[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"targeted-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:targeted-therapy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,49,71,96,122,149,167,194,227,256,280,306,330,355,380,403,442,469],{"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":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100543493","phase-2-fruquintinib-combined-with-sintilimab--radiotherapy-for-third-line-treatment-of-colorectal-cancer-with-liver-metastases-100543493",false,"NCT06356584","Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases","Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases: A Randomized, Controlled, Multicenter Phase II Trial","Inclusion Criteria:\n\n* ECOG PS 0-2\n* Histologically confirmed colorectal adenocarcinoma with liver metastases (8th edition AJCC)\n* MSS\u002FpMMR subtype\n* Previously received standard first- and second-line systemic anti-tumor therapy\n* At least one measurable lesion as defined by RECIST 1.1 criteria\n* Access to tumor samples for biomarker assessment\n* Expected survival of ≥3 months\n* Normal function of major organ systems (within 14 days before enrollment)\n* No systemic corticosteroid treatment within 7 days before treatment initiation, excluding physiological corticosteroid replacement therapy.\n* Fertile males or females with the potential for pregnancy must use highly effective contraception methods during the trial.\n\nExclusion Criteria:\n\n* Patients diagnosed with malignancies other than colorectal cancer within 3 years prior to enrollment.\n* Participating in an interventional clinical study or receiving other investigational drugs or treatments with study devices within the past 4 weeks before enrollment.\n* Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell co-stimulatory or co-inhibitory receptor (e.g., CTLA-4, OX-40, CD137), fruquintinib, etc.\n* Received traditional Chinese medicine or immune-modulating drugs with anti-tumor indications within the past 2 weeks before enrollment (excluding local use for controlling pleural effusion).\n* Experienced active autoimmune diseases requiring systemic therapy within the past 2 years before enrollment. Replacement therapy is not considered systemic therapy.\n* Diagnosed with immune deficiency or received systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of investigational treatment. After consultation with the sponsor, the use of physiological doses of corticosteroids may be approved.\n* Received liver radiotherapy within the past 2 weeks before enrollment.\n* Known presence of central nervous system metastases and\u002For carcinomatous meningitis.\n* Received systemic corticosteroid therapy within 7 days before enrollment.","ALL","18 Years","75 Years",{"count":20,"type":21},62,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. This prospective study will evaluate the efficacy of combined therapy involving sintilimab, fruquintinib, and radiotherapy in CRC with liver metastases. The primary objectives are to assess progression-free survival, overall survival, and treatment response rates. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for CRC with liver metastases by elucidating the efficacy and safety of this combined treatment approach.",[27,28,29,30,31],"Colorectal Cancer","Immunotherapy","Radiotherapy","Targeted Therapy","Liver Metastasis",[33,28,29,34,35],"Colorectal cancer","Targeted therapy","Liver metastasis","RECRUITING","2026-04-27",{"date":39,"type":40},"2026-04-28","ACTUAL",{"date":42,"type":40},"2024-04-01",{"date":44,"type":21},"2026-10-01",{"name":46,"class":47},"Shandong Cancer Hospital and Institute","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":48},"100595459","phase-2-olutasidenib-combined-with-co-targeted-therapy-in-relapsed-or-refractory-idh1-mutated-myeloid-malignancies-harboring-activated-signaling-pathway-mutations-100595459","NCT07032727","Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations","Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Participants with a diagnosis of relapsed and\u002For refractory AML (including biphenotypic or bilineage leukemia including a myeloid component) OR high-risk MDS, MPN, or MDS\u002FMPN (defined as ≥10% blasts on peripheral flow cytometry or bone marrow biopsy).\n3. Participants must have a documented IDH1 mutation.\n4. Participants must also have a documented co-signaling mutation in one or more of the following: KRAS, NRAS, PTPN11, CBL, NF1, FLT3-ITD, FLT3-TKD, KIT, JAK2, MPL, CALR, CSF3R.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.\n6. Adequate renal function with estimated GFR ≥ 30 by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).\n7. Adequate hepatic function, defined as direct bilirubin ≤ 2x upper limit of normal (ULN) and AST and ALT ≤ 3x ULN unless the increase is due to Gilbert's disease or leukemic involvement, in which case direct bilirubin, AST, and ALT ≤ 5x ULN will be considered eligible.\n8. The interval from prior treatment to time of initiation will be at least 14 days OR five half-lives for both cytotoxic and non-cytotoxic (e.g. immunotherapy agent(s)). Oral hydroxyurea and\u002For cytarabine (up to 2g\u002Fm2) is allowed for participants with rapidly proliferative disease prior tothe start and during the first two cycles of therapy, for clinical benefit and after discussion with the PI. Continuation of concurrent intrathecal therapy for controlled CNS disease is permitted.\n9. Ability to understand and the willingness to sign an informed consent document.\n\nExclusion Criteria\n\n1. Participants who have received prior olutasidenib (Rezlidhiai, previously FT-2102).\n2. Participants with translocation t(15;17) or acute promyelocytic leukemia (French-American British (FAB) class M3-AML).\n3. Participants with any concurrent uncontrolled clinically significant medical condition, including life threatening infection, which could place the patient at unacceptable risk of study treatment.\n4. Participants with any uncontrolled psychiatric illness that would limit compliance with study requirements.\n5. Participants with a New York Heart Association (NYHA) Functional Classification of III or IV.\n\n   • Participants with active graft-versus-host-disease (GVHD) status post stem cell transplant (Participants without active GVHD on phototherapy for chronic skin GVHD are permitted after discussion with the PI). Participants must have discontinued calcineurin inhibitors at least 4 weeks prior to the start of study treatment.\n6. Participants with active, uncontrolled CNS leukemia.\n7. Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n8. Known active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) infection. For participants with evidence of chronic HBV or HIV infection, the HBV or HIV viral load must be undetectable, respectively. For participants with a history of HCV, it must be treated and cured with an undetectable HCV viral load.\n9. Participant has white blood cell count \\>25 x 109\u002FL (Note: Hydroxyurea and cytarabine are permitted to mean this criterion).\n10. The effects of the study drug on the developing human fetus or transmission through breast feeding are unknown. Therefore, nursing women and women with a positive urine pregnancy test and excluded. Additionally, women of child-bearing potential (WOCBP) and men who are sexually active with WOCBP who are not willing to maintain adequate contraception are excluded.\n\n    a. WOCBP includes all female participants between the onset of menses (as early as 8 years of age) to 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n\n    ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n    iv. History of bilateral tubal ligation or another surgical sterilization procedure.\n\n    b. Approved methods of birth control are as follows: hormonal contraception (i.e. birth control pills, injection, transdermal patch, vaginal ring, hormonal implant), intrauterine device (IUD), tubal ligation or hysterectomy, subject\u002Fpartner post-vasectomy, double barrier methods (e.g. condom in combination with spermicide). Abstinence for the duration of the trial and drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately.\n\n    c. Adequate contraception must be maintained from initiation of the study drug until 90 days after the last dose of the study drug.\n11. History of an allergic reaction to venetoclax, gilteritinib, ruxolitinib, cladribine, or cytarabine.",{"count":56,"type":21},68,[24],"To learn about the safety and tolerability of study drug combinations in patients with relapsed\u002Frefractory, IDH1-mutated myeloid malignancies with a co-signaling mutation.",[30,60,61],"IDH1-Mutated Malignancies","Mutations","2026-04-13",{"date":64,"type":40},"2026-04-15",{"date":66,"type":40},"2025-09-12",{"date":68,"type":21},"2029-06-01",{"name":70,"class":47},"M.D. Anderson Cancer Center",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":80,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":48},"100626531","impact-of-emotional-status-on-prognosis-of-patients-with-bclc-stage-bc-hepatocellular-carcinoma-undergoing-hepatic-arterial-infusion-chemotherapy-combined-with-targeted-and-immunotherapy-100626531","NCT07436845","Impact of Emotional Status on Prognosis of Patients With BCLC Stage B\u002FC Hepatocellular Carcinoma Undergoing Hepatic Arterial Infusion Chemotherapy Combined With Targeted and Immunotherapy","Impact of Emotional Status on Prognosis of Patients With BCLC Stage B\u002FC Hepatocellular Carcinoma Undergoing Hepatic Arterial Infusion Chemotherapy Combined With Targeted and Immunotherapy: A Multicenter, Prospective, Observational Clinical Study","Inclusion Criteria:\n\n* 1: All patients provided voluntary, written informed consent prior to any study procedures.\n\n  2: Aged 18 years or older, both male and female.\n\n  3: Patients with clinically or pathologically confirmed Barcelona Clinic Liver Cancer (BCLC) stage B or C hepatocellular carcinoma, who are deemed eligible for hepatic arterial infusion chemotherapy (HAIC) combined with targeted and immunotherapy as assessed by the clinician.\n\n  4: No prior systemic antitumor therapy.\n\n  5: At least one intrahepatic evaluable lesion is present, with the intrahepatic lesion constituting the primary tumor burden. (According to RECIST v1.1 criteria, the measurable lesion must have a long diameter \\>= 10 mm on spiral CT scan, or enlarged lymph nodes must have a short diameter \\>= 15 mm.);\n\n  6: Child-Pugh score \\\u003C= 7 (Rated as Child-Pugh class A or B);\n\n  7: Able to swallow tablets normally;\n\n  8: ECOG performance status: 0-1;\n\n  9: Patients' psychological status and laboratory test indicators can be comprehensively documented at baseline and during the treatment period;\n\n  10: All patients have no history of other psychiatric disorders.\n\nExclusion Criteria:\n\n1\\. Presence of any active autoimmune disease or history of autoimmune diseases (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; childhood asthma that has completely resolved in adulthood and requires no intervention may be included; asthma requiring medical intervention with bronchodilators is excluded).\n\n2: Current use of immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (at a dose \\>10mg\u002Fday of prednisone or equivalent), continuing within 2 weeks prior to enrollment.\n\n3: Known history of central nervous system metastases or hepatic encephalopathy.\n\n4: Congenital or acquired immunodeficiency (e.g., HIV infection);\n\n5: History or presence of other malignancies within the past 3 years (with the exception of cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).\n\n6: Current use of antidepressant or anti-anxiety medications, or severe psychiatric disorders requiring other psychotropic medications.\n\n7: Any other condition deemed by the investigator as likely to affect the study results or lead to premature termination of the study, such as alcohol or drug abuse, other severe co-morbidities (including psychiatric disorders) requiring concomitant treatment, or severe laboratory abnormalities.\n\n\\-",{"count":79,"type":21},90,"2 Years","OBSERVATIONAL","This study is a multicenter, prospective, observational clinical trial designed to evaluate the impact of baseline emotional status on the clinical outcomes of patients with BCLC stage B\u002FC hepatocellular carcinoma undergoing HAIC combined with targeted immunotherapy. A total of 90 patients are planned to be enrolled and divided into a depressive mood group and a non-depressive mood group based on a PHQ-9\u002FGAD-7 score of ≥5 points. The primary study endpoint is progression-free survival (PFS), and the secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety profile. Dynamic assessments of patients' emotional status, quality of life (EORTC QLQ-C30), and peripheral blood levels of neuroendocrine-immune markers will be conducted at preset time points. The results indicate that emotional status may serve as an important modifiable factor influencing the efficacy of comprehensive therapy in patients with advanced liver cancer, providing an evidence-based basis for the formulation of psychosomatic integrated clinical intervention strategies in the future.",[84,85,86,28,30],"Hepatocellular Carcinoma (HCC)","Emotional Distress","HAIC(Hepatic Artery Infusion Chemotherapy)","2026-02-23",{"date":89,"type":40},"2026-02-27",{"date":91,"type":40},"2025-12-01",{"date":93,"type":21},"2028-01-01",{"name":95,"class":47},"Nanfang Hospital, Southern Medical University",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":117,"leadSponsor":119,"locationsCount":48},"100609850","phase-1-a-study-to-investigate-hla-g-targeted-exosome-sob100-in-healthy-subjects-100609850","NCT07219940","A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects","An Open-label and Dose-escalation Phase I Clinical Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of HLA-G-targeted Exosome (SOB100) in Healthy Subjects","αHLA-G Exo-01","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old\n2. Overtly healthy subject, who is considered to be generally healthy based on medical history, 12-lead ECG, and physical examinations, as judged by the Investigator\n3. Able to understand and comply with procedures in the protocol as judged by Investigator and sign the informed consent form (ICF)\n4. Adequate organ function\n\nExclusion Criteria:\n\n1. With known or suspected to be hypersensitivity to HLA-G related treatment.\n2. Confirmed active HIV, HBV, or HCV infection\n3. With active fungal, bacterial, viral or atypical infection requiring systemic medication\n4. History of cancer (malignancy) or have ever received any anti-cancer therapy\n5. Has ever received cell therapy or organ transplantation\n6. Substance abuse or addictive use of drugs for nonmedical purposes\n7. Female subject is lactating, has a positive pregnancy test or refuse to practice highly effective contraception\n8. Male subjects with a female spouse\u002Fpartner who is of childbearing potential refuse to adopt at least one highly effective method of contraception",true,{"count":106,"type":21},15,[108],"PHASE1","The investigational drug, SOB100, is an HLA-G targeted exosome equipped with a nanobody namely anti-HLA-G VHH on the exosome membrane. This is a Phase I dose escalation study to exam the tolerability, safety, and pharmacokinetics in healthy subjects.",[111,112,30],"Healthy Subjects","Exosome","2026-01-22",{"date":115,"type":40},"2026-01-26",{"date":91,"type":40},{"date":118,"type":21},"2027-03",{"name":120,"class":121},"Shine-On Biomedical Co., Ltd.","INDUSTRY",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":48},"100425581","phase-3-neoadjuvant-treatment-modalities-in-esophageal-cancer-100425581","NCT04821843","Neoadjuvant Treatment Modalities in Esophageal Cancer","Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer","Inclusion Criteria:\n\n* ≥18 years；\n* Esophageal or Esophagogastric cancer；\n* Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa (AJCC 8th)；\n* Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；\n* ECOG PS score: 0\\~1；\n* Estimated survival time ≥3 months；\n* Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g\u002FL ;Leukocytes: greater than or equal to 4,000 G\u002FL; Neutrophil: greater than or equal to 2,000 G\u002FL; Platelets: greater than or equal to 100,000\u002Fmm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml\u002Fmin; AST\u002FALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit；\n* Informed consent；\n\nExclusion Criteria:\n\n* With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc；\n* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer；\n* Existing active infection such as active tuberculosis and hepatitis；\n* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia；\n* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin；\n* Participation in other clinical trials currently or within 4 weeks of selection；\n* Pregnant or lactating females；\n* Absence of medical records.",{"count":130,"type":21},2000,[132],"PHASE3","Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1\u002FPD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.",[135,136,137,138,30,28,139],"Esophageal Cancer","Chemotherapy Effect","Chemoradiation","Surgery","Esophagogastric Juction Cancer","2026-01-18",{"date":142,"type":40},"2026-01-21",{"date":144,"type":40},"2002-01-01",{"date":146,"type":21},"2030-12-31",{"name":148,"class":47},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":164,"leadSponsor":165,"locationsCount":166},"100425577","phase-3-chemoradiotherapy-in-esophageal-or-esophagogastric-junction-cancer-100425577","NCT04821778","Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer","Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer","Inclusion Criteria:\n\n* ≥18 years；\n* Esophageal or Esophagogastric cancer；\n* Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa(AJCC 8th)；\n* Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；\n* ECOG PS score: 0\\~1；\n* Estimated survival time ≥3 months；\n* Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g\u002FL ;Leukocytes: greater than or equal to 4,000 G\u002FL; Neutrophil: greater than or equal to 2,000 G\u002FL; Platelets: greater than or equal to 100,000\u002Fmm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml\u002Fmin; AST\u002FALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit；\n* Informed consent；\n\nExclusion Criteria:\n\n* With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc；\n* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer；\n* Existing active infection such as active tuberculosis and hepatitis；\n* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia；\n* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin；\n* Participation in other clinical trials currently or within 4 weeks of selection；\n* Pregnant or lactating females；\n* Absence of medical records.",{"count":130,"type":21},[132],"Definitive chemoradiotherapy is the standard of care in unresectable esophageal or esophagogastric cancer. A multidisciplinary approach, including chemotherapy and radiotherapy, is important for these patients. Morerover, molecular targeting agents does not show clear efficacy in EC up to now. Nowadays, the pace of development of cancer immunotherapies is accelerating. Clinical evidence of the efficacy of immune checkpoint inhibitors and adoptive immunotherapies herald the onset of a new era in cancer immunotherapy. There have also been recent developments to provide a promising frontier in extending the use of immunotherpay or targeting agents to radiotherapy. The purpose of this study was to explore the optimal treatment modalities including PD-1\u002FPD-L1 antibody or targeted drug for patients with unresectable esophageal or esophagogastric junction cancer.",[160,161,137,30,28,136],"Esophagus Cancer","Esophagogastric Junction Cancer",{"date":142,"type":40},{"date":144,"type":40},{"date":146,"type":21},{"name":148,"class":47},5,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":182,"overallStatus":185,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100620295","phase-2-ma-crc-ii-016-shr-1811-100620295","NCT07355764","MA-CRC-II-016 SHR-1811","SHR-1811 Combined With Bevacizumab as Second-line Treatment in Patients Metastatic CRC","Inclusion Criteria:\n\n-Provide a written informed consent form to voluntarily participate in this study.\n\nMale or female subjects aged 18-75 years.\n\n* Patients with histologically or cytologically confirmed recurrent or metastatic colorectal adenocarcinoma that is not amenable to curative resection.\n* Patients who have experienced disease progression following first-line standard therapy with oxaliplatin combined with fluoropyrimidine-based drugs.\n* Patients with disease progression within 12 months after completion of neoadjuvant or adjuvant therapy are eligible for inclusion.\n* Patients who have previously received irinotecan as part of first-line therapy may be included if investigators from the leading center determine through discussion that the patient is likely to benefit from treatment in the control group.\n* HER2 expression status: Includes patients with HER2 overexpression (IHC 3+ \u002F IHC 2+ with FISH positivity) or HER2 low-to-moderate expression (IHC 2+ with FISH negativity or IHC 1+).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.\n* Ability to provide a report documenting RAS\u002FBRAF gene status.\n* Expected survival time of at least 6 months.\n* Presence of radiologically assessed measurable lesions at baseline (per RECIST 1.1 criteria). Measurable lesions should not have received prior local therapy such as radiotherapy. Lesions located within previously irradiated areas may be selected as target lesions if disease progression in these lesions is confirmed.\n* Adequate function of major organs, meeting the following requirements (administration of blood components or cell growth factors for corrective treatment is not allowed within 14 days prior to the first dose of study medication):\n* Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL Serum albumin ≥ 30 g\u002FL Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate \\> 60 mL\u002Fmin (calculated by the Cockcroft-Gault formula) Activated Partial Thromboplastin Time (APTT) and International Normalized Ratio (INR) ≤ 1.5 × ULN. Patients receiving stable-dose anticoagulant therapy (e.g., low-molecular-weight heparin or warfarin) with INR within the expected therapeutic range for anticoagulants are eligible for screening.\n* For female subjects of childbearing potential:\n\nA negative serum pregnancy test result is required within 3 days prior to the first dose, and the subject must not be breastfeeding.\n\nMust agree to use effective contraceptive measures during the study period and for at least 7 months after the last dose of SHR-A1811, or for at least 6 months after the last dose of other study medications.\n\n-For male subjects whose partners are of childbearing potential: The subject must have undergone surgical sterilization, or agree to use effective contraceptive measures during the study period and for at least 7 months after the last dose of SHR-A1811, or for at least 6 months after the last dose of other study medications.\n\nSperm donation is prohibited during the study period.\n\nExclusion Criteria:\n\n* Toxicities from prior anti-tumor therapies have not resolved to ≤ Grade 1 per the CTCAE v5.0 criteria (except for toxicities deemed to pose no safety risk by the investigator, e.g., alopecia) or to the levels specified in the inclusion\u002Fexclusion criteria.\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with a history of treated brain metastases may be enrolled provided that their brain metastases are stable, and they have not received steroid therapy for brain metastases for at least 28 days prior to study initiation. This exception does not apply to carcinomatous meningitis, as patients with carcinomatous meningitis are excluded regardless of clinical stability.\n* Known microsatellite instability-high (MSI-H) status confirmed by genetic testing or deficient mismatch repair (dMMR) status confirmed by immunohistochemistry.\n* A history of hypersensitivity to monoclonal antibodies, the formulation components of SHR-A1811, or anti-angiogenic agents.\n* Prior treatment with HER2-targeted antibody-drug conjugates (ADCs).\n* Major surgery, open biopsy, or severe trauma within 28 days prior to the first study drug administration.\n* Patients with any severe and\u002For uncontrolled diseases, including:\n\nPatients with inadequately controlled hypertension; Myocardial ischemia or myocardial infarction of Grade ≥1, cardiac arrhythmias (including QT interval ≥ 480 ms), or cardiac insufficiency of Grade ≥1; Active or uncontrolled severe infections; Hepatic diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 10⁴ copies\u002FmL or 2000 IU\u002FmL) or active hepatitis C (positive for hepatitis C antibody with HCV-RNA level above the lower limit of quantification of the assay); Subjects with urine protein ≥ ++ on routine urinalysis and confirmed 24-hour urine protein quantification \\> 1.0 g.\n\n* Clinically significant bleeding symptoms or confirmed bleeding diathesis (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis) within 3 months prior to the first study drug administration.\n* Arterial\u002Fvenous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, cerebral hemorrhage, cerebral infarction; deep vein thrombosis; pulmonary embolism) within 6 months prior to the first study drug administration. Subjects with superficial venous thrombosis may be enrolled at the investigator's discretion.\n* Presence of another concurrent progressive malignancy requiring active treatment, with the exception of non-melanoma skin cancer and carcinoma in situ of the cervix that have undergone potential curative treatment.\n* Any other factors judged by the investigator that may force the subject to discontinue the study prematurely, including severe concurrent illnesses (including mental illnesses) requiring concomitant treatment, severely abnormal laboratory test results, family or social factors that may affect subject safety or the collection of trial data.",{"count":175,"type":21},80,[24],"A randomized, controlled, multicenter clinical study of SHR-A1811 combined with bevacizumab for the second-line treatment of metastatic colorectal cancer",[179,180,30,181],"mCRC","HER2","Antibody-drug Conjugates",[183,179,184],"SHR-1811","second-line","NOT_YET_RECRUITING","2026-01-12",{"date":142,"type":40},{"date":189,"type":21},"2025-12-30",{"date":191,"type":21},"2028-01-31",{"name":193,"class":47},"Peking Union Medical College Hospital",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":204,"conditions":205,"keywords":213,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":48},"100431655","patient-centered-optimal-integration-of-survivorship-and-palliative-care-100431655","NCT04900935","Patient-centered, Optimal Integration of Survivorship and Palliative Care","Inclusion Criteria:\n\n* Age 18 or older\n* MGH Cancer Center patient\n* Within 6 months of diagnosis of metastatic NSCLC with oncogenic driver mutation (EGFR, ALK, ROS1, RET)\n* Receiving targeted therapy\n* Ability to respond in English or Spanish\n\nExclusion Criteria:\n\n* Cognitive impairment or serious mental illness that limits ability to provide informed consent\n* Need for urgent palliative care or hospice referral\n* Pregnant women\n* Prisoners",{"count":201,"type":21},70,[203],"NA","The goal of this study is to develop and test the feasibility of a supportive care model (POISE) for patients with metastatic Non-small Cell Lung Cancer (NSCLC). The main questions are\n\n* is POISE feasible to deliver and acceptable to patients\n* what is the effect of POISE on the distress patients feel related to their uncertain future, their confidence in their ability to manage cancer, and their understanding about what to expect Participants in the randomized controlled trial will receive either the new supportive care model, POISE, which consists of four visits with a trained palliative care clinician, or care as usual, and will be asked to complete three surveys.",[206,30,207,208,209,210,211,212],"Stage IV Non-small Cell Lung Cancer","Nonsmall Cell Lung Cancer","Carcinoma, Non-Small-Cell Lung","ALK-positive Non-small Cell Lung Cancer","EGFR Positive Non-small Cell Lung Cancer","Palliative Care","Survivorship",[206,30,207,208,209,210,214,215,216,217],"ROS1 Positive Non-Small Cell Lung Cancer","Palliative care","survivorship","RET Fusion positive Non-Small Cell Lung Cancer","2025-11-19",{"date":220,"type":40},"2025-11-24",{"date":222,"type":40},"2023-09-29",{"date":224,"type":21},"2027-09-01",{"name":226,"class":47},"Massachusetts General Hospital",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":246,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":254,"locationsCount":48},"100608177","phase-2-scrt-followed-by-capox--bev--pd-1-inhibitor-for-tnt-in-larc-100608177","NCT07198165","SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC","Short-Course Radiotherapy Combined With CAPOX and Bevacizumab, With or Without PD-1 Inhibitors, as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Histopathologically confirmed rectal adenocarcinoma with no prior antitumor therapy.\n* Exclusion of patients with BRAF mutations or MSI-H status, as determined by pre-enrollment genetic testing including RAS, BRAF, and MSI analysis. RAS mutation status is permitted regardless.\n* Absence of severe intestinal obstruction symptoms and no evidence of distant metastasis confirmed by imaging examinations such as CT, MRI, or PET\u002FCT.\n* Confirmation as locally advanced rectal cancer by rectal MRI, meeting one or more of the following criteria: T3c-d or T4, N2, EMVI(+), MRF(+), lateral lymph node metastasis; or patients with low-lying rectal cancer (≤5 cm from the anal verge) unsuitable for sphincter-preserving surgery prior to neoadjuvant therapy.\n* Age 18 to 75 years.\n* ECOG Performance Status of 0 to 1, without severe comorbid medical conditions.\n* Adequate organ function:\n\nHematopoietic: Hemoglobin ≥90 g\u002FL, Platelets ≥80 × 10\\^9\u002FL, Absolute Neutrophil Count ≥1.5 × 10\\^9\u002FL.\n\nHepatic: ALT and AST \\\u003C 2.5 × ULN. Renal: Serum Creatinine \\\u003C 1.5 × ULN.\n\n* Provision of signed and dated written informed consent.\n\nExclusion Criteria:\n\n* Patients found to have BRAF mutations or MSI-H status.\n* Patients who have previously received chemotherapy, radiotherapy, immunotherapy, targeted therapy, or surgical resection for colorectal cancer prior to enrollment.\n* History or presence of another malignancy (except for early-stage basal cell carcinoma or carcinoma in situ of the cervix) within the past 3 years, with the disease not under control.\n* Patients who are pregnant (confirmed by serum or urine β-HCG test) or breastfeeding.\n* Patients with severe cardiac, hepatic, renal, neurological, or psychiatric diseases.\n* Patients with active infections.\n* Poor overall health status, with an ECOG performance status ≥2.\n* Patients who have undergone organ transplantation requiring immunosuppressive therapy, or those requiring long-term corticosteroid treatment for autoimmune diseases.\n* Patients with comorbid conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the completion of the study.\n* Known hypersensitivity to any of the study drugs.",{"count":235,"type":21},104,[24],"This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.",[239,240,241,242,28,243,244,30,245],"Rectal Cancer","Rectal Adenocarcinoma","Rectal Cancer, Radiotherapy","Rectal Cancer Patients","Total Neoadjuvant Therapy","Total Neoadjuvant Treatment","Chemoradiotherapy",[247,243,28,34,245],"Rectal cancer","2025-09-27",{"date":250,"type":40},"2025-09-30",{"date":252,"type":40},"2025-09-05",{"date":146,"type":21},{"name":255,"class":47},"Ruijin Hospital",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":48},"100574853","phase-2-oral-chemotherapy-targeted-therapy-and-immunotherapy-withwithout-radiotherapy-as-3rd--or-later-line-therapy-for-advanced-msspmmr-colorectal-cancer-100574853","NCT06764680","Oral Chemotherapy, Targeted Therapy and Immunotherapy With\u002FWithout Radiotherapy as 3rd- or Later-line Therapy for Advanced MSS\u002FpMMR Colorectal Cancer","Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab With\u002FWithout Involved Lesions Irradiation as 3rd- or Later-line Therapy for Advanced MSS\u002FpMMR Colorectal Cancer: a Phase 2, Double Cohort Clinical Trial","Inclusion Criteria:\n\n1. patients with advanced colorectal adenocarcinoma of MSS\u002FpMMR confirmed by histologic or cytologic diagnosis;\n2. aged 18 years and older;\n3. have a quality of life score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG);\n4. can take oral medications;\n5. expected survival ≥ 3 months;\n6. progressed after standard second-line or more than second-line therapy (received oxaliplatin, irinotecan, and fluorouracil analogs);\n7. have a measurable target lesion according to RECIST v1.1 evaluation criteria;\n8. have a number of recurrent metastatic organs ≤ 2 for all measurable lesions, a maximum diameter of recurrent metastatic lesions ≤ 5 cm, and a total number of recurrent metastatic lesions ≤ 10;\n9. agree to provide previously stored tumor tissue specimens or perform biopsies to collect tumor lesion tissue for biomarker analysis\n10. have chest, abdomen and pelvis CT or whole body PET-CT results within 4 weeks before enrollment;\n11. no ascites;\n12. having adequate major organ function, electrocardiogram, blood, biochemistry and other basic tests to exclude contraindications to chemotherapy and radiotherapy;\n13. hemoglobin \\>8g\u002FL, platelets ≥100×10\\^9\u002FL, neutrophils ≥1.5×10\\^9\u002FL\n14. for patients with liver metastases, aminotransferases and bilirubin \\\u003C 5 times the upper limit of normal;\n15. for patients without liver metastases, aminotransferases and bilirubin should be \\\u003C2.5 times the upper limit of normal.\n16. women of childbearing age must have a negative pregnancy test and conscientiously observe contraceptive measures;\n17. prior systemic systemic therapy and radiation therapy for other lesions are allowed;\n18. in case of discomfort such as obstruction, bleeding, compression and pain caused by the tumor, the clinical situation that local treatment may benefit the patient may be discussed between the doctor and the patient as to whether radiation therapy is to be taken;\n19. if radiotherapy is required, the patient can be kept in a fixed position during radiotherapy;\n20. If SABR treatment is required, the patient can tolerate the physical restraint of the immobilization device;\n21. good control of the primary site: at least 3 months from radical treatment of the primary tumor, with no disease progression at the site of the primary site; or the primary tumor is not radically treated but, in the judgment of the investigator, there is no current disease progression and no threat to the patient's survival, and there is no indication for local therapy.\n\nExclusion Criteria:\n\n1. prior application of trefluridine tepidopyrimidine;\n2. prior application of PD-1 or PD-L1 monoclonal antibody;\n3. extensive bone metastases;\n4. extensive peritoneal metastases;\n5. malignant hydrothorax and ascites;\n6. clinical or imaging signs of spinal cord compression, or dural sac tumor visible on MRI within 2 mm of the spinal cord. If surgically resectable, it may be enrolled, but a maximum of 3 surgical sites are allowed;\n7. unstable brain metastases with clinical signs or imaging evidence that require surgical decompression;\n8. brainstem metastases;\n9. metastatic lesions invading any of the following structures: gastrointestinal tract (including esophagus, stomach, small intestine, large intestine), skin. Includes extensive\u002Fpoppy metastatic disease (e.g., brain, bone, lung, liver), or other sites where an adequate dose of irradiation could not be given (e.g., lymphovascular dissemination, malignant pleural and abdominal fluid, molluscum contagiosum metastases);\n10. multiple intracranial metastases only;\n11. pregnant or lactating females;\n12. no reliable contraception during the reproductive period\n13. patients with a known history of hypersensitivity to any of the study drugs, analogs, or excipients;\n14. patients at risk of gastrointestinal hemorrhage or gastrointestinal obstruction;\n15. patients with a history of thromboembolism, with the exception of thrombosis caused by PICCs or infusion ports\n16. patients with difficult-to-control hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90 mmHg after optimal antihypertensive treatment);\n17. patients with contraindications to treatment such as other chronic diseases;\n18. Patients with active infections;\n19. patients with a pre-existing condition of immunotherapy-associated myocarditis, pneumonia, colitis, hepatitis, or nephritis who, in the judgment of the investigator, are at greater risk for reuse of immunotherapy;\n20. patients with existing toxic side effects ≥ grade 2 due to prior therapy according to NCI CTCAE version 5.0 (except for alopecia, hyperpigmentation, etc.);\n21. severe medical comorbidities that preclude radiotherapy, including interstitial lung disease with current metastases requiring radiotherapy to the lungs, Crohn's disease requiring radiotherapy to the gastrointestinal tract, or connective tissue disease such as lupus erythematosus or scleroderma;\n22. there is an overlap between the current radiation field and the field of prior radiotherapy. It may be permissible to have had prior radiation therapy as long as the fusion cumulative dose meets the dose limits. For this case, request that the dose be accrued in accordance with the BED and discuss with the PI whether this can be performed;\n23. prior systemic nuclide therapy, such as Radium-223 or Lutetium-177);\n24. other circumstances that the investigator determines are not appropriate for inclusion in the study.",{"count":264,"type":21},57,[24],"The current phase 2, double cohort clinical trial was designed to determine the effectiveness of Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab with\u002Fwithout involved lesions irradiation as 3rd- or later-line therapy for advanced MSS\u002FpMMR colorectal cancer.",[268,269,30,28,270],"Colorectal Cancer Metastatic","Chemotherapy","Radiotherapy, Intensity-Modulated","2025-08-22",{"date":273,"type":40},"2025-08-24",{"date":275,"type":40},"2024-12-31",{"date":277,"type":21},"2026-12-31",{"name":279,"class":47},"Sun Yat-sen University",{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":185,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":4},"100590744","phase-2-high-dose-firmonertinib-combined-with-bevacizumab-and-intrathecal-pemetrexed-in-the-treatment-of-egfr-mutated-non-small-cell-lung-cancer-with-leptomeningeal-metastasis-100590744","NCT06971406","High-Dose Firmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed in the Treatment of EGFR-Mutated Non-Small Cell Lung Cancer With Leptomeningeal Metastasis","A Multicenter, Prospective Phase II Clinical Study of High-Dose Firmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed in the Treatment of EGFR-Mutated Non-Small Cell Lung Cancer With Leptomeningeal Metastasis","FLAME-1","Inclusion Criteria:\n\n1. Have obtained written informed consent from the patient or his or her legal representative.\n2. Age ≥18 years, male or female.\n3. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).\n4. EGFR mutations confirmed by genetic testing (EGFR Ex19del\u002FL858R\u002FEx20ins\u002FPACC\u002FL861Q).\n5. Leptomeningeal metastasis diagnosed by comprehensive clinical assessment according to \"EANO-ESMO\" diagnostic criteria, including symptom evaluation, imaging assessment, and\u002For cerebrospinal fluid (CSF) cytopathological evaluation.\n6. Both treatment-naïve leptomeningeal metastasis patients and those who progressed after standard antitumor therapies in clinical practice are eligible. ≤3 prior lines of therapy allowed (patients with \\>3 prior lines may enroll in the real-world study cohort).\n7. ECOG PS 0-2 (patients with ECOG PS \\>2 may enroll in the real-world study cohort).\n8. Prior radiotherapy or surgical treatment targeting the central nervous system (CNS) is permitted.\n9. Patients with CNS symptoms\u002Fsigns are allowed if these manifestations are not life-threatening.\n10. Patients previously treated with standard-dose third-generation EGFR TKIs, pemetrexed intravenous infusion, or bevacizumab are permitted.\n11. Adequate organ function:\n\n    Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelets ≥75×10\\^9\u002FL, hemoglobin ≥80g\u002FL Total bilirubin ≤1.5×ULN, AST\u002FALT ≤2.5×ULN (≤3×ULN for bilirubin and ≤5×ULN for AST\u002FALT in cases with liver metastasis) Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n12. Sexually active males or females of childbearing potential must use highly effective contraception (e.g., oral contraceptives, IUD, abstinence, or barrier methods with spermicide) during the trial and for 12 months after treatment completion.\n\nExclusion Criteria:\n\n1. Diagnosis of other malignancies within the past 5 years or history of other malignancies (except adequately controlled basal cell carcinoma of the skin, cervical carcinoma in situ, or ductal carcinoma in situ of the breast).\n2. Severe gastrointestinal disorders affecting drug administration or absorption, including but not limited to peptic ulcer disease, inflammatory bowel disease, etc.\n3. Known or suspected hypersensitivity to the investigational drugs (Firmonertinib, Bevacizumab, Pemetrexed) or any of their excipients.\n4. Prior treatment with high-dose third-generation EGFR TKI or intrathecal chemotherapy with Pemetrexed.\n5. Evidence of any severe or uncontrolled systemic diseases, including uncontrolled hypertension, diabetes, active bleeding, or active infections (e.g., hepatitis B\u002FC, HIV), which in the investigator's judgment may jeopardize patient participation or protocol compliance.\n6. History of steroid-requiring radiation pneumonitis or any evidence of active interstitial lung disease.\n7. Clinically significant cardiac arrhythmias (e.g., QTc interval \\>500 ms) or heart failure (left ventricular ejection fraction \\\u003C50%).\n8. Pregnant or lactating women.\n9. Patients currently participating in or having received investigational drug therapy within 2 weeks prior to enrollment.\n10. Other severe acute\u002Fchronic medical or psychiatric conditions or laboratory abnormalities that, in the investigator's opinion, may increase study-related risks, interfere with result interpretation, or compromise the patient's ability to complete the study or adhere to protocol requirements.",{"count":289,"type":21},100,[24],"Primary Objective:\n\nTo evaluate the efficacy of high-dose firmonertinib combined with bevacizumab and intrathecal pemetrexed in EGFR Ex19del\u002FL858R-mutated non-small cell lung cancer (NSCLC) with leptomeningeal metastasis (LM), as measured by Overall Survival (OS).\n\nSecondary Objectives:\n\n1. To assess the efficacy of this regimen in EGFR Ex20ins\u002FPACC\u002FL861Q-mutated NSCLC with LM.\n2. To further evaluate therapeutic outcomes across cohorts, including:\n\n   * Time to Treatment Failure (TTF)\n   * Leptomeningeal Objective Response Rate (ORR-LM)\n   * Clinical Response Rate\n3. To analyze the impact of this regimen on \\*quality of life\\* using standardized metrics:\n\n   * EORTC QLQ-C30\n   * EORTC QLQ-LC13\n4. To assess safety profiles across cohorts, focusing on:\n\n   * Incidence and severity of adverse events (AEs) graded per \\*CTCAE v5.0\\*\n   * Frequency of treatment-related toxicities\n\nExploratory Objectives:\n\nTo investigate correlations between dynamic changes in:\n\n* Plasma-derived circulating tumor DNA (ctDNA)\n* Cerebrospinal fluid-derived cell-free DNA (cfDNA) and clinical outcomes through comparative analysis of genomic profiling and epigenetic signatures before and after treatment.",[293,294,295,30],"Non Small Cell Lung Cancer","EGFR Mutation","Leptomeningeal Metastases","2025-05-06",{"date":298,"type":40},"2025-05-14",{"date":300,"type":21},"2025-05-15",{"date":302,"type":21},"2027-06-01",{"name":304,"class":305},"Qiming Wang","OTHER_GOV",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":48},"100584462","phase-2-sabr-combined-with-axitinib-and-toripalimab-in-recurrent-or-metastatic-rcc-100584462","NCT06889649","SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC","Prospective Study on the Efficacy and Safety of Stereotactic Ablative Body Radiotherapy Combined with Axitinib and Toripalimab in Recurrent or Metastatic Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions confirmed by PET\u002FCT or other systemic imaging.\n2. Patients with ≤5 metastatic lesions amenable to complete lesion coverage radiotherapy; or \\>5 lesions with at least 3 suitable for radiotherapy as evaluated by the radiotherapy and imaging departments.\n3. Age between 18-80 years.\n4. Expected survival of ≥12 weeks.\n5. Measurable disease based on RECIST Version 1.1.\n6. ECOG performance status of 0-2.\n\nExclusion Criteria:\n\n1. History of anti-PD-1 or PD-L1 antibody therapy, or radiotherapy.\n2. Use of corticosteroids or other immunosuppressants within 14 days before treatment.\n3. Autoimmune diseases.\n4. History of other malignancies.\n5. History of surgery within 28 days before treatment.\n6. Allergy to study drug components.","80 Years",{"count":315,"type":21},30,[24],"This is a prospective, single-center clinical trial designed to evaluate the safety and efficacy of combining stereotactic ablative body radiotherapy (SABR) with the targeted therapy Axitinib and the immunotherapy Toripalimab in patients with recurrent metastatic renal cell carcinoma (RCC). Patients will receive a treatment regimen consisting of Axitinib, Toripalimab, and comprehensive multi-lesion SABR. The primary endpoint is Progression-Free Survival 1 (PFS1), and secondary endpoints include Progression-Free Survival 2 (PFS2), Overall Survival (OS), Local Control (LC), Objective Response Rate (ORR), and Disease Control Rate (DCR). Adverse events will be monitored according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0). The aim of this study is to explore a potentially more effective treatment combination for recurrent metastatic RCC.",[319,30,28,320],"Radiation Therapy","Renal Cancer Metastatic","2025-03-19",{"date":323,"type":40},"2025-03-21",{"date":325,"type":40},"2019-01-01",{"date":327,"type":21},"2028-02-20",{"name":329,"class":47},"Peking University First Hospital",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":48},"100573107","phase-1-a-clinical-study-on-neoadjuvant-treatment-of-resectable-head-and-neck-squamous-carcinoma-with-immune-targeted-therapy-and-lysogenic-hsv-virus-100573107","NCT06741982","A Clinical Study on Neoadjuvant Treatment of Resectable Head and Neck Squamous Carcinoma With Immune-targeted Therapy and Lysogenic HSV Virus","A Prospective, Single-arm Clinical Study of Immune-targeted Therapy Combined With Lysogenic HSV Virus for the Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma","Inclusion Criteria:\n\n1. Age ≥18 and ≤70 years old, regardless of gender;\n2. Patients with head and neck squamous carcinoma who are pathologically confirmed and fulfill the following conditions:\n\n   1. Patients with locally advanced head and neck squamous carcinoma (excluding nasopharyngeal, salivary gland and thyroid malignant tumors) who are initially diagnosed and have no distant metastasis;\n\n      * Non oropharyngeal HNSCC carcinoma and HPV-negative oropharyngeal carcinoma, stages III, IVA and IVB;\n      * HPV-positive oropharyngeal cancers, stages II and III;\n      * HPV status of oropharyngeal cancer will be determined by p16 immunohistochemistry.\n   2. Treatable by surgical resection as evaluated by head and neck surgery;\n   3. Definite lymph node metastasis and lymph node stage is not N0 or Nx.\n3. An Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 1;\n4. Have adequate organ and bone marrow function as defined below:\n5. Subjects voluntarily enrolled in the study, signed an informed consent form, and were able to comply with the visits and related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Lymph node staging of N0 or Nx status;\n2. History of other malignancies (except history of cured and non-recurrent basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ, intramucosal carcinoma of the gastrointestinal tract, and other malignancies considered by the investigator to be eligible for enrollment);\n3. Any active autoimmune disease or history of autoimmune disease including, but not limited to, immune-related neurological disorders, multiple sclerosis, autoimmune (demyelinating) neuropathies, Guillain-Barre Syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal Necrolytic Elastosis (TEN) or Stevens-Johnson Syndrome (except for type I diabetes on stabilized doses of insulin);\n4. A history of anaphylaxis, severe drug allergy, known allergy to any component of a large protein preparation, PD-1 monoclonal antibody injection, or afatinib prescription (Note: severe allergy is defined as resulting in hospitalization);\n5. Received any of the following treatments:\n\n   1. Patients with prior use of PD-1 antibody, PD-L1 antibody, CTLA-4 antibody, EGFR antibody, or EGFR-TKI;\n   2. Patients who have received an anti-tumor vaccine;\n   3. Use of any active vaccine against infectious diseases (e.g., influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to the first dose or scheduled to be used during the study period;\n   4. Major surgery or severe trauma within 4 weeks prior to the first dose of study drug;\n6. Inhaled or topical steroids and adrenal hormones (\\>10 mg\u002Fday of prednisone) are permitted as an alternative therapy for patients requiring systemic therapy with corticosteroids (\\>10 mg\u002Fday of prednisone) or other immunosuppressive agents within 14 days prior to administration of study drug;\n7. Those with serious medical conditions such as abnormal class II or higher cardiac function (NYHA criteria), ischemic heart disease (e.g., myocardial infarction or angina pectoris), clinically significant supraventricular or ventricular arrhythmia with echocardiographic ejection fraction \\\u003C50%; QTc interval, \\>450 msec in men and \\>470 msec in women; and an abnormal electrocardiogram that, in the opinion of the investigator, poses an experimental drug There is an additional risk;\n8. Subjects with a known history of interstitial pneumonia, history of non-infectious pneumonia, or a high suspicion of interstitial pneumonia; or subjects who may interfere with the detection or management of suspected drug-related pulmonary toxicity; subjects with a prior history of pharmacogenetic or radiologic non-infectious pneumonia that is asymptomatic are permitted to enroll in the study; subjects with active tuberculosis, or with a history of prior tuberculosis infection that has not been controlled with treatment;\n9. Patients with hyperthyroidism and patients with organic thyroid disease are not eligible for enrollment; hypothyroidism treated with a stable dose of thyroid replacement hormone is eligible for enrollment, and hypothyroidism that can be controlled with thyroid replacement hormone treatment is eligible for enrollment (control or not will be confirmed by the investigator and\u002For the endocrinology department);\n10. Presence of an active infection, or fever of unknown origin during screening, 48 h prior to the first dose, or use of systemic antibiotics within 1 week prior to signing informed consent;\n11. Presence of active hepatitis B (HBV DNA ≥ 2000 IU\u002Fml or 104 copies\u002Fml) or hepatitis C (hepatitis C antibody positive with HCV RNA above the lower limit of detection of the analytical method), or known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS);\n12. A previous history of a definite neurologic or psychiatric disorder, such as epilepsy or dementia;\n13. a definite history of substance abuse or a history of alcohol abuse within 3 months;\n14. women who are pregnant or breastfeeding; subjects (and their partners) who have plans to have children, have sex without contraception, or are unwilling to use adequate contraception (e.g., use of condoms, contraceptive rings, or partner sterilization) during the screening period to 3 months after the end of their study;\n15. Received any investigational drug within 4 weeks prior to the first dose of study drug or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up;\n16. In the judgment of the investigator, the subject may have other factors affecting this study that would prevent completion of the trial medication and follow-up.","70 Years",{"count":339,"type":21},21,[108],"Evaluation of the safety and tolerability of immune-targeted therapy combined with neoadjuvant therapy with lysogenic HSV virus for patients with surgically resectable squamous carcinoma of the head and neck.",[343,344,345,28,30],"HNSCC","Lysogenic HSV Virus","Neoadjuvant Therapy","2024-12-18",{"date":348,"type":40},"2024-12-19",{"date":350,"type":40},"2024-12-15",{"date":352,"type":21},"2026-12-15",{"name":354,"class":47},"West China Hospital",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":361,"enrollmentInfo":362,"targetDuration":364,"studyType":81,"phases":4,"briefSummary":365,"conditions":366,"keywords":370,"overallStatus":185,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":4},"100569429","real-world-observational-study-of-targeted-therapy-in-patients-with-advanced-ros1-positive-nsclc-100569429","NCT06694129","Real-world Observational Study of Targeted Therapy in Patients With Advanced ROS1-positive NSCLC","Inclusion Criteria:\n\n* 1\\) Histologically or cytologically confirmed non-small cell lung cancer;\n* 2\\) TNM stage of the ninth edition is IIIB, IIIC, or IV;\n* 3\\) ROS1 fusion positive confirmed by one of the following qualified results: next-generation sequencing technology, fluorescence in situ hybridization, reverse transcription polymerase chain reaction;\n* 4\\) No prior systemic chemotherapy, radiation therapy, or surgery;\n* 5\\) Aged 18 years or older;\n* 6\\) ECOG PS score of 0-1.\n\nExclusion Criteria:\n\n* 1\\) any prior history of NSCLC and\u002For any prior treatment for NSCLC;\n* 2\\) prior systemic chemotherapy or radiation therapy or surgical treatment;\n* 3\\) the presence of a second primary tumor;\n* 4\\) hypersensitivity to ROS1-TKI or intolerance to it.","86 Years",{"count":363,"type":21},40,"3 Years","The purpose of this project is to conduct an observational study on the efficacy and safety of entrectinib in real-world patients with ROS1-positive NSCLC who have received entrectinib treatment, while exploring the mechanism of entrectinib's brain protection and resistance mechanism. Because this study is a non-interventional study, it will not interfere with your usual treatment. However, your medical data will be analyzed, and the results will help improve future treatment options for ROS1 positive NSCLC patients and improve their quality of life.This study was divided into three cohorts. Cohort 1: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had not received TKI treatment, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 2: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had received first-generation ROS1 TKI treatment with disease progression on crizotinib, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 3: For patients with ROS1-positive NSCLC who had failed multiple lines of treatment, they were treated with entrectinib until disease progression or intolerance (N=10). Regular follow-up was conducted and relevant clinical data were recorded, followed by Cox regression analysis and survival analysis. The information that needs to be recorded includes baseline and treatment genetic testing, demographic information, anti-cancer history, and concomitant medication use, as well as the use of study drugs and adverse events during treatment visits, survival and subsequent drug use after discharge, and the follow-up frequency consistent with clinical practice. Subjects are eligible for a complimentary NGS test upon the development of entrectinib resistance.",[367,368,369,30],"Non-Small Cell Lung Cancer","ROS1 Gene Rearrangement","Resistance",[367,368,34],"2024-11-16",{"date":373,"type":40},"2024-11-19",{"date":375,"type":21},"2024-12-01",{"date":377,"type":21},"2027-12-01",{"name":379,"class":47},"National Cancer Center, China",{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":388,"conditions":389,"keywords":392,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":48},"100554768","real-world-study-on-the-management-of-hematological-toxicities-associated-with-targeted-therapies-for-breast-cancer-100554768","NCT06503380","Real-world Study on the Management of Hematological Toxicities Associated With Targeted Therapies for Breast Cancer","Inclusion Criteria:\n\n* · The patients signed the informed consent and voluntarily participated in the study.\n\n  * A definite diagnosis of any type of breast cancer.\n  * Receiving or has completed targeted therapies.\n  * Investigator judged that the patient need to receive or had received treatment or prevention for CTIT, CIN or CRA induced by targeted therapies.\n\nExclusion Criteria:\n\n* · Pregnant or lactating women.\n\n  * Failure to understand the study or to obtain informed consent.\n  * The investigator determined other situations that are not suitable for inclusion.",{"count":387,"type":21},1000,"This multicenter, real-world, observational study will retrospectively and prospectively collect real-world data related to the investigational drugs. We plan to observe 1000 patients and collect data on treatment cycles N and N+1 of the targeted therapies. Retrospective data collection is based on existing patient diagnosis and treatment records, collecting information on patients who have completed two treatment cycles before January 1, 2024. Prospective data collection is based on routine clinical treatment during the study period, collected until the end of the next cycle of treatment or early termination of the study. To observe the disease characteristics and management mode of hematological toxicity related to targeted therapies of breast cancer, and explore the possible related factors of hematological toxicity, such as age, disease subtype, cancer stage, targeted therapy regimens, etc. This study will respect the medication choices of researchers in the study, without specifying which medication to choose for treatment, dosage, mode of administration (including single drug, combination therapy, or sequential therapy), and duration of administration.",[390,30,391],"Hematological Toxicity","Breast Cancer",[393,34,391],"Hematological toxicity","2024-07-30",{"date":396,"type":40},"2024-07-31",{"date":398,"type":40},"2024-07-15",{"date":400,"type":21},"2027-06-10",{"name":402,"class":47},"Fudan University",{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":22,"phases":413,"briefSummary":414,"conditions":415,"keywords":421,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":441},"100539700","phase-1-precision-therapy-for-solid-tumors-synergistic-cdk46-inhibition-and-anti-vegf-targeting-lncrna-100539700","NCT06307249","Precision Therapy for Solid Tumors: Synergistic CDK4\u002F6 Inhibition and Anti-VEGF Targeting LncRNA","Precision Therapy for Solid Tumors: Synergistic Inhibition of Cell Proliferation and Angiogenesis Via CDK4\u002F6 and Anti-VEGF Approach Targeting LncRNA Expression","PTST_PALBEVA","Inclusion Criteria:\n\n* Individuals of white ethnicity.\n* Age between \\> 18\n* Both males and females.\n* Diagnosis of selected cancer type (e.g., colorectal cancer, lung cancer, genitourinary cancers, breast cancer).\n* Cancer stage III\u002F IV with or without metastasis or lymph node dissemination at the time of enrollment.\n* Unrelated patients.\n\nExclusion Criteria:\n\n* History of hematological cancer types or previous cancers, recurrent or relapse.\n* Diagnosis of inflammatory bowel diseases.\n* Pre-existing cardiovascular diseases or coronary artery diseases.\n* Confirmed treated or untreated autoimmune diseases.\n* Metabolic disorders, diabetes, or hypertension.\n* Neurological diseases.\n* Evidence of cardiac, renal, bone, or cerebral damage.\n* Presence of more than one type of malignancies.\n* Active infections or myositis.\n* Familial polyposis.\n* Alcohol or smoking habits.\n* Body mass index (BMI) \\>30.\n* Significant weight loss within the last 2 years.\n* History of surgeries.\n* Pregnancy.\n* Related patients.",{"count":412,"type":21},50,[108],"Solid tumors pose significant challenges in current therapeutic approaches. Targeted therapy has emerged as a promising avenue, aiming to enhance treatment efficacy while minimizing adverse effects. This clinical trial focuses on an innovative combination of two targeted inhibitors, Palbociclib and Bevacizumab, for their potential synergistic effects in addressing these challenging malignancies. Moreover, this study incorporates a molecular approach by considering Long Non-Coding RNAs (LncRNAs) as biomarkers. Initiating with a focus on colorectal cancer, the study aims to expand its scope to other solid tumors, including lung, breast, ovarian and other cancers. Palbociclib, a cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor, disrupts the cell cycle progression, particularly in cancer cells with specific molecular characteristics. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, targets angiogenesis-a critical process for tumor growth and metastasis. The rationale behind combining these agents lies in their complementary mechanisms of action, potentially leading to enhanced antitumor effects. LncRNAs have shown promise in predicting treatment response and prognosis in various cancers, providing an additional layer of precision to the treatment strategy. By elucidating the molecular basis through LncRNA analysis, the trial aims to tailor the treatment to the specific molecular profile of each patient, ultimately striving for better outcomes and improved survival rates. This novel combination therapy, coupled with a personalized biomarker-driven approach, represents a cutting-edge strategy in the pursuit of more effective and individualized treatment for solid tumors.",[416,417,27,391,418,419,30,269,28,420],"Cancer","Solid Tumor","Ovarian Cancer","Lung Cancer","Precision Therapy",[422,423,424,425,426,427,428,429,430,431,416],"LncRNA","Anti-VEGF","CDK4\u002F6 inhibitor","Gene Polymorphism","Palbociclib","Bevacizumab","Inflammation","Immune Cells","Angiogenesis","Proliferative","2024-03-05",{"date":434,"type":40},"2024-03-12",{"date":436,"type":40},"2023-02-15",{"date":438,"type":21},"2027-12",{"name":440,"class":47},"Lebanese University",2,{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":451,"conditions":452,"keywords":455,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":48},"100527000","recisttm-criteria-in-evaluating-the-efficacy-of-targeted-therapy-for-nsclc-100527000","NCT06142058","RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC","Application of the RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for Advanced Non-small Cell Lung Cancer With Positive Driving Genes","Inclusion Criteria:\n\n* NSCLC patients with stage IIIB-IV\n* Driver gene positive (EGFR,ALK,C-MET, ROS,RET, HER2);\n* First line targeted therapy.\n* Performance status of 0-2 on the ECOG criteria.\n* Any one of the tumor markers is more than three times higher than the normal level, and the tumor markers include: CEA\\>15ng\u002Fml,CA-199\\>105U\u002Fml,CA-125\\>105 U\u002Fml, NSE\\>60 ng\u002Fml, SCCAg\\>7.5 ng\u002Fml, CYFRA21-1\\>21 ng\u002Fml, et al.\n* Measurable lesions present\n* Age\\>=18\n* Adequate hematologic (neutrophil count \\>= 1,500\u002FuL, platelets \\>= 60,000\u002FuL,hemoglobin≥70g\u002FL), hepatic (transaminase =\\\u003C upper normal limit(UNL)x2.5, bilirubin level =\\\u003C UNLx1.5), and renal (creatinine =\\\u003C UNL) function.\n* Informed consent from patient or patient's relative.\n\nExclusion Criteria:\n\n* Patients with dysphagia;\n* Unable to taking medication on time;\n* Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders",{"count":450,"type":21},44,"Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the prelimary criteria still need further improvement. Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes.",[453,454,30],"Evaluation","NSCLC",[456,454,457,458,459],"tumor marker","RECIST","RecistTM","positive driving gene","2023-11-15",{"date":462,"type":40},"2023-11-21",{"date":464,"type":21},"2023-11-13",{"date":466,"type":21},"2028-12-31",{"name":468,"class":47},"Xueqin Yang",{"id":470,"slug":471,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":11,"sex":476,"minAge":17,"maxAge":18,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":48},"100514792","phase-2-chidamideeverolimus-for-pik3ca-wild-typemutant-hrher2--advanced-breast-cancer-100514792","NCT05983107","Chidamide\u002FEverolimus for PIK3CA Wild-type\u002FMutant HR+\u002FHER2- Advanced Breast Cancer","A Prospective Cohort, Open, Phase II Clinical Study of Chidamide\u002FEverolimus Combined With Endocrine Therapy for PIK3CA Wild-type\u002FMutant Hormone Receptor Positive\u002FHuman Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer","Inclusion Criteria:\n\n* The age at the time of signing the informed consent form is ≥ 18 years old and ≤ 75 years old, for menopausal\u002Fpremenopausal women (premenopausal women need to receive ovarian function suppression treatment at the same time).\n* Breast cancer patients with HR positive (ER expression ≥ 10%, PR positive or negative) and HER2 negative (Immunohistochemical(IHC)0,1+; 2+, Fluorescence in situ hybridization(FISH) not expanded) confirmed by histology.\n* Histologically confirmed locally advanced breast cancer (no radical local treatment) or recurrent and metastatic breast cancer.\n* The patients who had previously progressed after the treatment of first-line or second-line cyclin-dependent kinases 4 and 6 inhibitors（CDK4\u002F6 inhibitors）of endocrine and whose chemotherapy was ≤ second-line (relapse during the period of new adjuvant\u002Fadjuvant treatment or within 12 months after the end of treatment was regarded as first-line chemotherapy), the PIK3CA gene mutation detection was performed a. PIK3CA Mutant subjects were enrolled in queue A; b. PIK3CA wild-type subjects were included in queue B.\n* At least one measurable primary lesion (according to RECIST v1.1 standard) before enrollment.\n* The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2.\n* The toxic and side effects caused by previous anti-tumor therapy were relieved to 0-1 levels before the screening period (judged according to The NCI Common Terminology Criteria for Adverse Events version5.0 (NCICTCAE5.0); except for toxicity that researchers believe does not pose a safety risk to the subjects due to hair loss).\n* The functional level of organs must meet the following requirements: 1) Blood routine:\n\nAbsolute neutrophil count(ANC)≥1.5 × 109\u002FL (growth factor not used within 14 days); Platelet(PLT) ≥100 × 109\u002FL (no corrective treatment used within 7 days); Hb ≥ 100 g\u002FL (without corrective treatment within 7 days); 2) Blood biochemistry: Total bilirubin(TBIL) ≤1.5 × upper limits of normal(ULN); Glutamine aminotransferase(ALT),Glutamic transaminase(AST)≤3 × ULN; Glutamine transpeptidase(GGT) ≤2.5 × ULN; If there is liver metastasis, then ALT and\u002For AST ≤ 5 × ULN; Glutamine transpeptidase GGT ≤5 × ULN; Urea, Blood urea nitrogen (BUN), creatinine (Cr) ≤1.5 × ULN; 3) Cardiac ultrasound: Left ventricular ejection fraction（LVEF）≥ 50%; 4) 12 lead ECG: QT interval (QTcF) corrected by Fridericia method, male\\\u003C450ms, female.\n\n* Expected survival time ≥ 3 months.\n* Voluntarily participate in this clinical trial and sign a written informed consent form.\n\nExclusion Criteria:\n\n* Those who have received any mammalian target of rapamycin（mTOR） and histone deacetylase（HDAC） inhibitors at any time in the past.\n* Received chemotherapy, Targeted therapy, immunotherapy, interventional therapy or other systematic anti-tumor treatment within 4 weeks before the first administration of the study drug, or received radiotherapy within 3 weeks Note: Nitroso urea or Mitomycin C is within 6 weeks before the first use of the study drug, oral fluorouracil and small molecule targeted drugs are within 2 weeks before the first use of the study drug or within 5 half lives of the drug (whichever is longer), Traditional Chinese medicine with anti-tumor indications should be used within 2 weeks before the first use of the study drug.\n* Subjects who have undergone major surgical procedures or obvious trauma within 4 weeks prior to enrollment, or are expected to undergo major surgical treatment.\n* Subjects with brain or subdural metastasis are excluded. Unless its stability has been maintained for at least 4 weeks or Asymptomatic brain metastasis can be included in the group.\n* According to the investigator's judgment, there are concomitant diseases (such as severe hypertension, Thyroid disease, hyperlipidemia, active infection, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study.\n* Patients with poor control of diabetes shall be determined by the researcher.\n* Clinically obvious gastrointestinal abnormalities that may affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, Bowel obstruction, etc.).\n* Severe cardiovascular injury (greater than a history of congestive heart failure at New York Heart Association(NYHA) level II, unstable angina or myocardial infarction within the past 6 months, or severe arrhythmia.\n* Subjects have active hepatitis (hepatitis B reference: HBsAg positive and hepatitis B virus(HBV) DNA ≥ 500 international unit(IU)\u002Fml; hepatitis C reference: hepatitis C virus(HCV) antibody positive and HCV copy number\\>upper limit of normal value); Subjects who are known to be positive for human immunodeficiency virus (HIV).\n* Female patients during pregnancy and lactation, female patients with Fertility and positive baseline Pregnancy test, or those of childbearing age who are unwilling to take effective contraceptive measures during the whole test period and within 90 days after the last administration of the study drug.\n* Have a clear history of neurological or mental disorders, including epilepsy or dementia, in the past.\n* Any medical condition in which the researcher believes that the subject is not suitable for entry into the study.","FEMALE",{"count":478,"type":21},102,[24],"To explore the efficacy and safety of chidamide combined with endocrine in phosphoinositide-3-kinase,catalytic,alpha gene(PI3KCA) wild type hormone receptor positive(HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer patients and to explore the efficacy and safety of Everolimus combined with endocrine therapy in patients with PI3KCA Mutant HR+\u002FHER2- advanced breast cancer.",[482,30],"HR+\u002FHER2- Advanced Breast Cancer","2023-08-01",{"date":485,"type":40},"2023-08-09",{"date":487,"type":40},"2023-07-20",{"date":489,"type":21},"2027-07-15",{"name":148,"class":47}]