[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xianglin Yuan\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"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",false,"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.","ALL","18 Years","75 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"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",[27],"Biliary Tract Cancer (BTC)","NOT_YET_RECRUITING","2026-05-24",{"date":31,"type":32},"2026-06-01","ACTUAL",{"date":34,"type":21},"2026-07-01",{"date":36,"type":21},"2028-12-31",{"name":38,"class":39},"Xianglin Yuan","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100561601","phase-1-the-combination-of-adebrelimab-apatinib-and-lrinotecan-liposome-for-second-line-treatment-of-advanced-gastric-cancer-100561601","NCT06592287","The Combination of Adebrelimab, Apatinib, and Lrinotecan Liposome for Second-line Treatment of Advanced Gastric Cancer","Prospective, Dual Arm, Open Ib\u002FII Phase Clinical Study of the Combination of Adebrelimab, Apatinib, and Lrinotecan Liposome for Second-line Treatment of Advanced Gastric Cancer","Inclusion Criteria:\n\n1. Age range: 18 to 75 years old, both male and female are acceptable;\n2. Patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;\n3. Patients who have only received one failed systemic treatment for advanced diseases in the past; After undergoing immunotherapy, the PFS of the treatment regimen containing immune checkpoint inhibitors must be greater than 7 months;\n4. According to the evaluation criteria for solid tumor efficacy 1.1 (RECIST v1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located within the previously irradiated area can also be selected as target lesions if progression is confirmed);\n5. ECOG score: 0-1 point;\n6. Expected survival period ≥ 12 weeks;\n7. The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 109\u002FL (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 109\u002FL, hemoglobin ≥ 90g\u002FL; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml\u002Fmin\u002F1.73 m2 (calculated according to the Cockcroft Gault formula);\n8. Female subjects with fertility, as well as male subjects with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine devices, birth control pills, or condoms) during the study treatment period, at least 6 months after the last use of Adebrelimab, at least 6 months after the last use of Apatinib, and at least 6 months after the last use of chemotherapy;\n9. HER2 negative;\n10. Voluntarily join this study, sign informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. History of gastrointestinal perforation and\u002For fistula within 6 months prior to the first use of medication;\n2. There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;\n3. Have a history of allergies to any component of Adebrelimab in the past;\n4. Have received any of the following treatments:\n\n   1. Received any other investigational drug within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug;\n   2. Simultaneously enrolled in another clinical study, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up;\n   3. Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug;\n   4. Subjects who need to receive corticosteroids (equivalent to\\>10mg prednisone per day) within 2 weeks prior to the first use of the study drug. Allow the use of hormones for routine chemotherapy pretreatment without the need for dose adjustment. Other special circumstances require communication with the researcher. In the absence of active autoimmune diseases, inhalation or local use of steroids and corticosteroids with a dosage greater than 10mg\u002Fday of prednisone efficacy dose are allowed as substitutes for adrenal cortex hormones;\n   5. Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the study drug;\n   6. Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug;\n5. The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 Grade 1 (excluding hair loss) or the level specified in the inclusion\u002Fexclusion criteria;\n6. Patients with active central nervous system metastases;\n7. Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to the above diseases or syndromes); Excluding childhood asthma\u002Fallergies with vitiligo or those who have already recovered, patients who do not require any intervention in adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin;\n8. Have a history of immune deficiency, including HIV test positive, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation, or active hepatitis (hepatitis B reference: HBV DNA test value exceeds 500 IU\u002Fml or 2500 copies\u002FmL);\n9. The subject has uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or are still poorly controlled after clinical intervention;\n10. Within 4 weeks prior to the first use of the investigational drug, there has been a severe infection (CTCAE 5.0\\>grade 2), such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc; Baseline chest imaging examination suggests the presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except for prophylactic use of antibiotics;\n11. History of interstitial lung disease (excluding history of radiation pneumonia and non infectious pneumonia that have not been treated with steroids);\n12. Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within the past year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment;\n13. Diagnosed with any other malignant tumor within 5 years prior to the first use of the investigational drug, except for malignant tumors with low-risk metastasis and mortality risk (5-year survival rate\\>90%), such as basal cell or squamous cell carcinoma or cervical carcinoma in situ that have been adequately treated;\n14. Pregnant or lactating women;\n15. According to the researcher\\'s assessment, there may be other factors that could force the subject to terminate the study midway, such as having other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the subject\\'s safety or the collection of trial data.",{"count":48,"type":21},66,[50,51],"PHASE1","PHASE2","This study is a prospective, dual arm, open Ib\u002FII phase clinical trial, with the main objective of exploring the safety and efficacy of Adebrelimab combined with Apatinib and Lrinotecan liposome for second-line treatment of advanced gastric cancer.\n\nThe study is divided into two stages. The first stage is the safety introduction period, which includes 6 patients. Observe whether the subjects experience dose limiting toxicity (DLT) during the observation period. If no subjects experience DLT during the observation period, the study enters the next stage. The dose of Lrinotecan liposome used during the safety introduction period is 80mg\u002Fm2, and the DLTs observation period is 1 cycle. If the patient cannot tolerate it, the dose will be reduced to 60mg\u002Fm2.\n\nIn the second stage, advanced gastric cancer subjects who have progressed to first-line treatment will be included in two cohorts: those who have previously received immune checkpoint inhibitor therapy and have first-line PFS\\>7m (cohort 1) and those who have received standard systemic chemotherapy (cohort 2). 30 subjects will be included in each population, and a total of 66 subjects are planned to be enrolled.\n\nThe study includes a screening period (from the signing of the informed consent form by the subjects to the first treatment, not exceeding 28 days), a treatment period (Adebrelimab combined with Apatinib and Lrinotecan liposome), and a follow-up period (including safety and survival follow-up).",[54],"Advanced Gastric Cancer",[56,57,58,59,60],"Second line advanced gastric cancer","Lrinotecan liposome","Immune checkpoint inhibitors","Anti-L1 antibody","apatinib","2024-09-13",{"date":63,"type":32},"2024-09-19",{"date":65,"type":21},"2024-09-30",{"date":67,"type":21},"2026-09-30",{"name":38,"class":39},1,""]