[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cervix-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cervix-carcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100565208","early-phase-1-177lulu-akir001-first-in-human-study-100565208",false,"NCT06639191","[177Lu]Lu-AKIR001 First-in-human Study","A Phase 1 Prospective, Open-label, First-in-human Study to Evaluate the Safety, Tolerability and Biodistribution of [177Lu]Lu-AKIR001 and Its Anti-tumour Effect in Adult Patients With CD44v6 Expressing Solid Tumours","AKIR001","Inclusion Criteria:\n\n1. Participant must be 18 years of age or older\n2. Willing and able to provide written informed consent\n3. Participant has one of the following histologically confirmed metastatic or locally advanced irresectable CD44v6 expressing (confirmed in pre-screening according to the pathology manual (Appendix III) solid malignancy in one of the following groups, with documented disease progression in the last 8 weeks during\u002Fafter available standard of care treatment options as mentioned below:\n\n   * For anaplastic, poorly differentiated and radioiodine refractory differentiated thyroid cancer (ATC, PDTC, RAI-R DTC):\n\n     * For BRAFv600E mutated tumours: BRAF\u002FMEK inhibitors.\n     * For BRAF-wildtype tumours at least one of the following: anthracycline- or taxane containing chemotherapy\u002F chemoradiotherapy, or other targeted therapies including vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKI), targeted therapies aimed at specific moleculo-pathological features (e.g., targeting NTRK, RET, ALK, PD-L1)\n     * For PDTC or RAI-R DTC: Radio-iodine refractory disease as deemed by treating physician and disease progression after at least one line of systemic targeted therapy (including VEGF, TKI, NTRK, RET, BRAF inhibitors)\n   * For HNSCC:\n\n     \\- At least one prior treatment with combination chemotherapy (either platinum based + 5-Fluorouracil or platinum based + taxane) together with PD1-inhibitor pembrolizumab if combined positive score (CPS) ≥1 or EGFR-inhibitor if CPS \\\u003C1 (or if immunotherapy is contraindicated)\n   * For NSCLC\n\n     \\- Treatment with at least two lines of systemic therapy, including checkpoint inhibitor based on PD-L1 status and chemotherapy with a platinum-based regimen.\n   * For vulvar SCC:\n\n     \\- After treatment with first line platinum\u002Fpaclitaxel+\u002F-bevacizumab +\u002F- pembrolizumab (the latter in case of PD-L1 positivity), and second line with weekly paclitaxel\n   * For cervical SCC:\n\n     * After treatment with first line systemic therapy with platinum\u002Fpaclitaxel+\u002F-pembrolizumab (the latter in case of PD-L1 positivity)\n4. Measurable disease per Response Criteria for Solid Tumours (RECIST) v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n6. Life expectancy of at least three months as estimated by the investigator.\n7. Adequate organ and bone marrow function within eight days before the first \\[177Lu\\]Lu-AKIR001 infusion:\n\n   * Peripheral white blood cells (WBC) ≥3.0 x 109\u002FL\n   * Absolute neutrophil count (ANC) ≥ 2,000\u002Fmm3\n   * Platelet \\> 100 x 109\u002FL\n   * Hemoglobin \\> 100 g\u002FL.\n   * Serum creatinine of ≤ 1.5x ULN or calculated creatinine clearance of ≥ 60 mL\u002Fmin\u002F1.73 m2 by Cockcroft- Gault\n   * Total serum bilirubin ≤ 1.5x ULN (unless due to Gilbert's syndrome, in which case direct bilirubin must be normal)\n   * Serum AST and ALT ≤1.5x ULN (or ≤ 5x ULN if participant has liver metastases)\n   * Left Ventricular Ejection Fraction \\>50% on echocardiography\n8. Contraceptives\n\n   * Females of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study treatment Phase and for six months after the last dose of study drug. Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If a female participant is of child-bearing potential (females are considered not of childbearing potential if they are at least one year postmenopausal and\u002For surgically sterile), she must have a documented negative serum pregnancy test before any \\[177Lu\\]Lu-AKIR001 infusion.\n   * Male participant must agree to practice effective barrier contraception (condom) during the entire study treatment period and through four months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.\n\nExclusion Criteria:\n\n1. Symptomatic brain metastases that are not previously treated and\u002For that require ongoing steroid-treatment\n2. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n3. Chemo-, targeted or radiotherapy within the last 4 weeks before enrolment in the study.\n4. Ongoing toxicities graded according to the Common Terminology Criteria for Adverse Events (CTCAE) \\> 1 from previous anti-cancer treatments.\n5. Pregnancy or lactation\n6. Uncontrolled hypertension, heart, liver, or kidney disease or other medical\u002F psychiatric disorders.\n7. Severe skin diseases requiring systemic anti-inflammatory treatment, including plaque psoriasis, Stevens Johnsons syndrome or dermatomyositis.\n8. A known history of Human Immunodeficiency Virus (HIV) infection, hepatitis B (HBsAg reactive) or hepatitis C (HCV RNA detected) infection or active tuberculosis.","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The goal of this clinical trial is to evaluate the safety and tolerability of increasing doses of \\[177Lu\\]Lu-AKIR001, both in relation to tolerable activity of lutetium-177 and the absorbed protein mass dose of AKIR-001 in patients with irresectable or metastatic CD44v6-expressing solid malignancies for whom no reasonable systemic treatment options are be available. The main question it aims to answer is:\n\n• What is the toxicity profile of the study drug \\[177Lu\\]Lu-AKIR001 according to the rate of Dose Limiting Toxicities and (Severe) Adverse Events? Participants will receive one \\[177Lu\\]Lu-AKIR001 infusion followed by a 6-week safety follow-up period, which can be extended up to 12 weeks. Possible additional infusions of the trial drug, up to a maximum number of four, can be given when clinical benefit is noted and toxicity is deemed acceptable.",[27,28,29,30,31,32],"Thyroid Gland Anaplastic Carcinoma","Poorly Differentiated Thyroid Carcinoma","Cancer Head and Neck","Cervix Carcinoma","Vulvar Cancer, Stage IV","Non-small Cell Lung Cancer Stage IV",[34,35,36,37,38],"Radiopharmaceutical","first-in-human","CD44v6","Lutetium-177","177Lu-AKIR001","RECRUITING","2026-01-28",{"date":42,"type":43},"2026-01-30","ACTUAL",{"date":40,"type":43},{"date":46,"type":21},"2028-11-01",{"name":48,"class":49},"Karolinska University Hospital","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":50},"100509188","phase-2-neoadjuvant-treatment-of-neuroendocrine-cervix-carcinomar-with-camrelizumab-combined-with-etoposide-and-cisplatin-100509188","NCT05910177","Neoadjuvant Treatment of Neuroendocrine Cervix Carcinomar With Camrelizumab Combined With Etoposide and Cisplatin","A Single Arm, Exploratory Clinical Study on the Neoadjuvant Treatment of Neuroendocrine Cervix Carcinoma With Camrelizumab Combined With Etoposide and Cisplatin","Inclusion Criteria:\n\n1\\. Age: 18 years ≤ Age ≤ 75 years, female patient. 2. Patients with cervical neuroendocrine carcinoma confirmed by histopathology or cytology (if mixed type carcinoma, the composition of neuroendocrine carcinoma is\\>60%), whose FIGO stage is stage I-II, and who can be operated according to the gynecological examination of an experienced Chief physician.\n\n3\\. According to the RECIST 1.1 standard, patients have at least one measurable diameter target lesion (tumor lesion CT scan length ≥ 10mm, lymph node lesion CT scan short diameter ≥ 15mm, scan layer thickness 5mm).\n\n4\\. ECOG PS 0-1 points. 5. The estimated postoperative survival time is greater than 3 months. 6. The main organs function normally and meet the following standards:\n\n1. The blood routine test must meet the following criteria: (no blood transfusion within 14 days)\n\n   1. HB ≥ 100g\u002FL\n   2. WBC ≥ 3 × 109\u002FL\n   3. ANC ≥ 1.5 × 109\u002FL\n   4. PLT ≥ 100 × 109\u002FL\n2. Biochemical examination must meet the following standards:\n\n   1. BIL\\\u003C1.5 times upper limit of normal value (ULN)\n   2. ALT and AST\\\u003C2.5ULN, GPT ≤ 1.5 × ULN\n   3. Serum Cr ≤ 1ULN, endogenous creatinine clearance rate\\>60ml\u002Fmin (Cockcroft Goult formula).\n\n      7\\. Not participating in other clinical studies before and during treatment.\n\n      8\\. Women of childbearing age must undergo a serum pregnancy study within 7 days before the first medication use, and the results should be negative. Female participants of childbearing age and male participants with partners of childbearing age must agree to contraception within 24 weeks after signing the informed consent form and the last administration of the study medication.\n\n      9\\. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.\n\n      Exclusion Criteria:\n      1. Those who have a history of chemotherapy, radiation therapy, targeted drug therapy, or immunotherapy in the past.\n      2. Patients who have Contraindication to surgical treatment and chemotherapy or whose physical condition and organ function do not allow large abdominal surgery.\n      3. Distant metastasis.\n      4. Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, Uveitis, enteritis, hepatitis, hypophysitis, Vasculitis, Myocarditis, nephritis, Hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Except for Vitiligo or recovered childhood asthma\u002Fallergy patients who do not need any intervention after adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin.\n      5. Have a history of immune deficiency, including positive Diagnosis of HIV\u002FAIDS, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation.\n      6. Accompanied by severe heart, lung, liver, and kidney diseases; Having neurological or mental illness; Individuals with jaundice or gastrointestinal obstruction and severe infections.\n      7. Pregnant or lactating women.\n      8. Suffering from coronary heart disease of grade I or above, arrhythmia (including prolonged QTc interval, female\\>470 ms), and cardiac dysfunction.\n      9. Patients with abnormal coagulation function (INR\\>1.5, APTT\\>1.5 ULN).\n      10. The subject has clinical cardiovascular symptoms or diseases that cannot be well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that are still poorly controlled without or after clinical intervention.\n      11. Have a history of Interstitial lung disease (excluding radiation pneumonia without hormone treatment) and non infectious pneumonia.\n      12. People who have been allergic to any component of Camrelizumab or any component of the study medication in the past.\n      13. Researchers believe that it is not suitable for inclusion.","FEMALE","75 Years",{"count":61,"type":21},30,[63],"PHASE2","This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of karelizumab combined with etoposide and cisplatin in the neoadjuvant treatment of neuroendocrine cervix carcinoma.",[66,30],"Carcinoma","2024-03-04",{"date":69,"type":43},"2024-03-06",{"date":71,"type":43},"2023-12-28",{"date":73,"type":21},"2026-08-31",{"name":75,"class":76},"Fujian Cancer Hospital","OTHER_GOV",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":58,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":50},"100519164","a-diagnostic-nomogram-for-predicting-vaginal-invasion-in-cervical-cancer-100519164","NCT06039982","A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer","Establish a New Noninvasive Diagnostic Model Based on Clinical Indicators to Evaluate the Vaginal Invasion in Cervical Cancer Patients","Inclusion Criteria:\n\n* Pathologically confirmed cervical cancer;\n* FIGO2018 stage IB-IIA according to the result of physical examination and images;\n* No preoperative treatment before surgery;\n* Abdominal MRI is performed within three weeks before surgery. Blood routine, biochemistry, blood tumor markers and coagulation function were examined within 1 week before surgery.\n* All patients undergo radical hysterectomy (RH) with bilateral pelvic lymphadenectomy or paraaortic lymph node dissection.\n\nExclusion Criteria:\n\n* Accompanied with other tumors;\n* Accompanied with chronic infectious and immune diseases;\n* Incomplete clinical data.","80 Years",{"count":86,"type":21},100,"OBSERVATIONAL","This study aims to develop a diagnostic nomogram based on clinical factors with the prediction values of vaginal invasion in cervical cancer to optimize the treatment plan and surgical procedures.",[30],"NOT_YET_RECRUITING","2023-09-23",{"date":93,"type":43},"2023-09-26",{"date":95,"type":21},"2023-11-01",{"date":97,"type":21},"2026-11-01",{"name":75,"class":76}]