"type":21},"2025-11",{"date":496,"type":21},"2028-12",{"name":498,"class":75},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":500,"slug":501,"hasResults":11,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":22,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":515,"leadSponsor":517,"locationsCount":127},"100600615","phase-2-a-randomized-two-cohort-prospective-phase-ii-clinical-study-of-the-second-line-treatment-of-advanced-biliary-system-tumors-with-liposomal-irinotecan-ii-combination-regimen-100600615","NCT07099794","A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen","Liposomal Irinotecan (II) and Fluorouracil and Calcium Folinate in Combination With or Without Renvastinib for Second-line Treatment of Advanced Biliary System Tumors: a Randomized, Two-cohort, Prospective Phase II Study","Inclusion Criteria:\n\n* The patients voluntarily joined the study and signed the informed consent;\n* Histologically or cell line confirmed advanced biliary system malignancies, including intrahepatic, extrahepatic, and gallbladder cancers;\n* Previous first-line combination therapy failed;\n* At least one measurable lesion meets the RECIST v1.1 criteria\n* ECOG PS：0\\~1；\n* Expected survival ≥12 weeks;\n* Essential organ and hematological function;\n* Patients need contraception;\n\nExclusion Criteria:\n\n* The patient had previously received irinotecan, 5-Fu, and antiangiogenic agents;\n* Patients had active malignancies other than BTC within 5 years or at the same time.\n* Clinical symptoms or diseases of the heart that are not well controlled;\n* Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);\n* Any clinically significant gastrointestinal disorder, including bleeding, inflammation, occlusion, or diarrhea \\> grade 2;\n* A thrombotic or embolic event occurred within 6 months prior to the start of the study therapy;\n* Use of strong CYP3A4\u002FCYP2C19 inducers including rifampicin (and its analogiaries) and hypericum perforatum or strong CYP3A4\u002FCYP2C19 inhibitors and\u002For strong UGT1A inhibitors within 14 days prior to signing the informed consent;\n* Known allergy to the study drug;\n* An uncontrolled infection occurs during screening;\n* Patients with congenital or acquired immune deficiency (e.g., HIV);\n* Have a history of brain metastases or have developed brain metastases;",{"count":507,"type":21},90,[56],"This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU\u002FLV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled.",[28],"2025-07-25",{"date":513,"type":37},"2025-08-01",{"date":513,"type":21},{"date":516,"type":21},"2029-08-31",{"name":518,"class":75},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":520,"slug":521,"hasResults":11,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":22,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":127},"100586781","phase-2-oncolytic-virus-h101-combined-with-lenvatinib-plus-toripalimab-compared-with-folfox-in-patients-with-advanced-biliary-tract-cancer-options-06-100586781","NCT06919848","Oncolytic Virus H101 Combined With Lenvatinib Plus Toripalimab Compared With FOLFOX in Patients With Advanced Biliary Tract Cancer (OPTIONS-06)","Oncolytic Virus H101 Combined With Lenvatinib Plus Toripalimab Compared With FOLFOX in Patients With Advanced Biliary Tract Cancer (OPTIONS-06): a Multicenter, Randomized, Phase 2 Study","Inclusion Criteria:\n\n* Written informed consent obtained.\n* Age ≥ 18 years at time of study entry.\n* Participants must have unresectable or metastatic histologically or cytologically confirmed biliary tract cancer.\n* Participants must have failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity.\n* At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.\n* Performance status (PS) ≤ 2 (ECOG scale).\n* Life expectancy of at least 12 weeks.\n* Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500\u002FL, platelets ≥75 x103\u002FL; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g\u002FdL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (if using the Cockcroft-Gault formula )\n* Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n* History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment\n* Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.\n* Prior treatment with oncolytic virus.\n* Prior treatment with Lenvatinib or other targeted therapy.\n* RFA and resection administered less than 4 weeks prior to study treatment start.\n* Radiotherapy administered less than 4 weeks prior to study treatment start.\n* Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.\n* Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.\n* Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.\n* Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to: a) history of interstitial lung disease b) Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection) c) known acute or chronic pancreatitis d) active tuberculosis e) any other active infection (viral, fungal or bacterial) requiring systemic therapy f) history of allogeneic tissue\u002Fsolid organ transplant g) diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment. h) Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma\u002Fatopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study. i) Live vaccine within 30 days prior to the first dose of treatment or during study treatment. j) History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS\n* Medication that is known to interfere with any of the agents applied in the trial.\n* Any other efficacious cancer treatment except protocol specified treatment at study start.\n* Patient has received any other investigational product within 28 days of study entry.\n* Prior therapy with an anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n* Female subjects who are pregnant, breast-feeding or male\u002Ffemale patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). \\[Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner\\]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.",{"count":527,"type":21},74,[56],"This study will evaluate the efficacy and safety of Oncolytic virus H101 combined with lenvatinib plus Toripalimab compared with FOLFOX in patients with advanced biliary tract cancer (BTC) who have progressed after first-line treatment.",[28],"2025-04-02",{"date":533,"type":37},"2025-04-09",{"date":535,"type":21},"2025-05-01",{"date":537,"type":21},"2027-05-01",{"name":450,"class":75},{"id":540,"slug":541,"hasResults":11,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":549,"briefSummary":550,"conditions":551,"keywords":552,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":127},"100585508","phase-2-neoadjuvant-tislelizumab-gemcitabine-cisplatin-and-s-1-for-resectable-high-risk-cholangiocarcinoma-100585508","NCT06903273","Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Resectable High-risk Cholangiocarcinoma","Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Patients with Resectable High-risk Intrahepatic Cholangiocarcinoma","TisGCS for BTC","Inclusion Criteria:\n\n\\- Subjects must meet the criteria of either (A) or (B), plus 1. to 6. (A) High-risk group (HR) Subjects have histologically-confirmed and potentially resectable intrahepatic cholangiocarcinoma, according to the definition of American Joint Cancer Committee staging system, 8th edition (AJCC 8th).\n\nPlus at least one of the following high-risk features,\n\n1. Solitary tumor with a maximal diameter ≥5 cm in the absence of vascular invasion.\n2. ≥T1b disease which is resectable.\n3. Multifocal tumors or single tumor with satellite nodules at the same anatomic liver lobe which is\u002Fare resectable.\n4. Tumor(s) with macroscopic intrahepatic vascular invasion but is\u002Fare potentially resectable.\n5. Image or histological evidence of hilar or portal lymph node involvement (N1).\n6. Initial serum cancer antigen-199 (CA199) ≥200 U\u002FmL.\n\n   (B) Very early recurrence group (VER) Subjects with previously resected cholangiocarcinoma under a curative intent and have an early recurrent disease (≤6 months post curative surgery) confined to the liver, with\u002Fwithout antecedent adjuvant local or systemic therapies, and can be re-resected under a curative intent.\n   1. Subjects present with at least one measurable lesion which can be accurately assessed by conventional techniques at least 1.0 cm by computed tomography (CT) or magnetic resonance imaging (MRI).\n   2. Subjects are above 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤1, have a life expectancy \\>3 months, have surgically resectable disease and are physically competent and willing to receive a curative operation following the study protocol\n   3. Subjects have adequate organ functions, including bone marrow reserve with a leukocyte count ≥3,000 \u002FµL and platelet count ≥50,000 \u002FµL, hepatic reserve with a serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin ≤3 times of upper normal testing limits (biliary drainage is permitted), renal reserve with a creatinine clearance ≥60 mL\u002Fmin and cardiac reserve with a New York Heart Association (NYHA) functional classification I at baseline.\n   4. Subjects have or agree to establish a vascular access that permits intravenous administration of medications and are capable of ingesting capsules per oral.\n   5. Subjects with reproductive potentials are willing to accept contraceptive measures during the trial.\n   6. Subjects are functionally and cognitively capable to be informed of the trial contents and objectives (including obtaining blood and tumor tissue for the trial investigation), and agree to sign the written consent for enrollment.\n\n   Exclusion Criteria:\n   1. Subjects have metastatic (M1) disease, recurrent cholangiocarcinoma which cannot be resected, recurrent cholangiocarcinoma which can be re-resected but occurs \\>6 months post previous surgery, or any other primary malignancies in which the subjects have been in disease-free status less than 2 years, excluding carcinoma in situ or resectable skin cancer.\n   2. Subjects have received a systemic therapy with either chemotherapeutics or immune checkpoint inhibitors, a major abdominal surgery or radiotherapy within 4 weeks before the trial enrollment.\n   3. Subjects are known to be severely allergic to any of the studied therapeutics.\n   4. Subjects have underlying chronic illnesses, including cardiopulmonary diseases, ischemic heart disease, inflammatory bowel disease, poorly-controlled diabetes mellitus, liver cirrhosis and\u002For debilitating autoimmune diseases or conditions.\n\n   5 Subjects are receiving or have received a systemic administration of an equivalent dose of daily 10 mg prednisone or above for ≥14 days in whatever indications within 4 weeks before the trial enrollment, or immunosuppressives for ≥7 days within 4 weeks before the trial enrollment.\n\n   6\\. Subjects have active bacterial, viral, fungal or mycobacterial infections that require systemic therapy, including active infection with human immunodeficiency virus (HIV), hepatitis B or C virus (HBV or HCV).\n\n   7\\. Subjects are planning to conceive or already in pregnancy or breastfeeding. 8. Subjects are currently participating in any other clinical trials or studies which potentially interfere the protocol commencement.",{"count":548,"type":21},35,[56],"To investigate the efficacy and tolerability of neoadjuvant tislelizumab, gemcitabine, cisplatin and S-1 (TisGCS) in patients with resectable high-risk iCCA.",[263,28],[90,237,553,554,555,556,557,558,559],"neoadjuvant","gemcitabine","S-1","preoperative","resectable","tislelizumab","cisplatin","2025-03-24",{"date":562,"type":37},"2025-03-30",{"date":564,"type":21},"2025-07-01",{"date":566,"type":21},"2029-07-01",{"name":568,"class":75},"National Cheng-Kung University Hospital"]