[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yunpeng Liu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100553036","adebrelimab-plus-apatinib-for-maintenance-therapy-of-extensive-stage-small-cell-lung-cancer-100553036",false,"NCT06480864","Adebrelimab Plus Apatinib for Maintenance Therapy of Extensive Stage Small Cell Lung Cancer","Adebrelimab Plus Apatinib for Maintenance Treatment of Extensive Stage Small Cell Lung Cancer After First-line Induction with Adebrelimab Plus Chemotherapy (CLOG2402-ADAPT): a Multi-center, Single-arm, Phase 2 Clinical Trial","Inclusion Criteria:\n\n1. Participants voluntarily enrolled in this study and signed an informed consent form, were compliant and co-operated with follow-up visits;\n2. Age 18 years and above, male and female;\n3. Diagnosis of extensive stage small cell lung cancer (ES-SCLC) confirmed by histology or pathology (according to the American Veterans Lung Cancer Association, VALG stage);\n4. ECOG physical condition score is 0-2;\n5. Subjects have not received systematic treatment for ES-SCLC in the past (including chemotherapy, VEGFR inhibitors and immune checkpoint inhibitors, etc.)\n6. Patients with limited stage small cell lung cancer (LS-SCLC) who have received radiotherapy, chemotherapy or radiochemotherapy require a treatment-free period of more than 6 months. Patients with asymptomatic brain metastases are allowed to have cranial radiotherapy during induction chemotherapy;\n7. Life expectancy \\>= 3 months;\n8. There must be a measurable target lesion that meets the RECIST 1.1 criteria (CT scan length of the tumour lesion \\>10mm);\n9. The function of major organs is normal, that is, the following criteria are met.\n\n   * Blood routine (not transfused, not using haematopoietic factors and not corrected with drugs within 14 days): ANC ≥ 1.5 x 109\u002FL; HB ≥ 90 g\u002FL; PLT ≥ 100 × 109\u002FL;\n   * Biochemical tests:\n\n   TBIL ≤ 1.5ULN; TBIL ≤ 1.5 ULN; ALT, AST ≤ 2.5 ULN;\n\n   \\- Renal function: Serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance ≥ 40 mL\u002Fmin. (apply the standard Cockcroft-Gault formula):\n\n   \\- Coagulation function must meet: INR ≤ 1.5 and APTT ≤ 1.5 ULN;\n10. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose. Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential must agree to use a highly effective method of contraception and breastfeeding for the duration of the study up to 90 days after the last administration of study drug. The Investigator or his\u002Fher designee, in consultation with the subject, will be required to confirm that the subject has knowledge of how to properly and consistently use the contraceptive method;\n11. For males, surgical sterilisation or agreement to use a highly effective method of contraception for the duration of the trial and for 90 days after the final administration of study drug;\n12. For female participants, agreement to refrain from breastfeeding for the duration of the study or for 180 days after the last dose of study treatment is required.\n\nExclusion Criteria:\n\n1. Patients with meningeal metastases;\n2. Prior treatment with any T-cell co-stimulation or immune checkpoint therapy, including, but not limited to, cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1\u002F2 inhibitors, CD137 agonists, or other agents that target T cells;\n3. Prior treatment with apatinib;\n4. Factors affecting oral administration of medications such as inability to swallow, post gastrointestinal resection, chronic diarrhoea, intestinal obstruction;\n5. Any active autoimmune disease or history of autoimmune disease (e.g., uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy), tuberculosis); and skin disorders (e.g., vitiligo, psoriasis, or alopecia) in which asthma has been in complete remission in childhood and has required no intervention in adulthood or in which systemic therapy is not required. or alopecia areata) may be included; patients requiring medical intervention with bronchodilators may not be included;\n6. Patients with congenital or acquired immune function defects such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU\u002Fml), hepatitis C (hepatitis C antibody positive with HCV-RNA above the lower limit of detection of the analytical method), or co-infection with both hepatitis B and hepatitis C;\n7. Urine routine suggesting urinary protein ≥ (++), or 24h urine protein amount ≥ 1g or severe hepatic or renal insufficiency;\n8. Subjects requiring systemic therapy with corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to first dose. Inhaled or topical corticosteroids and adrenal hormone replacement therapy at doses \\> 10 mg\u002Fday prednisone efficacy dose are permitted in the absence of active autoimmune disease;\n9. Subjects who have been treated with antitumour vaccines or other antitumour agents with immunostimulatory effects (interferon, interleukin, thymidine, immune cell therapy, etc.) within 1 month prior to the first dose;\n10. Concomitant other malignancies ≤5 years prior to enrolment, except adequately treatable carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localised prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;\n11. Evidence of previous or current pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiographic pneumonia, drug-induced pneumonia, active pneumonia confirmed by imaging, and severely impaired lung function;\n12. Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal pharmacological treatment);\n13. Myocardial ischaemia or myocardial infarction of class II or greater, poorly controlled arrhythmias (including QTc intervals ≥450 ms in men and ≥470 ms in women). Myocardial infarction, New York Heart Association class II or higher heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggestive of acute ischaemia or active pericardial disease, within 6 months prior to enrolment, according to NYHA criteria, class III-IV cardiac insufficiency or cardiac ultrasound suggestive of a left ventricular ejection fraction (LVEF) of \\\u003C 50% conduction system abnormalities;\n14. Complicated severe infection within 4 weeks prior to first dose or unexplained fever \\>38.5°C during screening\u002Fprior to first dose;\n15. Major surgery, open biopsy or significant trauma within 28 days prior to enrolment;\n16. An arterial\u002Fvenous thrombotic event within 6 months;\n17. A significant risk of coughing up blood, bleeding events, or perforation as assessed by the investigator;\n18. Known history of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation;\n19. Pregnant or lactating women; patients of childbearing potential who are unwilling or unable to use effective contraception;\n20. Known hypersensitivity, hypersensitivity or intolerance to adebelizumab, apatinib, chemotherapeutic agents or their excipients;\n21. Any condition which, in the opinion of the Investigator, may be detrimental to the subject or result in the subject's inability to meet or perform the requirements of the study.","ALL","18 Years",{"count":19,"type":20},38,"ESTIMATED","INTERVENTIONAL",[23],"NA","To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive stage small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy.",[26],"Small Cell Lung Cancer","RECRUITING","2025-01-02",{"date":30,"type":31},"2025-01-06","ACTUAL",{"date":33,"type":31},"2024-08-09",{"date":35,"type":20},"2026-08",{"name":37,"class":38},"Yunpeng Liu","OTHER",2,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100567282","phase-2-shr-a1811-combined-with-apatinib-in-the-treatment-of-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-and-colorectal-cancer-100567282","NCT06666166","SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer","Exploratory Clinical Study of SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer","Inclusion Criteria:\n\n1. Participants voluntarily enrolled in this study and signed an informed consent form, were compliant and co-operated with follow-up visits;\n2. Age 18-75 years, including 18 and 75 year, male and female;\n3. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;\n4. Has a life expectancy of greater than 3 months;\n5. Cohort A: Has histologically confirmed diagnosis of unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;\n6. Cohort B: Has histologically confirmed diagnosis of unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;\n7. There must be a measurable target lesion that meets the RECIST 1.1 criteria;\n8. The function of major organs meets the following criteria(not transfused, not using haematopoietic factors and not corrected with drugs within 14 days):\n\n   1. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n   2. PLT ≥100×10\\^9\u002FL;\n   3. Hb≥9g\u002FdL;\n   4. ALB≥3.0g\u002FdL;\n   5. total bilirubin ≤1.5 x ULN;\n   6. ALT\u002FAST ≤ 2.5 x ULN (When there is liver metastasis, ALT\u002FAST ≤ 5 x ULN);\n   7. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60mL\u002Fmin (according to Cockcroft-Gault formula);\n   8. prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n   9. Echocardiography （ECHO）\u002FCardiac radionuclide scan （MUGA showed i.LVEF≥50%);\n   10. Urine routine results showed that urine protein \\\u003C1+; For patients with urine protein ≥2+ at baseline, 24-hour urine collection and 24-hour urine protein quantification \\\u003C1g should be performed.\n9. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose and agree to use a highly effective method of contraception for the duration of the study up to 6 months after the last administration of study drug. Male subjects whose partner is a female of childbearing potential must agree to use a highly effective method of contraception for the duration of the study up to 6 months after the last administration of study drug.\n\nExclusion Criteria:\n\n1. Patients with meningeal metastases; Or patients with brain metastases that have not been treated with surgery or radiation, but those who have been stable for at least one month after treatment and have stopped using steroid drugs (such as 10mg\u002Fday prednisone or other equivalent hormones) for more than 2 weeks except;\n2. Uncontrolled pleural effusion or ascites;\n3. There are serious concomitant diseases: such as serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, hematopoietic disease, endocrine disease, cachexia, etc;\n4. Previously received antibody drug conjugate therapy containing topoisomerase I inhibitors, such as trastuzumab deruxtecan (DS-8201), etc; Subjects underwent surgery (except diagnostic surgery), radiotherapy, chemotherapy, macromolecular targeted therapy or immunotherapy within 4 weeks before the first dose of the study drug；Small molecule targeted drugs (including other oral targeted drugs used in clinical trials) whose last dose is less than 5 half-life period or 4 weeks (whichever is shorter) from the first dose; Subjects received palliative radiotherapy or local treatment less than 2 weeks after completion of treatment and before the first dose;\n5. Subjects who have been treated with live vaccine or attenuated vaccine within 1 month prior to the first dose;\n6. Subjects requiring systemic therapy with corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to first dose, excluding nasal spray or inhaled corticosteroids.\n7. The toxicity caused by previous anti-tumor treatments has not recovered to ≤ CTCAE grade 1 (excluding hair loss; according to the researcher's judgment, some tolerable chronic grade II toxicity can be excluded);\n8. Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); Active bleeding (such as local active ulcer lesions and fecal occult blood≥ ++), with a history of gastrointestinal bleeding within 6 months;\n9. Abnormal coagulation function (INR\\>1.5 or prothrombin time (PT)\\>ULN+4 seconds or APTT\\>1.5 × ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy;\n10. Subjects were co-administered a potent CYP3A4 or CYP2D6 inhibitor or inducer within 3 weeks prior to first dosing;\n11. Factors affecting oral administration of medications such as inability to swallow, chronic diarrhoea and intestinal obstruction;\n12. Any active autoimmune disease or history of autoimmune disease (e.g., autoimmune hepatitis, uveitis, enteritis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy)); and skin disorders (e.g., vitiligo, psoriasis, or alopecia) in which asthma has been in complete remission in childhood and has required no intervention in adulthood or in which systemic therapy is not required.subjects with autoimmune mediated hypothyroidism treated with thyroid replacement hormone at a stable dose and type I diabetes patients treated with insulin at a stable dose can be included;\n13. Subjects with immunodeficiency disease, such as HIV infection, congenital or acquired immune dysfunction, organ transplantation；\n14. Uncontrolled heart clinical symptoms or diseases, such as (1) New York Heart Association class II or higher heart failure; (2) unstable angina pectoris; (3) Myocardial ischaemia within 1 year; (4) Subjects with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n15. Complicated severe infection within 30 days prior to first dose, including but not limited to infection complications that require hospitalization, bacteremia, severe pneumonia, etc; active infections that have received therapeutic intravenous antibiotics within 2 weeks prior to the first dose. Subjects receiving prophylactic antibiotic treatment (such as preventing urinary tract infections) can be enrolled;\n16. Subjects with active hepatitis B (HBsAg positive with HBV DNA ≥ 500 IU\u002Fml), hepatitis C (hepatitis C antibody positive with HCV-RNA above the lower limit of detection of the analytical method);\n17. Evidence of previously clinically significant lung diseases, including but not limited to interstitial pneumonitis, pneumonitis, pulmonary fibrosis and radiographic pneumonia (Excluding radioactive changes do not require treatment), or suspected subjects with this type of diseases founded during the screening period;\n18. Allergy to any investigational drug or its excipients;\n19. Concomitant other malignancies ≤5 years prior to enrollment, except adequately treatable carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localised prostate cancer, and ductal carcinoma;\n20. Serious physical or mental illnesses or laboratory abnormalities. Any condition which, in the opinion of the Investigator, may be detrimental to the subject or result in the subject's inability to meet or perform the requirements of the study.","75 Years",{"count":49,"type":20},28,[51],"PHASE2","To evaluate the effectiveness and safety of SHR-A1811 combined with apatinib in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.",[54,55,56],"Advanced Gastric Carcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","Advanced Colorectal Cancer",[58,59,60,61],"apatinib","advanced gastric or gastroesophageal junction adenocarcinoma","advanced colorectal cancer","SHR-A1811","NOT_YET_RECRUITING","2024-10-29",{"date":65,"type":31},"2024-10-30",{"date":67,"type":20},"2024-12",{"date":69,"type":20},"2028-12",{"name":37,"class":38},1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":71},"100551704","irinotecan-hydrochloride-liposome-combined-with-capecitabine-and-lenvatinib-in-patients-with-biliary-tract-carcinoma-100551704","NCT06463548","Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma","Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Capecitabine and Lenvatinib for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma","Inclusion Criteria:\n\n1. Age ≥18 and ≤75 years\n2. Has histologically confirmed diagnosis of advanced (metastatic) and\u002For unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)\n3. For subjects who have progressed after receiving previous first-line therapy, relapse within 6 months after the end of (neo) adjuvant therapy is considered as first-line therapy failure\n4. The previous treatment regimen should be free of capecitabine and Lenvatinib, and the time of recurrence diagnosis should be greater than 6 months after the last dose, with no delayed toxic reactions\n5. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1)\n6. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1\n7. Has a life expectancy of greater than 3 months\n8. LVEF≥50%，no obvious abnormalities in myocardial enzyme spectra\n9. Good bone marrow function：ANC ≥1.5×109\u002FL, Hb≥90g\u002FL.PLT ≥100×109\u002FL, WBC≥3.0×109\u002FL\n10. Liver function：ALT\u002FAST ≤ 2.5 x ULN; When there is liver metastasis, ALT\u002FAST ≤ 5 x ULN，total bilirubin ≤1.5 x ULN\n11. Renal function：Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60mL\u002Fmin (according to Cockcroft-Gault formula)\n12. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international standardized ratio (INR) ≤1.5×ULN\n13. Urine routine results showed that urine protein \\\u003C2+; For patients with urine protein ≥2+ at baseline, 24-hour urine collection and 24-hour urine protein quantification \\\u003C1g should be performed.\n14. Patients with biliary obstruction or no evidence of persistent infection should receive adequate biliary drainage; Active or suspected infection is not allowed\n15. Adverse reactions caused by previous treatment must be restored to grade 1 or baseline according to CTCAE5.0 (except for toxicity such as alopecia, grade 2 and below peripheral neuropathy, which can be included after the investigator determines that there is no safety risk).\n16. Non-pregnant or lactating female; Effective contraception should be used by female\u002FMale of childbearing age during the study period and for 6 months after the end of study treatment\n17. There were no contraindications for the use of irinotecan liposomes, capecitabine and Lenvatinib\n18. The patient had good compliance, could understand the research process of this study, and signed a written informed consent\n\nExclusion Criteria:\n\n1. Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and skin basal cell carcinoma)\n2. Uncontrolled pleural effusion or ascites\n3. History of gastrointestinal bleeding or significant tendency to gastrointestinal bleeding within 6 months before the study, such as esophageal and gastric varices with bleeding risk, active local ulcers, and continuous positive fecal occult blood\n4. A deep vein thrombosis or embolism event occurred within 6 months before the start of treatment\n5. any known brain or meningeal metastases\n6. Subjects were co-administered a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing\n7. Subjects underwent large organ surgery (except needle biopsy, central venous catheterization, port catheterization, stenting for relief of biliary obstruction, percutaneous hepatobiliary drainage, and cholecystostomy) or an elective surgical program within 4 weeks before the first dose of the study drug\n8. Subjects had an active infection or unexplained fever \\>38.5 degrees during screening or before the first dose (the investigator determined that the subject's fever due to the tumor could be enrolled)\n9. Subjects with congenital or acquired immune dysfunction, such as HIV infection or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA≥1000 IU\u002Fml; Hepatitis C reference: HCV RNA≥1000 IU\u002Fml) Chronic hepatitis B virus carriers with HBV DNA \\\u003C 2000 IU\u002Fml must also receive antiviral therapy during the trial to be enrolled\n10. Subject has homozygous mutation or double heterozygous mutation of UGT1A1 allele\n11. There are serious concomitant diseases: such as uncontrolled diabetes after hypoglycemic drug treatment, uncontrolled hypertension, serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, uncontrolled epilepsy, central nervous system disease or mental disorder history, clear gastrointestinal bleeding tendency, intestinal paralysis, intestinal obstruction, etc\n12. Grade 1 diarrhea with an increase in the number of stools \\> 4 times per day compared to baseline; The moderate and severe effluents from stoma increased; Limited activities of daily living with the aid of tools or even self-rational activities of daily living; Life-threatening; Need urgent medical attention\n13. Had participated in other clinical investigators within 4 weeks before enrollment\n14. Unsuitable for participation in the trial by the investigator assessed",{"count":80,"type":20},30,[23],"To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.",[84],"Biliary Tract Carcinoma","2024-06-14",{"date":87,"type":31},"2024-06-18",{"date":89,"type":20},"2024-07-01",{"date":91,"type":20},"2026-12-31",{"name":37,"class":38},""]