[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"second-line-treatment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:second-line-treatment":58},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,70,93,124],{"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":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100646975","phase-1-mrg003-with-gemcitabine-for-second-line-advanced-pdac-100646975",false,"NCT07685470","MRG003 With Gemcitabine for Second-line Advanced PDAC","A Prospective, Single-arm, Ib\u002FII Exploratory Study of Becotatugvedotin(MRG003) in Combination With Gemcitabine for Second-line Advanced Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\nECOG performance status score of 0-2;\n\nHistopathologically confirmed locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC);\n\nFailure of prior first-line systemic therapy:\n\n1. Radiographic progression or worsening of clinical symptoms; disease progression occurring within 6 months after completion of neoadjuvant\u002Fadjuvant therapy is also considered first-line treatment failure.\n2. Intolerance to first-line therapy, as fully assessed by the investigator, may also allow enrollment into the study. Intolerance to prior study treatment is defined as follows:\n\ni. Any grade ≥3 hematologic toxicity (per NCI-CTCAE v5.0) that does not recover to grade 1 or pre-treatment level after 14 days of best supportive care; ii. Any grade ≥3 non-hematologic toxicity (excluding alopecia and asymptomatic laboratory abnormalities) per NCI-CTCAE v5.0 that does not recover to normal after 14 days of best supportive care.\n\nAdequate organ and bone marrow function;\n\nEstimated life expectancy \\> 3 months;\n\nSubjects must agree to provide sufficient tumor tissue samples for EGFR and PD-L1 immunohistochemistry (IHC) expression testing, next-generation sequencing (NGS), and multi-omics analysis. This includes archived tumor samples (paraffin blocks or unstained sections meeting the testing requirements specified in the study); if no archived tumor tissue sample is available, the subject agrees to undergo re-biopsy of the tumor lesion.\n\nExclusion Criteria:\n\n* Failure of first-line gemcitabine-based therapy.\n\nOther histologic types of pancreatic tumors, such as neuroendocrine tumors, acinar cell carcinoma, cystic carcinoma, etc.\n\nPrior treatment with an MMAE-loaded ADC (antibody-drug conjugate).\n\nCongenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies\u002FmL), or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay).\n\nKnown hypersensitivity to the study drug or any of its excipients, or a history of severe allergic reactions to other monoclonal antibodies.\n\nOccurrence of the following within 6 months before randomization: myocardial infarction, severe\u002Funstable angina pectoris, New York Heart Association (NYHA) Class ≥2 cardiac insufficiency, or symptomatic congestive heart failure.\n\nVaccination with a live vaccine within 4 weeks before the first dose of study drug. Inactivated virus vaccines for seasonal influenza (administered by injection) are permitted, but live attenuated influenza vaccine administered via the intranasal route is not allowed.\n\nKnown history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\nKnown history of substance abuse (psychoactive drugs) or drug addiction.\n\nPregnant or breastfeeding women.\n\nDiagnosis of any other malignancy within 5 years before study entry, except for curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma that have been treated with local therapy and cured.\n\nPresence of any other serious physical or psychiatric illness, or laboratory abnormalities that may increase the risk of study participation, interfere with the study results, or render the patient unsuitable for participation in the opinion of the investigator.\n\nNote: Subjects with hepatitis B meeting the following criteria may also be enrolled:\n\nHBV viral load \\\u003C 1000 copies\u002FmL (\\\u003C200 IU\u002FmL) before the first dose, and the subject must receive anti-HBV therapy during the entire study treatment period to prevent viral reactivation.\n\nFor subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.\n\nSubjects with active HCV infection (positive HCV antibody and HCV-RNA levels above the lower limit of detection).\n\nVaccination with a live vaccine within 30 days before the first dose (Cycle 1, Day 1).\n\nNote: Inactivated injectable vaccines for seasonal influenza are permitted within 30 days before the first dose; live attenuated influenza vaccine administered intranasally is not allowed.\n\nPresence of any serious or uncontrolled systemic disease, for example:\n\nClinically significant and severe, difficult-to-control abnormalities in cardiac rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation.\n\nUnstable angina pectoris, congestive heart failure, or chronic heart failure of NYHA Class ≥2.\n\nAny arterial thrombotic, embolic, or ischemic event (e.g., myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months before study treatment.\n\nPoorly controlled blood pressure (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg).\n\nActive tuberculosis.\n\nActive or uncontrolled infection requiring systemic therapy.\n\nClinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n\nLiver disease such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis.\n\nPoorly controlled diabetes mellitus (fasting blood glucose \\> 10 mmol\u002FL).\n\nUrinalysis showing proteinuria ≥ 2+, with confirmed 24-hour urine protein \\> 1.0 g.\n\nPsychiatric disorders that prevent the patient from cooperating with treatment.\n\nHistory or evidence of disease, treatment, or laboratory abnormalities that could interfere with the study results or prevent the subject from completing full participation in the study, or any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment, including potential risks that are not explicitly listed above.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a Phase Ib\u002FII clinical study aimed to evaluate the tolerability of becotatugvedotin in combination with gemcitabine, determine the clinically recommended dose for the combination regimen, and assess the efficacy and safety of becotatugvedotin combined with gemcitabine in patients with advanced second-line pancreatic ductal adenocarcinoma (PDAC). The study plans to enroll 27-30 patients, including 3-6 patients in the first stage (Phase I) and 24 patients in the second stage (Phase II).\n\nThe study consists of three periods: screening period (including baseline), treatment period, and follow-up period (safety follow-up and survival follow-up). Eligible patients must have locally advanced unresectable or metastatic pancreatic cancer confirmed by histopathology.\n\nPhase I: After the screening period, patients will receive treatment with becotatugvedotin and gemcitabine. Becotatugvedotin will be administered at doses of 1.5 mg\u002Fkg or 2.0 mg\u002Fkg once every 3 weeks (Q3W) using a 3+3 dose escalation design. Gemcitabine will be given at 1000 mg\u002Fm² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, dose-limiting toxicities (DLTs), withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Upon completion of Phase I, the study will proceed to Phase II.\n\nPhase II: After the screening period, patients will receive treatment with becotatugvedotin and gemcitabine. The dose of becotatugvedotin will be the recommended Phase II dose (RP2D) selected based on the results from Phase I, while gemcitabine will be administered at 1000 mg\u002Fm² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, intolerable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Tumor imaging assessments will be performed using RECIST v1.1 every 6 weeks (i.e., every 2 treatment cycles). Safety assessments will be conducted using the NCI-CTCAE version 5.0 criteria from the first dose through 30 days after the last dose.",[28,29],"Pancreatic Ductal Adenocarcinoma (PDAC)","Second Line Treatment","NOT_YET_RECRUITING","2026-07-01",{"date":33,"type":34},"2026-07-06","ACTUAL",{"date":36,"type":21},"2026-06-08",{"date":38,"type":21},"2029-06-07",{"name":40,"class":41},"Peking Union Medical College Hospital","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":53,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100622919","albumin-bound-paclitaxel-based-second-line-treatment-regimens-for-locally-advanced-or-metastatic-ggej-adenocarcinoma-100622919","NCT07389876","Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic G\u002FGEJ Adenocarcinoma","A Multicenter, Real-world Study on Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic Gastric\u002FGastroesophageal Junction Adenocarcinoma","G\u002FGEJ","Inclusion Criteria:\n\n* Fully understand this study and voluntarily sign the informed consent form;\n* Between 18 and 80 years old (inclusive), male or female;\n* Patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology;\n* ECOG performance status 0-2;\n* Known HER2 negative;\n* Expected survival ≥ 3 months;\n* Patients who have progressed on first-line systemic treatment with fluoropyrimidine-platinum combination and PD-1\u002FPD-L1 monoclonal antibody, or those who have progressed during maintenance treatment; patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have progressed within 6 months after the end of perioperative chemotherapy or adjuvant chemotherapy (counting from the end of the combined regimen);\n* Have not received taxane-based therapy previously;\n* Have at least one measurable lesion (meeting RECIST v1.1 criteria);\n* The functions of important organs meet the following requirements (no blood components or cell growth factors are allowed to be used within 14 days before enrollment):\n\nAbsolute neutrophil count ≥ 1.5×109\u002FL, white blood cell count ≥ 3.0×109\u002FL; Platelet count ≥ 90×109\u002FL; Hemoglobin ≥ 8g\u002FdL; Total bilirubin (TBIL) ≤ 1.5×ULN; ALT and AST ≤ 2.5×ULN; BUN and creatinine (Cr) ≤ 1.5×ULN (and creatinine clearance (CCr) ≥ 50mL\u002Fmin); Left ventricular ejection fraction (LVEF) ≥ 50%; Fridericia-corrected QT interval (QTcF) \\\u003C 470 milliseconds; INR ≤ 1.5×ULN, APTT ≤ 1.5×ULN; Thyroid function: TSH ≤ upper limit of normal (ULN). If abnormal, FT3 and FT4 levels should be examined. If FT3 and FT4 levels are normal, the patient can be enrolled; Premenopausal women and postmenopausal women for less than 1 year must have a negative serum or urine pregnancy test before treatment.\n\nExclusion Criteria:\n\n* Patients with other malignancies within 5 years before enrollment, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;\n* Patients who have received allogeneic bone marrow transplantation or organ transplantation in the past;\n* Patients with severe cardiovascular diseases within 6 months before enrollment, including unstable angina or myocardial infarction;\n* Patients allergic to the study drug or any of its auxiliary preparations;\n* Patients with uncontrolled hypertension before enrollment, defined as systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg;\n* Patients with any disease or condition that affects drug absorption before enrollment, or patients who cannot take oral medication;\n* Patients with active ulcers in the stomach and duodenum, ulcerative colitis or other digestive tract diseases before enrollment, or unremoved tumors with active bleeding, or other conditions that the investigator deems may cause gastrointestinal bleeding or perforation;\n* Patients with obvious bleeding tendency evidence or history within 3 months before enrollment (bleeding \\> 30 mL within 3 months, accompanied by hematemesis, melena, or hematochezia), hemoptysis (fresh blood \\> 5 mL within 4 weeks), or thromboembolic events (including stroke events and\u002For transient ischemic attacks) within 12 months;\n* Patients with significant clinical cardiovascular diseases, including but not limited to acute myocardial infarction, severe\u002Funstable angina or coronary artery bypass grafting within 6 months before enrollment; congestive heart failure with New York Heart Association (NYHA) classification \\> 2; drug-treated ventricular arrhythmias; left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* Patients with active or uncontrolled severe infections (≥ CTCAE v5.0 grade 2 infections);\n* Patients with known human immunodeficiency virus (HIV) infection. Patients with a history of clinically significant liver disease, including viral hepatitis \\[known hepatitis B virus (HBV) carriers must exclude active HBV infection, i.e., HBV DNA positive (\\> 1×104 copies\u002FmL or \\> 2000 IU\u002FmL); known hepatitis C virus (HCV) infection and HCV RNA positive (\\> 1×103 copies\u002FmL)\\];\n* Patients with any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; patients with childhood asthma that has completely resolved and does not require any intervention in adulthood can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included); replacement therapy is not considered systemic treatment, the following patients can be included: those with a history of autoimmune-related hypothyroidism and receiving thyroid hormone replacement therapy; type 1 diabetes that can be controlled with insulin treatment;\n* Patients who have used immunosuppressants or systemic hormone therapy to achieve immunosuppression within 7 days before enrollment (dose \\> 10 mg\u002Fday of prednisone or other equivalent efficacy hormones);\n* Patients with interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, or radiation pneumonitis;\n* Pregnant (positive pregnancy test before medication) or lactating women; Any other disease, clinically significant metabolic abnormalities, physical examination abnormalities or laboratory test abnormalities, as judged by the investigator, there is reason to suspect that the patient has a disease or condition that is not suitable for the use of the study drug (such as having epilepsy and requiring treatment), or will affect the interpretation of the study results, or put the patient at high risk;\n* Patients with urine routine indicating urine protein ≥ 2+ and 24-hour urine protein \\> 1.0g;\n* Patients deemed unsuitable for inclusion in this study by the investigator.","80 Years",{"count":52,"type":21},250,"1 Year","OBSERVATIONAL","This study is an open-label, multi-cohort real-world research that explores the efficacy and safety of different second-line treatment regimens for gastric\u002Fgastroesophageal junction adenocarcinoma that has failed first-line fluoropyrimidine, platinum-based chemotherapy combined with immunotherapy.",[57,58],"Gastric Cancer","Second-line Treatment","RECRUITING","2026-02-04",{"date":62,"type":34},"2026-02-05",{"date":64,"type":34},"2025-09-01",{"date":66,"type":21},"2028-09-01",{"name":68,"class":41},"Fudan University",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":91,"locationsCount":69},"100550367","phase-2-fruquintinib-after-icis-treatment-in-unresectable-hepatocellular-carcinoma-100550367","NCT06446154","Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma","Fruquintinib in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors : A Single-arm, Phase II Study","Inclusion Criteria:\n\n* patients aged 18 years or older\n* with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria\n* who had previously received immune checkpoint inhibitors\n* had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria\n* had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* had a Child-Pugh liver function score of 7 or less\n* had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109\u002Fl, platelet count ≥60×109\u002Fl, total bilirubin \\\u003C 30μmol\u002Fl, albumin ≥ 30g\u002Fl, aspartate transaminase and alanine transaminase ≤ 5×upper limit of the normal, creatinine clearance rate of ≤ 1.5×upper limit of the normal, and left ventricular ejection ≥ 45%)\n\nExclusion Criteria:\n\n* history of HIV, organ allograft\n* combined with other malignant tumors\n* evidence of hepatic decompensation, bleeding diathesis or event\n* allergy to the investigational agents or any agent given in association with this trial\n* incomplete medical information.",{"count":78,"type":21},36,[25],"Nowadays, there are few second-line treatment options for advanced hepatocellular carcinoma (HCC). In order to further improve the efficacy of second-line treatment for advanced HCC, we plan to conduct a phase II clinical study to explore the efficacy and safety of the new second-line treatment for advanced HCC.\n\nAs a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor -1\u002F2\u002F3 (VEGFR 1\u002F2\u002F3), fruquintinib had demonstrated a strong antitumor efficacy in colorectal cancer patients who had previously received standard chemotherapy. Compared with placebo, fuquinitinib significantly extended overall survival in patients with metastatic colorectal cancer (median OS, 9.3 months vs 6.6 months; HR, 0.65; p\\\u003C0.001) and progression-free survival (median PFS, 3.7 months vs 1.8 months; HR, 0.26; p\\\u003C0.001). Additionally, a phase II clinical study had showed that sintilimab combined with fruquintinib was with a promising anti-tumor activity in patients with advanced HCC who had received standard treatment, with a median PFS of 7.4 months and a tumor response rate of 31.6%.\n\nTherefore, we intend to conduct this clinical study to explore the efficacy and safety of fruquintinib as second-line treatment for patients with unresectable HCC previously treated with immune checkpoint inhibitors.",[82,83,84,58],"Hepatocellular Carcinoma","Immune Checkpoint Inhibitors","Anti-angiogenic Therapy","2024-12-29",{"date":87,"type":34},"2024-12-31",{"date":89,"type":34},"2024-12-27",{"date":31,"type":21},{"name":92,"class":41},"Sun Yat-sen University",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":69},"100567030","phase-2-anlotinib-plus-nab-paclitaxels-and-s-1-for-patients-with-advanced-biliary-tract-cancer-as-second-line-treatment-100567030","NCT06662877","Anlotinib Plus Nab-Paclitaxels and S-1 for Patients with Advanced Biliary Tract Cancer As Second-Line Treatment","Anlotinib Plus Nab-Paclitaxels and S-1 Versus FOLFOX for Patients with Advanced Biliary Tract Cancer As Second-Line Treatment: a Phase 2\u002F3, Multi-centric Double-stage Randomized Controlled Trial","Inclusion Criteria:\n\n1. Signed a written informed consent form before enrollment;\n2. Age \\>18 years, both male and female are eligible;\n3. Patients with pathologically confirmed advanced biliary tract that has progressed after first-line gemcitabine-based therapy;\n4. Have measurable lesions (according to RECIST 1.1 criteria, non-lymph node lesions with a long diameter ≥10 mm on CT scan, or lymph node lesions with a short diameter ≥15 mm on CT scan);\n5. ECOG Performance Status (PS) score: 0-1;\n6. Expected survival time longer than 12 weeks;\n7. Key organ functions meet the following criteria (without the use of any blood components or growth factors within 14 days): Hematology: Neutrophils ≥1.5×10⁹\u002FL; Platelet count ≥100×10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥50 ml\u002Fmin (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 2.5 times the ULN (if abnormal liver function is due to liver metastasis, then ≤ 5 times the ULN); urine protein \\\u003C 2+; if urine protein ≥ 2+, 24-hour urine protein quantification must show protein ≤1g;\n8. Normal coagulation function, no active bleeding or thrombotic diseases: International Normalized Ratio (INR) ≤ 1.5 × ULN; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; Prothrombin Time (PT) ≤ 1.5 × ULN;\n9. The subject voluntarily participates in this study, has good compliance, and is willing to cooperate with safety and survival follow-ups.\n\nExclusion Criteria:\n\n1. Subjects with a history of or concurrent malignancies, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix;\n2. Known allergy to macromolecular protein preparations or known hypersensitivity to the components of the administered drugs;\n3. Subjects with existing thyroid dysfunction that cannot be maintained within the normal range by medication;\n4. Uncontrolled hypertension despite optimal treatment, defined as systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>90 mmHg;\n5. Subjects with uncontrolled cardiac clinical symptoms or diseases, such as: (1) heart failure above NYHA class II, (2) unstable angina, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;\n6. Subjects with any active autoimmune disease or a history of autoimmune disease;\n7. Subjects using immunosuppressive agents or systemic or absorbable local corticosteroids for immunosuppressive purposes (prednisone dose \\>10 mg\u002Fday or equivalent efficacy corticosteroids) who continue to use them within 2 weeks before enrollment;\n8. Subjects with central nervous system metastases;\n9. Subjects with active infections or unexplained fever \\>38.5°C during screening or before the first dose (subjects with tumor-related fever, as judged by the investigator, may be enrolled);\n10. Subjects with significant hemoptysis (fresh blood) within 2 months before enrollment or daily hemoptysis volume ≥2.5 ml;\n11. Subjects with any condition that may increase the risk of gastrointestinal bleeding or perforation, such as active peptic ulcers, known intraluminal metastatic lesions, inflammatory bowel disease, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before the start of the study;\n12. Subjects with a history or current evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function;\n13. Subjects with a history or current evidence of bronchiectasis, cavitary pulmonary tuberculosis, lung abscess, rheumatic heart disease with mitral valve stenosis, or cardiogenic pulmonary edema, which could cause hemoptysis;\n14. Subjects with congenital or acquired immune deficiencies, such as those infected with HIV or with active hepatitis (transaminase levels not meeting inclusion criteria, hepatitis B reference: HBV DNA ≥1000 IU\u002Fml; hepatitis C reference: HCV RNA ≥1000 IU\u002Fml);\n15. Subjects who have received or may receive a live vaccine within 4 weeks before or during the study;\n16. Subjects with a known history of psychiatric drug abuse, alcoholism, or drug addiction;\n17. Pregnant or breastfeeding women or those planning to conceive during the study period;\n18. Subjects whom the investigator deems should be excluded from the study, such as those with factors that may lead to early termination of the study.",{"count":101,"type":21},206,[25,103],"PHASE3","Biliary tract cancer (BTC) presents with a 5-year survival rate less than 5%. The goal of this clinical trial is to evaluate if Anlotinib plus Nab-Paclitaxels and S-1 as second-line regimen can improve the treatment efficacy in advanced biliary tract cancer (BTC) after progression upon first-line standard treatment, in comparison with standard second-line FOLFOX regimen.",[106,29,107,108],"Biliary Tract Cancer","Chemotherapy","Tyrosine Kinase Inhibitor",[110,111,112,113,114,115],"biliary tract cancer","second-line treatment","Nab-Paclitaxels","S-1","Anlotinib","FOLFOX","2024-10-27",{"date":118,"type":34},"2024-10-29",{"date":120,"type":21},"2024-11-25",{"date":122,"type":21},"2029-09-01",{"name":92,"class":41},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":69},"100544843","exercise-in-patients-with-advanced-non-small-cell-lung-cancer-100544843","NCT06374160","Exercise in Patients With Advanced Non-small Cell Lung Cancer","Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer","BREATH","Inclusion Criteria\n\n* Patients with histologically confirmed non-small cell lung carcinoma in UICC stages IIIB and IV\n* First- or second-line therapy (inclusion up to 28 days after the first cycle) in palliative intention\n* Age ≥ 18 years\n* Signed informed consent\n\nExclusion Criteria\n\n* Severe cardiopulmonary disease (EF\\\u003C30%)\n* Newly occurring or progressive uncontrolled CNS (central nervous system) metastases\n* Expected life expectancy \\\u003C 3 months\n* Bone metastases with acute risk of fracture\n* ECOG (Eastern Cooperative Oncology Group) performance status \\> 2\n* Acute pulmonary embolism\n* Acute myocardial infarction\n* Requiring surgery for aortic aneurysm\n* Tension pneumothorax\n* Lack of proficiency in the German language\n* Active infection",{"count":133,"type":21},104,[135],"NA","Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far.\n\nThe BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise\u002Fonly endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches.\n\nThe primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise.",[138,139,29,140,141,142,143],"Advanced Lung Carcinoma","First Line Treatment","NSCLC Stage IV","NSCLC Stage IIIB","Palliative Treatment","NSCLC Stage IIIC","2024-04-15",{"date":146,"type":34},"2024-04-18",{"date":148,"type":21},"2024-05-01",{"date":150,"type":21},"2026-08-31",{"name":152,"class":41},"University Hospital, Essen"]