[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100472487","early-phase-1-pilot-trial-for-treatment-of-recurrent-glioblastoma-100472487",false,"NCT05432518","Pilot Trial for Treatment of Recurrent Glioblastoma","Biomarker and Tumor Cell Culture-Driven Pilot Trial for Treatment of Recurrent Glioblastoma","Inclusion Criteria:\n\n1. Study participant has provided informed consent prior to initiation of any study specific activities\u002Fprocedures.\n2. Adult participants, male and female, aged ≥18 who have a pathologically confirmed IDH-wild type glioblastoma, with first or second progression of the tumor, after initial treatment with radiation therapy and temozolomide.\n3. Recurrence is amenable to resection.\n4. Performance status: ECOG ≤2.\n5. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.\n6. Patients of childbearing potential must adhere to the contraception requirement from screening throughout the study period up to 180 days after the last dose of study intervention. Women\u002Fmen of childbearing potential must have agreed to use two highly effective contraceptive methods. In addition to routine contraceptive methods such as condom use, oral contraceptive, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy\u002Fvasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures.\n\n   Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n7. Able to undergo brain MRIs.\n8. Females must not be breastfeeding, throughout the study period up to 180 days after the last dose of study intervention.\n9. Male patients should agree to not donate sperm during the study for at least 6 months until discontinuation of study drug.\n\nExclusion Criteria:\n\n1. Patients with history of abnormal left ventricular ejection fraction (LVEF≤ 45%).\n2. Pregnant, breast-feeding, unwilling\u002Funable to comply with contraception requirements.\n3. Patients unable to consent.\n4. Abnormal (grade ≥2 CTCAE, version 5.0) laboratory values for hematology, renal, and liver function including:\n\n   1. Hemoglobin \\\u003C10,\n   2. Neutrophils \\\u003C1.5,\n   3. Platelets \\\u003C75,\n   4. ALT\u002FAST \\>3x ULN,\n   5. Bilirubin \\>1.5 x ULN,\n   6. eGFR \\\u003C60\n5. Patients with significant or recent gastrointestinal disorders with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption or severe diarrhea of any etiology) must be excluded from the clinical trial (Afatanib is not recommended in this patient population).\n6. Patients with a history of ILD (interstitial lung disease) must be excluded.\n7. Patients with severe hepatic impairment (Child Pugh C).\n8. A significantly abnormal ECG (baseline QTcF interval \\> 450 msec).\n9. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.\n10. Patients with known pre-existing pleural effusion.\n11. Active hepatitis B or C infection and\u002For known history of HIV infection.\n12. Has known psychiatric or substance abuse disorders that would interfere with compliance with the requirements of the trial.\n13. Subject will not be available for protocol-required study visits or procedures, to the best of the subject's and investigator's knowledge.\n14. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks from the date of signing the informed consent form.\n15. Patients who are hypersensitive to any ingredients in the formulation of the study drugs or their excipients.\n16. Patients receiving active treatment for a different cancer.\n17. If recent bacterial infection, patients need to have completed antibiotic course prior to commencing study drug.\n18. If recent COVID-19 infection, patients must have recovered from it prior to commencing study drug.\n19. Patients on strong CYP3A\u002Fp-gp inducers (for example, carbamazepine and phenytoin).\n\nN.B. Only patients receiving SOC neurosurgery in Alberta, Canada are eligible to participate in this trial.","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This will be a single-arm open-label prospective pilot feasibility trial recruiting 10 adult patients with recurrent glioblastoma who are assigned to receive the personalized study treatment based on the genetic profile of their recurrent GBM tumor resected at the time of surgery. It will be aimed to gather preliminary information on the study intervention and the feasibility of conducting a full-scale trial.",[26,27,28],"Glioblastoma","Recurrent Disease","Recurrent Glioblastoma",[26,27,28,30],"GBM","RECRUITING","2025-04-23",{"date":34,"type":35},"2025-04-25","ACTUAL",{"date":37,"type":35},"2023-06-27",{"date":39,"type":20},"2027-12-01",{"name":41,"class":42},"AHS Cancer Control Alberta","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":5},"100459288","phase-2-penpulimab-in-combination-with-cetuximab-as-first-line-treatment-in-rm-scchn-100459288","NCT05260671","Penpulimab in Combination With Cetuximab as First-line Treatment in R\u002FM SCCHN","An Exploratory Clinical Study to Evaluate the Efficacy and Safety of Penpulimab in Combination With Cetuximab as First-line Treatment in Patients With Recurrent\u002FMetastatic Squamous Cell Carcinoma of the Head and Neck (R\u002FMSCCHN)","Inclusion Criteria:\n\n* Age: ≥ 18 years, male or female;\n* Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx) (SCCHN);\n* Recurrent\u002Fmetastatic SCCHN not suitable for local treatment such as surgery or radiotherapy in the opinion of the investigator;\n* At least one measurable tumor lesion according to RECIST 1.1 criteria;\n* The tumor expresses PD-L1, with a comprehensive positive score CPS ≥ 1;\n* Eastern Cooperative Oncology Group (ECOG) PS: 0-1\n* Expected survival ≥ 3 months;\n* Normal function of major organs, meeting the following criteria: blood routine examination criteria must be met: (no blood transfusion within 14 days before screening) 1) HB ≥ 90 g\u002FL; 2) ANC ≥ 1.5 × 109\u002FL; 3) PLT ≥ 75 × 109\u002FL; biochemistry: (without transfusion or blood product within 14 days before screening) 1) BIL ≤ 1.5 × upper limit of normal (ULN) (≤ 3 × ULN for patients with Gilbert's syndrome); 2) ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis); 3) Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50ml\u002Fmin (Cockcroft-Gault formula); 4) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; left ventricular ejection fraction (LVEF) ≥ 50% assessed by cardiac Doppler ultrasound;\n* Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and are willing to use reliable contraception during the trial and must be non-lactating patients; male subjects must use reliable contraception from the start of treatment to 6 months after the last dose;\n* The subjects voluntarily join the study, sign the ICF, have good compliance, and cooperate in the follow-up\n\nExclusion Criteria:\n\n* Received systemic chemotherapy, but excluding chemotherapy for locally advanced disease as a part of multimodal treatment. Note: Chemotherapy for locally advanced disease includes induction chemotherapy, radiotherapy with concurrent chemotherapy, and adjuvant chemotherapy;\n* Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways;\n* Previous use of anti-EGFR drugs such as cetuximab, nimotuzumab, gefitinib, and afatinib;\n* Pregnant or lactating, or planning to become pregnant during the study period;\n* Current participation and receipt of study treatment, or participation in an investigational drug trial or use of an investigational device within 4 weeks prior to randomization;\n* Presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which may present with clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and\u002For progressive growth;\n* Any active autoimmune disease or history of autoimmune disease (but not limited to autoimmune hepatitis, interstitial pneumonia, enteritis, hypophysitis, vasculitis, nephritis; positive HIV test or history of the above diseases, or history of organ transplantation; but the following patients are allowed: vitiligo, psoriasis, alopecia, well-controlled type I diabetes mellitus, Hypothyroidism with euthyroidism treated by replacement therapy;\n* Treatment with systemic immunosuppressive drugs within 2 weeks before the start of study treatment or anticipation of the need for systemic immunosuppressive drugs during study treatment, with the following exceptions: 1) Intranasal, inhaled, topical steroids, or topical steroids (e.g., intra-articular); 2) Physiological doses of systemic corticosteroids (≤ 10 mg\u002Fday prednisone or equivalent); 3) Steroid premedication for hypersensitivity (e.g., premedication for CT scan);\n* Significant cardiovascular disease, such as cardiac insufficiency above class II (New York Heart Association (NYHA) classification) or left ventricular ejection fraction \\\u003C 50%, unstable angina pectoris, myocardial infarction within 1 year, arrhythmia requiring treatment, QTc ≥ 450 ms (male), QTc ≥ 470 ms (female);\n* The subject has an active infection or infectious disease, requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection; or has an unexplained fever (body temperature \\> 38.5℃) during the screening period or prior to the first dose;\n* Interstitial lung disease or non-infectious lung disease (including past medical history and prevalence), uncontrolled systemic diseases, including pulmonary fibrosis, acute lung disease, diabetes (fasting blood glucose (FBG) \\> 8.9 mmol\u002FL), hypertension (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 90 mmHg), kidney disease (urine routine showed urine protein ≥ 2 +, or 24 h urine protein quantification \\> 1.0g), etc., except for local interstitial pneumonia induced by radiotherapy;\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n* Subjects with a history of other malignancies within the past 5 years, but except for cured cervical carcinoma in situ, squamous cell carcinoma of the skin, basal cell carcinoma of the skin, localized prostate cancer, or other carcinomas in situ with definitive resection;\n* Virological screening meets any of the following criteria: hepatitis B HBsAg positive and HBV-DNA ≥ 10\\^3 copies\u002Fml; hepatitis C: HCV antibody positive and HCV-RNA positive (results greater than the lower limit of detection of the analytical method);\n* Participants may need to be vaccinated during the study or have received a live viral vaccine within 4 weeks prior to enrollment. Seasonal influenza vaccine without live virus is permitted.\n* Patients with other concomitant diseases that seriously jeopardize the patient's safety or affect the patient's completion of the study, as judged by the investigator.","80 Years",{"count":53,"type":20},48,[55],"PHASE2","This trial is a multicenter, prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of Penpulimab injection combined with cetuximab in the first-line treatment of recurrent\u002Fmetastatic squamous cell carcinoma of the head and neck.",[58,27,59],"Head and Neck Neoplasms","Metastatic Cancer","2023-10-16",{"date":62,"type":35},"2023-10-18",{"date":64,"type":35},"2022-01-25",{"date":66,"type":20},"2026-12-25",{"name":68,"class":42},"Eye & ENT Hospital of Fudan University"]