[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611775":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":21,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":21,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":21,"enrollmentInfo":62,"targetDuration":21,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":77,"whyStopped":21,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Women's Hospital School Of Medicine Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant Ivonescimab Plus Paclitaxel and Cisplatin, Followed by Chemoradiotherapy","EXPERIMENTAL","Participants in this arm will receive two cycles of neoadjuvant therapy consisting of Ivonescimab (20 mg\u002Fkg, intravenous infusion on Day 1 of each 21-day cycle) combined with paclitaxel (175 mg\u002Fm² or albumin-bound paclitaxel 260 mg\u002Fm²) and either cisplatin (75 mg\u002Fm²) or carboplatin (AUC = 5), at the discretion of the investigator. After completion of neoadjuvant treatment, participants will undergo concurrent chemoradiotherapy with weekly cisplatin (40 mg\u002Fm² × 5 weeks) or carboplatin (AUC = 2), in combination with pelvic external beam radiation therapy (EBRT) and brachytherapy per institutional protocol.",[13,14],"Drug: Ivonescimab Combined With Chemotherapy","Combination Product: CONCURRENT CHEMORADIATION (CISPLATIN)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Ivonescimab Combined With Chemotherapy","Participants will receive neoadjuvant therapy consisting of Ivonescimab at 20 mg\u002Fkg administered via intravenous infusion on Day 1 of each 21-day cycle, for a total of 2 cycles. Ivonescimab will be administered in combination with paclitaxel (175 mg\u002Fm², intravenous infusion) or albumin-bound paclitaxel (260 mg\u002Fm², intravenous infusion), and cisplatin (75 mg\u002Fm², intravenous infusion) or carboplatin (AUC = 5). All chemotherapy drugs are administered on Day 1 of each cycle. The choice between cisplatin or carboplatin, and between solvent-based or albumin-bound paclitaxel, will be made at the investigator's discretion based on patient tolerance and clinical condition.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"COMBINATION_PRODUCT","CONCURRENT CHEMORADIATION (CISPLATIN)","Following completion of neoadjuvant therapy, participants will undergo concurrent chemoradiotherapy consisting of weekly cisplatin (40 mg\u002Fm², intravenous infusion, once per week for 5 weeks) or carboplatin (AUC = 2, once weekly for 5 weeks), administered concurrently with pelvic external beam radiation therapy (EBRT) and intracavitary brachytherapy. Radiotherapy will be delivered per institutional standards, including a total pelvic EBRT dose of approximately 45-50.4 Gy in 25-28 fractions and image-guided brachytherapy with a total equivalent dose of at least 80-85 Gy EQD2 to point A or tumor residual volume. The choice of chemotherapy agent and radiation technique will be determined by the investigator based on clinical condition and institutional protocol.",[9],[28],{"name":29,"affiliation":5,"role":30},"Qiu Tang","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Lumeng Luo","CONTACT","86-18368193927","luolumeng@zju.edu.cn",[38],{"facility":39,"status":21,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":21},"Women's Hospital, School of Medicine, Zhejiang University","Hangzhou","Zhejiang","310000","China","CN",{"type":46,"coordinates":47},"Point",[48,49],120.16142,30.29365,{"lat":49,"lon":48},{"type":52,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100611775","phase-2-neoadjuvant-ivonescimab-plus-chemotherapy-followed-by-concurrent-chemoradiotherapy-in-high-risk-locally-advanced-cervical-cancer-100611775",false,"NCT07244965","Neoadjuvant Ivonescimab Plus Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Locally Advanced Cervical Cancer","Neoadjuvant Ivonescimab Combined With Paclitaxel and Cisplatin, Followed by Concurrent Chemoradiotherapy in Patients With High-Risk Locally Advanced Cervical Cancer：A Phase II, Single-Arm Study","Inclusion Criteria:\n\n* Able to understand and voluntarily sign the written informed consent form before any study-specific procedures.\n* Female participants aged ≥18 years on the day of signing informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Expected survival time ≥3 months.\n* Histologically confirmed diagnosis of cervical cancer.\n* Histological types limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n* No prior anti-tumor treatments (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, and immunotherapy). Note: Lymph node dissection or biopsy for clinical staging is allowed.\n* FIGO 2018 stage III-IVA cervical cancer unsuitable for curative surgery. Lymph node metastasis may be confirmed by biopsy or imaging. Imaging-based lymph node metastasis must meet: MRI\u002FCT showing positive lymph node with short-axis diameter ≥10 mm, and ≥15 mm to be used as target lesion.\n* At least one measurable lesion per RECIST v1.1 criteria.\n* PD-L1 CPS score ≥1 in tumor tissue.\n* Must provide tumor tissue sample before treatment (FFPE blocks or ≥5 unstained slides, preferably freshly obtained).\n* Adequate organ function as per screening labs:\n* Hematological (without transfusion or growth factors within 2 weeks):\n* ANC ≥1.5×10⁹\u002FL\n* Platelets ≥90×10⁹\u002FL\n* Hemoglobin ≥9.0 g\u002FdL\n* Renal:\n* Creatinine ≤1.5×ULN or CrCl ≥50 mL\u002Fmin (≥60 mL\u002Fmin if cisplatin is planned), calculated by Cockcroft-Gault:\n\nCrCl (mL\u002Fmin) = \\[(140 - age) × weight (kg) × 0.85\\] \u002F \\[serum creatinine (mg\u002FdL) × 72\\]\n\n* Hepatic:\n* Total bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's syndrome suspected)\n* AST and ALT ≤2.5×ULN\n* Coagulation:\n* INR ≤1.5×ULN and APTT ≤1.5×ULN (unless on anticoagulants with stable dosing)\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose, and agree to use effective contraception during treatment and for at least 120 days after last dose of study drug and 180 days after chemoradiotherapy.\n* Effective contraception includes hormonal contraception, IUDs, or double barrier methods. Periodic abstinence and rhythm methods are not acceptable.\n\nExclusion Criteria:\n\n* Cervical cancer of non-eligible histology (e.g., neuroendocrine carcinoma, sarcoma).\n* Evidence of distant metastasis, including inguinal lymph node metastasis or lymph node involvement above L1 vertebral level.\n* History of total hysterectomy (removal of uterus and cervix). Subtotal hysterectomy or cornuostomy preserving the cervix is acceptable.\n* Anatomical or geometric contraindications to brachytherapy.\n* Active malignancies within 2 years, except for treated non-melanoma skin cancer, superficial bladder cancer, in-situ breast cancer (note: cervical carcinoma in situ history is exclusionary).\n* Bilateral hydronephrosis deemed non-relievable by nephrostomy or ureteral stenting.\n* Anti-tumor therapy within 2 weeks before treatment initiation (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, immunotherapy, or immuno-co-stimulatory agents like ICOS, CD40, CD137, GITR, OX40 antibodies).\n* Immunomodulatory drugs (e.g., thymosin, interferon, IL-2) within 2 weeks before treatment.\n* Systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressants within 2 weeks, except:\n* Inhaled, ophthalmic, or topical steroids ≤10 mg\u002Fday prednisone or equivalent\n* Physiologic hormone replacement ≤10 mg\u002Fday prednisone or equivalent\n* Prophylactic corticosteroids for hypersensitivity (e.g., CT contrast)\n* Active infections requiring systemic treatment (e.g., active TB, syphilis, systemic fungal infections), except HBV antiviral therapy.\n* Severe infection within 4 weeks prior to treatment (e.g., hospitalization, sepsis, severe pneumonia).\n* Major surgery or significant trauma (e.g., fractures) within 4 weeks, or planned elective major surgery. Pelvic\u002Fpara-aortic lymph node dissection not exclusionary.\n* Live vaccines within 4 weeks.\n* Active or history of autoimmune diseases except for:\n* Vitiligo, alopecia, psoriasis, or eczema not requiring systemic therapy\n* Autoimmune thyroiditis requiring only stable hormone therapy\n* Type I diabetes requiring only stable insulin replacement\n* Any of the following cardiovascular\u002Fcerebrovascular diseases:\n* MI, unstable angina, PE, aortic dissection, DVT, or arterial embolism within 6 months\n* NYHA Class II or greater heart failure\n* Significant arrhythmias needing long-term treatment (stable asymptomatic Afib allowed)\n* Stroke (CVA) within 6 months\n* LVEF \\\u003C50%\n* History of myocarditis or cardiomyopathy\n* Known primary or secondary immunodeficiency, including HIV antibody positivity.\n* Active HBV infection: HBsAg positive with HBV DNA \\>1000 IU\u002FmL or \\>5000 copies\u002FmL; active HCV infection.\n* Exception: treated and stable HBV patients with HBV DNA ≤500 IU\u002FmL (or ≤2500 copies\u002FmL); cured HCV patients (HCVAb+ but HCV RNA-) allowed.\n* History of or active inflammatory bowel disease (Crohn's, ulcerative colitis), diverticulitis.\n* Known history of allogeneic organ or stem cell transplantation.\n* Interstitial lung disease or history of non-infectious pneumonitis.\n* History of severe hypersensitivity to monoclonal antibodies.\n* Known contraindications to cisplatin\u002Fcarboplatin or paclitaxel.\n* Pregnant or breastfeeding women.\n* Any condition that may interfere with the study drug's safety or efficacy evaluation as judged by the investigator (e.g., other serious illness, psychiatric disorders).","FEMALE","18 Years",{"count":63,"type":64},42,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","This is a single-arm, phase II clinical trial evaluating the efficacy and safety of neoadjuvant Ivonescimab combined with paclitaxel and cisplatin (TP regimen), followed by concurrent chemoradiotherapy, in patients with high-risk, locally advanced cervical cancer (FIGO stage III-IVA). Eligible participants will receive two cycles of neoadjuvant Ivonescimab plus TP chemotherapy, followed by standard concurrent chemoradiotherapy. The primary endpoints include progression-free survival (PFS) and objective response rate (ORR) following neoadjuvant treatment. Secondary endpoints include overall survival (OS), disease control rate (DCR), safety, and quality of life (EORTC QLQ-C30). Exploratory analysis will focus on identifying predictive biomarkers for Ivonescimab efficacy.",[70],"LOCALLY ADVANCED CERVICAL CANCERS",[72,73,74,75,76],"Ivonescimab","Cervical Cancer","Neoadjuvant","Immune Checkpoint Inhibitor","Concurrent Chemoradiotherapy","NOT_YET_RECRUITING","2025-11-20",{"date":80,"type":81},"2025-11-24","ACTUAL",{"date":83,"type":64},"2025-12-01",{"date":85,"type":64},"2029-07-01",{"name":5,"class":6},1]