[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uterine-cervical-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uterine-cervical-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,80,111,144,168,185],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100535670","evaluation-of-first-void-urine-as-an-alternative-to-cervical-sampling-for-human-papillomavirus-hpv-testing-in-cervical-cancer-screening-single-center-study-100535670",false,"NCT06254846","Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus (HPV) Testing in Cervical Cancer Screening (Single-center Study).","URAPREV","Inclusion Criteria:\n\n* Female\n* Age between 30 and 65\n* Consulting in the Gynecology-Obstetrics department for primary cervical cancer screening\n* Patient affiliated or entitled to a social security regimen\n* Patient who has received information about the study and expressed non-opposition\n\nExclusion Criteria:\n\n\\-",true,"FEMALE","30 Years","65 Years",{"count":21,"type":22},350,"ESTIMATED","INTERVENTIONAL",[25],"NA","Papillomaviruses are responsible for almost all cervical cancers. In France, there are more than 3000 new cases of cervical cancer each year and nearly 1000 deaths. One of the ways to prevent this cancer is screening by PCR on cervical sample for which national coverage rate remains very insufficient (\\\u003C60%). The invasive and uncomfortable nature of cervical sampling has been identified as a major obstacle to screening. In this context, an alternative sample, such as the first-void urine, seems to be judicious. Nevertheless, some studies have shown a lack of sensitivity of the HPV PCR test on urine. As underlined by the French National Authority for Health (HAS), this is mainly due to a lack of standardization of urine collection. In this study, the investigators therefore propose to evaluate the performance of the HPV PCR test on first-void urine using a standardized protocol. Through a questionnaire, they will also evaluate the acceptability of the first void urine collection device.",[28],"Uterine Cervical Cancer",[30,31,32],"HPV","Cervical cancer","Cancer screening","RECRUITING","2026-05-05",{"date":36,"type":37},"2026-05-06","ACTUAL",{"date":39,"type":37},"2024-05-23",{"date":41,"type":22},"2027-05",{"name":43,"class":44},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100428322","detecting-hpv-dna-in-anal-and-cervical-cancers-100428322","NCT04857528","Detecting HPV DNA in Anal and Cervical Cancers","Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy","Inclusion Criteria:\n\n* Stage I-III anal cancer or stage I-IVA cervical cancer that is p16+ based on immunohistochemistry.\n* Age ≥ 18 years\n* Planned to undergo radiation therapy as definitive treatment, with or without concurrent systemic therapy\n\nExclusion Criteria:\n\n* Anal carcinoma not associated with HPV-16, 18, 31, 33, or 35 will be removed from the\n* Planned to undergo radiation therapy as an adjuvant or post-operative therapy","ALL","18 Years",{"count":56,"type":22},20,"OBSERVATIONAL","This is a research study for individuals who have cancer associated with human papillomavirus (HPV) and are being treated with radiation as part of standard care for their cancer. Doctors leading this study will use blood tests to find out if they can detect the HPV virus in the blood of study participants before, during, and after radiation treatment. They will also collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in the future that could provide more information about HPV-associated cancers and how they respond to treatment. Participation in this study will last approximately 2 years.",[60,61,62,63,64,28],"Cervical Cancer","Anal Cancer","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Cervical Carcinoma","HPV-Related Carcinoma",[30,66,67,68,69],"radiation treatment","cervical cancer","anal cancer","uterine cervix","2026-03-02",{"date":72,"type":37},"2026-03-04",{"date":74,"type":37},"2020-10-06",{"date":76,"type":22},"2027-11-15",{"name":78,"class":44},"University of Chicago",2,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":53,"minAge":54,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":45},"100565292","phase-2-dynamic-ctdna-assessment-in-cervical-and-anal-canal-tumors-optimizing-follow-up-and-clinical-outcomes-100565292","NCT06640283","Dynamic ctDNA Assessment in Cervical and Anal Canal Tumors: Optimizing Follow-up and Clinical Outcomes","Dynamic Assessment of ctDNA in Patients With Cervical and Anal Canal Tumors to Optimize Follow-up and Clinical Outcomes in the Brazilian Unified Health System (SUS)","ANA","Inclusion Criteria:\n\n1. Histological diagnosis of anal canal or cervical cancer.\n2. Documented presence of HPV.\n3. Locally confined or locally advanced disease, defined as:\n\n   1. Anal canal carcinoma stage I to III, according to American Joint Committee on Cancer (AJCC) 8th edition;\n   2. Cervical carcinoma stage I B2 to IV A, according to AJCC 8th edition.\n4. Indication for definitive treatment with radiotherapy, with or without concomitant chemotherapy.\n5. Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 - 1.\n6. Age ≥ 18 years.\n7. Signing of the Informed Consent Form (ICF).\n8. HIV-positive patients may be included if Cluster of Differentiation 4(CD4) count is greater than or equal to 200.\n9. Patients may participate in other concurrent studies, as long as they do not involve interventions related to the treatment of the underlying cancer.\n\nExclusion Criteria:\n\n1. Patients with unequivocal distant metastasis at diagnosis.\n2. For participants with positive ctDNA after treatment, those candidates for participation in Phase II will be excluded if there is unequivocal radiological progression in the first imaging exam after the completion of radiotherapy (with or without chemotherapy) or routine indication for salvage surgery immediately after the conclusion of definitive treatment.\n3. Need for recurrent blood transfusions, such as weekly frequency.\n4. Another uncontrolled disease representing a life risk, as determined by medical judgment.\n5. Personal history of another active invasive malignant neoplasm in the last 5 years, except for non-melanoma skin carcinomas and in situ carcinomas.\n6. Pregnant individuals.\n7. Active opportunistic infection or disease.\n8. History of autoimmune diseases.",{"count":89,"type":22},150,[91],"PHASE2","After definitive radiotherapy (RT) treatment (with or without chemotherapy), cervical and anal canal neoplasms frequently exhibit disease persistence or recurrence. Due to the local inflammatory process post-treatment, response assessment by imaging (current gold standard) is limited, often necessitating multiple follow-ups and repeated invasive biopsies. Conventional follow-up is complex and costly, requiring equipment from secondary and tertiary services, trained radiologists, and patient exposure to radiation and contrast.\n\nIn this context of human papillomavirus(HPV)-related neoplasms, recent studies have demonstrated the role of ctDNA (circulating tumor DNA) in assessing the risk of recurrence or disease progression, providing a rationale for using the tool in two fronts:\n\n* Optimizing follow-up based on serial monitoring of ctDNA;\n* Selecting patients with positive ctDNA after RT, who are at high risk of recurrence, for treatment intensification.\n\nMonitoring with ctDNA as a standalone follow-up tool in cases evolving with negative ctDNA after RT has the potential to replace imaging exams, being a minimally invasive test performed on a peripheral blood sample. Currently, ctDNA testing has expensive methodologies not available in the Unified Health System (SUS). This project aims to develop a methodology for ctDNA evaluation focused on HPV ctDNA research that is low-cost and executable in SUS, as well to assess the accuracy of this test in the population with HPV-related tumors.\n\nAdditionally, we will evaluate whether the early introduction of immunotherapy in patients with positive ctDNA after definitive treatment can increase cure rates. Immunotherapy already has a well-defined role in the treatment of metastatic HPV-related neoplasms. Recently, the use of anti-programmed death-1 (anti-PD1) has also shown benefits in patients with locally advanced cervical cancer with a high risk of recurrence who are candidates for chemoradiotherapy (CRT). Therefore, its use focused on HPV-related tumors, as well as a better understanding of which patients benefit from this strategy, warrants further investigation.",[64,28,94,62,63],"Anal Canal Cancer",[30,96,97,98,99,100,101],"ctDNA","Cervical tumors","Anal canal tumors","Molecular diagnosis","Diagnostic test","Biomarkers","2025-12-18",{"date":104,"type":37},"2025-12-24",{"date":106,"type":37},"2025-03-14",{"date":108,"type":22},"2027-01",{"name":110,"class":44},"Instituto do Cancer do Estado de São Paulo",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":53,"minAge":54,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":122,"conditions":123,"keywords":128,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":4},"100591099","phase-2-immune-pet-and-proteomics-for-the-assessment-of-response-to-spatially-fractionated-or-palliative-radiotherapy-with-or-without-immunotherapy-100591099","NCT06976021","Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy","Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy Ocena Efektu immunomodulującego Radioterapii Paliatywnej, w Tym Radioterapii z Przestrzennym zróżnicowaniem Dawki, Podanej Samodzielnie Lub z immunoterapią, u Chorych którzy Wyczerpali możliwość Leczenia Systemowego i Radioterapii Radykalnej, Przy Wykorzystaniu Immuno-PET i badań Proteomicznych","INTROSPECTION","Inclusion Criteria:\n\n1. Pathologically confirmed diagnosis of clear cell renal cell carcinoma, melanoma, cervical cancer, endometrial cancer or triple negative breast cancer.\n2. Patients nnot eligible for radical treatment with radiotherapy (including stereotactic radiotherapy of the tumor in the potential planned area of irradiation in the study), chemotherapy and palliative immunotherapy in accordance with applicable national standards but who qualify for palliative radiation treatment\n3. General condition according to Karnofsky scale: 60-100\n4. Patients with tumor (index lesion) larger than 5 cm in size that can be irradiated with either SHORT or SFRT technique (presence of other tumors that may be independently treated locally is not an exclusion criterion)\n5. The tumor may be assessed using iRECIST\n6. Age over 18 years\n7. Granted written, informed consent to participate in the research experiment\n8. No contraindications to treatment with Pembrolizumab (according to the information provided in the product characteristics).\n9. Expected survival time over 6 months.\n\nExclusion criteria\n\n1. Lack of consent to participate in the experiment\n2. Contraindications to Pembrolizumab according to the product characteristics\n3. Pregnancy and lactation\n4. Inability of the patient to cooperate, including claustrophobia that prevents imaging tests from being performed as planned.\n5. Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout treatment and for 5 months after its completion.\n6. Condition after organ transplantation",{"count":120,"type":22},60,[91],"The aim of the study is to evaluate the response to four schemes of treatment with novel diagnostic tools - Immuno-PET and proteomics as well as standard imaging (magnetic resonsonce imaging and computed tomography). Two fractionation schedules of radiotherapy will be used. The first will be a common standard of palliative irradiation - 20 Gy delivered in five fractions of 4 Gy (SHORT). The other is called Spatially Fractionated Radiotherapy (SFRT). SFRT is delivered in one fraction of 20 Gy but the dose is diversified inside the tumor to produce areas of high and low doses distributed alternately. This kind of irradiation may be able to stimulate immune response and improve the efficiency of immunotherapy. A drug belonging to the class of immunotherapeutic agents - Pembrolizumab will be added to the treatment scheme in two arms of the study to check that assumption. The response of the target tumor will be evaluated with PET study using Pembrolizumab labeled with zirconium-89 which will show the spatial distribution of immune receptors within the target tumor and other involved sites if there are any. The examination will be repeated after the treatment to evaluate changes in distribution of the immune receptors necessary for the drug to work. Additionally, the researchers will repeatedly test the presence and concentration of a wide panel of proteins in blood to evaluate response to the treatment more precisely.",[124,28,125,126,127],"Triple Negative Breast Cancer","Uterine Corpus Cancer","Malignant Melanoma","Clear Cell Renal Cell Carcinoma",[129,130,131,132,133],"spatially fractionated radiotherapy","immunotherapy","immuno-PET","proteomics","signaling pathways","NOT_YET_RECRUITING","2025-05-08",{"date":137,"type":37},"2025-05-16",{"date":139,"type":22},"2025-06",{"date":141,"type":22},"2029-12",{"name":143,"class":44},"Maria Sklodowska-Curie National Research Institute of Oncology",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":19,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":45},"100553884","a-multicenter-randomized-controlled-study-of-photoelectric-detection-in-cervical-cancer-screening-100553884","NCT06491888","A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening","A Multicenter Randomized Controlled Study of Fluorescence Photoelectric Cervical Lesion Image Detector in Cervical Cancer Screening","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.\n* 2\\. Have clear cervical cancer screening results, meet HPV16\u002F18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.\n* 3\\. Fully informed and agreed to participate in the study.\n* 4\\. No history of cervical cancer disease and cancer in other parts.\n\nExclusion Criteria:\n\n* 1\\. Cannot meet all Inclusion Criteria.\n* 2\\. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。\n* 3\\. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.",{"count":152,"type":22},4200,[25],"The main purpose of this study is to verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study.\n\nThe secondary objectives were to compare the relative pathological accuracy of the fluorescence photoelectric cervical lesion image detection results with the HPV detection results and cytological results, and to compare the lesion area displayed by the fluorescence photoelectric cervical lesion image detector with the lesion area that appeared after traditional colposcopy chemical staining.\n\nIn this study, 4200 subjects who have been evaluated and can be enrolled (these subjects have the indication of referral to colposcopy) will be included in the study, and they will be divided into two groups according to the principle of randomization. The histological results were obtained after routine colposcopy and biopsy. The experimental group first underwent colposcopy and biopsy after the judgment of the fluorescent photoelectric cervical lesion image detector to obtain histological results. Finally, the accuracy of the relative pathological results, the detection rate of CIN2 +, negative predictive value and positive predictive value of the two groups were compared.",[28,156,157,158],"Cervical Intraepithelial Neoplasia","High Grade Squamous Intraepithelial Lesions","Low Grade Squamous Intraepithelial Lesions","2024-08-13",{"date":161,"type":37},"2024-08-15",{"date":163,"type":22},"2024-08",{"date":165,"type":22},"2025-07",{"name":167,"class":44},"Lei Li",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":19,"enrollmentInfo":173,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":45},"100553118","a-multicenter-real-world-study-of-screening-of-cervical-cancer-based-on-photoelectric-detection-100553118","NCT06481930","A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection",{"count":174,"type":22},20000,"The main purpose of this study is to explore the accuracy and clinical value of fluorescent photoelectric cervical lesion image detector as a screening and shunt tool for cervical lesions through a multi-center, large-sample real-world study with histopathology as the gold standard. The secondary purpose of the study was to verify the coincidence of the fluorescent photoelectric cervical lesion image detector with traditional colposcopic chemical staining.\n\nThis study is expected to include 20,000 participants with definite histological results, and compare the specificity and sensitivity, negative predictive value and positive predictive value of three cervical lesion screening methods, such as fluorescent photoelectric cervical lesion image detector, HPV nucleic acid detection and cytology detection. The advantages and disadvantages of fluorescent photoelectric cervical disease image detector, HPV nucleic acid detection and cytology examination were analyzed, and their application scenarios were provided to provide evidence-based medical support for the establishment of comprehensive prevention and treatment system of cervical cancer suitable for China's national conditions.",[28,157,158],"2024-06-30",{"date":179,"type":37},"2024-07-03",{"date":181,"type":22},"2024-07",{"date":183,"type":22},"2026-07",{"name":167,"class":44},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":196,"conditions":197,"keywords":202,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":4},"100502610","phase-2-cadonilimab-plus-nab--paclitaxel-for-patients-with-recurrent-or-metastatic-cervical-cancer-resistant-to-immune-checkpoint-inhibitors-100502610","NCT05824494","Cadonilimab Plus Nab -Paclitaxel for Patients With Recurrent, or Metastatic Cervical Cancer Resistant to Immune Checkpoint Inhibitors","A Single-arm, Open-label, Multicenter Phase II Study of Cadonilimab Combined With Nab -Paclitaxel in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer Previously Treated With Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n1. Subjects are autonomous and fully autonomous, understand and voluntarily sign a written informed consent within 30 days before enrollment.\n2. Age ≥ 18 and ≤ 75 years old on the date of signing the informed consent form, female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n4. Expected survival period ≥ 3 months.\n5. Persistent, recurrent or metastatic cervical cancer confirmed by histology or cytology.\n6. Subjects who have previously failed treatment with PD-1, PD-L1 or CTLA4 inhibitors.\n7. There is at least one measurable tumor lesion according to the RECIST v1.1 standard; tumor lesions in the previous radiotherapy area or other locoregional treatment sites are generally not regarded as measurable lesions, unless the lesion has definite progression and persists after 3 months of radiotherapy, Or the tumor nature of the lesion is confirmed by biopsy.\n8. All subjects need to provide informed consent to provide freshly obtained tumor tissue samples or tumor tissue samples archived within 5 years (formalin-fixed paraffin-embedded \\[FFPE\\] tissue wax blocks or at least 5 unstained tumor tissue Biopsy samples, preferably freshly obtained tumor tissue samples). If the subject cannot provide the tumor tissue sample archived within 5 years before randomization or the tumor tissue sample is not suitable for use, a biopsy must be performed to collect fresh tumor tissue; if the investigator judges that there is a safety risk in the subject's tumor tissue biopsy, the Discuss with medical monitor.\n9. The subject agrees to collect tumor tissue and peripheral blood samples required during the screening period and the research process and apply them to relevant research.\n10. The results of laboratory tests after the screening period suggest that the subject has good organ function:\n\n    1. Hematology (no blood components and cell growth factor supportive treatment are allowed within 2 weeks before randomization): i. The absolute value of neutrophils ANC ≥ 1.5 × 109\u002FL (1,500\u002Fmm3); ii. Platelet count ≥ 100 × 109\u002FL (100,000\u002Fmm3); iii. Hemoglobin ≥ 90 g\u002FL.\n    2. Kidneys: i. Calculated creatinine clearance\\* (CrCl) ≥ 50 mL\u002Fmin\n\n       \\* CrCl will be calculated using the Cockcroft-Gault formula (Cockcroft-Gault formula) CrCl (mL\u002Fmin) = {(140 - age) × body weight (kg) × 0.85}\u002F (serum creatinine. (mg\u002FdL) × 72) ii. Urinary protein \\\u003C 2+ or 24-hour (h) urine protein quantitative \\\u003C 1.0 g.\n    3. Liver: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN ii. AST and ALT ≤ 2.5× ULN iii. Serum albumin (ALB) ≥ 28 g\u002FL\n    4. coagulation function: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (if the subject is receiving anticoagulant therapy, the subject must receive a stable dose of anticoagulant and coagulation parameters at the time of screening (PT\u002FINR and APTT) were within expected ranges with anticoagulant therapy).\n    5. Cardiac function: i. Left ventricular ejection fraction (LVEF) ≥ 50%.\n11. Female subjects of childbearing potential must have a serum pregnancy test within 3 days before the first dose and the result is negative. If a female subject of childbearing potential has sex with an unsterilized male partner, the subject must use an acceptable and effective method of contraception since screening and must agree to continue using these precautions until after the last dose of the study drug 6 months; Periodic abstinence and rhythm contraception are unacceptable contraceptive methods.\n\n    1. Females of childbearing potential are defined as females who have not been surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or who have not undergone menopause (menopause is defined as at least Menopause for 12 consecutive months, serum follicle-stimulating hormone level is within the laboratory reference range for postmenopausal women);\n    2. A highly effective contraceptive method is one that has a low rate of contraceptive failure (eg, less than 1% per year) when used correctly and consistently. Not all birth control methods are equally effective. Female subjects of childbearing potential must use barrier contraception or hormonal contraception (such as oral contraceptives) to ensure that pregnancy does not occur.\n12. The subjects are willing and able to comply with the schedule of visits, treatment plans, laboratory tests, and other requirements of the study.\n\nExclusion Criteria:\n\n1. Suffering from other active malignant tumors within 3 years before randomization, except locally curable tumor types and those who have been cured, such as Squamous cell carcinoma of the skin, basal cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the breast.\n2. Severe immunotherapy-related toxicity occurred during the previous anti-PD-1\u002FPD-L1 monoclonal antibody treatment, including but not limited to: grade 3\u002F4 pneumonia, proteinuria, uveitis or episcleritis, myasthenia gravis, Pancreatitis, hepatitis, bullous skin disease (including SJS, TEN); grade 2-4 encephalitis, myocarditis; any grade of Guillain-Barré syndrome, transverse myelitis; severe inflammation that significantly affects the quality of life of the patient sex joints.\n3. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other unmarketed clinical research drugs and other anti-tumor treatments within 4 weeks before the first use of the study drug.\n4. Received nab-paclitaxel drug therapy within 6 months before the first use of the study drug. Known contraindications to nab-paclitaxel or hypersensitivity to any of its components.\n5. Received drugs with immunomodulatory effects (such as thymosin, interferon, interleukin-2) within 2 weeks before randomization; received Chinese patent medicines with anti-tumor indications (such as Aidi injection, etc.) within 2 weeks before randomization.\n6. Received major organ surgery (not including needle biopsy, etc.) or experienced significant trauma within 4 weeks before the first use of the study drug, or required elective surgery during the trial\n7. There is central nervous system metastasis or cancerous meningitis.\n8. Pleural effusion, pericardial effusion, or peritoneal effusion with uncontrollable need for repeated drainage (more than once a month) of subjects.\n9. Suffering from active or recurrent autoimmune diseases; except the following: vitiligo, alopecia, psoriasis, or eczema that do not require systemic treatment; hypothyroidism caused by autoimmune thyroiditis that only requires stable doses of Hormone replacement therapy; type 1 diabetes requiring only a steady dose of insulin replacement therapy.\n10. Subjects who need to use \\> 10 mg\u002Fday prednisone or equivalent dose of glucocorticoid or other immunosuppressive drugs for systemic treatment within 14 days before randomization; except the following\n\n    1. Inhaled, ophthalmic or topical glucocorticoid therapy with a dose of ≤ 10 mg\u002Fday prednisone or equivalent dose is allowed.\n    2. Physiological glucocorticoid replacement therapy, with a dose of ≤ 10 mg\u002Fday prednisone or an equivalent dose of glucocorticoid.\n    3. Glucocorticoids as prophylaxis for hypersensitivity reactions (eg, before CT examination).\n11. Live vaccines have been used within 4 weeks before randomization.\n12. Known primary or secondary immunodeficiency, including human immunodeficiency virus (HIV) antibody test positive.\n13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n14. Known history of interstitial lung disease or non-infectious pneumonia.\n15. Serious infection occurred within 4 weeks before randomization, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia.\n16. There are active infections that require systemic treatment (including active tuberculosis and active Treponema pallidum infection), and have used systemic antibacterial, antiviral or antifungal drugs within 2 weeks before randomization; Note: for type B Antiviral drugs used for viral hepatitis are excluded.\n17. Active hepatitis B subjects, inactive or asymptomatic hepatitis B virus (HBV) carriers (hepatitis B surface antigen \\[HBsAg\\] positive) and HBV DNA\\> 1000 IU\u002FmL), and subjects with active hepatitis C virus.\n18. Suffering from active or documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), active diverticulitis. There are clinical manifestations of gastrointestinal obstruction, or routine parenteral fluid rehydration, parenteral nutrition, or indwelling gastric tube are required.\n19. Any of the following cardiovascular and cerebrovascular diseases:\n\n    1. Myocardial infarction, unstable angina, pulmonary embolism, aortic dissection, deep venous thrombosis and any arterial thromboembolic events occurred within 6 months before randomization;\n    2. Heart failure with New York Heart Association (NYHA) functional class ≥ II;\n    3. There are severe arrhythmias that require long-term drug intervention; patients with atrial fibrillation who are asymptomatic and have stable ventricular rates are allowed;\n    4. Cerebrovascular events (CVA) occurred within 6 months before randomization;\n    5. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n    6. Previous history of myocarditis or cardiomyopathy.\n    7. Hypertension (defined as systolic blood pressure \\> 150 mmHg, diastolic blood pressure \\> 100 mmHg) that remains uncontrolled after adequate antihypertensive drug treatment, or a history of hypertensive crisis or hypertensive encephalopathy.\n\n       20\\) Known history of severe hypersensitivity to other monoclonal antibodies. 21) NCI CTCAE v5.0 ≥ grade 3 peripheral neuropathy exists. 22) The toxicity of previous anti-tumor therapy has not been relieved, defined as the toxicity has not recovered to NCI CTCAE v5.0 ≤ 2 grades, or the level specified in the inclusion\u002Fexclusion criteria (except hair loss) 23) The investigator believes that it may lead to risk of receiving the study drug treatment, or any condition that will interfere with the evaluation of the study drug or the safety of the subjects or the interpretation of the study results (such as suffering from other serious diseases or mental diseases, etc.).\n\n       24\\) Enroll in another clinical study at the same time, unless it is an observational, non-interventional clinical study or follow-up period of an interventional study.\n\n       25\\) Pregnant or lactating women. 26) Subjects considered by the investigator to be inappropriate to participate in the trial due to other reasons.","75 Years",{"count":194,"type":22},58,[91],"This is a phase II trial of combination therapy of cadonilimab(Bispecific Anti-PD-1\u002FCTLA-4 Antibody) plus nab-Paclitaxel in patients with recurrent or metastatic cervical cancer that had failed PD-1\u002FPD-L1 blockade therapy. As a bispecific antibody against PD-1 and CTLA-4, cardonirimab can not only induce the production of a large number of T cells in the early stage of immune response by antagonizing CTLA-4, but also block PD-1 and PD-L1\u002FL2 combination. Thereby restoring the killing function of T cells to tumor cells and reducing the exhaustion of T cells.The hypothesis is the combination of cadonilimab and nab-Paclitaxel will overcome PD-1\u002FPD-L1 blockade-resistance to enhance the response of patients with persistant, recurrent or metastatic cervical cancer.",[198,199,60,200,28,201],"Uterine Cervical Neoplasms","Cancer of Cervix","Cervical Neoplasms","Cancer of the Uterine Cervix",[203,204],"PD-1","immune checkpoint inhibitor","2023-05-04",{"date":207,"type":37},"2023-05-06",{"date":209,"type":22},"2023-06",{"date":211,"type":22},"2026-06",{"name":213,"class":44},"Women's Hospital School Of Medicine Zhejiang University"]