[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hua Li\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,65],{"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":40},"100585293","phase-2-icariin-soft-capsules-combined-with-tace-as-adjuvant-therapy-for-hcc-100585293",false,"NCT06900478","Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for HCC","Icariin Soft Capsules Combined With TACE as Adjuvant Therapy for Hepatocellular Carcinoma With High-Risk Recurrence Factors:A Single-Center, Prospective Study","Inclusion Criteria:\n\n* Age between 18 and 80 years;\n* ECOG Performance Status (PS) of 0 or 1;\n* Histologically or cytologically diagnosed as HCC\n* Fully recovered from surgical resection or ablation prior to enrollment;\n* Presence of the following high-risk recurrence factors after resection or ablation: tumor maximum diameter \\> 5 cm; multiple tumors; microvascular or major vascular invasion; margin distance from the tumor edge \\\u003C 1 cm; poorly differentiated tumors (Edmondson grade III-IV); lymph node metastasis; persistent abnormal AFP or abnormal prothrombin (DCP);\n* Child-Pugh class A5-B7;\n* Expected survival time \\> 3 months;\n* Normal major organ function: Hemoglobin ≥ 80 g\u002FL, Absolute Neutrophil Count (ANC) ≥ 1.5 × 10\\^9\u002FL, Platelet count ≥ 50 × 10\\^9\u002FL, Serum albumin ≥ 30 g\u002FL, Total bilirubin ≤ 2 ULN, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤ 2.5 × ULN, Alkaline Phosphatase (ALP) ≤ 2.5 × ULN, Creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 ml\u002Fmin, International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;\n* Negative HIV test results at screening;\n* Hepatitis B virus (HBV) DNA\\\u003C500 IU\u002FmL;\n* No major vascular invasion (Vp3 or Vp4) of the portal vein or any level of major vascular invasion of the hepatic veins or inferior vena cava;\n* Within 7 days prior to screening, women of childbearing potential must confirm a negative serum pregnancy test and agree to use effective contraception during the study drug administration and for 60 days after the last dose of the study drug;\n\nExclusion Criteria:\n\n* Known cases of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;\n* HCC recurrence prior to study enrollment;\n* Co-infection with HBV and delta hepatitis virus;\n* Clinically significant ascites (Note: ascites detectable only through imaging studies are permitted to participate in the study);\n* History of hepatic encephalopathy;\n* Receipt of any other investigational drug treatment within 4 weeks prior to Day\n\n  1 of Cycle 1;\n* Presence of abdominal wall fistula, gastrointestinal perforation, refractory non-healing gastric ulcers, or history of active gastrointestinal bleeding within 6 months prior to enrollment;\n* History of another malignancy tumor , except for the cured skin basal cell carcinoma and cervical carcinoma in situ)\n* Active tuberculosis;\n* Functional impairment of major organs (heart, lungs, kidneys, etc.), severe infections, or \\> grade 2 adverse events (Common Terminology Criteria for Adverse Events (CTCAE) version 5.0);\n* Very early-stage HCC, solitary tumors, size \\\u003C 2 centimeters;\n* Any allergy to the drugs used in the TACE regimen or known components of epimedium soft capsules;\n* History of organ transplantation;\n* Pregnant or breastfeeding female patients, or those unwilling to use contraception during the trial;\n* Any other diseases, metabolic disorders, abnormal physical examination results, or laboratory test results that raise suspicion of contraindications for the investigational drug, may affect the reliability of study results, or place the patient at high risk for treatment complications, or affect patient compliance.","ALL","18 Years","80 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a prospective, single-center, phase II study，to evaluate the efficacy and safety of icariin soft capsules combined with TACE as adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after resection.",[27],"Hepatocarcinoma","NOT_YET_RECRUITING","2025-03-27",{"date":31,"type":32},"2025-03-28","ACTUAL",{"date":34,"type":21},"2025-03-30",{"date":36,"type":21},"2027-02-28",{"name":38,"class":39},"Hua Li","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100501028","phase-1-ablation-in-combination-with-lenvatinib-and-anti-pd-1-antibodies-100501028","NCT05803928","Ablation in Combination With Lenvatinib and Anti-PD-1 Antibodies","Ablation in Combination With Lenvatinib and Anti-PD-1 Antibodies in Patients With Early Recurrence After Radical Resection\u002FAblation of HCC: a Prospective, Randomized, Controlled Clinical Study","Inclusion Criteria:\n\n1. Age ≥18 years old, ≤75 years old, gender unlimited;\n2. primary hepatocellular carcinoma proved pathologically and clinically;\n3. 2 months after radical resection or ablation, imaging examination (MRI, CT plain enhanced) showed no tumor lesions, HCC recurred within 3 years after surgery, no extrahepatic metastasis;\n4. ECOG score 0-1;\n5. Recurrent liver cancer meets the Milan criteria: single tumor diameter ≤5cm or multiple tumors less than 3 with a maximum diameter ≤3cm, no major vascular invasion, no lymph node metastasis or extrahepatic metastasis;\n6. Child-Pugh liver function grades: A, B;\n7. Expected survival \\> 6 months;\n8. Adequate organ function: ① no need for growth factors and blood components within 2 weeks prior to enrollment; (2) Cardiac function: no heart disease, coronary heart disease, cardiac function level 1-2; ③ In the first 7 days of enrollment, liver and kidney function was adequate and laboratory indicators were suitable (untreated) : HGB≧9.0g\u002Fdl, neutrophils ≧1,500\u002Fmm3, PLT≧50x109\u002FL, serum ALB≧28g\u002FL, TBIL\\\u003C2mg \u002FdL, ALT, AST\\\u003C 5 times of the upper limit of normal value, Bun, Cr\\\u003C 1.5 times of the upper limit of normal value, INR\\\u003C1.7 or extended PT\\\u003C3s;\n9. Patients with normal blood pressure or hypertension should use antihypertensive drugs to control blood pressure within the normal range;\n10. Diabetic patients should control fasting blood glucose ≤8mmol\u002FL by hypoglycemic drugs;\n11. No other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation, etc.) that conflict with the Plan;\n12. No history of other malignant tumors;\n13. Women of childbearing age must have a negative blood pregnancy test within seven days, and subjects of childbearing age must use appropriate contraception during the test and for six months after the test;\n14. The patient agrees to participate in the clinical study and sign the Informed Consent.\n\nExclusion Criteria:\n\n* (1) previous radiotherapy, hormone therapy or molecular targeted therapy; (2) Patients with distant metastasis confirmed by imaging; (3) The subject has had or co-has other malignancies (other than cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); (4) The subject is known to be allergic to macromolecular protein preparations, or to any component of anti-PD-1 antibodies; (5) Subject has any history of active autoimmune disease or autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with childhood leukoplectic disease or complete remission of asthma can be incorporated into adults without any intervention; Subjects requiring medical intervention with bronchodilators are not included; (6) Subjects were taking immunosuppressants, or systemic or absorbable topical hormone therapy for immunosuppressive purposes (doses \\>10mg\u002F day of prednisone or other therapeutic hormones) and were still taking them within 2 weeks prior to enrollment; (7) Clinical symptoms of heart disease or disease not well controlled, such as: heart failure of grade 2 or above A.N. B. Unstable angina pectoris; C. Myocardial infarction within 1 year; D. Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (8) Abnormal coagulation function (PT\\>16s, APTT\\>43s, TT\\>21s, Fbg\\>2g\u002FL), bleeding tendency or receiving thrombolytic or anticoagulant therapy; (9) The patient has current (within 3 months) gastrointestinal conditions such as esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding from unexcised tumors, or other conditions identified by the investigator as likely to cause gastrointestinal bleeding and perforation; (10) Previous or current severe bleeding (bleeding \\>30 ml within 3 months), hemoptysis (fresh blood \\>5 ml within 4 weeks), or thromboembolic events (including stroke events and\u002For transient brain dysfunction) within 12 months; (11) Previous and current patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, severe impairment of lung function, etc.; (12) of congenital or acquired immune deficiency, such as HIV infection, active hepatitis (transaminase does not meet the criteria for the hepatitis b reference: HBV DNA of 10 or higher ⁴ \u002F ml; Hepatitis C reference: HCV RNA≥103\u002Fml); Chronic hepatitis B virus carriers with HBV DNA\\\u003C2000 IU\u002Fml (\\\u003C104 copies \u002Fml) must also receive antiviral therapy during the trial to be enrolled; (13) Subjects are participating in other clinical studies or less than one month has passed since the end of the previous clinical study; Subjects may receive other systemic antitumor therapies during the study; (14) The subject is known to have a history of psychotropic, alcohol, or drug abuse; (15) Imaging examination confirmed tumor recurrence or metastasis 2 months after surgery; (16) The researcher believes that it should be excluded from this study. For example, in the researchers' judgment, the subjects had other factors that might have led to the study's termination, such as other serious medical conditions (including mental illness) requiring combination treatment. Serious laboratory abnormalities, accompanied by family or social factors, may affect the safety of the subject or the collection of data and samples.","75 Years",{"count":50,"type":21},70,[52],"PHASE1","Lenvatinib is an oral multi-target receptor tyrosine kinase inhibitor (TKI) inhibitor that mainly inhibits the Endothelial growth factor receptor (VEGFR) VEGFR-1,2,3; Fibroblast growth factor receptor, FGFR) FGFR-1,2,3,4; Platelet-derived growth factor receptor (PDGFR) PDGFRα; The kinases RET and KIT, thereby inhibiting tumor cell proliferation, inducing apoptosis, and playing an anti-angiogenic role, have been approved by the FDA and CFDA as first-line treatment for patients with advanced liver cancer. lenvatinib showed longer disease progression than sorafenib (8.9 months vs. sorafenib. 3.7 months), longer progression-free survival (7.4 months vs. 3.7 months), and higher disease control rates (24.1% vs. 9.2%). Therefore, lenvatinib has obvious advantages in HCC treatment because of its strong anti-angiogenic and anti-tumor growth effects.\n\nCindilimab is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thereby blocking the programmed death receptor-1 (PD-1)\u002Fprogrammed death receptor-1 ligand (PD-L1) pathway induced by tumor immune tolerance, and reactivating the antitumor activity of lymphocytes.\n\nIn summary, recurrence after radical treatment of liver cancer is an urgent clinical problem. Recurrent HCC treatment represented by resection, ablation and TACE is difficult to achieve more satisfactory efficacy. The main ablative techniques includes radiofrequency ablation, microwave ablation and cryoablation.As a local treatment for liver cancer, ablation has the risk of incomplete ablation and insufficient ablation margin, and because RFA cannot resolve micrometastases, tumor growth, invasion and metastasis occur. Therefore, ablation combined with lenvatinib and immune checkpoint inhibitors have theoretical complementary advantages, and this study intends to compare the clinical efficacy and safety of ablation combined with lenvatinib plus anti-PD-1 antibodies in the treatment of patients with early recurrent liver cancer compared with ablation alone.",[55],"Hepatocellular Carcinoma","RECRUITING","2024-07-23",{"date":59,"type":32},"2024-07-24",{"date":61,"type":32},"2024-01-01",{"date":63,"type":21},"2025-04-01",{"name":38,"class":39},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":72,"minAge":17,"maxAge":18,"enrollmentInfo":73,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":40},"100533929","clinical-study-of-individualized-treatment-of-relapsed-or-drug-resistant-advanced-gynecological-tumors-guided-by-ptc-model-100533929","NCT06232213","Clinical Study of Individualized Treatment of Relapsed or Drug-resistant Advanced Gynecological Tumors Guided by PTC Model","The PTC Microtumor Model is Used to Guide the Feasibility Study of Treatment for Patients With Drug-resistant or Relapsed Advanced Ovarian Epithelial Cancer or Endometrial Cancer","Inclusion Criteria:\n\n1. Age ≥18 years, ≤80 years\n2. Recurrent\u002Fdrug-resistant gynecological tumors include: ① patients with advanced high-grade ovarian serous cancer whose tumor is uncontrolled or recurrent within 6 months after receiving platinum-based chemotherapy; ② Advanced ovarian high-grade serous cancer patients with platinum resistance at first treatment; ③ Patients with advanced or recurrent endometrial adenocarcinoma.\n3. Life expectancy \\> 6 months;\n4. Malignant tumors that are not being treated by other systems or are in an active phase;\n5. Have at least one measurable target lesion according to RECIST1.1 criteria;\n6. Specimen requirements: fresh specimens with sufficient cell culture, including tissue samples and abdominal effusion;\n7. Physical strength score: ECOG 0-2;\n8. Major organ functions must meet clinical treatment requirements:\n\n   * Blood routine: neutrophil (ANC) ≥1.5x109\u002FL; Platelet count (PLT) ≥90x109\u002FL; Hemoglobin (Hb) ≥90g\u002FL; ② Blood biochemistry: total bilirubin (TBIL) ≤1.5x upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5xULN; Urea nitrogen (BUN) and creatinine (Cr) ≤1.5 x ULN\n\n(3) Heart color ultrasound: left ventricular ejection fraction (LVEF) ≥55%;\n\n④ 12-lead ECG: Fridericia method corrected QT period (QTcF) \\\u003C 470 msec. (9) Consent to abstinence from sex or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment for female patients who are not menopausal or have not been surgically sterilized; (10) Patients participating in the study (or their legal representatives) understand and voluntarily sign informed consent, have good compliance, and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Patients who are unable to provide sufficient fresh samples;\n2. pregnant and lactating women, female patients with fertility and positive pregnancy tests, or patients of childbearing age who are unwilling to take effective contraceptive measures during the whole test period;\n3. The patient has uncontrollable co-morbidity, including but not limited to: symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade III hypertension, liver insufficiency, renal insufficiency, diabetes uncontrolled blood sugar, arrhythmia and mental illness;\n4. Other circumstances in which the investigator determines that participation in the study is not appropriate.","FEMALE",{"count":74,"type":21},40,"OBSERVATIONAL","The clinical treatment of patients with resistant\u002Frelapsed\u002Fadvanced gynecological malignancies is very difficult, and the difficulty lies in the selection of effective drugs. This study was a cohort study of recurrent\u002Fdrug-resistant advanced ovarian high-grade serous carcinoma and advanced\u002Frecurrent endometrial adenocarcinoma treated in our hospital. A total of 20 cases were included in the proposed study group, including 12 cases of high-grade serous ovarian carcinoma and 8 cases of endometrial adenocarcinoma. Twenty patients who did not use PTC model to guide treatment at the same period were selected as controls. To compare the consistency of in vitro drug sensitivity detection results of PTC microtumor with clinical therapeutic effect, and to explore the feasibility of using PTC microtumor model to guide the treatment of patients with drug-resistant\u002Frecurrent advanced ovarian epithelial cancer or endometrial cancer. The clinical therapeutic effects of the study group and the control group were compared, and the rates of CR, PR, SD, PFS, OS and TTP were evaluated by RECIST1.1 standard. PTC models based on different clinical samples (tissue and ascites) were compared to analyze the consistency of in vitro drug sensitivity detection results and the relationship with clinical efficacy.",[78],"Personalized Cancer Treatment","2024-01-22",{"date":81,"type":32},"2024-01-30",{"date":83,"type":32},"2023-09-01",{"date":85,"type":21},"2026-09-30",{"name":38,"class":39},""]