[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-tract-neoplasms-immunotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-tract-neoplasms-immunotherapy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100645135","phase-2-a-phase-ii-study-of-adjuvant-durvalumab-combined-with-gemoxgc-chemotherapy-followed-by-lenvatinib-versus-capecitabine-in-biliary-tract-cancer-100645135",false,"NCT07679399","A Phase II Study of Adjuvant Durvalumab Combined With GEMOX\u002FGC Chemotherapy Followed by Lenvatinib Versus Capecitabine in Biliary Tract Cancer.","A Randomized, Open-label, Phase II Clinical Study of Durvalumab Combined With GEMOX\u002FGC Chemotherapy Followed by Lenvatinib Versus Capecitabine as Adjuvant Therapy for Biliary Tract Cancer.","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated with the follow-up.\n2. When signing the informed consent form, one must be at least 18 years old and no older than 75 years old, and there is no restriction on gender.\n3. Histologically confirmed cholangiocarcinoma or gallbladder cancer (excluding pancreatic cancer or ampullary cancer)\n4. Having undergone radical surgical treatment (R0 or R1 resection)\n5. The ECOG score is between 0 and 1\n6. The hematology and organ functions are adequate. Based on the following laboratory test results obtained within 14 days prior to the start of the treatment (unless otherwise specified)\n7. Blood routine test: (Within 14 days before screening, no blood transfusion, no use of G-CSF, and no use of drugs for correction) Hb ≥ 90 g\u002FL; Neutrophils ≥ 1.5 × 10\\^9\u002FL; PLT ≥100×10\\^9\u002FL\n8. Biochemical test: (No albumin transfusion within 14 days)\n9. Appropriate liver function: ALT and AST ≤ 2.5 × ULN; serum bilirubin ≤ 2.0 × normal upper limit (ULN); these conditions do not apply to patients with confirmed Gilbert syndrome. Any clinically significant biliary obstruction should be relieved before enrollment. Albumin ≥ 2.8 g\u002FdL. Appropriate renal function: creatinine ≤ 1.5 × ULN, or creatinine clearance rate (CCr) \\> 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula)\n10. Coagulation function: International Normalized Ratio (INR) ≤ 1.5\n11. Fertile women: Agree to abstain from sexual intercourse (avoiding heterosexual intercourse) or use a contraceptive method with a failure rate of less than 1% during the treatment period and for at least 6 months after the last administration. If the female patient has menstruated, has not reached post-menopausal status (continuous absence of menstruation for ≥ 12 months, no other causes found apart from menopause), and has not undergone sterilization surgery (removal of ovaries and\u002For uterus), then it is considered that the patient is fertile. Examples of contraceptive methods with a failure rate of less than 1% include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormonal release intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (such as calendar days, ovulation period, symptom-based body temperature, or post-ovulation methods) and withdrawal from sexual intercourse are unacceptable contraceptive methods.\n12. Male: Agree to abstinence (not engaging in heterosexual sexual intercourse) or use of contraceptive measures, agree not to donate sperm, defined as follows: When the female partner has reproductive capacity, the male patient must abstain from sexual activity during the treatment period and for 6 months after the last administration, or use condoms and other contraceptive methods to ensure a contraceptive failure rate of less than 1% per year. During the same period, the male patient must also agree not to donate sperm. When the female partner is pregnant, the male patient must abstain from sexual activity or use condoms for contraception during the treatment period and for 6 months after the last administration, to avoid any impact on the fetus. The reliability of sexual abstinence should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (such as calendar days, ovulation period, symptom-based body temperature or after ovulation methods) and withdrawal from sexual intercourse are unacceptable contraceptive methods.\n\nExclusion Criteria:\n\n1. Pancreatic cancer or ampullary cancer\n2. Not yet fully recovered from the surgery or with unremoved bile duct obstruction\n3. Pregnant women (with a positive pregnancy test before taking the medicine) or lactating women\n4. Having had other untreated malignant tumors in the past (within the last 5 years) or simultaneously, excluding cured skin basal cell carcinoma, skin squamous cell carcinoma, in situ breast cancer and in situ cervical cancer, treated superficial bladder cancer, and prostate adenocarcinoma that underwent surgical treatment and whose PSA tumor marker was within the normal range.\n5. Who has previously received immunotherapy or chemotherapy\n6. Serious coexisting diseases that may interfere with the treatment of the proposed plan, including potential severe infections\n7. There is drug abuse; or any medical, psychological or social condition that may affect the research, the patient's compliance, be unstable, or even potentially endanger the patient's safety.\n8. Significant clinical cardiovascular and cerebrovascular diseases, including but not limited to acute myocardial infarction occurring within 6 months prior to enrollment, severe\u002Funstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, congestive heart failure (NYHA classification ≥ 2 grade); arrhythmias requiring anti-arrhythmic drugs (except beta-blockers or digoxin); repeated electrocardiogram QTc interval \\> 480 milliseconds (ms)\n9. Presence of persistent infection of grade 2 or above (CTCAE 5.0)\n10. Having a history of thromboembolic events within the past 6 months (including stroke and\u002For transient ischemic attack)\n11. Hypertension that has not been well controlled by antihypertensive drugs (systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg)\n12. Participants who had active autoimmune diseases or autoimmune disease history in the past two years; those with active, known, or suspected autoimmune diseases that may affect important organ functions or that may require systemic immunosuppressive therapy, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome related to vascular thrombosis, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis. However, type 1 diabetes, hypothyroidism requiring only hormone replacement, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) or participants who will not have a recurrence without external triggering factors are allowed. Alternative therapies (such as thyroid hormone, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered as a form of systemic treatment.\n13. A known history of active tuberculosis (with the tuberculosis bacteria)\n14. Those who have a history of gastrointestinal bleeding within the past 6 months or have a clear tendency towards gastrointestinal bleeding, such as esophageal varices with bleeding risk, active gastrointestinal ulcer lesions, or fecal occult blood ≥ (++), are not eligible for enrollment; those with evidence or history of ≥ 3 grade (CTCAE 5.0) bleeding events due to bleeding mechanism disorders are also excluded.\n15. Severe non-healing wounds, ulcers or fractures\n16. There are unresolved toxicities of grade \\> 1 that were caused by any previous treatment\u002Foperation (CTCAE 5.0, except for hair loss, anemia, and hypothyroidism)\n17. Patients who have objective evidence of severe lung function impairment in the past and at present, such as a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, or drug-related pneumonia\n18. After the researchers' comprehensive assessment of the patient's condition, it was determined that the patient was not suitable for participating in this study.\n19. At the same time, he\u002Fshe was also involved in another clinical study.","ALL","18 Years","75 Years",{"count":20,"type":21},222,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is designed as a prospective, randomized, open-label, phase II clinical trial to systematically evaluate the efficacy and safety of durvalumab combined with GEMOX\u002FGC chemotherapy followed by lenvatinib, compared with capecitabine monotherapy, as adjuvant therapy for biliary tract cancer (BTC) after curative-intent resection.The primary objective is to determine whether the combination regimen can significantly improve the 1-year recurrence-free survival (RFS) rate. Secondary objectives include assessment of overall survival (OS) and the incidence of treatment-related adverse events. The overall aim is to identify a more effective and safer treatment strategy for postoperative adjuvant therapy in BTC.",[27],"Biliary Tract Neoplasms Immunotherapy",[29,30,31,32,33],"Biliary Tract Cancer","durvalumab","lenvatinib","capecitabine","adjuvant therapy","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2025-06-01",{"date":42,"type":21},"2027-06-01",{"name":44,"class":45},"Peking Union Medical College Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":46},"100644567","phase-2-phase-ii-study-of-trastuzumab-rezetecan-combined-with-adebrelimab-and-lenvatinib-as-first-line-therapy-for-advanced-her2-positiveher2-low-biliary-tract-cancer-100644567","NCT07670273","Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive\u002FHER2-Low Biliary Tract Cancer","A Prospective, Open-label, Multicenter Phase II Clinical Study of Rikang Trastuzumab in Combination With Adebrelimab and Lenvatinib for First-line Treatment of HER2-positive or Low-expressing Locally Advanced or Metastatic Biliary Tract Cancer","Inclusion Criteria:\n\n1. The HER2-positive subjects voluntarily participated in the study and agreed to sign the written informed consent form, and they had good compliance.\n2. Age ≥ 18 years old, gender not limited;\n3. Locally advanced or metastatic cholangiocarcinoma, including cholangiocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma) and gallbladder cancer, which has been confirmed by pathological histology or cytology;\n4. Not suitable for radical surgical resection or local treatment. Subjects who have not received any systemic anti-tumor therapy in the past; allowed to have received radical treatment previously (including surgical treatment and postoperative adjuvant chemotherapy and\u002For radiotherapy), and the interval from the last administration of radical treatment to disease recurrence is at least 6 months, and no systemic anti-tumor treatment was received during the recurrence or metastasis stage.\n5. HER2 positive (IHC 3+ or IHC 2+ and FISH detects HER2\u002FCEP17 ≥ 2.0), HER2 low expression (IHC 2+\u002FFISH- or IHC 1+);\n6. There is at least one measurable lesion that meets the requirements of RECIST v1.1.\n7. The ECOG score is between 0 and 1.\n8. Expected survival period ≥ 12 weeks;\n9. The organs and bone marrow have sufficient functions and meet the following requirements: (within 14 days before starting the treatment) 1) Blood routine examination: (within 14 days before the screening, no blood transfusion, no use of granulocyte colony-stimulating factor \\[G-CSF\\], no use of drugs to correct): A. Hemoglobin (Hb) ≥ 90 g\u002FL; B. Neutrophil count (ANC) ≥ 1.5 × 109\u002FL; C. Platelet count (PLT) ≥ 75 × 109\u002FL; 2) Blood biochemical examination should meet the following standards (no albumin transfusion within 14 days before the screening): A. Serum total bilirubin \\[BIL\\] ≤ 2xULN (for Gibert syndrome patients, ≤ 3xULN); B. Alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] ≤ 3.0xULN; C. For patients with liver metastasis, ALT and AST should be ≤ 5xULN; Serum creatinine (Cr) ≤ 1.5xULN or endogenous creatinine clearance rate ≥ 50 ml\u002Fmin (Cockcroft-Gault formula): Male: Cr clearance rate = ((140 - age) × weight) \u002F (72 × blood Cr); Female: Cr clearance rate = ((140 - age) × weight) \u002F (72 × blood Cr) × 0.85 (weight unit: kg; blood Cr unit: mg\u002FmL)\n10. For both male subjects with fertile partners and female subjects with fertile partners, they must take effective contraceptive measures from the moment they sign the informed consent form until 7 months after the last administration of the test drug. During the same period, male subjects must agree not to donate sperm, and female subjects must agree not to donate eggs. For female subjects with fertility, the serum HCG test must be negative within 7 days before the first administration of the drug, and they must be in the non-breastfeeding period.\n\nExclusion Criteria:\n\n1. Histological or cytological pathology confirmed that the bile duct tumors were of non-adenocarcinoma pathological types such as ampullary carcinoma, small cell carcinoma, neuroendocrine tumor, sarcoma, mucinous cystic tumor, etc.\n2. Having another active malignant tumor within 5 years or simultaneously; excluding cervical carcinoma in situ that has been fully treated, as well as basal cell or squamous cell carcinomas of the skin.\n3. Participants who have previously received immunotherapy, HER2-targeted, or ADC drug treatment, including immune checkpoint inhibitors (such as anti-PD-1\u002FL1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (such as CD40, CD137, OX40 antibodies, etc.), and any other treatments targeting the immune mechanism of tumor treatment;\n4. The adverse reactions from previous anti-tumor treatments have not yet recovered to a NCI-CTCAE v5.0 rating of ≤ 1 (excluding cases of hair loss, meeting the numerical requirements of the inclusion criteria, or other situations determined by the investigator not to affect the treatment with the study drug).\n5. Any disease evidence determined by the researchers (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, moderate or severe ascites with clinical symptoms; uncontrollable or moderate to large amounts of pleural effusion, pericardial effusion, accompanied by acute or chronic uncontrolled pancreatitis, active bleeding disorders, active infections, active ILD\u002Finterstitial lung disease, severe chronic gastrointestinal diseases related to diarrhea, mental disorders\u002Fsocioeconomic conditions) or the history of allogeneic organ or syngeneic bone marrow transplantation that the researchers consider makes the subject unsuitable for participation in the study or affects the compliance with the study protocol;\n6. History of severe cardiovascular and cerebrovascular diseases: Within 12 months prior to randomization, there were manifestations of NYHA \"grade 3 or above\" congestive heart failure, unstable angina pectoris, myocardial infarction, poorly controlled arrhythmia or cerebral hemorrhage; cardiac echocardiography showed left ventricular ejection fraction (LVEF) \\\u003C 50%; corrected QT interval (QTe) \\> 480ms (calculated using the Fredericia method; if QTc is abnormal, it can be continuously detected for 3 times at intervals of 2 minutes, and the average value is taken); poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg, based on the average value obtained from ≥ 2 measurements); previous occurrence of hypertensive crisis or hypertensive encephalopathy.\n7. The subjects have congenital or acquired immune system deficiencies (such as HIV-infected individuals); or have a history of organ transplantation;\n8. Those who had active tuberculosis within one year prior to enrollment, or those who had a history of active tuberculosis infection more than one year ago but did not receive proper treatment.\n9. The study excluded those who had a history of gastrointestinal bleeding within 6 months prior to treatment or who had a clear tendency towards gastrointestinal bleeding; those with known hereditary or acquired bleeding disorders (such as coagulation dysfunction) or thrombosis tendencies;\n10. Within 4 weeks prior to the start of the treatment, if one has undergone major surgical procedures (except for biopsy procedures); if the surgical incision has not fully healed; if major surgical treatment is expected to be required during the study period; if a minor traumatic surgical procedure (such as biopsy procedures) was performed within 7 days prior to the start of the treatment.\n11. Severe, non-healed or open wounds, active ulcers or untreated fractures;\n12. Previous or current presence of central nervous system metastasis;\n13. The first study requires that the subjects use attenuated live vaccines within 28 days before the start of the treatment, or that they are expected to use attenuated live vaccines during the study treatment period or within 60 days after the last administration of the study drug.\n14. Patients with active autoimmune diseases, or those with a history of autoimmune diseases and who require long-term use of systemic glucocorticoids (equivalent dose of prednisone ≥ 10 mg\u002Fday, for more than 2 weeks) or immunosuppressants.\n15. Based on the researchers' assessment, there are other factors that might have affected the research results or led to the premature termination of this study, such as alcohol abuse, drug abuse, having other serious diseases (including mental illnesses) that require combined treatment, severely abnormal laboratory test values, family or social factors, and other situations that might have affected the safety of the subjects or the collection of trial data.",{"count":55,"type":21},70,[24],"This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low biliary tract cancer. The primary objective is the objective response rate (ORR). Key secondary objectives include efficacy endpoints-progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DoR)-and safety assessments comprising adverse events (AEs), serious adverse events (SAEs), vital signs, and laboratory findings.",[27],[29,60,61,62,63,64],"Immune Checkpoint Inhibitors","Trastuzumab Rezetecan","Adebrelimab","Lenvatinib","HER2-Positive\u002FLow-Expression","2026-06-25",{"date":67,"type":38},"2026-06-26",{"date":69,"type":38},"2026-04-29",{"date":71,"type":21},"2028-04-29",{"name":44,"class":45},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":46},"100533796","phase-2-pembrolizumab-with-or-without-lenvatinib-or-chemotherapy-in-first-line-treatment-of-advanced-biliary-tract-cancer-100533796","NCT06230471","Pembrolizumab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer","A Phase II, Multicenter, Randomized Study of Pembrolizumab With or Without Chemotherapy or Lenvatinib in First-Line Treatment of Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n* • The subjects voluntarily participate in the study and agree to sign the informed consent form, are compliant, and cooperate with follow-up.\n\n  * They are over 18 years of age and gender is not restricted when signing the informed consent form.\n  * They have histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.\n  * Patients who are diagnosed with unresectable or metastatic disease and have not received prior treatment are eligible for inclusion.\n  * Patients who have undergone curative surgery and experienced disease recurrence after more than 6 months; or patients who have completed adjuvant therapy (chemotherapy and\u002For radiotherapy) and have been disease-free for more than 6 months after completing adjuvant therapy are eligible for inclusion.\n  * They have at least one measurable lesion (as defined by RECIST 1.1, the measurable lesion is a spiral CT scan long diameter ≥10mm or lymph node short diameter ≥15mm).\n  * Their ECOG score is 0-1 in the week prior to enrollment.\n  * Based on the investigator's assessment, their estimated survival time is ≥3 months.\n  * Patients with active hepatitis B or C require relevant antiviral treatment, with HBV-DNA \\\u003C2000 IU\u002Fml (\\\u003C104 copies\u002Fml), and have received at least 14 days of antiviral treatment before participating in the study. HCV RNA-positive patients must follow local standard treatment guidelines for antiviral therapy, and their liver function is within CTCAE Grade 1 elevation.\n  * Their hematological and organ functions are adequate, based on laboratory test results obtained within 14 days before the start of the study (unless otherwise specified):\n  * Hematology: (no blood transfusion, no G-CSF, no drug correction within 14 days prior to screening) Hb ≥90 g\u002FL; neutrophil count ≥1.5×109\u002FL; PLT\n\n    ≥100×109\u002FL.\n  * Biochemistry: (no albumin transfusion within 14 days) Appropriate liver function: ALT and AST ≤2.5×ULN; for patients with liver metastases, ALT and AST ≤5 × ULN. Serum bilirubin ≤2.0×ULN; these conditions do not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction should be resolved before randomization. Appropriate renal function: creatinine ≤1.5×ULN, or creatinine clearance rate (CCr) \\>50mL\u002Fmin (using the standard Cockcroft-Gault formula): Female: CrCl = ((140 - age) x weight (kg) x 0.85) \u002F 72 x serum creatinine (mg\u002F dL) Male: CrCl = ((140 - age) x weight (kg) x 1.00) \u002F 72 x serum creatinine (mg\u002F dL)\n\n    * Women of childbearing potential: agree to abstain from sexual intercourse or use contraceptive methods with a failure rate of less than 1% during the treatment period and for at least 6 months after the last dose. If a female patient has menstruation and has not reached menopause (continuous absence of menstruation for ≥12 months without other reasons), and has not undergone sterilization surgery (removal of ovaries and\u002For uterus), she is considered to be of childbearing potential. Examples of contraceptive methods with a failure rate of less than 1% include bilateral tubal ligation, male sterilization, hormone-based contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual restraint should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (such as calendar day, ovulation period, symptom temperature, or post-ovulation method) and ejaculation outside the vagina are unacceptable contraceptive methods.\n    * Male: agree to abstain from sexual intercourse or use contraceptive measures, agree not to donate sperm, as defined below: When the female partner is of childbearing potential, male patients must abstain during the treatment period and for 6 months after the last dose, or use a condom plus other contraceptive methods to achieve a failure rate of less than 1%. Male patients must also agree not to donate sperm during the same period. When the female partner is already pregnant, male patients must abstain or use a condom to prevent fetal exposure to the study during the treatment period and for 6 months after the last dose. The reliability of sexual restraint should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (such as calendar day, ovulation period, symptom temperature, or post-ovulation method) and ejaculation outside the vagina are unacceptable contraceptive methods.\n\nExclusion Criteria:\n\n* • Previous systemic treatment received.\n\n  * ECOG score \\> 1.\n  * Pancreatic cancer.\n  * Pregnant (positive pregnancy test before medication) or breastfeeding women.\n  * Known allergy or intolerance to recombinant humanized PD-1 monoclonal antibody drugs, lenvatinib and its components (or any excipients).\n  * Received local anti-tumor treatment within 4 weeks before the first study drug treatment, including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection (allowing palliative radiotherapy for bone metastases at least 2 weeks before study drug treatment).\n  * Previous or existing grade 3 or higher gastrointestinal fistula or non gastrointestinal fistula (such as skin) according to CTCAE 5.0 criteria.\n\nMultiple factors affecting oral administration of lenvatinib (such as inability to swallow, chronic diarrhea and intestinal obstruction, or other conditions that significantly affect drug intake and absorption).\n\n* Major surgery (except biopsy) has been performed within 4 weeks before the first study drug treatment, or the surgical incision has not completely healed; minor surgery (such as simple excision, biopsy, etc.) was performed within 7 days before the first study intervention.\n* Significant cardiovascular and cerebrovascular diseases, including but not limited to acute myocardial infarction, severe\u002Funstable angina pectoris, cerebrovascular accidents or transient ischemic attacks within 6 months before enrollment, congestive heart failure (New York Heart Association classification ≥2), arrhythmia requiring antiarrhythmic drugs (except beta blockers or digoxin), and repeated electrocardiogram showing QTc interval \\>480 milliseconds (ms). Hepatic or renal dysfunction, with manifestations such as jaundice, ascites, and\u002F or bilirubin \\>3×ULN, creatinine ratio \\>3.5g\u002F24 hours, or renal failure requiring blood or peritoneal dialysis, and\u002For urinary routine showing urine protein ≥++ or confirmed 24-hour urine protein quantification \\>1.0g.\n* Persistent infection \\> grade 2 (CTCAE 5.0).\n* History of thrombotic events (including stroke and\u002For transient ischemic attacks) within the past 6 months.\n* Poorly controlled hypertension (systolic blood pressure \\>160mmHg, diastolic blood pressure \\>100mmHg) despite treatment with antihypertensive medications. Active autoimmune disease or history of autoimmune disease within the past 2 years; participants with active, known, or suspected autoimmune diseases that may affect important organ function or require systemic immunosuppressive therapy are excluded, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome associated with thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. However, participants with type 1 diabetes, hypothyroidism requiring only hormone replacement, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia) or participants who will not relapse without external triggering factors are allowed.\n\nReplacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n\n* Known active central nervous system (CNS) metastasis and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate as long as they are stable (evidence of no progression on imaging at least 4 weeks before the first trial treatment and any neurological symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not used steroids for at least 7 days before trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability. Participants with known or untreated brain metastases or epilepsy requiring medication are also excluded. Planned or prior organ or allogeneic bone marrow transplantation. Known history of active tuberculosis (Mycobacterium tuberculosis). History of gastrointestinal bleeding within the past 6 months or clear evidence of gastrointestinal bleeding tendencies, such as bleeding esophageal varices, locally active gastrointestinal ulcerative lesions, fecal occult blood ≥(++), cannot be included; if fecal occult blood (+), gastroscopy is required; evidence or history of bleeding mechanism disorders of grade ≥3 (CTCAE 5.0), or other bleeding disorders.\n\n  * Known human immunodeficiency virus (HIV) infection.\n  * Known active hepatitis B or C infection and not receiving regular treatment.\n  * During the screening period, HBV DNA ≥2000 IU\u002Fml (or ≥104 copies\u002F ml) must be reduced to \\\u003C2000 IU\u002Fml (or \\\u003C104 copies\u002Fml) with entecavir before enrollment. For eligible participants with Anti-HBc (+)\u002FHBsAg (+)\u002F HBV DNA\\\u003C 2000 IU\u002Fml or Anti-HBc (+)\u002FHBsAg (-)\u002FHBV DNA\\\u003C 2000 IU\u002F ml, antiviral therapy must be administered during the trial period using the original medication or entecavir or tenofovir.\n  * Severe non-healing wounds, ulcers, or fractures.\n  * History of substance abuse or any medical, psychological, or social condition that may affect the study, patient compliance, or endanger patient safety.\n  * Unresolved toxicity of grade \\>1 (CTCAE 5.0) caused by any prior treatment\u002Fprocedure, except for hair loss, anemia, and hypothyroidism.\n  * Severe non-healing wounds, ulcers, or fractures.\n  * Objective evidence of severe pulmonary impairment, such as a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or drug-related pneumonia.\n  * Treatment with a strong CYP3A4 inhibitor (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole, etc.) within 7 days before participating in the study, or treatment with a strong CYP3A4 inducer (e.g., phenytoin, phenobarbital, primidone, carbamazepine, rifampin, rifabutin, rifapentine, or St. John's Wort) within 12 days before participating in the study.\n  * Concomitant malignancy, except for previously treated skin basal cell carcinoma, squamous cell carcinoma, carcinoma in situ of the breast or cervix, superficial bladder cancer that has been treated, and prostate cancer that has been treated with surgery and has a normal range of PSA tumor markers, or any other malignancy that has not been cured within the past 5 years.\n  * The investigator determines that the participant is unsuitable for the study based on overall medical condition.\n  * Concurrent participation in another clinical study.","80 Years",{"count":82,"type":21},60,[24],"Explore the impact of the first-line application of Pembrolizumab with or without Lenvatinib or chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers",[27],"2025-12-02",{"date":88,"type":38},"2025-12-09",{"date":90,"type":38},"2023-01-09",{"date":92,"type":21},"2026-04-30",{"name":44,"class":45}]