[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ovarian-neoplasms-malignant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ovarian-neoplasms-malignant":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"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":26,"conditions":27,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100635247","phase-2-tiaoshen-anti-cancer-protocol-and-cbt-for-insomnia-and-survival-in-ovarian-cancer-100635247",false,"NCT07550205","Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer","Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer: A Multicenter Randomized Trial","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years (inclusive).\n2. Performance status (PS) score of 0-2.\n3. Histologically or cytologically confirmed primary epithelial ovarian carcinoma, with postoperative FIGO stage III-IV, and scheduled to receive postoperative standard first-line platinum-based chemotherapy.\n4. Having undergone ovarian cancer debulking surgery, in a stable condition at enrollment (no active infection, no severe hepatic or renal impairment, etc.), and planned for postoperative first-line platinum-based chemotherapy.\n5. Meeting the diagnostic criteria for ovarian cancer-related insomnia (difficulty initiating sleep, sleep maintenance disturbance \\[nocturnal awakening ≥2 times\\], early morning awakening with inability to return to sleep, occurring ≥3 times per week and lasting ≥1 month).\n6. Possess the ability to comprehend assessment scales and undergo Cognitive Behavioral Therapy for Insomnia (e.g., Mini-Mental State Examination score ≥24, or education level above primary school).\n7. Voluntarily sign the informed consent form, agree to receive the study treatment, and able to independently complete a sleep diary.\n\nExclusion Criteria:\n\n1. Previous systematic treatment with Cognitive Behavioral Therapy for Insomnia.\n2. History of chronic insomnia, depression, or other psychiatric disorders prior to ovarian cancer diagnosis, AND with a Patient Health Questionnaire-9 score ≥15 and a Generalized Anxiety Disorder-7 score ≥15, AND long-term use of hypnotic or psychotropic medications.\n3. Pregnant or lactating women.\n4. Comorbid severe primary diseases of the cardiovascular, cerebrovascular, pulmonary, hepatic, renal, or hematopoietic systems.\n5. Language barriers that would prevent completion of assessments or therapy.\n6. Comorbid autoimmune diseases, congenital or acquired immunodeficiency diseases, hematological diseases, or long-term use of corticosteroids or immunosuppressants.\n7. Active hepatitis B, active tuberculosis, or other severe or uncontrolled infectious diseases.\n8. History of chronic alcohol dependence.\n9. Concurrent other primary malignant tumors (except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, etc.).\n10. Participation in any other clinical trial within 3 months prior to enrollment.\n11. Legally incompetent, or any medical or ethical reason that may hinder the continuation of the study.","FEMALE","18 Years","80 Years",{"count":20,"type":21},360,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Study Title: A Multicenter, Randomized Controlled Trial of Tiaoshen Anti-cancer Protocol Combined with Cognitive Behavioral Therapy for Insomnia in Improving Sleep and Survival in Ovarian Cancer Patients Purpose: This study aims to evaluate whether a combined therapy of traditional Chinese medicine (TCM) and modern psychotherapy can improve sleep and potentially extend survival for patients with ovarian cancer. Many patients experience severe, cancer-related insomnia, which lowers quality of life and may affect treatment outcomes.\n\nIntervention \\& Design: This is a randomized, double-blind, placebo-controlled trial conducted across multiple hospitals. Approximately 360 eligible patients with advanced ovarian cancer and significant insomnia will be enrolled.\n\nParticipants will be randomly assigned to one of two groups for the initial 18-week phase:\n\nExperimental Group: Receives the Tiaoshen Anti-cancer herbal formula granules plus standard Cognitive Behavioral Therapy for Insomnia (CBT-I).\n\nControl Group: Receives inactive placebo granules plus the same standard CBT-I. Neither the participants nor their treating doctors will know which granules are assigned during this phase. The primary goal is to compare the improvement in sleep quality between the two groups. Key secondary goals include assessing the therapy's impact on patients' anxiety, depression, overall quality of life, and the length of time before the cancer progresses (progression-free survival). All patients will receive standard-of-care chemotherapy.",[28,29,30,31,32],"Ovarian Neoplasms Malignant","Sleep Initiation and Maintenance Disorders","Medicine, Chinese Traditional","Chinese Herbal Medicine","Cognitive Behavioral Therapy",[34,35,36,37,38,39],"Ovarian Cancer","Cancer-Related Insomnia","Traditional Chinese Medicine","Cognitive Behavioral Therapy for Insomnia","Randomized Controlled Trial","Progression-Free Survival","NOT_YET_RECRUITING","2026-04-19",{"date":43,"type":44},"2026-04-24","ACTUAL",{"date":46,"type":21},"2026-05-01",{"date":48,"type":21},"2029-09-30",{"name":50,"class":51},"Shanghai Municipal Hospital of Traditional Chinese Medicine","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":52},"100626443","phase-1-intraperitoneal-sk-nk-cell-injection-for-advanced-ovarian-cancer-with-massive-ascites-100626443","NCT07435701","Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer With Massive Ascites","A Single-Arm, Open-Label Phase I\u002FII Clinical Trial of Intraperitoneal Perfusion of SK-NK Cell Injection for the Treatment of Advanced Ovarian Cancer Patients With Massive Ascites","Inclusion Criteria:\n\nVoluntarily sign the written Informed Consent Form (ICF) and be able to comply with study procedures and follow-up.\n\nFemale, aged 18 to 75 years. ECOG performance status of 0 to 2. Histologically or cytologically confirmed advanced ovarian cancer. Participants must have failed at least two lines of standard therapy (disease progression or intolerance), have no standard therapy available, or be unable to receive standard therapy for other reasons .\n\nComplicated by massive malignant ascites, defined as a volume of ≥ 2000 mL indicated by Ultrasound or CT.\n\nExpected survival time ≥ 3 months.\n\nAdequate organ function (no blood transfusion, cell growth factors, etc., within 14 days prior to enrollment), defined as:\n\nNeutrophils (ANC) ≥ 1.0×10\\^9\u002FL Platelets (PLT) ≥ 80×10\\^9\u002FL Hemoglobin (Hb) ≥ 80 g\u002FL Total Bilirubin (TBIL) ≤ 1.5×ULN (≤ 3×ULN for Gilbert's syndrome or liver metastasis) ALT and AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis is present) INR ≤ 1.5×ULN and APTT ≤ 1.5×ULN (unless on anticoagulant therapy) Creatinine clearance ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault formula) Toxicities from prior therapies must have recovered to ≤ Grade 1 (except for alopecia and ≤ Grade 2 neurotoxicity caused by chemotherapy) .\n\nExclusion Criteria:\n\nPrior receipt of other cell therapies. Presence of loculated (septated) ascites indicated by CT or Ultrasound. Receipt of any systemic anti-tumor therapy (including chemotherapy, targeted therapy, etc.) within 3 weeks prior to intraperitoneal perfusion.\n\nReceipt of Traditional Chinese Medicine (herbal) with anti-tumor indications within 3 weeks prior to intraperitoneal perfusion.\n\nReceipt of systemic corticosteroids (≥ 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 2 weeks prior to intraperitoneal perfusion (inhaled, topical, or physiologic replacement doses are allowed).\n\nMajor surgery within 4 weeks prior to screening or planned major surgery during the study period.\n\nHistory of other malignancies within 5 years (except for cured local tumors with low risk of recurrence, such as non-melanoma skin cancer).\n\nHistory of active or suspected autoimmune or inflammatory disease. History of organ transplantation or hematopoietic stem cell transplantation.\n\nPresence of active infection, including:\n\nActive Hepatitis B (HBsAg positive and HBV-DNA \\> 1000 copies\u002FmL) Active Hepatitis C (HCV antibody positive and HCV-RNA detected) Systemic active infection requiring antibiotic treatment Congenital or acquired immunodeficiency (e.g., HIV infection) Vaccination with live or attenuated vaccines within 4 weeks prior to intraperitoneal perfusion.\n\nSevere cardiovascular diseases, including:\n\nUncontrolled hypertension (SBP \\> 160 mmHg and\u002For DBP \\> 100 mmHg) History of hypertensive crisis or hypertensive encephalopathy Cardiovascular accident, TIA, myocardial infarction, unstable angina, or significant vascular disease within 6 months NYHA Class ≥ II heart failure or LVEF \\\u003C 50% Severe arrhythmia uncontrolled by medication (QTc ≥ 450 ms for males, ≥ 470 ms for females), or congenital Long QT syndrome Severe respiratory disease (e.g., history of severe interstitial lung disease, severe COPD), FEV1 \\\u003C 2L, or DLCO \\\u003C 40%.\n\nHistory of clear neurological or psychiatric disorders, including epilepsy or dementia.\n\nOther conditions considered unsuitable for the study by the investigator (e.g., prior Grade ≥ 3 adverse events from immunotherapy).",{"count":61,"type":21},29,[63,24],"PHASE1","This is a single-center, open-label, Phase I\u002FII clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of SK-NK Cell Injection administered via intraperitoneal (IP) perfusion in patients with advanced ovarian cancer complicated by massive ascites .\n\nThe study focuses on patients who have failed standard therapies and are suffering from severe ascites. The treatment involves the direct infusion of allogeneic, highly activated Natural Killer (NK) cells (SK-NK) into the abdominal cavity .\n\nThe study consists of two phases:\n\nPhase I (Dose Escalation): To determine the safety profile and the Recommended Phase 2 Dose (RP2D) using a \"3+3\" design with three increasing dose levels.\n\nPhase II (Dose Expansion): To further evaluate the efficacy of the treatment in controlling ascites and suppressing tumor growth at the determined RP2D.\n\nParticipants will receive the study treatment once weekly for 4 weeks.",[28,66],"Ascites",[68,69,70,71,72,73,74],"SK-NK Cell Injection","Natural Killer Cells","NK Cell Therapy","Intraperitoneal Perfusion","Adoptive Immunotherapy","Immunotherapy","Massive Ascites","RECRUITING","2026-03-13",{"date":78,"type":44},"2026-03-17",{"date":80,"type":44},"2026-01-05",{"date":82,"type":21},"2026-12-31",{"name":84,"class":51},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences"]