[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-cervical-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-cervical-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,45,72,100,122,150,184,221,249,279,303,332,356,379,403,423,443,464,488,508,531,549],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100522211","phase-3-study-of-volrustomig-in-women-with-high-risk-locally-advanced-cervical-cancer-evolve-cervical-100522211",false,"NCT06079671","Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)","A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)","eVOLVECervical","Inclusion Criteria:\n\nFor inclusion in the study, patients should fulfill the following criteria:\n\n1. Female.\n2. Aged at least 15 years at the time of screening. Note: Participants \\\u003C 18 years of age: physical changes should be aligned with Tanner Stage III.\n3. Body weight \\> 35 kg.\n4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.\n5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.\n6. Provision of FFPE tumor sample to assess the PD-L1 expression.\n7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.\n8. WHO\u002FECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.\n9. Adequate organ and bone marrow function.\n10. Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.\n2. Evidence of metastatic disease.\n3. Intent to administer a fertility-sparing treatment regimen.\n4. History of organ transplant or allogenic stem cell transplant.\n5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.\n6. Uncontrolled intercurrent illness.\n7. History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.\n8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.\n9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.\n10. History of anaphylaxis to any biologic therapy or vaccine.\n11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg\u002Fday of prednisone (or equivalent) in the preceding 14 days.\n12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.\n13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.\n14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.\n15. Exposure to immune mediated therapy prior to the study for any indication.\n16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.\n17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.","FEMALE","15 Years",{"count":20,"type":21},800,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.",[27],"Locally Advanced Cervical Cancer",[29,30,31],"Locally Advanced Cervical Cancer;","Adolescent and Young Adult;","Volrustomig","RECRUITING","2026-06-25",{"date":35,"type":36},"2026-06-26","ACTUAL",{"date":38,"type":36},"2023-09-22",{"date":40,"type":21},"2030-09-30",{"name":42,"class":43},"AstraZeneca","INDUSTRY",205,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100637623","evaluation-of-persistent-infection-by-oncogenic-human-papillomavirus-hpv-in-patients-treated-for-cervical-carcinoma-and-its-relation-to-prognostic-factors-100637623","NCT07600515","Evaluation of Persistent Infection by Oncogenic Human Papillomavirus (HPV) in Patients Treated for Cervical Carcinoma and Its Relation to Prognostic Factors","ANIHTA","Inclusion Criteria:\n\n* Diagnosis of HPV-associated squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma\n* Treatment-naïve\n* FIGO 2018 stage IB3 to IVA\n* Candidates for curative-intent pelvic radiotherapy with concurrent chemoradiation\n\nExclusion Criteria:\n\n* Tumors with rare histology, such as small cell tumors, sarcomas, and lymphomas\n* FIGO 2018 stages IA, IB1, IB2, and IVB\n* Planned initial treatment is surgical or palliative\n* Uncertain primary tumor site (cervix vs. endometrium)\n* Pregnant or in the postpartum period\n* Immunosuppression (e.g., HIV infection with active disease, autoimmune diseases, transplant recipients)","18 Years",{"count":54,"type":21},100,"OBSERVATIONAL","Cervical cancer is strongly associated with HPV infection, yet current post-treatment follow-up relies on cytology and imaging, which have limited accuracy, particularly after radiotherapy. Emerging evidence suggests that HPV clearance is linked to better outcomes and that HPV testing may outperform cytology in detecting recurrence.\n\nThis study aims to evaluate a panel of prognostic biomarkers to identify patients at higher risk of recurrence. These include cervical and circulating HPV-DNA (presence, genotype, and load), vaginal microbiota, host DNA methylation, SOD2 expression, and immune profile.\n\nBy enabling earlier and more accurate detection of recurrence, these biomarkers may improve patient outcomes, reduce reliance on costly imaging, and support earlier discharge for low-risk patients.",[27,58],"Prognostic Biomarker",[60],"Cervical cancer recurrent or persistent","NOT_YET_RECRUITING","2026-06-02",{"date":64,"type":36},"2026-06-03",{"date":66,"type":21},"2026-05-10",{"date":68,"type":21},"2030-05-10",{"name":70,"class":71},"Instituto do Cancer do Estado de São Paulo","OTHER",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100618966","phase-1-a-clinical-study-of-nanocrystalline-megestrol-acetate-in-concurrent-chemoradiotherapy-for-locally-advanced-cervical-cancer-100618966","NCT07338487","A Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer","A Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer","Eligibility Criteria:\n\n1. Voluntarily sign the written ICF.\n2. Age ≥ 18 years at the time of enrollment.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n4. Expected survival period ≥ 6 months.\n5. Histologically or cytologically confirmed locally advanced cervical cancer (Stage IB3\u002FIIA2\u002FIIB-IVA) that is not amenable to complete surgical resection, classified according to the International Federation of Gynecology and Obstetrics (FIGO) staging system.\n6. Scheduled to undergo radical concurrent chemoradiotherapy.\n7. At least one measurable tumor lesion according to RECIST v1.1.\n8. Adequate organ function defined as follows:\n\n   a) Hematology (without any blood component or growth factor support within 7 days prior to initiation of study treatment): i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL (1,500\u002Fmm³); ii. Platelet count ≥ 100 × 10⁹\u002FL (100,000\u002Fmm³); iii. Hemoglobin ≥ 90 g\u002FL. b) Renal: i. Calculated creatinine clearance\\* (CrCl) ≥ 50 mL\u002Fmin\n   * CrCl will be calculated using the Cockcroft-Gault formula:\n\n   CrCl (mL\u002Fmin) = (140 - age) × weight (kg) × F \u002F (serum creatinine \\[mg\u002FdL\\] × 72) F = 1 for males; F = 0.85 for females ii. Urine protein ≤ 1+ or 24-hour urinary protein quantification \\\u003C 1.0 g. c) Hepatic: i. Total bilirubin (TBil) ≤ 1.5 × ULN; for patients with liver metastases or confirmed\u002Fsuspected Gilbert's disease, TBil ≤ 3 × ULN; ii. AST and ALT ≤ 2.5 × ULN; for patients with liver metastases, AST and ALT ≤ 5 × ULN; iii. Serum albumin (ALB) ≥ 28 g\u002FL. d) Coagulation: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (unless the patient is receiving anticoagulant therapy and coagulation parameters \\[PT\u002FINR and APTT\\] are within the therapeutic range at screening).\n\n   e) Cardiac: i. Left ventricular ejection fraction (LVEF) ≥ 50%.\n9. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if urine pregnancy test result is not confirmed negative, a serum pregnancy test will be required, and the serum result shall prevail). If a female patient of childbearing potential engages in sexual activity with a non-sterilized male partner, she must use acceptable contraceptive methods starting from screening and continue for 120 days after the last dose of study drug; whether to discontinue contraception after this time point should be discussed with the investigator. If a non-sterilized male patient engages in sexual activity with a female partner of childbearing potential, he must use effective contraceptive methods from screening until 120 days after the last dose; whether to discontinue contraception after this time point should be discussed with the investigator.\n10. The patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be ineligible for this study:\n\n1. Conditions affecting gastrointestinal absorption such as dysphagia, malabsorption, or uncontrolled vomiting; ongoing tube feeding or parenteral nutrition; presence of anorexia nervosa, psychogenic anorexia, or pain-induced feeding difficulties.\n2. Current or planned use of medications that increase appetite or weight, including but not limited to: adrenal corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.\n3. Diagnosis of Cushing's syndrome, adrenal or pituitary insufficiency; poorly controlled diabetes mellitus.\n4. Current radiographic or clinical evidence of gastrointestinal obstruction.\n5. Active autoimmune disease requiring systemic treatment within the past two years (e.g., disease-modifying agents, corticosteroids, immunosuppressants). History of non-infectious pneumonitis\u002Finterstitial lung disease requiring systemic glucocorticoid therapy, or current non-infectious pneumonitis.\n6. Uncontrolled concurrent illnesses including but not limited to decompensated cirrhosis, renal failure, uncontrolled metabolic disorders, severe active peptic ulcer disease\u002Fgastritis, or psychiatric\u002Fsocial conditions that would limit compliance with study requirements or the ability to provide written informed consent.\n7. Within 12 months prior to the first dose: unstable angina requiring hospitalization, myocardial infarction, congestive heart failure (NYHA Class II or higher), vascular disease (e.g., aortic aneurysm at risk of rupture), or other cardiac impairments that may affect safety evaluation of the study drug (e.g., poorly controlled arrhythmia, myocardial ischemia). Within 6 months prior to the first dose: history of esophagogastric varices, severe ulcers, gastrointestinal perforation and\u002For fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding.\n8. Within 6 months prior to the first dose: any arterial thromboembolic events, Grade 3 or higher venous thromboembolism per NCI CTCAE v5.0 requiring urgent intervention (e.g., pulmonary embolism or intracardiac thrombosis), transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy. Within 1 month prior to the first dose: acute exacerbation of chronic obstructive pulmonary disease. Current hypertension with systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg despite oral antihypertensive therapy.\n9. History of severe bleeding tendency or coagulopathy; clinically significant bleeding symptoms within 1 month prior to the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing\u002Fexpectorating ≥1 teaspoon of fresh blood or small clots, or blood without sputum; patients with blood-tinged sputum are eligible), epistaxis (excluding minor nasal bleeding and blood-tinged postnasal drip).\n10. Within 4 weeks prior to the first dose: severe infections including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; within 2 weeks prior to the first dose: active infection requiring systemic antimicrobial therapy (excluding antiviral therapy for hepatitis B\u002FC).\n11. Any condition, treatment, or laboratory abnormality that may confound study results, impede complete study participation, or make participation not in the patient's best interest.",{"count":80,"type":21},88,[82],"PHASE1","Cervical cancer, ranking as the fourth most prevalent malignancy in women globally, presents significant challenges in nutritional management. Approximately 31% of patients develop cancer-related malnutrition\u002Fcachexia, with 10-20% of deaths directly attributable to nutritional depletion. The disease process and its treatment - particularly concurrent chemoradiotherapy (CCRT) - create a destructive cycle through multiple mechanisms. Tumor-derived factors (including activins and myostatin) and inflammatory cytokines (such as TNF-α and IL-6) actively promote muscle and fat catabolism. CCRT toxicity, especially from platinum-based drugs, worsens this condition by inducing mitochondrial dysfunction and accelerating protein degradation, leading to clinically significant sarcopenia. This metabolic disruption has dire consequences, with studies showing severe weight loss during CCRT correlating with a 2.37-fold increase in mortality risk (HR 2.37, p=0.036).\n\nNanocrystalline megestrol acetate (MA) emerges as a promising therapeutic intervention with dual mechanisms of action. Centrally, it modulates D2 receptors to upregulate neuropeptide Y (NPY), effectively stimulating appetite. Peripherally, it suppresses key inflammatory cytokines (IL-6 and TNF-α), thereby reducing systemic inflammation and muscle wasting. Its efficacy is well-established, with endorsement from major oncology guidelines (ASCO, NCCN, ESMO) for cancer cachexia management. A comprehensive meta-analysis of 35 clinical trials involving 4,234 patients demonstrated MA's superiority over placebo, showing significant improvements in appetite (RR 2.2), weight gain (RR 1.6), and quality of life (RR 1.8).\n\nThe nanocrystalline formulation represents a substantial pharmacological advancement over conventional MA. While traditional preparations have limited solubility (2 µg\u002FmL) and require high-fat meals for adequate absorption, the nanocrystalline version (with particles reduced to 26.6 nm) demonstrates 22% greater bioavailability. This translates to clinically meaningful differences: fasting-state peak concentrations increase from 187 ng\u002FmL to 1,133 ng\u002FmL, the time to observable effect shortens from 14 days to just 3 days, and 12-week weight gain improves from 3.5 kg to 5.4 kg (with 40% being lean mass). Dose optimization studies confirm 800 mg\u002Fday as the optimal conventional MA dose, with the nanocrystalline equivalent being 625 mg\u002Fday due to its enhanced bioavailability.\n\nThe proposed clinical investigation will evaluate this intervention in FIGO IB3-IVA cervical cancer patients (n=5) undergoing CCRT. The study employs a two-arm design comparing nanocrystalline MA (625 mg\u002Fday) plus CCRT against CCRT alone. Primary endpoints focus on BMI changes at 8 weeks, with secondary assessments of nutritional status, inflammatory markers, and quality of life measures. This research aims to establish nanocrystalline MA as a means to break the cachexia cycle in cervical cancer treatment, potentially improving both treatment tolerance and survival outcomes.",[27,85],"Cachexia",[27,87,85,88,89],"Nanocrystalline Megestrol Acetate","Clinical Research","Control Group","2026-04-23",{"date":92,"type":36},"2026-04-24",{"date":94,"type":21},"2026-04-30",{"date":96,"type":21},"2026-12-05",{"name":98,"class":71},"Second Xiangya Hospital of Central South University",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100627617","phase-2-cadonilimab-combined-with-rt-in-lacc-patients-ineligible-for-ccrt-100627617","NCT07450963","Cadonilimab Combined With RT in LACC Patients Ineligible for CCRT","Cadonilimab Combined With Radical Radiotherapy in Locally Advanced Cervical Cancer Patients Ineligible for Concurrent Chemotherapy - A Prospective, Single Arm, Phase II Trial","Inclusion Criteria:\n\n1. Female, age ≥18 years.\n2. Histologically confirmed cervical squamous cell carcinoma or adenosquamous carcinoma.\n3. FIGO 2018 stage IB3-IVA, or medically inoperable disease requiring definitive radiotherapy.\n4. ECOG performance status 0-2, life expectancy ≥6 months.\n5. Presence of at least one absolute or relative contraindication to concurrent cisplatin based chemotherapy, defined as:\n\n   * Age ≥70 years; OR\n   * Renal impairment: serum creatinine \\>1.5 × upper limit of normal (ULN) or calculated creatinine clearance (CrCl) \\\u003C50 mL\u002Fmin (Cockcroft Gault); OR\n   * Cardiac dysfunction: New York Heart Association class ≥II; OR\n   * Prior allergic reaction to platinum agents; OR\n   * Patient refusal of chemotherapy after thorough counselling.\n6. Adequate organ function:\n\n   * Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome)\n   * AST and ALT ≤2.5 × ULN\n7. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Prior or concurrent invasive malignancy unless disease free for ≥5 years (exceptions: non melanoma skin cancer, cured in situ carcinoma).\n2. No histological confirmation of cervical cancer.\n3. Prior exposure to anti PD 1\u002FPD L1, anti CTLA 4, or other immune checkpoint inhibitors.\n4. Congenital or acquired immunodeficiency (e.g., HIV infection).\n5. Active hepatitis B (HBsAg positive with detectable HBV DNA) or hepatitis C (HCV RNA positive).\n6. Pregnancy or lactation (negative serum\u002Furine β hCG required for premenopausal women).\n7. Severe uncontrolled comorbidities precluding safe radiotherapy:\n\n   * Unstable angina, myocardial infarction, or congestive heart failure requiring hospitalisation within 6 months\n   * Acute bacterial or systemic fungal infection\n   * Chronic obstructive pulmonary disease exacerbation requiring hospitalisation\n   * Active connective tissue disease (e.g., systemic lupus erythematosus, scleroderma)\n8. Psychiatric illness or social condition that would limit study compliance.\n9. Inability to understand the study purpose or refusal to sign informed consent.\n10. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.",{"count":108,"type":21},45,[110],"PHASE2","Concurrent chemoradiotherapy (CRT) is the standard of care for locally advanced cervical cancer (LACC). However, a substantial proportion of patients have contraindications to cisplatin based chemotherapy due to advanced age, renal impairment, cardiac dysfunction, or other comorbidities. For these patients, no evidence based standardised treatment exists. Immunotherapy combined with radiotherapy may offer a chemotherapy sparing alternative. Cadonilimab, a PD 1\u002FCTLA 4 bispecific antibody, has demonstrated significant efficacy in advanced cervical cancer. This study aims to evaluate the efficacy and safety of cadonilimab combined with radical radiotherapy in LACC patients ineligible for concurrent chemotherapy.\n\nThis is an investigator initiated, prospective, single centre, single arm, open label, Simon's two stage phase II trial. A total of 45 patients will be enrolled. Eligible participants are women aged \\>18 years with histologically confirmed cervical squamous cell carcinoma or adenosquamous carcinoma, FIGO 2018 stage IB3-IVA, and absolute or relative contraindications to cisplatin based chemotherapy. All patients will receive radical radiotherapy (external beam radiotherapy 45-50.4 Gy\u002F25-28 fractions plus high dose rate brachytherapy 6-8 Gy × 3-5 fractions) concurrently with three cycles of cadonilimab 10 mg\u002Fkg intravenously every 3 weeks. The primary endpoint is complete response (CR) rate assessed at 4 weeks post radiotherapy. Secondary endpoints include 2 year progression free survival, 2 year local control, 2 year locoregional control, 5 year overall survival, safety (CTCAE v5.0 and RTOG late toxicity), and quality of life (EORTC QLQ C30 and QLQ BR23). Assuming a historical CR rate of 69% with radiotherapy alone, we hypothesise that the combination will increase CR to 85%. With α=0.05 (two sided) and 80% power, Simon's optimal two stage design requires 43 evaluable patients; after accounting for 5% dropout, 45 patients will be recruited.",[27],"2026-03-03",{"date":115,"type":36},"2026-03-05",{"date":117,"type":21},"2026-03",{"date":119,"type":21},"2034-02",{"name":121,"class":71},"Ruijin Hospital",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":99},"100626465","clinical-feasibility-of-the-architect-applicator-in-cervical-cancer-brachytherapy-100626465","NCT07435987","Clinical Feasibility of the ARCHITECT Applicator in Cervical Cancer Brachytherapy","Clinical Feasibility of the ARCHITECT Applicator in High-dose-rate Cervical Cancer Brachytherapy","ARCHITECT","Inclusion Criteria:\n\n* Locally advanced cervical cancer (FIGO 2018 stage 1B3-IVA) with indication for primary radiotherapy including brachytherapy\n* Written informed consent\n\nExclusion Criteria:\n\n* Unable to give informed consent;\n* Tumour extension in the lower 2\u002F3rd of the vagina;\n* Requiring a Geneva tandem with ovoids' size 13 mm in the first application for brachytherapy;\n* Known nylon allergy.",{"count":131,"type":21},25,[133],"NA","This prospective, non-randomised, single centre, phase I trial assesses the clinical feasibility of the use of the patient-tailored ARCHITECT applicator in locally advanced cervical cancer brachytherapy.",[27,136],"Uterine Carcinoma",[138,139,140],"Brachytherapy","Patient-tailored applicator","3D-printed applicator","2026-02-20",{"date":143,"type":36},"2026-02-27",{"date":145,"type":21},"2026-05",{"date":147,"type":21},"2027-12",{"name":149,"class":71},"Erasmus Medical Center",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":99},"100612087","this-is-a-multicentre-international-study-evaluating-ct-based-igabt-with--without-either-trus-during-btpre-bt-mr-as-per-ibs-gecestro-abs-recommendations-for-target-contouring-as-an-alternative-to-mrigabt-for-cervical-cancer-from-implementation-perspectives-under-embrace-iiitriplet-impact-study-100612087","NCT07249021","This is a Multicentre International Study Evaluating CT-based IGABT With \u002F Without Either TRUS During BT\u002FPre BT MR as Per IBS-GECESTRO-ABS Recommendations for Target contouring-as an Alternative to MRIGABT for Cervical Cancer From Implementation Perspectives Under EMBRACE-III:TRIPLET IMPACT Study.","Integration of Multi-modality Imaging Protocols With emphAsis on CT in Image Guided Adaptive Brachytherapy (IGABT) for Cervical Cancer - EMBRACE III-IMPACT STUDY","IMPACT","Inclusion Criteria:\n\n1. Cancer of the uterine cervix considered suitable for curative treatment with definitive chemo radiotherapy including brachytherapy.\n2. Biopsy showing invasive squamous-cell carcinoma or adenocarcinoma or adeno - squamous cell carcinoma of the uterine cervix.\n3. FIGO (2018) stage IB2 to IVA\n4. Willingness to participate by signing informed consent form.\n\nExclusion Criteria:\n\n* Other previous or current primary malignancies except carcinoma in situ of the cervix.\n\n  * Metastatic Inguinal Nodes not amenable to radical radiation therapy\n  * Metastatic disease in para-aortic region beyond renal vessels\n  * Not eligible for concurrent cisplatin chemotherapy (creatinine clearance \\\u003C 50mg\u002Fml\u002Fmin)\n  * Previous pelvic or abdominal radiotherapy.\n  * Previous total or partial hysterectomy.\n  * Patients receiving BT alone.\n  * Patients receiving EBRT alone.\n  * Patients receiving any form of neoadjuvant anti-neoplastic therapy prior to definitive treatment or adjuvant therapy\n  * Active infection or severe medical condition which precludes radical chemoradiotherapy.\n  * Pregnant or lactating or childbearing potential without adequate contraception.",{"count":159,"type":21},1200,"Title: Integration of Multi-modality Imaging Protocols with Emphasis on CT in Image-Guided Adaptive Brachytherapy (IGABT) for Cervical Cancer - EMBRACE III-TRIPLET : IMPACT Study Locally advanced cervical cancer (LACC) remains a major health challenge, particularly in low- and middle-income countries (LMICs), which account for the majority of global cases. The standard curative treatment involves a combination of external beam radiotherapy (EBRT) with concurrent chemotherapy, followed by brachytherapy (BT). Brachytherapy plays a crucial role in achieving high local control by delivering radiation directly to the tumour through internally placed radioactive sources.\n\nHistorically, BT dose prescription was based on two-dimensional (2D) X-ray images and defined anatomical \"points,\" achieving 5-year local control rates of 60-70%. Over the last decade, magnetic resonance imaging (MRI)-based image-guided adaptive brachytherapy (MR-IGABT) has transformed practice by enabling three-dimensional (3D) target-based dose prescription and adaptation to tumour regression. The landmark EMBRACE I study, involving over 1300 patients, demonstrated over 90% 5-year local control rates with MR-IGABT, establishing it as the international gold standard endorsed by NCG, ICRU, NCCN, and ESGO-ESTRO guidelines.\n\nHowever, MRI-based planning for IGABT remains logistically and financially challenging for many centres, especially in LMICs. CT and transrectal ultrasound (TRUS) have emerged as feasible alternatives, offering broader accessibility. Despite encouraging outcomes from smaller institutional studies, the lack of standardized and validated target delineation concepts for CT-IGABT has led to significant variability in clinical implementation. Recognizing this, the Indian Brachytherapy Society (IBS), American Brachytherapy Society (ABS), and GEC-ESTRO jointly published consensus recommendations in 2020 to standardize CT-IGABT practices across diverse clinical environments.\n\nAt Homi Bhabha Cancer Hospital and Research Centre, Visakhapatnam, our prior work (RetroLACER Study) demonstrated that CT-based IGABT can achieve outcomes comparable to MR-IGABT, highlighting its feasibility and potential for wider adoption. Building on this foundation, the EMBRACE III-IMPACT Study seeks to evaluate whether CT-IGABT can be systematically and uniformly implemented in a multi-centre setting and to benchmark clinical outcomes against the standards set by MR-IGABT.\n\nStudy Design:\n\nThis is a multicentre, prospective, observational study planned to include approximately 1200 participants with locally advanced cervical cancer. All participants will receive standard-of-care treatment, including EBRT, concurrent weekly cisplatin chemotherapy, and brachytherapy with image-guided planning.\n\nObjectives:\n\nTo assess the feasibility of implementing standardized CT-IGABT protocols across diverse clinical environments.\n\nTo evaluate local control, disease-free survival, and treatment-related toxicity outcomes for CT-IGABT.\n\nTo compare and benchmark CT-IGABT outcomes with established MR-IGABT benchmarks from prior international studies.\n\nParticipant Involvement:\n\nParticipants will undergo standard diagnostic imaging, EBRT with weekly cisplatin, and brachytherapy using CT-based planning. Imaging and treatment data will be collected, anonymized, and submitted to a central database for review. Regular follow-up visits will monitor tumour control and treatment-related side effects.\n\nBenefits:\n\nParticipants receive internationally standardized, quality-assured treatment protocols. Centres gain access to expert review and QA support from international collaborators, potentially improving treatment quality and outcomes.\n\nThe study supports global efforts to establish CT-IGABT as a cost-effective, accessible alternative to MRI-based IGABT, expanding equitable cancer care access.\n\nRisks:\n\nThe study is observational and involves standard treatment; therefore, risks and costs are comparable to routine cervical cancer care.\n\nConfidentiality and Ethics:\n\nAll data will be anonymized and handled in compliance with ethical and regulatory standards. Participant confidentiality will be strictly maintained. Written informed consent will be obtained before study participation.\n\nSignificance:\n\nBy validating standardised CT-based protocols and establishing outcome benchmarks, the study aims to facilitate widespread adoption of IGABT in resource-limited settings, ultimately improving treatment accessibility and survival outcomes.",[27,138,162,163],"CT","Transrectal Ultrasound",[165,166,167,168,169,170,171,172,173,174],"Cervical cancer","CT-guided brachytherapy","Image-Guided Adaptive Brachytherapy (IGABT)","Locally advanced cervical cancer","Implementation study","Resource-limited settings","Low- and middle-income countries (LMICs)","EMBRACE III","Trans-rectal ultrasound during BT","Pre BT MR Imaging","2025-11-21",{"date":177,"type":36},"2025-11-25",{"date":179,"type":21},"2025-11",{"date":181,"type":21},"2031-11",{"name":183,"class":71},"Homi Bhabha Cancer Hospital & Research Centre",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":192,"minAge":52,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":207,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":99},"100514215","microenvironment-tumor-effects-of-radiotherapy---comprehensive-radiobiology-assessment-trial-100514215","NCT05975593","MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial","MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)","METEOR-CRATR","Inclusion Criteria:\n\n* Confirmation of intent to receive radiotherapy for one of the following diagnoses:\n\n  * Cervical cancer\n  * Pancreatic cancer\n* ECOG performance status ≤ 2\n* At least 18 years old\n* Able to understand and willing to sign an IRB-approved written informed consent document\n\nExclusion Criteria:\n\n* Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician","ALL",{"count":194,"type":21},60,[133],"This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.",[198,27,199,200,201,202,203,204,205,206],"Locally Advanced Cervical Carcinoma","Locally Advanced Pancreas Cancer","Locally Advanced Pancreatic Carcinoma","Locally Advanced Pancreatic Cancer","Cervical Cancer","Pancreas Cancer","Pancreatic Cancer","Cancer of the Cervix","Cancer of the Pancreas",[208,209,165,210,211],"Radiotherapy","Chemotherapy","Pancreatic cancer","Biospecimen","2025-11-07",{"date":214,"type":36},"2025-11-12",{"date":216,"type":36},"2024-01-11",{"date":218,"type":21},"2032-12-31",{"name":220,"class":71},"Washington University School of Medicine",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":99},"100597200","phase-2-neoadjuvant-iparomlimab-and-tuvonralimab-plus-chemotherapy-eclipse-for-locally-advanced-cervical-cancer-nice-cc-100597200","NCT07055399","Neoadjuvant Iparomlimab and Tuvonralimab Plus Chemotherapy-eclipse for Locally Advanced Cervical Cancer (NICE-CC)","Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Chemotherapy-eclipse for Locally Advanced Cervical Cancer：A Single-arm, Open-label, Phase II Trial","NICE-CC","Inclusion Criteria:\n\n* 1、Written informed consent\n* 2、18-70 years old\n* 3、Adequate organ function and ECOG of 0 \\~1\n* 4、Without systemic therapy at the time of enrollment\n* 5、FIGO 2018 stage IB3, IIA2, or IIIC1r\n* 6、Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix\n* 7、Measurable lesions could be defined by RECIST v1.1\n* 8、Willing to get blood\u002F tumor tissue tested\n* 9、Patients who observed the rules about the scheduled visit, study schedule, and medical examination\n* 10、The function of major organs is normal, and the following criteria are met:\n* 10.1 Blood routine examination must meet: (no blood transfusion within 14 days)\n\nHb≥90g\u002FL:\n\nANC≥1.5x10\\^9\u002FL; PLT≥100x10\\^9\u002FL;\n\n* 10.2 The biochemical examination must meet the following standards BIL \\\u003C 1.5 × ULN; ALT and AST \\\u003C 2.5xULN; ALB≥ 28 g\u002FL\n* 11、Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures.\n\nExclusion Criteria:\n\n* 1、History of other malignancies within 3 years\n* 2、Participate in other clinical trials at the same time\n* 3、Active autoimmune disease, which needs systemic therapy\n* 4、Uncontrolled infection, which needs systemic therapy\n* 5、History of allogeneic tissue\u002Fsolid organ transplant\n* 6、Serious illness, such as severe mental disorders, cardiac disease, coagulation disorders, digestive system disease, etc\n* 7、Active HBV, HCV, or HIV infection\n* 8、Pregnant or lactating female patients\n* 9、Drug or alcohol abuse\n* 10、 Unable or unwilling to sign the informed consent","70 Years",{"count":231,"type":21},43,[110],"Locally advanced cervical cancer (LACC) remains a significant global health concern with limited treatment options. Recent advancements suggest that using neoadjuvant anti-PD-1 inhibitors in combination with chemotherapy, followed by radical surgery, may be an effective treatment strategy for patients with PD-L1-positive LACC. This study aims to evaluate the efficacy and safety of preoperative treatment with iparomlimab and tuvonralimab-a bifunctional PD-1\u002FCTLA-4 dual blocker-combined with chemotherapy for LACC.",[27],[202,236,237,238],"neoadjuvant","chemo-immunotherapy","iparomlimab and tuvonralimab;","2025-09-05",{"date":241,"type":36},"2025-09-11",{"date":243,"type":36},"2025-08-21",{"date":245,"type":21},"2029-09-01",{"name":247,"class":248},"Fujian Cancer Hospital","OTHER_GOV",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":99},"100600950","phase-2-neoadjuvant-chemotherapy-plus-cadonilimab-for-locally-advanced-cervical-cancer-100600950","NCT07104149","Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer","Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer : a Multicentre, Single Arm, Phase 2 Trial","Histologically confirmed cervical carcinoma, FIGO stage IB3, IIA2, IIB, IIIC1, and assessed as resectable by the researcher。\n\nInclusion Criteria:\n\n* Female, age ≥18 years;\n* Histologically confirmed cervical cancer, FIGO stage IB3, IIA2, IIB, IIIC, and assessed by the researcher as resectable;\n* No previous systemic treatment for the current disease, including surgical treatment, antitumor chemoradiotherapy\u002Fimmunotherapy, etc.;\n* Patients who agree to undergo radical surgical treatment and are judged by the surgeon to have no surgical contraindications;\n* ECOG score of 0-1;\n* Expected survival time \\>6 months;\n* Sufficient organ function, the subject must meet the following laboratory indicators:\n\nNeutrophil absolute count (ANC) ≥1.5x10\\^9\u002FL ; Platelets ≥100x10\\^9\u002FL ;Hemoglobin \\>9g\u002FdL ; Total bilirubin ≤1.5× upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN; Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml\u002Fmin; international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; Normal thyroid function; Myocardial enzymes within the normal range\n\nExclusion Criteria:\n\n* Diagnosis of other malignancies within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has undergone radical resection).\n* Current participation in an interventional clinical study or receipt of other investigational drugs or devices within 4 weeks prior to the first dose.\n* Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors .\n* Systemic treatment with Chinese herbal medicines with antitumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukin, excluding local use for pleural effusion control) within 2 weeks prior to the first dose.\n* Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal\u002Fpituitary insufficiency) are not considered systemic treatment.\n* Systemic glucocorticoid therapy (excluding nasal sprays, inhalations, or other local routes) or any immunosuppressive therapy within 7 days prior to the first dose.\n* History of allogeneic organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.\n* Known hypersensitivity to any study drug.\n* Presence of multiple factors affecting cisplatin use (e.g., platinum allergy).\n* Inadequate recovery from prior intervention-related toxicity or complications (i.e., \\>Grade 1 or not returned to baseline, excluding fatigue or alopecia).\n* Known history of Human Immunodeficiency Virus（ HIV） infection .\n* Untreated active hepatitis B （HBV）(defined as HBsAg-positive with HBV-DNA exceeding the upper limit of normal at the study site).\n* Active hepatitisC (HCV) infection (HCV antibody-positive with HCV-RNA above the lower detection limit).\n* Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1).\n* Pregnant or lactating women.\n* Severe or uncontrolled systemic diseases, including:Symptomatic resting Electrocardiograph abnormalities (e.g., complete left bundle branch block, ≥Grade II heart block, ventricular arrhythmia, atrial fibrillation).Unstable angina, congestive heart failure, or chronic heart failure ≥NYHA class II.Arterial thromboembolism, ischemia, myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to enrollment.Poorly controlled hypertension (systolic \\>140 mmHg, diastolic \\>90 mmHg).History of non-infectious pneumonitis requiring glucocorticoids within 1 year or current active interstitial lung disease.\n* Active tuberculosis.\n* Active or uncontrolled infection requiring systemic therapy.\n* Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.\n* Liver diseases (e.g., cirrhosis, decompensated liver disease, acute\u002Fchronic active hepatitis).\n* Poorly controlled diabetes (fasting blood glucose \\>10 mmol\u002FL).\n* Urine protein ≥++ on urinalysis with 24-hour urine protein \\>1.0 g.\n* Psychiatric disorders impairing compliance.\n* Any condition (e.g., medical history, abnormal lab\u002Ftest results, concurrent treatments) that may interfere with study outcomes, participation, or pose risks, as judged by the investigator.","75 Years",{"count":258,"type":21},29,[110],"Main Purpose of this study is to determine the efficacy and safety of Cadonilimab combined with chemotherapy (cisplatin) for locally advanced cervical cancer.\n\nThis is an multicentre, single Arm, Phase 2 Trial study of Cadonilimab with Cisplatin in the treatment of locally advanced cervical cancer. 29 eligible patients will receive Cadonilimab（10mg\u002Fkg, iv., D1, q3w）with Cisplatin ( 75mg\u002F m2, iv., D2， q3w) for a total of 2-4 cycles before radical surgical treatment.",[262,263,264,265,266,267,268,27,269],"Female, Age ≥ 18 Years Old","No Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy\u002FImmunotherapy","ECOG Score of 0-1","Histologically Confirmed Cervical Cancer, FIGO Stage IB3, IIA2, IIB, IIIC, and Assessed by the Researcher as Resectable Lesion","Sufficient Organ Function","The Result of the Urine or Serum Pregnancy Test for the Subject is Negative","Subjects Should Take Contraceptive Measures","Expected Survival Time >6 Months","2025-08-01",{"date":272,"type":36},"2025-08-05",{"date":274,"type":36},"2025-03-10",{"date":276,"type":21},"2027-06-30",{"name":278,"class":71},"The First Affiliated Hospital of Zhengzhou University",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100575354","study-on-disease-characteristics-and-treatment-in-locally-advanced-or-recurrent--metastatic-cervical-cancer-in-italy-100575354","NCT06771193","Study on Disease Characteristics and Treatment in Locally Advanced or Recurrent \u002F Metastatic Cervical Cancer in Italy","RETRACE Study - Retrospective Observational Study Evaluating Disease Characteristics and Treatment Landscape of High-risk Locally Advanced (LA) or Recurrent \u002F Metastatic (R\u002FM) Cervical Cancer in Italy","RETRACE","Inclusion Criteria:\n\n* Patient (or their legally acceptable representatives) must have signed and dated the Informed Consent \\& Privacy Form (ICF)\n* Age ≥18 years\n* Diagnosis of a cervical cancer\n* Locally advanced stage (not suitable for curative surgery) or recurrent or metastatic disease\n* Any treatment received between January 2018 and December 2021 for advanced disease\n\nExclusion Criteria:\n\n* Patients participating in a pharmacological clinical trial for the treatment of advanced disease\n* Patients who participated in a clinical trial\n* Patients who were administered with Pembrolizumab, Olaparib or Levantinib or medications from these class of drugs",{"count":288,"type":21},200,"Multicenter, Observational, Retrospective charts review. Observational study with descriptive purpose only. Retrospective data capture in consecutive patients diagnosed with CC who attended the Oncologic Clinics from Jan 2018 to Dec 2021 (using medical records, either electronic or not), inserted in eCRF and analyzed.",[202,27,291,292],"Recurrent Cervical Cancer","Metastatic Cervical Cancer","2025-07-16",{"date":295,"type":36},"2025-07-20",{"date":297,"type":36},"2024-12-17",{"date":299,"type":21},"2025-12",{"name":301,"class":43},"MSD Italia S.r.l.",11,{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":318,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":99},"100528111","phase-3-evaluation-of-concomitant-chemo-radiotherapy-with-cisplatine-vs-gemcitabin-in-locally-advanced-cervicouterine-cancer-100528111","NCT06156514","Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer","Evaluation of Concomitant Chemo-radiotherapy With Cisplatin vs Gemcitabine as the First Line of Treatment in Patients With Locally Advanced Cervical Cancer, With Comorbidities and Preserved Renal Function, is a Phase III Clinical Trial.","MICHELE","Inclusion Criteria:\n\n* Singed informed consent.\n* Women with Age ≥ 18 years.\n\n  1. -In women of childbearing age it should be documented: a) negative pregnancy test in serum at the beginning of the study (14 days before the start of QT-RT); b) Accept the use of some method of contraception approved by your attending physician during the study and 12 weeks after the treatment has ended.\n  2. -In postmenopausal women (surgical or natural menopause) at least one of the following parameters must be met for inclusion.\n* Previous bilateral oophorectomy\n* Age ≥ 60 years\n* Age \\\u003C60 years and amenorrhea for at least 12 months and levels of follicle stimulating hormone and estradiol within postmenopausal interval parameters.\n* Diagnosis of CaCu EC IB2 mg\u002Fdl With histological confirmation (epidermoid, adenocarcinoma or adenoescamoso).\n* Patients who are candidates for treatment with concomitant QT \u002F RT.\n* ECOG 0-2.\n* Measurable disease by CT scan and magnetic resonance imaging of the pelvis according to the RECIST criteria v1.1\n* No previous treatment.\n* Creatinine clearance ≥ 60 ml \u002F min calculated by the CKD-EPI formula.\n* Patients with adequate hematological and hepatic functioning, defined by the following parameters:\n\n  1. Hb equal to or greater than 10g \u002Fl. (Transfusion prior to treatment is allowed to reach this level of hemoglobin).\n  2. Leukocytes greater than or equal to 4000 \u002F mm3.\n  3. Platelets equal to or greater than 100,000mm3.\n  4. Total bilirubin ≤1.5 times the upper limit of normal (ULN) and. Transaminases less than 1.5 times the LSN\n* Patients with a prior diagnosis of the following comorbidities:\n\n  * Diabetes mellitus type 2, which has: fasting serum glucose \\\u003C250 mg\u002Fdl.\n  * Systemic arterial hypertension G1 or G2 according to CTCAE v4.03\n  * Child Pugh A liver disease\n  * Cardiovascular diseases such as: Ischemic heart disease undergoing asymptomatic treatment, without clinical data of stable or unstable angina or for acute myocardial infarction.\n  * Compensated heart failure in functional class I of the New York Heart Association.\n  * Systemic Lupus Erythematosus with mild or inactive lupus activity (less than or equal to 4 points according to the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI).\n\nExclusion Criteria:\n\n* Patients with a second neoplasm.\n* Pregnant or lactating patients.\n* Patients with small cell and \u002F or neuroendocrine CaCu.\n* Patients with impaired renal function with a GFR \\\u003Cor equal to 60ml \u002F min calculated by the CKD-EPI formula\n* Patients with a history of active TB (TB)\n* Patients with a history of Human Immunodeficiency Virus (HIV) infection\n* Patients with vesico-vaginal or vesicorectal fistulas at diagnosis\n* Concomitant treatment with another experimental drug. Social, family or geographical conditions that suggest a poor attachment to the study\n\nCriteria Interruption of Treatment (Withdrawal of patients)\n\nA patient will be discontinued from the study under the following circumstances:\n\n* Evidence of disease progression.\n* If treating physician considers that a change of therapy may benefit the patient.\n* If patient withdrew consent\n* Due to unmanageable toxicity By pregnancy or if the patient does not wish to continue using the contraceptive methods indicated by the attending physician",{"count":312,"type":21},140,[24],"The purpose of this phase III clinical trial, is to evaluate the efficacy and safety of concomitant chemo-radiotherapy with Cisplatin vs Gemcitabine as the first line of treatment in patients with locally advanced cervical cancer, with comorbidities and preserved renal function.",[27,316,317],"Gemcitabine","Chemo-radiotherapy",[319,320,316,321,322],"Locally advanced cervical cancer (LACC)","Concomitant chemo-radiotherapy","Cisplatin","Comorbidities","2025-05-22",{"date":325,"type":36},"2025-05-28",{"date":327,"type":36},"2019-11-06",{"date":329,"type":21},"2029-12-31",{"name":331,"class":248},"National Institute of Cancerología",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":344,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":355,"locationsCount":99},"100522301","curcumin-supplementation-in-cervical-cancer-100522301","NCT06080841","Curcumin Supplementation in Cervical Cancer","Evaluation of Curcumin Supplementation on p53 Levels and Apoptosis in Tumor Cells From Patients With Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n1. Understanding the nature of the study and giving a written consent report.\n2. Women \\> 18 years old.\n3. ECOG performance status: 0-2.\n4. Be willing and able to comply with scheduled visits, treatment plans, and laboratory tests.\n5. Patients with a histological cervical cancer diagnosis: squamous cell, adenosquamous, adenocarcinoma, and glassy cell carcinoma.\n6. Classified with clinical stage IB3-IVA (FIGO 2018).\n7. Candidates to receive concomitant QT-RT followed by BT.\n8. With disease measurable by any imaging method (CT\u002FMRI\u002FPET-CT) according to RECIST v 1.1 criteria.\n9. Patients without prior treatment based on QT-RT.\n10. Hemoglobin ≥ 10 g\u002FdL.\n11. Leukocytes ≥ 4000\u002Fmm3.\n12. Platelets ≥ 100,000\u002Fmm3.\n13. Adequate liver function.\n\nExclusion Criteria:\n\n1. Patients undergoing nutritional treatment or ingesting any dietary supplement, including those containing turmeric or turmeric derivatives, ginger, or rhizome of the turmeric family.\n2. Patients with uncontrolled intercurrent diseases, including active infections that contraindicate CT.\n3. Patients receiving concomitant treatment with an experimental drug.\n4. Patients with vesicovaginal or vesicorectal fistula are diagnosed.\n5. Patients with previous or concomitant malignancy except non-melanoma skin carcinoma.",{"count":340,"type":21},30,[133],"Brief Summary.\n\nThe goal of this pilot study is to learn about the effect of curcumin supplementation in locally advanced cervical cancer patients. The main questions it aims to answer are:\n\n* Does curcumin supplementation increase the levels of p53 and apoptosis in tumor cells from cervical cancer patients?\n* At which dose of curcumin supplementation is the broader effect observed for p53 expression and apoptosis in tumor cells from cervical cancer patients?\n* Are all doses safe for supplementation?\n\nParticipants will be asked to take curcumin tablets throughout their cancer treatment. Researchers will compare 6 different groups, each group will receive a different dose of curcumin with or without piperin, to see the dose with the broader effect and safety of curcumin supplementation:\n\n1. 1 g of curcumin\n2. 1 g of curcumin + piperine\n3. 3 g of curcumin\n4. 3 g of curcumin + piperine\n5. 6 g of curcumin\n6. 6 g of curcumin + piperine",[27],[345,346,347,348,349],"curcumin","locally advanced cervical cancer","p53","apoptosis","chemoradiotherapy",{"date":351,"type":36},"2025-05-25",{"date":353,"type":36},"2023-04-19",{"date":117,"type":21},{"name":331,"class":248},{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":256,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":364,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":99},"100586495","phase-2-neoadjuvant-chemo-immunotherapy-followed-by-concurrent-chemoradiotherapy-and-immunotherapy-in-lacc-100586495","NCT06916117","Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in LACC","A Prospective Single Arm Trial of Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n* (1)Age between 18 and 75; (2)Untreated patients with pathologically proven squamous carcinoma; (3)T3-4N1-2M0 cervical cancer; (4)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1; (5)Adequate hematological, renal and hepatic functions: (6)Hemoglobin \\> 8.0 g\u002Fdl ; Neutrophils \\> 2000 cells\u002Fμl; Leukocytes \\> 4 × 109\u002FL; Platelets \\> 100 × 109\u002FL; Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL); Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL); Serum ALT\u002FAST ≤ 2.5× UNL; Serum Total bilirubin ≤ 1.5× UNL; (7)Life expectancy \\> 6 months; (8)Eligible for concurrent chemoradiotherapy assessed by principle investigator; (9)No obvious active bleeding; (10)Written informed consent must be available before study registration.\n\nExclusion Criteria:\n\n* (1)Recurrent or distant metastatic disease; (2)Prior malignancies (other than curable non-melanoma skin cancer) within 5 years; (3)Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants; (4)Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study; (5)Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study; (6)Previous organ transplantation or HIV patients; (7)Allergic to macromolecular proteins \u002Fmonoclonal antibodies, or to any test drug component; (8)Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\\> 2000 IU\u002Fml or 104 copies\u002Fml; hepatitis C virus (HCV) RNA\\> 10\\^3 copies\u002Fml.",{"count":340,"type":21},[110],"Concurrent chemoradiotherapy -immunotherapy followed by ICI maintenance was proved to improve the PFS by the Keynote-A18 in the LACC patients, and still more than 30% progressed. Neoadjuvant chemo-immunotherapy in LACC resulted in higher pCR rate. This prospective single arm study is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patients.",[27],[368,369,349],"immunotherapy","LACC","2025-03-31",{"date":372,"type":36},"2025-04-08",{"date":374,"type":21},"2025-04-05",{"date":376,"type":21},"2028-12-30",{"name":378,"class":71},"RenJi Hospital",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":229,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":402},"100538248","phase-2-neoadjuvant-immunochemotherapy-in-pd-l1-negative-lacc-100538248","NCT06288360","Neoadjuvant Immunochemotherapy in PD-L1-negative LACC","Neoadjuvant Chemotherapy Plus Camrelizumab in PD-L1-negative Locally Advanced Cervical Cancer: a Multicentre, Single-arm, Phase 2 Trial","Inclusion Criteria:\n\n1. FIGO 2018 stage IB3, IIA2, or IIB\u002FIIIC1r (tumor size\\>4cm) cervical cancer and without any treatment (After undergoing gynecological examinations by two associate chief physicians or above, the staging of the patients was determined);\n2. Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. In principle, the size of the lesion as shown by the magnetic resonance imaging examination is used as the criterion.\n3. Histologically confirmed squamous carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma of the cervix;\n4. Negative PD-L1 expression on preoperative pathological examination (Combined positive score \\\u003C 1);\n5. 18-70 years of age;\n6. Eastern Cooperative Oncology Group score ≤ 1;\n7. WBC≥3.5\\*10\\^9\u002FL, NEU≥1.5\\*10\\^9\u002FL, Platelet≥100×10\\^9 \u002FL; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value;\n8. Well-compliance and willing to keep in touch;\n9. Willing to participate in this study, sign the informed consent, and comply with the requirements and limitations outlined in the Informed Consent Form (ICF) and this form.\n\nExclusion Criteria:\n\n1. Active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for the following: vitiligo, alopecia areata, Graves's disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years, hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin replacement therapy, asthma that subsides completely in childhood and does not require intervention in adulthood, or diseases that do not recur in the absence of external triggers;\n2. Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or antibodies against immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), or any other therapy targeting a tumor's immune mechanism of action;\n3. Known hypersensitivity to any component and\u002For any excipient of the trial prescribed medication;\n4. Immunosuppressive drugs or systemic corticosteroids for immunosuppression (\\> mg\u002Fday of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;\n5. Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;\n6. Active systemic infection requiring systemic treatment;\n7. Serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;\n8. Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 1,000 IU\u002FmL, or patients with active hepatitis C. Inactive HBsAg carriers, patients with hepatitis B who have received treatment and are in stable condition (HBV \\\u003C 1000 IU\u002FmL), and patients with cured hepatitis C are eligible for enrollment. HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test;\n9. Known active tuberculosis (TB), patients with suspected active TB should undergo chest X-ray and sputum examination in conjunction with clinical signs and symptoms for exclusion;\n10. Immunodeficiency or human immunodeficiency virus (HIV antibody positive);\n11. Subjects with active inflammatory bowel disease or a history of such disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). Subjects who are unable to swallow or who have malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely interfere with drug intake and absorption;\n12. Known interstitial lung disease that is symptomatic or may interfere with detection or treatment of immune-associated pneumonia;\n13. Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose, inactivated seasonal influenza virus vaccine is permitted;\n14. Have received a prior allogeneic bone marrow transplant or solid organ transplant;\n15. History of primary malignant tumor within the last 5 years;\n16. Have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.) and severe trauma within 28 days prior to the first dose of the implantable infusion device is permitted;\n17. With a history of gastrointestinal perforation, gastrointestinal fistula, or female genital fistula;\n18. Uncontrolled other co-morbidities, symptoms, or medical history, including (i) persons with one of the following cardiovascular diseases or cardiovascular risk factors: myocardial infarction, unstable angina, pulmonary embolism, acute\u002Fcontinuous myocardial ischemia, cerebral vascular accident, transient ischemic attack, or other arterial or venous thrombosis, embolism, or cerebral ischemic event of clinical significance\u002Frequiring pharmacologic intervention; and persons who have had, within 6 months, a symptoms of congestive heart failure (New York Heart Association (NYHA) class III and above); (ii) clinically significant bleeding symptoms or a history of significant bleeding characteristics such as gastrointestinal bleeding, gastric ulcer bleeding, or vasculitis within 1 month prior to the first dose; (iii) clinically active hemoptysis, active diverticulitis, abdominal abscesses, and gastrointestinal obstruction; and (iv) uncontrolled pleural effusion, pericardial effusion, or ascites requiring Repeated drainage of ascites; ⑤ Abnormal liver or kidney development or history of surgery;\n19. Pregnant or breastfeeding female patients; women of childbearing age who refuse to accept contraceptive measures during neoadjuvant immunotherapy;\n20. Concurrent participation in other interventional clinical trials; participation in observational and non-interventional clinical trials is permitted;\n21. Any condition that, in the judgment of the investigator, may result in risk in the receipt of the study drug or that would interfere with the evaluation of the safety of the study drug or the interpretation of the study results. Patients who, in the judgment of the Investigator, are unlikely to comply with the study steps, restrictions, and requirements are not permitted to participate in this study.",{"count":387,"type":21},40,[110],"This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer.",[202,27,391,392],"PD-L1 Negative","Neoadjuvant Chemoimmunotherapy","2025-03-17",{"date":395,"type":36},"2025-03-20",{"date":397,"type":36},"2024-09-12",{"date":399,"type":21},"2030-12-12",{"name":401,"class":71},"Tongji Hospital",12,{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":256,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":99},"100583910","a-clinical-study-of-pelvic-concurrent-chemoradiotherapy-combined-with-ct-guided-intracavitary-brachytherapy-with-adaptive-simultaneous-dose-escalation-for-locally-advanced-cervical-cancer-100583910","NCT06882473","A Clinical Study of Pelvic Concurrent Chemoradiotherapy Combined with CT-guided Intracavitary Brachytherapy with Adaptive Simultaneous Dose Escalation for Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n1. Sign the informed consent;\n2. Age :18 to 75 years old;\n3. Histologically or cytologically confirmed cervical cancer;\n4. According to the International Federation of Gynecology and Obstetrics (FIGO 2018) stage IB3, IIA2, IIB, III, IV (local advanced), and had not received treatment before enrollment;\n5. Measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;\n6. ECOG physical performance score 0-2;\n7. Expected survival time \\>= 3 months;\n8. LVEF \\>= 55%;\n9. Bone marrow function: neutrophil \\>= 1.5×109\u002FL, platelet ≥ 100×109\u002FL, white blood cell 4.0-10.0×109\u002FL, hemoglobin \\>= 90 g\u002FL;\n10. Liver and kidney function: serum creatinine \\\u003C= 1.5 times upper limit of normal; AST and ALT≤2.5 times upper limit of normal (ULN) or \\\u003C= 5 times ULN in the presence of liver metastasis; Total bilirubin \\\u003C=1.5 times upper limit of normal, or \\\u003C= 2.5 times upper limit of normal if the patient has Gilbert's syndrome;\n11. Subjects of childbearing age must agree to use effective contraception during the trial, and women of childbearing age must have a negative serum or urine pregnancy test;\n12. Non-lactating patients;\n\nExclusion Criteria:\n\n1. Patients with prior abdominal or pelvic radiotherapy;\n2. being mentally ill and unable to cooperate with treatment;\n3. Serious uncontrolled medical diseases, such as serious internal medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;\n4. Unable to tolerate cisplatin chemotherapy;\n5. receiving other experimental drugs or participating in clinical trials for other anticancer treatment purposes within 30 days before the first radiotherapy;\n6. Severe infection within 4 weeks before study treatment, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia;\n7. Human immunodeficiency virus (HIV) -positive persons;\n8. HBsAg positive and HBV-DNA titer \\>= 1×10\\^3 IU\u002FmL; Participants were eligible for inclusion if they were HBsAg positive and had a peripheral blood HBV-DNA level of \\\u003C 1×10\\^3 IU\u002FmL, and if the investigator considered the participant to be in a stable phase of chronic hepatitis B without increasing the risk to the participant.\n9. Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive and HCV RNA test positive;\n10. Patients judged by the investigator to be ineligible for the study.",{"count":410,"type":21},20,[133],"The standard treatment for locally advanced cervical cancer is cisplatin-based concurrent chemoradiotherapy with external beam radiotherapy (EBRT) and Brachytherapy (BT). overall treatment time (OTT) has been found to be an important predictor of treatment response. Some studies have shown that the acceleration of tumor cell regeneration during the extension of radiotherapy leads to poor local control. Prolonging the overall treatment time of cervical cancer radiotherapy for more than 8 weeks leads to an increase in pelvic local control failure. Therefore, shortening OTT has great potential benefits from both clinical efficacy and social benefits. Shortening OTT in radical cervical cancer radiotherapy includes hypofractionated EBRT and shortening the interval between BT and EBRT. However, further shortening OTT may lead to an increase in acute and late toxicity. Adaptive radiotherapy (ART) strategies systematically monitor variations in target and neighbouring structures to inform treatment-plan modification during radiotherapy. The application of image-guided adaptive brachytherapy (IGABT) has clearly demonstrated the advantages of this approach in the treatment of cervical cancer. Previous studies have shown that the implementation of IGABT can achieve personalized treatment, dose increase, improve clinical efficacy, reduce normal tissue toxicity and side effects, and strengthen international standardized quality control. In this study, online adaptive pelvic EBRT combined with IGABT based on uRT-linac was performed under online CT guidance.\n\nThe aim of this study is to evaluate the safety and efficacy of pelvic concurrent chemoradiotherapy combined with CT-guided intracavitary brachytherapy with adaptive simultaneous dose escalation in locally advanced cervical cancer.",[27],"2025-03-12",{"date":416,"type":36},"2025-03-18",{"date":418,"type":21},"2025-03-15",{"date":420,"type":21},"2027-03-15",{"name":422,"class":71},"Peking University Third Hospital",{"id":424,"slug":425,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":17,"minAge":430,"maxAge":229,"enrollmentInfo":431,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":441,"locationsCount":4},"100574453","study-of-laparoscopic-radical-hysterectomy-based-on-space-anatomy-in-patients-with-ib3-and-iia2-cervical-cancer-100574453","NCT06759480","Study of Laparoscopic Radical Hysterectomy Based on Space Anatomy in Patients With IB3 and IIA2 Cervical Cancer","Comparison Between Laparoscopic Radical Hysterectomy Based on Space Anatomy and Abdominal Radical Hysterectomy for Stage IB3 and IIA2 Cervical Cancer: a Multicenter Retrospective Cohort Study","Inclusion Criteria:\n\n1. Aged between 20 to 70 years\n2. Preoperative clinical diagnosis was FIGO 2018 stage IB3 or IIA2 cervical cancer;\n3. Patients who received standard Querleu-Morrow type C radical hysterectomy (including ARH or LRH based on space anatomy) and pelvic lymphadenectomy;\n4. no preoperative suspected lymph nodes metastasis, parametrial involvement or lower 1\u002F3 vagina involvement.\n\nExclusion Criteria:\n\n1. patients who had active double cancer or uncontrolled serious concurrent disease that might compromise prognosis;\n2. pregnancy;\n3. incomplete radical surgery;\n4. follow-up time less than 6 months or lost to follow-up","20 Years",{"count":432,"type":21},500,"Radical hysterectomy is an effect treatment for FIGO IB3 and IIA2 cervical cancer patients who refuse to receive radical concurrent chemoradiotherapy. However, due to the large tumor size, both patients and surgeons encountered the risk of substantial bleeding, urinary tract damage, and unsatisfactory resection during surgery. Therefore, the exploration of effective and safe surgical treatments is crucial in enhancing the quality of life and prognosis for patients. Laparoscopic radical hysterectomy (LRH) offers the advantages of reduced bleeding and accelerated recovery, thereby minimizing patient discomfort and enhancing their quality of life. However, the prognosis of patients who received LRH or traditional abdominal radical hysterectomy (ARH) remains controversial. We proposed a modified LRH skill based on new space anatomy concept. In our previous single-center study, the result demonstrates that LRH based on space anatomy leads to less intraoperative blood loss and decreased ureteral injury rate compared with traditional skill. The benefits of this new method for patient survival remain uncertain. In this multicenter retrospective study, we aim to assess clinical prognosis and safety of this new LRH compared with traditional abdominal radical hysterectomy (ARH) in FIGO IB3 and IIA2 cervical cancer.",[27],"2025-01-03",{"date":437,"type":36},"2025-01-06",{"date":439,"type":21},"2024-12-27",{"date":418,"type":21},{"name":442,"class":71},"International Peace Maternity and Child Health Hospital",{"id":444,"slug":445,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":229,"enrollmentInfo":450,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":402},"100538249","phase-2-neoadjuvant-chemoimmunotherapy-versus-concurrent-chemoradiotherapy-for-lacc-100538249","NCT06288373","Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC","Neoadjuvant Chemoimmunotherapy Combined With Surgery Versus Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: a Multicenter Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Locally advanced (2018 FIGO staged IB3, IIA2 and IIB（tumor size\\> 4cm) ) cervical cancer，staging determined by two physicians of associate seniority or higher after gynecologic examination and imaging evaluation);\n2. At least one measurable lesion at baseline according to RECIST 1.1 criteria, with lesion size based primarily on magnetic resonance imaging;\n3. Pathologically confirmed diagnosis of cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma (common type), and adenosquamous carcinoma;\n4. Positive PD-L1 expression, Combined Positive Score (CPS) ≥1;\n5. Patient age ≥18 years and ≤70 years;\n6. ECOG score ≤1;\n7. Laboratory tests: WBC (white blood cell count) ≥ 3.5×109\u002FL, NEU (neutrophil count) ≥ 1.5×109\u002FL, PLT (platelet count) ≥ 100×109\u002FL, total bilirubin ≤ 1.5 times the upper limit of normal, ALT (alanine aminotransferase) and AST (aspartate aminotransferase) ≤ 1.5 times the upper limit of normal, serum creatinine (BUN) ≤ 1.5 times the upper limit of normal or creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaboration equation, or the Modification of Diet in Renal Disease equation);\n8. Be willing to follow up and good compliance;\n9. Be willing to sign the informed consent, including compliance with the requirements and restrictions listed in the informed consent and program；\n10. Agree to use effective contraception measures during the trial period and for 5 months after the last dose of pembrolizumab or 6 months after chemotherapy (whichever is longer).\n\nExclusion Criteria:\n\n1. Any active autoimmune disease or history of autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;\n2. Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known hypersensitivity to any component of the study medication or other monoclonal antibodies;\n3. Has a history of human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL), and hepatitis C (HCV antibody positive, and HCV-RNA above the lower limit of detection of the assay);\n4. Receipt of immunosuppressive medications or systemic corticosteroid therapy for immunosuppression (\\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to study dosing;\n5. Diagnosed with another primary malignancy within 5 years prior to the first use of the investigational drug;\n6. Received other investigational drugs\u002Ftreatments or participated in another clinical trial within 4 weeks prior to randomization. Participation in observational and non-interventional clinical trials is allowed;\n7. Pregnant or breastfeeding female patients;\n8. Uncontrolled co-morbidities, including but not limited to New York Heart Association (NYHA) class 2 or higher, severe\u002Funstable angina pectoris, myocardial infarction within ≤ 6 months prior to study drug administration, severe arrhythmias requiring medication or intervention; difficult-to-control hypertension; cerebral vascular accidents or brain disorders within ≤ 6 months prior to study drug administration, or individuals with adjudicated abnormal behavioral skills; hematologic disorders: coagulation abnormalities (INR \\>2. 0, PT\\>16s), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy; abnormalities in hepatic or renal development or a history of surgery; and development of an active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study drug;\n9. Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first dose of study drug; inactivated seasonal influenza virus vaccine is permitted;\n10. Patients with a prior allogeneic bone marrow or solid organ transplant;\n11. Drug and\u002For alcohol abuse;\n12. Patients who, in the opinion of the investigator, are unlikely to comply with the procedures, restrictions, and requirements of the study may not be enrolled in the study.",{"count":451,"type":21},440,[110,24],"It is a prospective, open-label, randomized, controlled phase II\u002FIII clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \\>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group.",[202,27,455,392],"Concurrent Chemoradiotherapy","2024-10-26",{"date":458,"type":36},"2024-10-30",{"date":460,"type":36},"2024-04-22",{"date":462,"type":21},"2031-03-01",{"name":401,"class":71},{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":22,"phases":473,"briefSummary":474,"conditions":475,"keywords":476,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":99},"100492108","phase-2-study-of-cadonilimab-combined-with-radiotherapy-in-the-treatment-of-locally-advanced-cervical-cancer-100492108","NCT05687851","Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer","A Single-arm, Multicenter, Phase II Study to Evaluate Cadonilimab（AK104） Combined With Radiotherapy For The Treatment of Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign written informed consent.\n2. Women aged ≥18 years at the time of study entry.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.\n4. Life expectancy ≥12 weeks.\n5. Intolerance to chemotherapy regimens.\n6. Histologically confirmed cervical cancer.\n\n   1. Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix;\n   2. Not receiving systemic anti-tumour therapy (including but not limited to radiotherapy, targeted therapy and immunotherapy, etc; concurrent chemotherapy is not included. Note: Removal or biopsy of pelvic lymph nodes or para-aortic lymph nodes for the purpose of clinical staging is allowed).\n   3. Locally advanced cervical cancer（LACC）: The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3\u002FIIA2, IIB-IVA.\n7. At least one measurable tumor lesion according to RECIST v1.1 criteria.\n8. Available archived tumor tissue samples or recent biopsies.\n9. Adequate organ function.\n10. For fertile women with negative serum pregnancy and effective contraception within 7 days before administration (until 120 days after the last administration of the study drug and at least 180 days after radiotherapy)\n\nExclusion Criteria:\n\n1. Other histological types of cervical cancer (eg, neuroendocrine carcinoma, small cell carcinoma, sarcoma, etc).\n2. Evidence of distant metastases.\n3. Have received total hysterectomy.\n4. Subject with other active malignancies within 2 years prior enter the study.\n5. Subject who cannot receive brachytherapy.\n6. Active or prior documented autoimmune disease that may relapse.\n7. History of interstitial lung disease or noninfectious pneumonitis.\n8. Subject with the clinically significant cardio-cerebrovascular disease.\n9. History of severe hypersensitivity reactions to other mAbs.\n10. Prior allogeneic stem cell transplantation or organ transplantation.\n11. Subjects who require systemic treatment with glucocorticoid (\\>10 mg\u002Fday of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior enter the study.\n12. Receipt of live attenuated vaccines within 30 days prior to the first dose of the study drug.\n13. Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).\n14. Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the study drug or interpretation of subject safety or study results.",{"count":472,"type":21},33,[110],"Cadonilimab（AK104）is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.\n\nThis is a single-arm, multicenter, open-label, phase II study, the purpose of this study is to evaluate the efficacy and safety of Cadonilimab plus radiotherapy in participants with locally advanced cervical cancer who do not tolerate chemotherapy.",[27],[477,478],"Local advanced cervical cancer","Concurrent chemoradiotherapy","2024-09-08",{"date":481,"type":36},"2024-09-19",{"date":483,"type":36},"2022-12-29",{"date":485,"type":21},"2026-12",{"name":487,"class":71},"Chongqing University Cancer Hospital",{"id":489,"slug":490,"hasResults":11,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":99},"100520374","phase-2-zimberelimab-combined-with-albumin-bound-paclitaxel-and-cisplatin-in-neoadjuvant-treatment-of-lacc-100520374","NCT06055738","Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of LACC","An Exploratory Clinical Study of Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n1. Voluntary participation in clinical research.\n2. Age ≥18 years old, female.\n3. Squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix confirmed by histology\u002Fcytology.\n4. Previously untreated locally advancedcervical cancer (2018 FIGO stage IB3, IIA2) .\n5. At least one measurable lesion was suitable for target lesion according to RECIST v1.1 .\n6. Within 14 days before the first treatment, the major organ functions were basically normal.\n7. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;\n8. Subjects agree to provide sufficient tumor tissue samples for PD-L1 expression detection;\n9. If hepatitis B surface antigen (HBsAg) is positive and\u002For hepatitis B core antibody (HBcAb) is positive, hepatitis B virus DNA (HBV DNA) is detected, HBV DNA \\\u003C 104 copies \u002Fml or \\\u003C 2000IU\u002FmL can be enrolled. Or those who had received antiviral therapy for at least 4 weeks before the first dose of study drug and were willing to continue antiviral therapy during the study were eligible for enrollment. Those with HCV antibody positive should be excluded.\n10. Subjects of childbearing age and their sexual partners agreed to consent to contraceptive use after signing an informed consent form, during treatment and for at least 6 months after the last dose of the study intervention.\n\nExclusion Criteria:\n\n1. Patients with active autoimmune disease or a history of autoimmune disease.\n2. Previous history of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation).\n3. Use of immunosuppressive drugs within 14 days prior to treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., not more than 10 mg\u002F day of prednisolone or another corticosteroid at the physiological dose of the drug).\n4. Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-lymphocyte antigen 4 (CTLA-4) antibody.\n5. Arterial or venous thromboembolic events within the previous 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein embolism or any other major thromboembolism, implantable venous access port or catheter-derived thrombosis, or superficial venous thrombosis. Except for patients with stable thrombus after conventional anticoagulant therapy, prophylactic use of low-dose low molecular weight heparin was allowed.\n6. Previous history of gastrointestinal perforation, gastrointestinal fistula, genital fistula (such as vesicovaginal fistula, urethrovaginal fistula, vesicovaginal fistula, etc.); Patients were allowed if the perforation or fistula had been treated with diversion surgery, resection, or repair, and the disease was recovered or relieved as judged by the investigator.\n7. Symptomatic congestive heart failure (New York Heart Association class II-IV) Arrhythmias with poorly controlled symptoms.\n8. Active pulmonary tuberculosis, receiving anti-tuberculosis treatment.\n9. Interstitial lung disease.\n10. Severe infections that are active or poorly controlled clinically. Severe infection within 3 weeks before treatment, including but not limited to patients hospitalized for complications of infection, bacteremia, or severe pneumonia.\n11. Central nervous system metastasis, leptomeningeal metastasis, spinal cord compression, or leptomeningeal disease.\n12. Human immunodeficiency virus (HIV) infection, known syphilis infection.\n13. Have received live vaccine within 4 weeks of the first use of the experimental drug, or plan to receive live vaccine during the study.\n14. Known or suspected allergy to the trial drug or any drug related to the trial.\n15. Pregnant or lactating women.\n16. There were other conditions deemed by the investigator to be inappropriate for enrollment.",{"count":410,"type":21},[110],"This is a prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Zimberelimab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer.",[27],"2023-09-20",{"date":501,"type":36},"2023-09-28",{"date":503,"type":21},"2023-10-09",{"date":505,"type":21},"2027-12-30",{"name":507,"class":71},"Tang-Du Hospital",{"id":509,"slug":510,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":256,"enrollmentInfo":515,"targetDuration":4,"studyType":22,"phases":517,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":530,"locationsCount":99},"100468308","comparing-the-efficacy-of-surgery-staging-and-image-staging-of-locally-advanced-cervical-cancer-100468308","NCT05378087","Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer","Non-randomized Concurrent Controlled Trial of Surgery Staging or Image Staging of Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n1. The patients with good compliance, voluntarily signed the informed consent form and participated in the study.\n2. Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma\n3. Stage (FIGO2018): IB3, IIA2, IIB-IVA;\n4. ECOG score: 0 \\~ 1;\n5. The expected survival \\>6 months;\n6. The result of a pregnancy test (serum or urine) within seven days must be negative for women of childbearing age, who must take contraception during the trial.\n\nExclusion Criteria:\n\n1. Activity or uncontrol severe infection;\n2. Liver cirrhosis or other decompensated liver disease;\n3. A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease;\n4. Chronic renal insufficiency or renal failure;\n5. Other malignancies were diagnosed within five years or needed treatments;\n6. Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association);\n7. The CT\u002FMRI\u002FPET\u002FCT show that the para-aortic lymph nodes are positive;\n8. A history of pelvic artery embolization;\n9. A history of pelvic radiotherapy;\n10. A history of partial hysterectomy or radical hysterectomy;\n11. A history of severe allergic reaction to platinum drugs;\n12. The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis;\n13. Patients who cannot understand the research regimen and refuse to sign the informed consent form;\n14. Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.",{"count":516,"type":21},1956,[133],"The study is a domestic multicenter, prospective, non-randomized controlled concurrent trial. It will be assessed whether surgery staging on locally advanced cervical cancer is superior to image staging for improving progression-free survival and overall survival.",[27],[521,522,168,523],"surgery staging","image staging","PFS","2023-08-29",{"date":526,"type":36},"2023-08-31",{"date":528,"type":36},"2022-06-27",{"date":218,"type":21},{"name":487,"class":71},{"id":532,"slug":533,"hasResults":11,"nctId":534,"briefTitle":535,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":256,"enrollmentInfo":537,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":99},"100512256","study-on-the-relationship-between-plasma-mrd-and-cfdna-hpv-and-the-efficacy-and-prognosis-of-locally-advanced-cervical-cancer-after-concurrent-chemoradiotherapy-100512256","NCT05950087","Study on the Relationship Between Plasma MRD and cfDNA HPV and the Efficacy and Prognosis of Locally Advanced Cervical Cancer After Concurrent Chemoradiotherapy","Inclusion criteria\n\n* Age: ≥ 18 years old, ≤ 75 years old.\n* Pathological histologic confirmation of cervical cancer.\n* Imaging or PET\u002FCT examination can be performed to understand the tumor and complete all follow-up.\n* Measurable lesions before treatment.\n* Good physical condition: ECOG score 0-1 (or KPS score 70-100).\n* Estimated survival≥ 6 months.\n* The baseline blood routine and biochemical indexes before radiotherapy and chemotherapy met the following standards: hemoglobin ≥ 80g\u002FL, absolute neutrophil count (ANC) ≥ 1.5×109\u002FL, platelet ≥ 100×109\u002FL, ALT, AST ≤ 2.5 times the normal upper limit; Serum albumin ≥ 30 g\u002FL.\n* There are three preoperative items: if the patient has syphilis, plum repellent therapy is required before treatment.\n* The patient has no history of allergy to rubber products.\n* Cardiopulmonary function is basically normal\n\nExclusion Criteria:\n\n* Those who are allergic to rubber products.\n* Those with severe acute infection and uncontrolled or purulent and chronic infection wounds that do not heal, chronic hepatitis B active stage, active tuberculosis, syphilis outbreak and AIDS.\n* Patients with pre-existing severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and intractable hypertension.\n* Those with neurological or psychiatric diseases or mental disorders that are not easy to control, poor compliance, unable to cooperate with and describe treatment responses, uncontrolled primary brain tumors or central nervous system metastases, and those with obvious cranial hypertension signs or neuropsychiatric symptoms.\n* with malignant serous effusion.\n* History of severe enteritis and cystitis, bleeding, intestinal perforation, rectovaginal fistula, rectoval bladder fistula, etc.\n* Those who have participated in other clinical trials.\n* Other situations in which the investigator believes that the subject is not suitable to participate in this experiment",{"count":340,"type":21},"Cervical cancer CC is the most common malignant tumor in the female reproductive system, seriously endangering women's health and life, and is one of the leading causes of death for women worldwide.Globally, HPV causes about 85% of cervical cancers and about 60% of oropharyngeal cancers, causing more than 500,000 cancers each year.ctDNA is a potential biomarker because it contains tumor-specific genetic and epigenetic abnormalities that can be used in cancer diagnosis and prognosis prediction.MRD is considered a promising prognostic marker that can be used to identify individuals at increased risk of recurrence and individuals who may benefit from treatment.The expression level of MRD and plasma HPV before and after radiotherapy and chemotherapy for cervical cancer was analyzed by liquid biopsy ctDNA detection technology, which predicted the efficacy of cervical cancer radiotherapy and chemotherapy, which was helpful for monitoring and estimating the risk of disease recurrence after cervical cancer radiotherapy and chemotherapy, and verified the expression of MRD and plasma HPV as the basis for adjuvant chemotherapy after cervical cancer radiotherapy and the basis for optimal chemotherapy time node selection.",[27],"2023-07-14",{"date":542,"type":36},"2023-07-18",{"date":544,"type":36},"2022-11-01",{"date":546,"type":21},"2026-12-31",{"name":548,"class":71},"Guizhou Provincial People's Hospital",{"id":550,"slug":551,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":256,"enrollmentInfo":556,"targetDuration":4,"studyType":22,"phases":558,"briefSummary":559,"conditions":560,"keywords":561,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":99},"100500685","phase-2-study-of-chemoradiotherapy-with-envafolimab-for-the-treatment-of-locally-advanced-cervical-cancer-100500685","NCT05799469","Study of Chemoradiotherapy With Envafolimab For The Treatment of Locally Advanced Cervical Cancer","A Single-arm Exploratory Clinical Study of Envafolimab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n* The subject voluntarily joins this study and is able to sign the informed consent form with good compliance;\n* Female aged 18-75 years (at the time of signing the informed consent);\n* ECOG score of 0-1 within 7 days prior to first study intervention dose;\n* Expectation of life ≥ 12 weeks;\n* Locally advanced squamous cell carcinoma , adenocarcinoma or adenosquamous -carcinoma of the cervix confirmed by pathological histological or clinical diagnosis according to cervical cancer F IGO stage (2018 version) as I B3 , IIA2 , IIB , I II-IVA stage ;\n* Pathological specimens (≥ 18 eligible tissue sections) may be provided for biomarker testing;\n* No prior surgery for cervical cancer (excluding staging surgery), radiotherapy, chemotherapy, systemic therapy (including investigational agents), or immunotherapy ;\n* At least 1 measurable cervical lesion or metastatic lymph node meeting RECIST1.1 target lesion criteria by CT scan or MRI within 28 days prior to treatment;\n* Adequate major organ function meeting the following criteria:\n\n  1. Hematology (need not be transfused within 14 days and hematopoietic stimulating factor drugs within 7 days without correction testing): hemoglobin (Hb) ≥ 90 g\u002FL; absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; platelets (PLT) ≥ 80 × 109\u002FL;\n  2. Biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum total bilirubin (TBIL) ≤ 1.5 × ULN (in subjects with Gilbert 's syndrome, ≤ 3 × ULN); serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n  3. Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;\n  4. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%;\n  5. Thyroid function is normal，defined as thyroid stimulating hormone (TSH) within normal limits. If baseline TSH is out of normal range, subjects with total T3 (or FT3) and FT4 within normal range can also be enrolled;\n  6. Adequate organ function as judged clinically appropriate for the study by the physician.\n* Subjects of childbearing potential must use adequate contraception during this study and for 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating.\n\nExclusion Criteria:\n\n* Patients who had or currently had other malignant tumors within 3 years prior to the start of study treatment;\n* Inability to perform (complete) brachytherapy due to anatomy, tumor shape, contraindications, etc.;\n* Grade ≥ 1 unresolved toxicity due to any prior therapy (according to National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events Version 5.0 \\[CTCAE 5.0\\]);\n* Subjects with any severe and\u002For uncontrolled disease. Including:\n\n  1. Unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);\n  2. Patients with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms) and ≥ Grade 2 congestive heart failure (New York Heart Association \\[NYHA\\] classification);\n  3. Active or uncontrolled serious infection (≥ CTCAE Grade 2 infection);\n  4. Cirrhosis, active hepatitis \\* ; \\* active hepatitis (hepatitis B reference: HBsAg positive, and HBV DNA test value more than the upper limit of normal; hepatitis C reference: HCV antibody positive, and HCV viral titer test value more than the upper limit of normal) ; patients with previous HBV infection or cured HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and the absence of HBsAg) are eligible; among patients with positive HCV antibody, patients can participate in this study only when HCV RNA is negative by polymerase chain reaction (PCR); Note: subjects with positive HBsAg or positive anti-HBc or hepatitis C，who are eligible for inclusion need continuous antiviral treatment to prevent virus activation ;\n  5. Previous (non infectious) pneumonia\u002Finterstitial lung disease still requires steroid treatment or currently has (non infectious) lung disease;\n  6. Active syphilis;\n  7. Patients with renal failure requiring hemodialysis or peritoneal dialysis;\n  8. Patients with a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n* Poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL);\n* Urine routine showed urine protein ≥ + +, and confirmed 24-hour urine protein \\> 1.0g;\n* Patients who received major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment; or had wounds or fractures that were not healed for a long time;\n* Severe arterial\u002Fvenous thrombotic events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism within 6 months before the start of study treatment;\n* Patients who have a history of psychotropic substance abuse and cannot quit or have mental disorders;\n* Study treatment related:\n\n  1. History of live vaccination 28 days prior to start of study treatment or planned live vaccination during the study;\n  2. Patients who have experienced severe hypersensitivity reactions after using monoclonal antibodies;\n  3. Active autoimmune disease requiring systemic therapy (eg, use of therapeutic drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to start of study treatment, with the exception of alternative therapies (eg, thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency);\n  4. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (prednisone at a dose \\> 10 mg\u002Fday or other equivalent efficacy physiological dose hormone) and continued to use within 2 weeks before the first study dose;\n  5. Patients with a history of active tuberculosis;\n* Participating or participating in other clinical investigators;\n* Patients who are unable to comply with the trial protocol or cooperate with follow-up according to the investigator 's judgment;\n* Patients with a history of severe allergy;\n* Known hypersensitivity to active ingredients or excipients of the study drug, such as envafolimab and cisplatin;\n* Subjects who have concomitant diseases that, in the investigator 's judgment, would seriously jeopardize the subject' s safety or affect the completion of the study, or who are considered unsuitable for enrollment for other reasons.",{"count":557,"type":21},36,[110],"This is a single-arm, single-center, exploratory study, the purpose of this study is to evaluate the efficacy and safety of envafolimab combined with Chemoradiotherapy in participants with locally advanced cervical cancer.",[27],[202,562,478,563],"Local advanced","Immune checkpoint inhibitors","2023-04-03",{"date":566,"type":36},"2023-04-05",{"date":568,"type":21},"2023-05-01",{"date":570,"type":21},"2027-12-31",{"name":487,"class":71}]