[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-type-endocervical-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-type-endocervical-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100566348","phase-2-in10018-with-nab-paclitaxel-and-cadonilimab-for-metastatic-or-recurrent-gastric-type-cervical-adenocarcinoma-phase-2-trial-100566348",false,"NCT06654011","IN10018 With Nab-Paclitaxel and Cadonilimab for Metastatic or Recurrent Gastric-Type Cervical Adenocarcinoma: Phase 2 Trial","IN10018 Plus Nab-Paclitaxel and Cadonilimab for Metastatic, Recurrent, or Persistent Gastric-Type Adenocarcinoma of the Cervix: A Multicenter, Single-Arm, Phase II Trial","Inclusion Criteria:\n\n1. Females 18-75 years of age.\n2. Patients must have metastatic, recurrent or persistent gastric-type adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and\u002For radiation therapy.\n3. Patients must have had at least one prior systemic chemotherapeutic regimen for metastatic, recurrent or persistent carcinoma of the cervix. (Note: Prior adjuvant therapy is NOT counted as a systemic chemotherapeutic regimen for management of metastatic, recurrent or persistent carcinoma of the cervix, adjuvant therapy includes cisplatin given concurrent with primary radiation therapy (CCRT).\n4. Patients must have measurable disease per REClST 1.1; measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded as ≥ 10 mm with computed tomography (CT) scan, magnetic resonance imaging (MRI); a lymph node must be ≥ 15 mm in short axis.\n5. Eastern Cooperative Oncology Group score 0-1.\n6. Life expectancy exceeds 3 months.\n7. AEs due to previous treatments should be resolved to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy are eligible.\n8. NEU ≥ 1.5\\*10\\^9 \u002FL, Platelet ≥ 75×10\\^9 \u002FL, Hemoglobin ≥ 90 g\u002FL; Serum creatinine ≤ 1.5 times the upper limit of normal (ULN).; Urinary protein \\\u003C 2+ or 24h urinary protein quantity \\\u003C 1.0 g; AST and ALT ≤ 2.5 times ULN; Total bilirubin ≤ 1.5 times ULN; Albumin levels ≥ 28 g\u002FL; Coagulation function: Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 times the ULN.\n9. Female participants must test negative for HCG in urine or blood, except in cases of menopause or prior hysterectomy. Female patients of childbearing potential and their partners must use effective contraception during the study and for 6 months after the final dose of the study drug.\n10. Willing to participate in this study, and sign the informed consent.\n\nExclusion Criteria:\n\n1. Patients with cervical cancer histologically diagnosed as squamous cell carcinoma, usual-type adenocarcinoma, clear cell carcinoma, adenosquamous carcinoma, small cell carcinoma, or any non-gastric-type adenocarcinoma.\n2. Participate in other drug clinical trials at the same time.\n3. Known hypersensitivity to any component of the IN10018 formulation or to cadonilimab.\n4. Patients with active autoimmune disease or a history of autoimmune disorders.\n5. Patients with concomitant conditions requiring immunosuppressive medications or systemic or absorbable local corticosteroids at immunosuppressive doses. The use of prednisone \\>10 mg\u002Fday or an equivalent dose is prohibited within 2 weeks prior to the first administration of the investigational drug.\n6. HIV infection or a positive test for acquired immunodeficiency syndrome (AIDS).\n7. Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n8. Necrotic lesions identified within 4 weeks prior to enrollment, where there is a high risk of major bleeding as determined by the investigator.\n9. Severe infections occurring within 4 weeks prior to the first dose of study treatment.\n10. Known active tuberculosis (TB) or suspicion of active TB.\n11. Untreated chronic hepatitis B infection or hepatitis B virus (HBV) carriers with HBV DNA levels exceeding 1000 IU\u002FmL, or patients with active hepatitis C infection.\n12. Patients with known leptomeningeal disease, spinal cord compression, or active brain metastases.\n13. Uncontrolled severe medical conditions that, in the investigator's judgment, would interfere with the patient's ability to receive study treatment, including but not limited to severe cardiovascular disease, cerebrovascular disease, uncontrolled diabetes, or uncontrolled infections.\n14. Receipt of a live vaccine within 4 weeks prior to the first dose of study treatment. Note: Inactivated seasonal influenza vaccines are permitted.\n15. Pregnant or breastfeeding female patients, or female patients of childbearing potential who refuse to use effective contraception.\n16. Patients with symptomatic or unstable third-space fluid accumulations (e.g., pleural effusion, ascites, pericardial effusion) requiring repeated drainage.\n17. Patients with a prior genetic test report indicating mutations associated with hyperprogression under immunotherapy, such as MDM2\u002F4 amplification or EGFR mutations.\n18. Not eligible for the study judged by researchers.","FEMALE","18 Years","75 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Gastric-type adenocarcinoma of the cervix is the most commonly diagnosed HPV-independent subtype of cervical cancer, characterized by a poor prognosis and limited responsiveness to existing therapies. Therefore, the exploration of new treatment modalities is critically important. This is an open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of IN10018 plus nab-paclitaxel and cadonilimab in the treatment of adult women with metastatic, recurrent, or persistent gastric-type adenocarcinoma of the cervix.",[27,28],"Cervical Adenocarcinoma","Gastric-type Endocervical Adenocarcinoma","RECRUITING","2026-01-11",{"date":32,"type":33},"2026-01-13","ACTUAL",{"date":35,"type":33},"2025-02-17",{"date":37,"type":21},"2026-11-01",{"name":39,"class":40},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100582995","phase-3-comparative-study-of-adjuvant-therapy-for-postoperative-cervical-gastric-type-adenocarcinoma-100582995","NCT06870565","Comparative Study of Adjuvant Therapy for Postoperative Cervical Gastric-type Adenocarcinoma","A Multicenter Randomized Study Comparing Paclitaxel and Platinum-based Concurrent Chemoradiotherapy With Short-term Adjuvant Chemotherapy Versus Platinum-based Monotherapy Concurrent Chemoradiotherapy in Patients With Postoperative Cervical Gastric-type Adenocarcinoma With High-risk Factors for Recurrence.","Inclusion Criteria:\n\n1. Pathologically confirmed Gastric-type endocervical adenocarcinoma;\n2. Based on standard examination procedures, it is determined that one of the following risk factors is combined: positive margin, positive paracervical involvement, adnexal involvement, positive lymph nodes, tumor diameter ≥ 4cm, infiltration of the outer 1\u002F3 of the cervical stroma, and vascular tumor thrombus. The specific inclusion can be discussed by two senior clinical doctors;\n3. Medical history inquiry and gynecological examination must be performed within 14 days before enrollment to confirm the size of the tumor and International Federation of Gynecology and Obstetrics (FIGO) stage;\n4. Chest Computed Tomography (CT) plain scan, abdominal enhanced CT scan, or Positron Emission Tomography (PET)\u002FCT examination within 30 days before enrollment;\n5. Pelvic CT, Magnetic Resonance Imaging (MRI) or PET\u002FCT examination within 30 days before enrollment;\n6. General condition score 0-1 points;\n7. Age 18-65 years old;\n8. Laboratory examinations must be performed within 14 days before enrollment, and bone marrow, liver function, and kidney function tests are performed:\n\n   1. White blood cell (WBC) ≥ 3.5 x 10E9\u002FL (normal range)\n   2. Neutrophils ≥ 1.5 x 10E9\u002FL;\n   3. Platelets ≥ 100 x 10E9\u002FL;\n   4. Hemoglobin ≥ 100 g\u002FL (transfusion or other methods are acceptable)\n   5. Liver function is within the normal range: alanine aminotransferase (ALT), aspartate aminotransferase (AST) \\\u003C 1.5 times the upper limit of normal, alkaline phosphatase (ALP) \\\u003C 2.5 times the upper limit of normal, bilirubin \\\u003C upper limit of normal.\n   6. Renal function is within the normal range: creatinine clearance rate (CCr) \\> 60 ml\u002Fmin.\n\nCalculation formula: CCr=(140-age)×weight (kg)\u002F\\[72×Scr (mg\u002Fdl)\\] or CCr=\\[(140-age)×weight (kg)\\]\u002F\\[0.818×Scr (umol\u002FL)\\] g) International prothrombin ratio (INR) ≤ 1.5 9. Women of childbearing age must agree to take effective contraceptive measures during the entire treatment study; 10. Patients must sign an informed consent form before enrollment;\n\nExclusion Criteria:\n\n1. Pathological types of non-gastric adenocarcinomas such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, small cell carcinoma, neuroendocrine carcinoma, and sarcoma of cervical cancer;\n2. Stage IVB;\n3. Previous invasive malignant tumors: excluding non-malignant melanoma skin cancer;\n4. Systemic chemotherapy in the past 3 years;\n5. Previous history of pelvic or abdominal radiotherapy, which may cause overlap of irradiation field for this radiotherapy;\n6. Distant metastatic lesions in other organs;\n7. The following serious active concurrent diseases:\n\n1\\) Unstable angina and\u002For congestive heart failure requiring hospitalization in the past 6 months 2) Transmural myocardial infarction in the past 6 months 3) Acute bacterial or fungal infection requiring intravenous antibiotic treatment at the time of registration 4) Exacerbation of chronic obstructive pulmonary disease or other respiratory diseases requiring hospitalization or hindering the study 5) Jaundice or coagulation disorder caused by poor liver function 6) Acquired immunodeficiency disease (Patients diagnosed with Acquired Immune Deficiency Syndrome (AIDS), or patients suspected of having AIDS who refuse HIV testing); 7) Other immunocompromised states (e.g. organ transplantation, long-term use of glucocorticoids); 8. Pregnant women, breastfeeding women.","65 Years",{"count":50,"type":21},238,[52],"PHASE3","Background: Gastric-type endocervical adenocarcinoma (G-EAC) is a new classification of cervical mucinous carcinoma. G-EAC is a unique human papillomavirus unrelated adenocarcinoma that can be distinguished from typical endocervical adenocarcinoma (UEA). In China, adjuvant therapy for cervical cancer after surgery includes not only radiotherapy (RT) or concurrent chemoradiotherapy (CCRT), but also chemotherapy in many cases. However, no previous prospective study has analyzed the adjuvant therapy of G-EAC. This study is the first randomized phase III trial, which aims to recommend better adjuvant treatment options for G-EAC patients at high risk of recurrence in China, in order to better optimize and personalize patient care and improve recurrence-free survival and overall survival.\n\nMethods: This trial is a prospective, multicenter study led by the Department of Radiotherapy, Affiliated Hospital of Obstetrics and Gynecology, Zhejiang University. Recruitment will begin in February 2025, and it is expected that 238 patients with postoperative cervical gastric adenocarcinoma with high risk of recurrence will be recruited from 16 clinical centers in China. Patients will be randomly assigned to the experimental group or the control group in a 1:1 ratio. The experimental group will receive paclitaxel combined with platinum-based concurrent chemoradiotherapy and short-term adjuvant chemotherapy, and the control group will receive the current standard treatment regimen, i.e., platinum-based concurrent chemoradiotherapy, without adjuvant chemotherapy. The primary endpoint of the study is the 2-year progression-free survival, and the secondary endpoints are disease treatment failure pattern, overall survival rate, acute\u002Fchronic toxicity incidence, and quality of life assessment.",[28,55],"Cervical Cancer","NOT_YET_RECRUITING","2025-03-13",{"date":59,"type":33},"2025-03-17",{"date":61,"type":21},"2025-03",{"date":63,"type":21},"2030-12",{"name":65,"class":40},"Women's Hospital School Of Medicine Zhejiang University"]