[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peritoneal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peritoneal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,43,69,103,115,143,170,209,230,254,356,386,414,451,476,497,520,543,568],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053788","phase-2-an-evaluation-of-maintenance-therapy-combination-mirvetuximab-soravtansine-and-olaparib-100053788",false,"NCT05887609","An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib","A Phase II Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine-gynx and Olaparib in Recurrent Platinum Sensitive Ovarian, Peritoneal, and Fallopian Tube Cancer","Inclusion Criteria:\n\n* Provision to sign and date the consent form\n* Stated willingness to comply with all study procedures and be available for the duration of the study\n* Be a woman aged ≥18 years of age\n* Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1\n* Patients must have a confirmed diagnosis of high-grade serous or endometrioid EOC, primary peritoneal cancer, or fallopian tube cancer\n* Patients must have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of prior platinum therapy (not inclusive of current\u002Fmost recent platinum therapy)\n* Patients must have had documented complete or partial response, or stable disease, as defined by RECIST 1.1, from last line of platinum therapy\n* Patients must have available archival tissue block or slides to confirm FRalpha positivity\n* Patients' tumor must have FRalpha high or medium expression\n* Prior anticancer therapy:\n\n  * Patients must have received at least one prior platinum-based chemotherapy regimen for platinum sensitive recurrent disease.\n  * Most recent prior chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles\n  * Most recent prior chemotherapy regimen must have been platinum based\n  * Patients must have had testing for BRCA mutation (tumor or germline) and, if positive, must have received a prior PARP inhibitor as either treatment or maintenance therapy\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy\n  * Maintenance therapy (eg, Bevacizumab, PARP inhibitors) will be considered part of preceding line of therapy (ie, not counted independently)\n  * Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)\n  * Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance\n  * Prior Bevacizumab use is allowed, but concurrent use with study combination is prohibited.\n  * Cycle 1 Day 1 of trial therapy must be within 8 weeks of last dose of previous chemotherapy.\n* Patients must have adequate hematologic, liver, and kidney function as defined as:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (1500\u002FµL)\n  * Platelet count ≥ 100 x 109\u002FL (100,000 µL)\n  * Hemoglobin ≥ 10.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Serum creatinine ≤ 1.5 x upper limit of normal (ULN)\n  * Patients must have creatinine clearance estimated of ≥51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test\n  * Aspartate aminotransferase (AST)(Serum Glutamic Oxaloacetic Transaminase (SGOT)) and alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in which case they must be ≤ 5x ULN\n  * Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \\\u003C 3.0 x ULN)\n  * Serum albumin ≥ 2 g\u002FdL\n\nExclusion Criteria:\n\n* Patients with clear cell, mucinous, sarcomatous, low grade\u002Fborderline, germ cell, or sex-cord stromal type ovarian tumor\n* Patients who have progressed through most recent chemotherapy regimen. Stable disease (SD) is permissible.\n* Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment\n* Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions require ongoing treatment\u002Fmonitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and\u002For monocular vision\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of MDS\u002FAML.\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to:\n\n  * Uncontrolled major seizure disorder\n  * Unstable spinal cord compression\n  * Any psychiatric disorder that prohibits obtaining informed consent.\n  * Active hepatitis B or C infection (whether or not on active antiviral therapy)\n  * Immunocompromised patients, e.g., patient who are known to be serologically positive for human immunodeficient virus(HIV)\n  * Active cytomegalovirus infection\n  * Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV\n* Patients with a history of multiple sclerosis (MS) or other demyelinating disease and\u002For Lambert-Eaton syndrome (paraneoplastic syndrome)\n* Patients with clinically significant cardiac disease including, but not limited to, any of the following\n\n  * Myocardial infarction ≤ 6 months prior to first dose\n  * Uncontrolled ventricular arrhythmia, recent (within 3 months)\n  * Superior vena cava syndrome\n  * Unstable angina pectoris\n  * Uncontrolled congestive heart failure (New York Heart Association \\> class II)\n  * Uncontrolled ≥ Grade 3 hypertension (per CTCAE)\n  * Uncontrolled cardiac arrhythmias\n* Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment\n* Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)\n* Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD) or Extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan , including noninfectious pneumonitis\n* Persistent toxicities (\\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia\n* Patients requiring use of folate-containing supplements (eg, folate deficiency)\n* Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks.\n* Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.\n* Patients with prior hypersensitivity to monoclonal antibodies (mAb)\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n* Women who are pregnant or breastfeeding, and who do not agree to use a highly effective contraceptive method(s) while on study drug and for at least 3 months after the last dose of MIRV and at least 6 months after the last dose of Olaparib. Females of childbearing potential must have a negative serum pregnancy test within 72 hours of study entry.\n* Patients who received prior treatment with MIRV or other FRα- targeting agents\n* Patients with duodenal stent or other GI disorder\u002Fdefect that would interfere with absorption of oral medication\n\n  * Includes patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication\n* Patients with known untreated or symptomatic central nervous system (CNS) metastases\n* Patients with a history of other malignancy within 3 years prior to enrollment\n\n  * Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible\n* Prior known hypersensitivity reaction to study drugs and\u002For any of their excipients\n* Minor or major surgical procedure within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n* Inability to comply with study and follow-up procedures\n* Patients deemed otherwise clinically unfit for clinical trial per investigators discretion","FEMALE","18 Years","100 Years",{"count":20,"type":21},53,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer.",[27,28,29],"Ovary Cancer","Peritoneal Cancer","Fallopian Tube Cancer","RECRUITING","2026-07-09",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2023-10-03",{"date":38,"type":21},"2031-01-31",{"name":40,"class":41},"University of Colorado, Denver","OTHER",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100444784","phase-2-zen003694-combined-with-talazoparib-in-patients-with-recurrent-ovarian-cancer-100444784","NCT05071937","ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer","Phase ll Study of a BET Inhibitor, ZEN003694, Combined With a PARP Inhibitor, Talazoparib, in Patients With Recurrent Ovarian Cancer","Inclusion Criteria:\n\n1. Females age ≥ 18 years (at time of signing informed consent)\n2. ECOG status 0 or 1\n3. Pathologically documented ovarian, fallopian tube, or primary peritoneal carcinoma.\n4. Prior therapy with PARPi either as maintenance or therapeutic settings.\n5. All recurrent ovarian cancer both platinum sensitive and platinum resistant are allowed.\n6. Any prior number of cancer therapy regimens\n7. Measurable disease per RECIST 1.1\n8. Known BRCA1\u002F2 status\n9. Adequate laboratory parameters at Screening including:\n\n   1. Hemoglobin ≥ 9.0 gm\u002FdL without transfusions during the 4 weeks prior to Screening\n   2. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL\n   3. Platelet count ≥ 150,000\u002Fmm3\n   4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.0 x ULN or if liver function abnormalities due to liver metastases AST and ALT ≤ 5.0 x ULN\n   5. Total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN for subjects with known Gilbert's syndrome)\n   6. Serum Creatinine ≤ 1.5 X ULN\n   7. Prothrombin time (PT), international normalized ratio (INR) and partial thromboplastin time (PTT) \\\u003C 1.5 x ULN\n10. Female subjects may be enrolled if they are not of childbearing potential, permanently sterile or who are post-menopausal, defined as no menses for at least 1 year without an alternative medical cause and FSH levels in the post-menopausal range. Female subjects of childbearing potential may be enrolled if they consistently and correctly use a highly effective form of contraception. Highly effective forms of contraception include: combined (estrogen and progestogen hormonal contraceptives (oral, intravaginal, transdermal) associated with inhibition of ovulation; progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence. Female subjects should not donate eggs from the time point of study drug administration until at least 7 months thereafter\n11. Females of childbearing potential must have a negative serum pregnancy test before the first dose of study drug and must agree to serum pregnancy tests during the study.\n12. Females may not be breast-feeding at the first dose of study drug, during study participation or through 7 months after the last dose of study drug.\n13. Ability to swallow capsules and comply with study procedures.\n14. Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures.\n15. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable with evidence of no disease progression for 6 months.\n\n    Exclusion Criteria:\n16. Current or anticipated use of medications known to be strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows. Strong inhibitors, inducers or substrates must be discontinued at least 7 days prior to the first administration of study drug.\n17. Current or anticipated use within 7 days prior to the first administration of study drug, or during the study, of strong P-gp inhibitors.\n18. Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed\n19. Radiation to \\>25% of the bone marrow\n20. Treatment with a bone-targeted radionuclide within 6 weeks of first dose of study drug\n21. Prior chemotherapy or radiation within 3 weeks of study enrollment\n22. Have previously received an investigational BET inhibitor (including previous participation in studies with Zenith drug, ZEN003694)\n23. QTcF interval \\> 470 msec\n24. Insufficient recovery from prior treatment-related toxicities except for alopecia, fatigue and Grade 2 neuropathy\n25. Non-healing wound, ulcer or bone fracture (not including a pathological bone fracture caused by a pre-existing pathological bone lesion)\n26. Brain metastases not adequately treated and\u002For clinically stable (at the discretion of the Investigator) for at least 6 months prior to the start of study treatment.\n27. Patients with ovarian carcinosarcoma\n28. Known impaired cardiac function or clinically significant cardiac disease such as uncontrolled supraventricular arrhythmia, ventricular arrhythmia requiring therapy, or congestive heart failure (New York Heart Association functional class III or IV)\n29. Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug\n30. Known myelodysplastic syndrome\n31. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, or any other condition that could compromise safety or the patient's participation in the study\n32. Impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 or talazoparib\n33. Other known active cancer requiring therapy at time of study entry or that progressed or required treatment within 3 years prior to starting study drug (except for skin basal cell carcinoma or squamous cell carcinoma or in situ cervical cancer)\n34. History of infection with (screening tests not required): human immunodeficiency virus; hepatitis B virus with currently active disease defined as hepatitis B surface antigen (HBsAg) positivity; or hepatitis C virus unless previously treated and viral load is undetectable except following situations:\n\n    * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment are eligible for this trial.\n    * Patients with a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection are allowed to be included if: participant on a stable dose of antiviral therapy, HBV viral load below the limit of quantification. HCV viral load below the limit of quantification.\n35. Major surgery other than diagnostic surgery, dental surgery or stenting within 4 weeks prior to the first administration of study drug\n36. Concurrent participation in another clinical investigational treatment trial\n37. Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule",{"count":51,"type":21},33,[24],"This Phase 2, open label, study with safety lead in of oral talazoparib in combination with ZEN003694 given daily in 28-day cycles will enroll patients with recurrent ovarian, fallopian tube or primary peritoneal carcinoma.",[55,28,29],"Ovarian Cancer",[57,58],"PARP enzyme","bromodomain and extra terminal domain (BET) proteins","2026-06-16",{"date":61,"type":34},"2026-06-18",{"date":63,"type":34},"2023-04-21",{"date":65,"type":21},"2034-12-31",{"name":67,"class":41},"Alexander B Olawaiye, MD",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":68},"100641453","transcriptional-pathways-of-surgical-pain-modulated-by-music-therapy-exposure-transpose-100641453","NCT07653594","TRANScriptional Pathways Of Surgical Pain Modulated by Music Therapy Exposure (TRANSPOSE)","TRANScriptional Pathways Of Surgical Pain Modulated by Music Therapy Exposure (TRANSPOSE): A Single Arm Pilot Study","Inclusion Criteria:\n\n* Age 50 to 80\n* Able to speak and understand English\n* Scheduled to undergo a surgery meeting the following criteria: (1) traditional open surgery (not laparoscopic or robotic) via laparotomy (midline or subcostal incisions), (2) length of surgery \\>3 hours, and (3) curative-intent surgical resection of a cancer in the stomach, pancreas, bile ducts, liver, or peritoneal surfaces\n* Participant reports pain intensity of 4\u002F10 or above to study staff on day 1 post-surgery or any other day post-surgery through discharge\n\nExclusion Criteria:\n\n* Significant visual impairment that has not been corrected\n* Significant hearing impairment that has not been corrected\n* Significant cognitive impairment that would prevent participant from participating in the study","ALL","50 Years","80 Years",{"count":80,"type":21},20,[82],"NA","Participants may take part in this study if they are scheduled to undergo a surgery that meets the following: (1) traditional open surgery via laparotomy, (2) length of surgery \\>3 hours, and (3) curative-intent surgical resection of a cancer in the stomach, pancreas, bile ducts, liver, or peritoneal surfaces. The purpose of this study is (1) to evaluate the feasibility of collecting blood samples prior to surgery, post-surgery and pre- music-assisted relaxation and imagery (MARI) intervention, and immediately post-MARI intervention and (2) to identify gene expression changes associated with MARI and explore their relationship with immediate changes in pain intensity. Participants will be in this study for the duration of their hospital admission for surgery.",[85,86,87,88,89,28],"Surgery","Stomach Cancer","Pancreas Cancer","Bile Duct Cancer","Liver Cancer",[91,92],"Music therapy","Music-assisted relaxation and imagery","NOT_YET_RECRUITING","2026-06-15",{"date":96,"type":34},"2026-06-17",{"date":98,"type":21},"2027-01",{"date":100,"type":21},"2027-12",{"name":102,"class":41},"Case Comprehensive Cancer Center",{"id":104,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":25,"conditions":107,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":112,"leadSponsor":113,"locationsCount":114},"100507455",{"count":20,"type":21},[24],[27,28,29],"2026-06-02",{"date":110,"type":34},"2026-06-04",{"date":36,"type":34},{"date":38,"type":21},{"name":40,"class":41},5,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":125,"conditions":126,"keywords":131,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100416360","phase-1-microdevice-in-ovarian-fallopian-tube-and-peritoneal-cancer-100416360","NCT04701645","Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer","Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Ovarian, Fallopian Tube, and Peritoneal Cancer","Inclusion Criteria:\n\n* Participants must have suspected or confirmed clinically advanced stage (III-IV, defined as disease outside of the pelvis) ovarian, fallopian tube, or peritoneal cancer. If a patient has suspected ovarian cancer but final histologic analysis does not show evidence of ovarian cancer, the patient will be removed from the study and replaced.\n* Participants must meet one of the following clinical categories:\n\n  * Cohort 1: Patients with a new or suspected diagnosis of ovarian cancer who are deemed surgical candidates for primary cytoreductive surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.\n  * Cohort 2: Patients with newly diagnosed ovarian cancers who are being considered for either primary surgery or neoadjuvant chemotherapy by their surgical gynecologic oncologist, and who require a laparoscopic procedure to determine their candidacy for surgery.\n  * Cohort 3: Patients with recurrent ovarian cancer who are candidates for secondary cytoreduction, e.g. to confirm diagnosis of recurrent ovarian cancer and\u002For remove oligometastatic lesions.\n  * Cohort 4: Patients with newly diagnosed ovarian cancers who have undergone neoadjuvant chemotherapy and are deemed surgical candidates for interval debulking surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.\n* Participants must be 18 years of age or older.\n* Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures by their treating gynecologic oncologist and medical oncologist.\n* Participants will undergo laboratory testing within 14 days\\* prior to the microdevice placement.\n\n  * Patients must have absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelets ≥ 75,000\u002FmcL\n  * PT (INR) \\\u003C 1.5\n  * PTT \\\u003C 1.5x control\n  * Women of childbearing potential must have negative pregnancy test (urine or serum) \\*\\*Cohort 4 patients should undergo laboratory testing within 7 days prior to the microdevice placement\n* Participants must be evaluated by a surgical gynecologic oncologist who will determine the clinically appropriate treatment strategy (primary surgery or neoadjuvant chemotherapy) based on clinical history and extent of disease. The patient's surgical and\u002For medical gynecologic oncologist must also confirm the patient's medical fitness to undergo an additional biopsy procedure and the indicated surgical procedure. The patient must have a plan to undergo surgery for clinical purposes.\n* The following criteria must be met:\n\n  * Participants must have undergone an abdominal\u002Fpelvic CT scan that both assesses the extent of disease and identifies an area of tumor amenable to safe microdevice placement. CT scans with both oral and IV contrast media are preferred but not required.\n\nCT scans performed at outside institutions are acceptable providing that the images are considered adequate to assess the stage of the disease and to assess the safety and feasibility of the placement of the microdevices and their retrieval during standard-of care surgery. CT scan must be completed within 4 weeks prior to the microdevice placement.\n\n* Patient has sufficient volume of disease as measured by CT scan to allow implantation of the microdevice.\n* Patient has sufficient volume of disease that removal of the lesion where the microdevice is placed will not potentially affect adequate tissue for diagnosis.\n* A lesion can be selected where the microdevice is to be implanted that is\n\n  * Amenable to percutaneous placement\n  * Amenable to removal at the time of surgery or laparoscopy. If patient is undergoing laparoscopy, the lesion must be able to be removed using a laparoscopic approach in a manner that would not significantly alter the procedure or affect patient safety, per opinion of the surgical oncologist.\n\n    * Patients must have the ability to understand and the willingness to sign a written informed consent document.\n    * Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.\n\nExclusion Criteria:\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit the safety of a biopsy and\u002For surgery.\n* Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the microdevice placement and the potential risk to the pregnancy of the biopsy\u002Fdevice placement in an abdominal lesion.\n* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures.\n* Significant risk factors (including, but not limited to, high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines. (Patients taking low-dose aspirin only do not need to be excluded.)",{"count":80,"type":21},[124],"PHASE1","This pilot study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.\n\nThe name of the study intervention involved in this study is:\n\n-implantable microdevice",[55,29,28,127,128,129,130],"Ovarian Cancer Stage III","Ovarian Cancer Stage IV","Fallopian Tube Cancer Stage IV","Fallopian Tube Cancer Stage III",[55,29,28,132,127,128,129,130],"Implantable Microdevice","2026-05-14",{"date":135,"type":34},"2026-05-18",{"date":137,"type":34},"2022-11-01",{"date":139,"type":21},"2027-06-30",{"name":141,"class":41},"Brigham and Women's Hospital",2,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":169},"100402145","phase-1-a-study-of-azenosertib-zn-c3-in-patients-with-ovarian-cancer-100402145","NCT04516447","A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer","A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer","MUIR","INCLUSION CRITERIA:\n\nFor Part 1:\n\n* Histologically or cytologically confirmed FIGO Stage III\u002FIV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.\n* Subjects must have received 1 or 2 prior therapeutic regimens\u002Flines of therapy in the advanced or metastatic setting. At least one regimen must have contained cisplatin or carboplatin.\n* The disease must be platinum resistant (ie, the PFI must have been \\\u003C 6 months). Platinum refractory disease (ie, PD during first-line platinum-based therapy) is allowed.\n\nFor Part 2 Dose Escalation:\n\nPrior therapy:\n\n• Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy\n\nResponse to prior platinum therapy:\n\n1. In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.\n2. In the 2L setting:\n\n   1. Progressive Disease \\>183 days after receiving the last dose of platinum chemotherapy in the 1L setting,\n   2. Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy.\n\n      * Adequate hematologic, and organ function\n\nFor Part 2 Dose Expansion:\n\n* Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease\n* Subjects must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined inclusion criteria may apply\n\nEXCLUSION CRITERIA:\n\n* Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.\n* Subjects with carcinosarcomas (even if there is a serous component)\n* A serious illness or medical condition(s)\n* Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.\n\nAdditional protocol-defined exclusion criteria may apply",{"count":152,"type":21},172,[124],"This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.",[156,157,29,28],"Solid Tumor","Epithelial Ovarian Cancer",[156],"2026-04-01",{"date":161,"type":34},"2026-04-07",{"date":163,"type":34},"2020-10-26",{"date":165,"type":21},"2028-06-30",{"name":167,"class":168},"K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc","INDUSTRY",24,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":187,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},"100538389","phase-2-study-of-acute-normovolemic-hemodilution-anh-in-people-with-ovarian-cancer-who-are-having-cytoreductive-surgery-100538389","NCT06290193","Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery","A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer","Inclusion Criteria:\n\n* Adults (≥18 years)\n* BLOODS score ≥2 as calculated by surgeon\n* High preoperative suspicion (or diagnosis) of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (stage IIIC or IV), as determined by CT or MRI of the abdomen\u002Fpelvis\n* Planned for exploratory laparotomy and primary or interval cytoreductive surgery\n* Preoperative hemoglobin concentration ≥10 mg\u002Fdl within 45 days of surgery\n* Patients scheduled for cytoreductive surgery, with or without other planned procedures o Note: Patients scheduled for only diagnostic laparoscopy should not be included\n\nExclusion Criteria:\n\n* A history of active coronary artery disease\n\n  o Patients with a history of coronary artery disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 45 days of surgery.\n* A history of cerebrovascular disease\n* A history of congestive heart failure\n* A history of uncontrolled hypertension\n* A history of restrictive or obstructive pulmonary disease\n* A history of renal dysfunction (Cr \\>1.6 mg\u002Fdl)\n* Abnormal coagulation parameters (INR \\>1.5 not on coumadin, or platelet count \\\u003C100,000 mcL)\n* Presence of active infection\n* Evidence of hepatic metabolic disorder (bilirubin \\>2 mg\u002Fdl, ALT \\>75 U\u002FL in the absence of biliary tract obstruction)\n* Preoperative autologous blood donation within last 30 days or plan to donate autologous blood prior to surgery\n* Refusal to accept allogenic or autologous blood transfusion\n* Patients scheduled for cytoreductive surgery with planned Hyperthermic Intraperitoneal Chemotherapy (HIPEC)",{"count":178,"type":21},86,[24],"Participants will be scheduled for primary cytoreductive surgery as part of their standard care. Before surgery, participants will be assigned by chance to a study group. Depending on which group they are in, they will receive either acute normovolemic hemodilution\u002FANH during surgery or standard surgical management during surgery. The researchers think acute normovolemic hemodilution\u002FANH may decrease the need for allogenic blood transfusion\u002FABT in people having primary cytoreductive surgery.",[55,182,183,184,185,186,128,129,29,28],"Fallopian Tube Carcinoma","Ovarian Carcinoma","Peritoneal Carcinoma","Ovarian Cancer Stage IIIC","Fallopian Tube Cancer Stage IIIC",[188,189,190,191,192,193,194,195,196,197,198,199,200],"ovarian cancer","ovarian carcinoma","ovarian cancer stage IIIC","ovarian cancer stage IV","fallopian tube cancer","fallopian tube carcinoma","fallopian tube cancer stage IIIC","fallopian tube cancer stage IV","peritoneal cancer","peritoneal carcinoma","Acute Normovolemic Hemodilution","Memorial Sloan Kettering Cancer Center","23-392","2026-03-31",{"date":159,"type":34},{"date":204,"type":34},"2024-02-23",{"date":206,"type":21},"2029-02-23",{"name":199,"class":41},7,{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100445477","early-phase-1-using-aspirin-to-improve-immunological-features-of-ovarian-tumors-100445477","NCT05080946","Using Aspirin to Improve Immunological Features of Ovarian Tumors","Pilot Study to Assess the Efficacy of Aspirin to Improve Immunological Features of Ovarian Tumors","Inclusion Criteria:\n\n* Participants that are greater than or equal to 18 years of age\n* For U.S. sites, patients can read and understand English or Spanish; for Canadian site, participants can read and understand English or French\n* Histology confirmed, or clinical suspicion of, invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma. Must be grade 2 or 3 or high (where high is defined as grade 2\u002F3). All histologies including serous, endometrioid, clear cell sarcoma, or carcinosarcoma histology is acceptable. Mixed histology also acceptable.\n* Treatment naïve for this cancer diagnosis\n* Planned for neoadjuvant chemotherapy (platinum-based doublet with taxane +\u002F- anti-VEGF antibody) for at least 3 but no more than 5 cycles followed by an interval debulking surgery. \\[Note: this study evaluates response while on neoadjuvant treatment. The final collection of specimen and questionnaire is at the time of surgery and immediate post-operative state. Therefore, there are no eligibility criteria related to treatment in the adjuvant setting (e.g., intraperitoneal treatment) and adjuvant therapy should proceed as the physician deems appropriate.\\]\n* Measurable disease as defined by RECIST 1.1, CT scan (with or without contrast) within 12 weeks of study enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2\n* Able to provide tissue biopsy (core or excisional) sufficient for diagnosis and biomarker analysis, may use outside archival tissue if available.\n* If currently using anti-coagulation medication, no contraindication for temporary stoppage of use during the study based on physician judgement\n* Willing and able to swallow pills without difficulty\n* Un-transfused platelet count \\> 100,000 cells\u002FμL\n* Willing and able to participate in all required evaluations and procedures in this study protocol (e.g. undergoing treatment, scheduled visits and examinations, serum testing, questionnaires, pill log\u002Fdiary)\n* Absolute neutrophil count \\> 1.5 x 109 cells\u002FL\n* Hemoglobin \\> 9.0 g\u002FdL, may use transfusions and the value can be post-transfusion\n* Estimated creatinine clearance of \\> 30 mL\u002Fmin, calculated using the formula Cockcroft-Gault \\[(140-age) x Mass (kg)\u002F(72 x creatinine mg\u002FdL)\\] x 0.85 for female\n* No severe hepatic impairment defined as AST or ALT elevation \\\u003C 2.5 x institutional ULN, unless liver metastasis is present \\\u003C 5 x ULN\n\nExclusion Criteria:\n\n* Definite contraindication for either aspirin use or stopping current aspirin use based on physician's clinical judgment\n* History of vascular event in the last 12 months (e.g., myocardial infarction or unstable angina, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant \\[serious or significant\\] arrhythmias, significant vascular disease, congestive heart failure or vascular interventions).\n* History of hypertensive crisis and\u002F or uncontrolled HTN, systolic blood pressure \\> 150 mmHg; diastolic blood pressure \\> 90mmHg. Participants must have blood pressure \\\u003C 150\u002F90 mmHg taken in a clinic setting by a medical professional within 2 weeks prior to starting study.\n* Current or history of ulcers which prohibits aspirin consumption, severe hepatic failure, or acute or chronic renal disease where aspirin use is contraindicated\n* History of gastrointestinal or genitourinary bleeding or other bleeding diathesis or coagulopathy within 6 months prior to enrollment of study\n* Uncontrolled erosive esophagitis requiring 2 or more treatments\n* Other cancer diagnosis in the last 3 years other than non-melanoma skin cancer\n* Autoimmune disorder requiring systemic therapy\n* Chronic steroid use defined as 3 weeks in the past year or any length of time in the past 30 days.\n* Other aspirin or NSAID hypersensitivities or contraindications (e.g. allergy)\n* History of bariatric surgery\n* Currently pregnant at the Screening visit or planning on becoming pregnant during the study period\n* Participant is unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication.\n* Metabolism CYP2C9, known G6PD deficient patients",{"count":217,"type":21},100,[219],"EARLY_PHASE1","The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma",[55,29,28],{"date":159,"type":34},{"date":224,"type":34},"2021-11-02",{"date":226,"type":21},"2026-12",{"name":228,"class":41},"H. Lee Moffitt Cancer Center and Research Institute",4,{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":68},"100590624","prospective-clinico-biological-database-of-patients-with-ovarian-andor-peritoneal-andor-fallopian-tube-carcinoma-100590624","NCT06969833","Prospective Clinico-biological Database of Patients With Ovarian and\u002For Peritoneal and\u002For Fallopian Tube Carcinoma","Study of Prognostic Factors Associated With Overall Survival in Patients Initially Treated for Advanced Ovarian and\u002For Peritoneum and\u002For Fallopian Tubes Carcinoma: Analysis Using a Prospective Clinico-Biological Database","BCB-OVAIRE","Eligibility criteria for pre-registration:\n\n* Patient aged 18 or over\n* Informed consent warranted\n* Patient affiliated to a social security regimen\n* Suspected diagnosis of advanced and invasive ovarian cancer and\u002For primary peritoneal cancer and\u002For fallopian tube cancer (IIB to IV FIGO stages)\n* Pre-registration during standard care at the Oscar Lambret Centre, from diagnosis and before confirmation of definitive FIGO stage\n\nNon eligibility criteria for pre-registration:\n\n* Patient deprived of liberty or under curatorship or guardianship\n* Refusal to participate\n\nInclusion criteria:\n\n• Confirmed diagnosis of advanced and invasive ovarian cancer and\u002For primary peritoneal cancer and\u002For fallopian tube cancer (IIB to IV FIGO stages)\n\nExclusion criteria:\n\n• Dismissed diagnosis of advanced and invasive ovarian cancer and\u002For primary peritoneal cancer and\u002For fallopian tube cancer , or other type of cancer",{"count":239,"type":21},371,[82],"Cancer of the ovary and\u002For peritoneum and\u002For fallopian tube have a very poor prognosis, and require the implementation of collaborative research tools and new innovative therapies. The main objective of this study is to implement prognostic model of overall survival on patients included prospectively as part of the initial treatment of advanced ovarian and\u002For peritoneum, and\u002For fallopian tubes carcinoma (this cohort corresponds to the \"Turquoise\" care pathway of the Oscar Lambret Center) regardless of the treatment carried out,, integrating both patient's and tumor's characteristics. A clinical and biological database is implemented for this purpose.\n\n371 patients will be recruited over a 5-year period at the Oscar Lambret Center.\n\nThe active participation of each patient will be 2 years (from the date of pre-registration until the end of study participation, defined by the date of the last intervention specific to the research), then the data from standard care and survival data will be collected until the last follow-up of the last patient, 2 years after the last pre-registration.",[243,244,28],"Cancer of the Ovary","Cancer of the Fallopian Tube","2026-03-25",{"date":247,"type":34},"2026-03-30",{"date":249,"type":34},"2025-06-27",{"date":251,"type":21},"2032-06-27",{"name":253,"class":41},"Centre Oscar Lambret",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":341,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":68},"100432171","virtual-reality-for-gi-cancer-pain-to-improve-patient-reported-outcomes-100432171","NCT04907643","Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Inclusion Criteria:\n\n* Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period\n* Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible\n* Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments\n* Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible.\n* Have brain metastases\n* Have a prognosis of \\\u003C3 months from the time of enrollment per treating oncologist","99 Years",{"count":263,"type":21},360,[82],"Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.\n\nTo address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.",[267,268,269,270,271,87,89,272,273,86,274,28,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,88,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340],"Cancer Pain","Visceral Pain","Gastrointestinal Neoplasms","Cancer of Gastrointestinal Tract","Small Intestine Cancer","Colon Cancer","Biliary Tract Cancer","Rectum Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Cancers - Anus","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Small Intestine","Small Intestine Cancer Stage III","Small Intestine Cancer Stage IV","Small Intestine Cancer, Recurrent","Pancreas Cancer, Stage III","Pancreas Cancer, Stage IV","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc","Liver Cancer Stage IV","Colon Cancer Stage III","Colon Cancer Stage IV","Stomach Cancer Stage III","Stomach Cancer Stage IV","Stomach Cancer Recurrent","Rectum Cancer, Recurrent","Gastrointestinal Cancers - Liver","Anal Cancer","Anal Cancer Stage III","Anal Cancer Stage IV","Anal Cancer Recurrent","Anal Cancer Metastatic","Anal Cancer, Stage IIIA","Anal Cancer, Stage IIIB","Appendix Cancer","Ampullary Cancer","Bile Duct Cancer Stage III","Bile Duct Cancer Stage IV","Bile Duct Cancer Stage IVA","Bile Duct Cancer Stage IVB","Bile Duct Cancer Recurrent","Carcinoid Tumor","Carcinoid Tumor of Pancreas","Carcinoid Tumor of Large Intestine","Carcinoid Tumor of GI System","Carcinoid Tumor of Colon","Carcinoid Tumor of Liver","Carcinoid Tumor of Cecum","Carcinoid Tumor of Ileum","Carcinoid Tumor of Rectum","Carcinoid Tumor of the Small Bowel","Carcinoid Tumor of the Stomach","Large Intestine Cancer","Esophagus Cancer","Esophagus Cancer, Stage III","Esophagus Cancer, Stage IV","Esophagus Cancer, Recurrent","Gallbladder Cancer","Gallbladder Cancer Stage III","Gallbladder Cancer Stage IV","Gastric (Stomach) Cancer","Neuroendocrine Tumor","Peritoneum Cancer","Rectal Cancer","Esophagus Cancer, Stage I","Esophagus Cancer, Stage II","Gallbladder Cancer Stage I","Gallbladder Cancer Stage II","Bile Duct Cancer Stage I","Bile Duct Cancer Stage II",[342,343,344,345,346],"Virtual Reality","VR","support","GI cancer","cancer pain","2026-02-18",{"date":349,"type":34},"2026-02-20",{"date":351,"type":34},"2021-10-05",{"date":353,"type":21},"2027-03-16",{"name":355,"class":41},"Cedars-Sinai Medical Center",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":385},"100439960","phase-3-niraparib-vs-niraparib-plus-bevacizumab-in-patients-with-platinumtaxane-based-chemotherapy-in-advanced-ovarian-cancer-100439960","NCT05009082","Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum\u002FTaxane-based Chemotherapy in Advanced Ovarian Cancer","Niraparib vs Niraparib in Combination With Bevacizumab in Patients With Carboplatinum-taxane Based Chemotherapy in Advanced Ovarian Cancer (A Multicentre Randomised Phase III Trial)","Inclusion Criteria:\n\n1. Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the clinical trial requirements.\n2. Female patients ≥ 18 years with histologically confirmed primary advanced invasive high grade non-mucinous, non-clear cell epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer FIGO III\u002FIV (except FIGO stage IIIA2 without nodal involvement) according to recent FIGO classification (= FIGO stage IIIB - IV according to FIGO 2009 classification).\n3. All patients must have had either upfront primary debulking surgery OR plan to undergo chemotherapy with interval debulking surgery.\n4. Patients must have available tumor samples to be sent to central laboratory as formalin-fixed, paraffin-embedded (FFPE) sample for determination of BRCA status prior to randomization for stratification.\n5. Patients must be able to commence systemic therapy within 8 weeks of cytoreductive surgery.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.\n7. Estimated life expectancy \\> 3 months.\n8. Adequate bone marrow function (within 28 days prior to day 1, cycle 1 and within 3 days prior to day 1, cycle 2)\n\n   * Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\\^9\u002FL\n   * Platelets (PLT) ≥ 100 x 10\\^9\u002FL\n   * Hemoglobin (Hb) ≥ 9 g\u002FdL (can be post-transfusion)\n9. Adequate coagulation parameters (within 28 days prior to day 1, cycle 1 and within 7 days prior to day 1, cycle 2)\n\n   * Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x institutional upper limit of normal (ULN).\n   * The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to institution medical standard) and the patient has been on a stable dose of anticoagulants for at least one week at the time of randomization.\n10. Adequate liver and kidney function (within 28 days prior to day 1, cycle 1 and within 3 days prior to day 1, cycle 2)\n\n    * Total bilirubin ≤ 1.5 x ULN (≤ 2.0 x ULN in patients with known Gilbert's syndrome) OR direct bilirubin ≤ 1.0 x ULN.\n    * Aspartate aminotransferase \u002F Serum Glutamic Oxaloacetic Transaminase (ASAT\u002FSGOT) and Alanine aminotransferase \u002F Serum Glutamic Pyruvate Transaminase (ALAT\u002FSGPT) ≤ 2.5 x ULN, unless liver metastases are present, in case of liver metastases values must be ≤ 5 x ULN.\n    * Urine dipstick for proteinuria \\\u003C 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours.\n    * Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 30 mL\u002Fmin (see Appendix 2).\n11. Patients must have normal blood pressure (BP) or adequately treated and controlled BP, with a systolic BP of ≤ 140 mmHg and diastolic BP of ≤ 90 mmHg for eligibility. Patients must have a BP of ≤ 140\u002F90 mmHg taken in the clinic setting by a medical professional within 4 weeks prior to day 1, cycle 1 and within 7 days prior to day 1, cycle 2.\n12. Negative urine or serum pregnancy test within 7 days prior to day 1, cycle 1 in women of childbearing potential (WOCBP), confirmed prior to treatment on day 1.\n13. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after administration of the last dose of medication.\n\n    A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and\u002For uterus).\n\n    Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include but are not limited to bilateral tubal ligation and\u002For occlusion, male sterilization, and intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n14. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other clinical trial procedures, that include the completion of patient-reported outcomes questionnaires.\n\nExclusion Criteria:\n\n1. Non-epithelial tumor origin of the ovary.\n2. Ovarian tumors of low malignant potential (e.g. borderline tumors) and low grade tumors.\n3. Planned intraperitoneal cytotoxic chemotherapy.\n4. Malignancies other than ovarian cancer within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ of the breast, or stage I p53 wild type endometrial cancer).\n5. Prior systemic treatment for ovarian cancer.\n6. Prior treatment with Poly adenosine diphosphate ribose polymerase (PARP) inhibitor.\n7. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted).\n8. Prior randomization in this trial.\n9. Major surgery within 1 week of starting study treatment or patient who has not completely recovered from the effects of any major surgery. Core biopsy or other minor surgical procedure within 7 days prior to day 1, cycle 1 is permitted.\n10. History or clinical suspicion of brain metastases or spinal cord compression. CT\u002FMRI of the brain is mandatory (within 4 weeks prior to day 1, cycle 1) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to day 1, cycle 1) in case of suspected spinal cord compression.\n11. Significant traumatic injury during 4 weeks preceding the potential first dose of bevacizumab.\n12. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to day 1, cycle 1.\n13. History or evidence of thrombotic or hemorrhagic disorders within 3 months prior to day 1, cycle 1.\n14. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy e.g. uncontrolled seizures.\n15. Pregnant or lactating women.\n16. Treatment with any other investigational agent, or participation in another clinical trial testing a drug within 4 weeks or 5 times the half-life of the drug, whichever is longer, prior to day 1, cycle 1 or concomitantly within this trial.\n17. Known hypersensitivity to bevacizumab and its excipients, Chinese hamster ovary cell products or other recombinant human or humanized antibodies. Known hypersensitivity to niraparib, paclitaxel and carboplatin and its components or excipients.\n18. Non-healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no severe evidence of facial dehiscence or infection are eligible; regular wound examination will be performed.\n19. Clinically significant cardiovascular disease, including\n\n    * Myocardial infarction or unstable angina within 6 months of day 1, cycle 1\n    * New York Heart Association (NYHA) Grade 2 Congestive Heart Failure (CHF),\n    * Poorly controlled cardiac arrhythmia despite medication (patients with rate-controlled atrial fibrillation are eligible)\n    * Grade ≥ 3 peripheral vascular disease (i.e. symptomatic and interfering with activity of daily living (ADL) requiring repair or revision)\n    * Significant vascular disease including aortic aneurysm requiring surgical repair\n20. Pre-existing sensory or motor neuropathy ≥ Grade 2.\n21. (Intentionally left blank)\n22. Patients with a history of or current Nephrotic syndrome.\n23. Persistent cancer-related bowel obstruction (including subocclusive disease). Patients with a known history of ileus, who have been successfully treated and who are free of symptoms, may be eligible after consultation of sponsor.\n24. History of abdominal fistula or tracheoesophageal fistula or gastrointestinal perforation or active gastrointestinal bleeding or anastomotic insufficiency within 6 months of day 1, cycle 1.\n25. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of niraparib.\n26. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.\n27. Any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).\n28. Previous allogeneic bone marrow transplant or previous solid organ transplantation.\n29. Current or recent (within 10 days prior to day 1, cycle 1) chronic use of aspirin \\> 325 mg\u002Fday. Patients treated with other inhibitors of platelet aggregation such as clopidogrel, prasugrel, ticlopidine, tirofibane or dipyridamole should not be included into the trial.\n30. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. This includes also any psychiatric disorder that prohibits obtaining informed consent.\n31. Patient has known active hepatitis B or hepatitis C.\n32. Patient has a history of Posterior Reversible Encephalopathy Syndrome (PRES).\n33. Patients with chronic inflammatory bowel disease and active treatment for disease control.",{"count":364,"type":21},970,[366],"PHASE3","This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin\u002Fpaclitaxel\u002Fbevacizumab followed by bevacizumab and niraparib compared to carboplatin\u002Fpaclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer.",[55,29,28],[370,371,372,373,374,375],"High Grade Epithelial Ovarian Cancer","Advanced Ovarian Cancer","Niraparib","Bevacizumab","Carboplatin","Paclitaxel","2025-09-03",{"date":378,"type":34},"2025-09-10",{"date":380,"type":34},"2022-09-13",{"date":382,"type":21},"2031-12",{"name":384,"class":41},"AGO Study Group",65,{"id":387,"slug":388,"hasResults":11,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":22,"phases":396,"briefSummary":397,"conditions":398,"keywords":399,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":68},"100594675","phase-2-personalised-timing-of-interval-debulking-surgery-in-advanced-ovarian-cancer-100594675","NCT07022535","Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer","Personalised Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Pilot Study","PRESELECT-0","Inclusion Criteria:\n\n1. Patients must be at least 18 years old.\n2. Patients who have Eastern Cooperative Oncology Group (ECOG) score 0-1.\n3. Patients who are competent to give informed consent.\n4. Patients who have stage III-IV histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer not amenable for primary debulking surgery (PDS).\n5. Patients who are planned for neoadjuvant chemotherapy (NACT) using platinum-based chemotherapy +\u002F- bevacizumab or biosimilar. Those who are receiving NACT before interval debulking surgery (IDS) are also eligible.\n6. Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal).\n7. Patients who have baseline computed tomography of at least abdomen and pelvis, or positron emission tomography (PET)-CT. Magnetic resonance imaging (MRI) is also acceptable but the same modality has to be used when assessing the feasibility of IDS.\n8. Patients who agree to undergo IDS, where the time of IDS may differ from the usual clinical practice.\n9. Patients who agree to receive adjuvant chemotherapy, if clinically indicated. The total number of chemotherapy should be at least four or above.\n\nExclusion Criteria:\n\n1. Patients who have borderline malignancy, or non-epithelial ovarian cancer like germ cell or sex cord tumor, or metastatic diseases from other origins like Krukenberg's tumor\n2. Patients who are eligible for PDS\n3. Patients who are not fit for PDS because of medical morbidities or refusal of operation\n4. Patients who have already started NACT outside the study centres, except those who have just had one cycle within 21 days and the baseline CA125 is available.\n5. Patients who are pregnant",{"count":395,"type":21},18,[24],"About 70% of epithelial ovarian cancer patients are diagnosed at advanced stage. When primary optimal surgery is not possible, neoadjuvant chemotherapy will followed by interval debulking surgery is one treatment option. However, there is no consensus on the optimal timing of the surgery. CA125 is a well-known tumor marker in ovarian cancer. Its kinetic change has been proven to correlate with the patients' response to chemotherapy and chance of optimal resection. This study aims to utilize the kinetic change of CA125 to customize the timing of surgery for individual patients.",[55,29,28],[400,188,401,402,403,404],"advanced","neoadjuvant chemotherapy","interval debulking surgery","KELIM","CA 125","2025-06-29",{"date":407,"type":34},"2025-07-02",{"date":409,"type":34},"2024-05-28",{"date":411,"type":21},"2025-12-31",{"name":413,"class":41},"The University of Hong Kong",{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":422,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":424,"briefSummary":425,"conditions":426,"keywords":436,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":68},"100593065","phase-1-intra-tumoral-it-injection-of-vvdd-hil2-2-rg-1-for-metastatic-gastrointestinal-and-peritoneal-tumors-100593065","NCT07001592","Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors","A Phase I Dose-Escalation Trial of vvDD-hIL2-2-RG-1 (Vaccina Virus Double Deleted) Administered by Intra-tumoral (IT) Injection for Metastatic Gastrointestinal and Peritoneal Tumors","RIOT3","Inclusion Criteria:\n\n1. Males or females age, 18 to \\\u003C 70 years at the time of consent\n2. Histologically confirmed metastases from gastrointestinal tumors with molecular determinants for MSI and KRAS.\n3. For microsatellite stable (MSS) tumors, subjects must have failed (or be ineligible for) standard 1st and 2nd line chemotherapy. For microsatellite instability-high (MSI-H) tumors, subjects must also have failed (or be ineligible for) systemic immunotherapy.\n4. Karnofsky Performance Status (KPS) of \\> 70\n5. Anticipated survival of at least 12 weeks.\n6. Written informed consent in accordance with national, local, and institutional guidelines obtained prior to any study procedures (subject or subject's legally authorized representative (LAR) must have the ability to understand and willingness to sign a written informed consent).\n7. Adequate bone marrow function: WBC \\> 2,000 and \\\u003C50,000 cells\u002Fmm3, ANC \\> 1,000 cells\u002Fmm3, hemoglobin \\>8 g\u002FdL, and platelet count \\>100,000 cells\u002Fmm3.\n8. Adequate renal function: serum creatinine level ≤ 2xULN\n9. Adequate liver function: Serum bilirubin \\\u003C 1.5 x ULN\n10. Acceptable coagulation status: INR \\\u003C ULN +15%. All patients must be able to suspend anticoagulant therapy for study specific biopsies and intra-tumoral injection.\n11. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must have negative serum or urine pregnancy test.\n12. If sexually active, to prevent pregnancy and to prevent the spread of virus, subject must use an acceptable method of contraception as well as barrier contraception from screening through 6 weeks following study treatment with vvDD-hIL-2-RG-1.\n13. Subjects must be willing to comply with all study procedures, requirements, adhere to post-treatment care instructions and follow-up examinations.\n14. Have measurable disease based on RECIST 1.1 criteria.\n15. Have at least one tumor at least 1 cm in diameter amenable to safe intra-tumoral injection.\n\nExclusion Criteria:\n\n1. Pregnant or nursing an infant.\n2. Systemic corticosteroid or other immunosuppressive medication use within 2 weeks of the study treatment.\n3. Significant immunodeficiency (e.g. due to underlying illness and\u002For medication) in subject or household contacts (must be able to avoid household contact with immunodeficient person for 3 weeks).\n4. Clinically significant active infection or uncontrolled medical condition (e.g., pulmonary, neurological, cardiovascular, gastrointestinal, genitourinary) considered high risk for investigational new drug treatment, per investigator discretion.\n5. Active eczema or psoriasis or other inflammatory skin conditions\n6. Unstable cardiac disease which includes but is not limited to any of the following within 6 months prior to study entry: myocardial infarction (MI), unstable angina, congestive heart failure, myocarditis, ventricular arrhythmias diagnosed and requiring medication.\n\n   * New York Heart Association functional class III-IV heart failure on active treatment\n   * Pulse oximetry of \\\u003C 90% in room air at rest\n7. Subjects who have received radiation, chemotherapy or other potentially immunosuppressive therapy within 2 weeks prior to study screening and within 4 weeks prior to anticipated vvDD-hIL-2-RG-1 treatment.\n8. Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination.\n9. Subjects who, in the opinion of the Investigator, have a medical condition that would subject the subject to prohibitive risk by participation in this study, or who may be unable to safely complete the required tumor biopsies.\n10. Subjects with household contacts who are children \\\u003C 5 years old, have active eczema, psoriasis or other inflammatory skin conditions or have a significant immunodeficiency due to underlying illness (e.g. human immunodeficiency virus) and\u002For medication (e.g. systemic corticosteroids) will be excluded unless alternate living arrangements can be made during the subject's active dosing period and for three weeks following the study medication.\n11. Vaccination with a live virus in the previous 60 days prior to Day 0.\n12. Inability or unwillingness to give informed consent.\n13. Is unable or unwilling to comply with protocol follow-up requirements. -","69 Years",{"count":395,"type":21},[124],"This research study aims to evaluate the safety and determine the optimal dose of a new experimental drug, vvDD-hIL2 (vaccinia virus double-deleted human interleukin 2), in patients with advanced abdominal cancer. The study will involve three dose levels, with three to six patients enrolled at each level.\n\nvvDD-hIL2 is a genetically modified vaccinia virus, derived from the virus previously used for smallpox vaccination. The modification is intended to target and destroy tumors while minimizing harm to healthy tissues by stimulating the body's immune response.\n\nParticipants will receive an injection of vvDD-hIL2 directly into their abdominal tumors at AHN West Penn. The study team will monitor for side effects and assess tumor response to the treatment.\n\nActive participation will last up to two months, involving seven clinic visits and approximately four lab visits at AHN West Penn Hospital. Visits will include standard of care procedures as well as study-specific tests and exams. Most visits will last one to two hours, with some extending to two to three hours. The drug administration day will require a twelve-hour visit.\n\nEffectiveness and side effects will be evaluated through blood draws, oral swabs, urinalysis and tissue biopsies. Tissue samples will be used for genomic analysis and stored for potential future research. Data collected may also be used for future research purposes.\n\nPrevious human trials of vvDD-hIL2 have reported side effects such as pain, rash or inflammation at the injection site, low-grade fevers, flu-like symptoms, and fatigue. There is a rare risk of rash transmission to close contacts with skin openings, and information on limiting contact and managing rash development will be provided.",[427,428,89,429,430,431,432,28,184,433,434,435],"Gastric Neoplasms","Esophageal Cancer","Liver Metastasis","MSS-CRC","MSS","Gastric Adenocarcinoma","Peritoneal Metastases","MSI-H","Gastric Cancer",[437,438,439,440,441],"Oncolytic virus","vaccinia","immunotherapy","intra-tumoral","intra-peritoneal","2025-06-02",{"date":444,"type":34},"2025-06-03",{"date":446,"type":34},"2025-05-06",{"date":448,"type":21},"2028-05",{"name":450,"class":41},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":22,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":229},"100377571","phase-1-bp1001-a-in-patients-with-advanced-or-recurrent-solid-tumors-100377571","NCT04196257","BP1001-A in Patients With Advanced or Recurrent Solid Tumors","A Phase I\u002FIb Study of BP1001-A (a Liposomal Grb2 Antisense Oligonucleotide) in Patients With Advanced or Recurrent Solid Tumors","Inclusion Criteria:\n\n1. All participants, ≥ 18 years of age, with histologic evidence of advanced or recurrent solid tumors, who are not candidates for regimens or protocol treatments known to confer clinical benefit.\n2. ECOG Performance Status Score of 0 or 1.\n3. Participants must be willing to undergo pre-treatment biopsies. Participants who complete 1 cycle of treatment will undergo post-treatment biopsies. Post-treatment biopsies will be offered to participants who do not complete 1 cycle of treatment.\n4. For the dose expansion phase, participants must have recurrent or persistent epithelial ovarian, primary peritoneal, fallopian tube or endometrial tumor and must be participants for whom single agent paclitaxel would be considered a reasonable treatment option.\n5. Endometrial cancer patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, squamous cell, transitional cell carcinoma, and mesonephric carcinoma.\n\n   Ovarian tumor patients with the following histologic epithelial cell types are eligible: High-grade serous carcinoma, endometrioid carcinoma, clear cell carcinoma, squamous carcinoma, transitional cell (Brenner) carcinoma, mixed epithelial-stromal carcinoma, undifferentiated or other epithelial carcinoma.\n\n   Uterine carcinosarcoma and other sarcomas of the uterus are not eligible.\n6. Estimated life expectancy \\> 3 months in the Investigator's opinion.\n7. All participants must have measurable disease per RECIST criteria v1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be \\>\u002F= 20 mm when measured by conventional techniques, including plain x-ray, CT, and MRI, or \\>\u002F= 10 mm when measured by spiral CT. Measurable disease lesions must be amenable to pre- and post-treatment biopsy.\n8. Participants must have at least one \"target lesion\" to be used to assess response on this protocol as defined by RECIST v1.1. Tumors within a previously irradiated field will be designated as \"non-target\" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.\n9. Participants must have adequate:\n\n   1. Bone marrow function: HgB \\>\u002F= 9 g\u002FdL, WBC \\>\u002F= 3,000\u002FmcL, ANC \\>\u002F= 1,500\u002FmcL, PLT \\>\u002F= 100,000\u002FmcL\n   2. Hepatic function: Total bilirubin within normal institutional limits, AST and ALT \\\u003C 2.5 X institutional ULN\n   3. Renal function: Serum creatinine \\\u003C 1.5 x ULN or eGFR \\> 60 mL\u002Fmin according to Cockcroft-Gault formula\n   4. Neurologic function: Neuropathy (sensory and motor) \\\u003C\u002F= CTCAE Grade 1\n   5. Blood coagulation parameters: PT such that INR is \\\u003C 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a PTT \\\u003C 1.2 times control\n10. Participants previously treated with docetaxel (regardless of response) are eligible for this trial.\n11. Participants in the dose expansion phase who previously received paclitaxel for primary or recurrent disease are eligible if they did not progress on therapy or relapse within 6 months of completing therapy. Participants with persistent disease at the completion of primary therapy with paclitaxel are not eligible.\n12. Participants should be free of active infection requiring antibiotics, with the exception of uncomplicated UTI.\n13. Any hormonal therapy directed at the malignant tumor must be discontinued at least two weeks prior to BP1001-A treatment. Continuation of hormone replacement therapy is permitted; stable regimens of hormonal therapy for prostate cancer (e.g., leuprolide, a gonadotropin-releasing hormone \\[GnRH\\] agonist), ovarian or breast cancer are not exclusionary.\n14. Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least four weeks prior to first dose of BP1001-A (6 weeks for nitrosoureas or mitomycin C).\n15. Female participants of childbearing potential must have a negative urine pregnancy test performed within 24 hours prior to the start of study treatment. Post-menopausal subjects (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.\n16. Female participants of childbearing potential must agree to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the duration of the study and for at least 6 months after the last dose of treatment.\n17. Male participants must agree to use an acceptable method of contraception for the duration of the study.\n18. Participants must be willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. For the dose expansion phase, participants must not have low grade serous ovarian carcinoma or mucinous ovarian carcinoma.\n2. For the dose expansion phase, participants must wait at least two weeks after receiving any strong inhibitor, inducer, or substrate of both CYP3A4 and CYP2C8 before investigational drug administration.\n3. Participants who had previous bone marrow or hematopoietic stem cell transplant.\n4. Participants may not be receiving any other investigational agents.\n5. Female participants who are pregnant or breast-feeding.\n6. History or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months of registration on this study.\n7. Within the past 6 months, participant has had any of the following: myocardial infarction, unstable angina pectoris, coronary\u002Fperipheral artery bypass graft, cerebrovascular accident, or transient ischemic attack.\n8. Presence of concurrent conditions that, in the opinion of the Investigator and\u002For Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, NYHA class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia, or clinically significant baseline ECG abnormality (e.g., QTcF \\>470 msec).\n9. Active pleural effusion or pleural or pericardial effusion with symptoms. Pleural or pericardial effusion that has received treatment and resolved according to the Investigator, is acceptable.\n10. Participants who are ineligible to undergo an MRI scan for reasons such as claustrophobia or the presence of implanted devices or metallic foreign bodies that are not MR compatible, such as ferromagnetic implants or pacers or with a known history of allergic reaction to gadolinium contrast agents.\n11. Any condition which, in the Investigator's opinion, makes the subject unsuitable for trial participation.\n12. A prior history of ≥ Grade 3 hypersensitivity to paclitaxel or docetaxel or with products mixed in Cremephor EL or Tween 80®.\n13. Unresolved toxicity higher than CTCAE Grade 1 attributed to any prior therapy or procedure, excluding alopecia.\n14. Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.\n15. Participants with HIV infection who have CD4+ T-cell counts \\\u003C 350 cells\u002FmcL or with clinically active hepatitis B or C infection.\n16. Participants who have a major surgical procedure, open biopsy, dental extractions, or other dental surgery\u002Fprocedure that results in an open wound, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to registration.\n17. (For dose expansion phase) Subjects ineligible or unable to receive paclitaxel as treatment for their disease.",{"count":459,"type":21},50,[124],"This is a phase I, open-label, study of BP1001-A in participants with advanced or recurrent solid tumors. The dose escalation phase will determine the safety and the maximum tolerated dose (MTD) or maximum administered dose (MAD) of BP1001-A as a single agent. After the MTD or MAD of BP1001-A is established, the dose expansion phase will commence and determine the safety, toxicity and response of BP1001-A in combination with paclitaxel.",[463,464,465,466,28,156],"Solid Tumor, Adult","Carcinoma, Ovarian Epithelial","Fallopian Tube Neoplasms","Endometrial Cancer","2025-03-06",{"date":469,"type":34},"2025-03-07",{"date":471,"type":34},"2022-08-19",{"date":473,"type":21},"2027-10",{"name":475,"class":168},"Bio-Path Holdings, Inc.",{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":68},"100572596","phase-2-fluzoparib-with-or-without-bevacizumab-for-neoadjuvant-therapy-in-advanced-ovarian-cancer-100572596","NCT06735326","Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer","A Randomized, Open-Label, Multi-Cohort Study of Fluzoparib Monotherapy or in Combination With Bevacizumab as Neoadjuvant Therapy in Patients With Advanced Ovarian Cancer","Inclusion Criteria:\n\n1. The subject voluntarily agrees to participate and signs the informed consent form.\n2. Age ≥18 years (calculated as of the date of signing the informed consent).\n3. Pathologically diagnosed with newly diagnosed, FIGO stage III-IV high-grade (or moderate\u002Flow-grade) serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; grade ≥II endometrioid adenocarcinoma of the ovary; Mixed tumors: high-grade serous or ≥II grade endometrioid component must be \\>50%.\n4. The subject has at least one measurable lesion that can be assessed by CT or MRI (RECIST v1.1).\n5. According to the investigator's assessment, the patient is unable to achieve R0 resection or cannot tolerate surgery.\n\n   a) Criteria for determining inability to achieve R0 resection include: i. Fagotti laparoscopic score ≥8. ii. If laparoscopic assessment is difficult, an upper abdominal Suidan's CT score ≥3.\n\n   b) Criteria for inability to tolerate surgery include: i. Body mass index (BMI) ≥40. ii. Multiple chronic diseases. iii. Malnutrition or hypoalbuminemia. iv. Moderate to large ascites. v. Newly diagnosed venous thromboembolism. vi. ECOG performance status \\>2. vii. Other reasons judged by the investigator.\n6. Expected survival \\>12 weeks.\n7. ECOG performance status: 0-2.\n8. Confirmed germline BRCA1\u002F2 mutations by professional genetic testing.\n9. Function of major organs meets the following requirements (no blood products or colony-stimulating factors allowed within 14 days prior to the first dose):\n\n   1. Absolute neutrophil count ≥1.5 × 10\\^9\u002FL.\n   2. Platelet count ≥100 × 10\\^9\u002FL.\n   3. Hemoglobin ≥9 g\u002FdL.\n   4. Serum albumin ≥3 g\u002FdL.\n   5. Bilirubin ≤1.5 times the upper limit of normal (ULN).\n   6. ALT and AST ≤2.5 times ULN, must be ≤5 times ULN in the presence of liver metastases.\n   7. Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n10. Female patients of childbearing potential must have a negative blood pregnancy test within one week before the first dose and are not breastfeeding. They must agree to use effective contraception during the study and for 6 months after the last dose of Bevacizumab\u002FFluzoparib\u002Fchemotherapy. Pregnancy, if confirmed, must be terminated as soon as possible.\n11. The subject is willing to cooperate in completing quality of life surveys during the treatment and follow-up periods and agrees to have the survey results used for clinical research.\n\nExclusion Criteria:\n\n1. Patients with other untreated malignant tumors within the past 5 years, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and breast cancer without relapse for over 3 years after radical surgery.\n2. Patients with untreated central nervous system metastases. Patients who have previously received systemic or curative brain or meningeal metastasis treatment (radiotherapy or surgery) and have stable imaging confirmed for at least 1 month, and have stopped systemic steroid treatment (dosage \\>10 mg\u002Fday prednisone or equivalent) for more than 2 weeks, and have no clinical symptoms, may be included.\n3. Patients who have previously received treatment with known or potential PARP inhibitors or Bevacizumab.\n4. Patients unable to swallow tablets or with gastrointestinal dysfunction that may affect drug absorption, as judged by the investigator.\n5. Patients who have experienced bowel obstruction or gastrointestinal perforation within the last 3 months.\n6. Patients with poorly controlled heart conditions or diseases, such as:\n\n   1. NYHA Class II or higher heart failure.\n   2. Unstable angina.\n   3. Myocardial infarction within 1 year.\n   4. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n   5. QTc \\>470 ms.\n7. Patients with clinically significant bleeding symptoms or a clear bleeding tendency (such as gastrointestinal bleeding, bleeding ulcers, or vasculitis) within 3 months prior to the first dose, or with positive occult blood in the stool at baseline. If positive, it should be rechecked, and if still positive, clinical judgment should be made, including possible gastrointestinal endoscopy if necessary.\n8. Patients who have received platelet or red blood cell transfusion within 14 days before starting treatment.\n9. Patients with active ulcers, non-healing wounds, or fractures.\n10. Patients who have experienced any severe bleeding event graded ≥2 in CTCAE 5.0 within 4 weeks before the first dose.\n11. Patients with active infections or unexplained fever \\>38.5°C during screening or before the first dose.\n12. Patients with congenital or acquired immune deficiency (e.g., HIV-infected individuals) or active hepatitis (HBV reference: HBsAg positive, HBV DNA ≥500 IU\u002Fml; HCV reference: HCV antibody positive, HCV RNA \\> normal upper limit).\n13. Patients who have previously received radiotherapy, chemotherapy, hormonal therapy, or molecular targeted therapy, with less than 4 weeks since the last dose of treatment (less than 5 half-lives for oral molecular-targeted agents); patients who have not recovered from treatment-related adverse events (except for hair loss) to ≤1 grade as per CTCAE 5.0.\n14. Patients who have experienced arterial thrombosis or ≥grade 3 venous thromboembolic events within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism.\n15. Patients with a history of hereditary or acquired bleeding disorders or coagulation dysfunction (e.g., hemophilia, platelet dysfunction, thrombocytopenia, etc.).\n16. Patients who may receive other systemic antitumor treatments during the study period.\n17. Patients with uncontrolled hypertension, despite antihypertensive treatment (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg).\n18. Pregnant or breastfeeding women, or women planning pregnancy during the study treatment.\n19. Patients with other factors, as judged by the investigator, that may lead to the premature termination of the study, such as other severe diseases (including psychiatric disorders) requiring concurrent treatment, severe laboratory abnormalities, or factors related to family or social circumstances that may impact the patient's safety, or the collection of data and samples.",{"count":484,"type":21},105,[24],"This study is a randomized, open-label, multi-cohort, multicenter clinical trial, aimed at evaluating the efficacy and safety of Fluzoparib monotherapy, Fluzoparib in combination with Bevacizumab, and standard chemotherapy (Paclitaxel plus Carboplatin) as neoadjuvant treatments in newly diagnosed, germline BRCA1\u002F2-mutated epithelial ovarian cancer patients (FIGO stage III\u002FIV). The study also aims to assess the efficacy and safety of Fluzoparib as maintenance therapy following surgery and chemotherapy.\n\nThe primary endpoint of the study is the objective response rate (ORR) for neoadjuvant therapy, as assessed by the investigator using RECIST v1.1 criteria. Secondary endpoints include R0 resection rate, overall survival (OS), and progression-free survival (PFS). The study will also evaluate the safety, tolerability, and patient-reported outcomes (EQ-5D-5L) across the three treatment cohorts.",[55,29,28],"2024-12-11",{"date":490,"type":34},"2024-12-16",{"date":492,"type":34},"2024-11-27",{"date":494,"type":21},"2028-10-01",{"name":496,"class":41},"Qilu Hospital of Shandong University",{"id":498,"slug":499,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":505,"enrollmentInfo":506,"targetDuration":4,"studyType":508,"phases":4,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":68},"100494480","post-splenectomy-infections-after-surgery-for-peritoneal-malignancies-opsi-100494480","NCT05718726","Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI)","Overwhelming Post-Splenectomy Infections (OPSI) After Cytoreductive Surgery and Hyperthemic Intraperitoneal Chemotherapy: a Prospective Observational Study","OPSI","Inclusion Criteria:\n\n\\- Patients aged \\>18 and \\\u003C80 years Patients capable of providing informed consent Patients who have a splenectomy in conjunction with complete cytoreductive surgery (CRS) for any pathology\n\nExclusion Criteria:\n\n\\- Patients who are \\\u003C18 and \\>80 Patients who do not provide informed consent Patients on immunosuppression therapy","79 Years",{"count":507,"type":21},300,"OBSERVATIONAL","The spleen is involved in maintaining immunity and plays an important role in the elimination of encapsulated bacteria and parasites. Patients who undergo splenectomy in conjunction with complete CRS for peritoneal malignancy are at risk of overwhelming post-splenectomy infections post-operatively. These patients are therefore administered vaccinations to lower the risk of infections but as they do not completely eliminate the risk, patients are also prescribed prophylactic antibiotics without clear evidence that they are useful in preventing OPSI. The use of prophylactic antibiotics is not without risk with potential short and long-term risks including resistance, interaction with other medication, clostridium difficile infections, fungal infections, other changes to the microbiome and cost. This study will investigate the incidence of OPSI post splenectomy and assess compliance with prophylactic antibiotics. This is an observational study where consented patients will be telephoned at fixed time points which are 1,6,12 weekly and 6 monthly for a period of five years post-operatively. As part of routine care patients will be telephoned by the clinical nurse specialist at weeks 1,6 and 12. In addition to this the research nurse will telephone the patient 6 monthly for a period of 5 years and complete a questionnaire. The research nurse will complete the questionnaire during each telephone call and this should not take more than 20 minutes. At the start of the telephone call, consent will be confirmed each time and the research nurse will check that the patient is still happy to participate before going ahead.",[511,28],"Infection;Post Surg Procedure","2024-11-25",{"date":492,"type":34},{"date":515,"type":34},"2021-03-25",{"date":517,"type":21},"2031-02-01",{"name":519,"class":41},"Hampshire Hospitals NHS Foundation Trust",{"id":521,"slug":522,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":11,"sex":76,"minAge":527,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":529,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":68},"100485177","quadratus-lumborum-block-after-cytoreductive-surgery-and-hyperthermic-intra-peritoneal-chemotherapy-100485177","NCT05597683","Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy","Quadratus Lumborum Block for Analgesia After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (CRS and HIPEC): a Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\n\\- Adult patients who are scheduled to undergo cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC)\n\nExclusion Criteria:\n\n1. Allergy to local anesthetics or fentanyl\n2. Chronic pain\n3. Drug abuse\n4. Patients who are unable to use patient-controlled analgesia\n5. Skin infection at site for quadratus lomborum block\n6. pregnant or breatfeeding women\n7. Patients who are unable to communicate","19 Years",{"count":459,"type":21},[82],"This study aims to assess whether transmusculr quadratus lomborum block (QL block) can reduce postoperative pain after cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC). Patients will be randomly assigned to either QL block group or control group. Ultrasound-guided bilateral transmuscular quadratus lomborum block will be performed in QL block group using 0.375% ropivacaine. Multimodal analgesic regimen including acetaminophen, nonsteroidal antiinflammatory drugs (NSAIDs), and rescue opioids will be used in every patient. Primary outcome is opioid consumption for 24 hours after surgery. Secondary outcomes included pain scores, time to first rescue analgesics, quality of recovery score, length of hospital stay.",[532,533,28],"Cytoreductive Surgery","Hyperthermic Intra-peritoneal Chemotherapy","2024-08-14",{"date":536,"type":34},"2024-08-15",{"date":538,"type":34},"2022-11-15",{"date":540,"type":21},"2025-01-10",{"name":542,"class":41},"Gangnam Severance Hospital",{"id":544,"slug":545,"hasResults":11,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":22,"phases":553,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":68},"100445447","phase-2-adaptive-chemotherapy-for-ovarian-cancer-in-patients-with-replased-platinum-sensitive-high-grade-serous-or-high-grade-endometrioid-ovarian-cancer-100445447","NCT05080556","Adaptive ChemoTherapy for Ovarian Cancer in Patients With Replased Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer","A Multicentre Phase II Randomised Controlled Trial to Evaluate the Efficacy of Adaptive Therapy (AT) With Carboplatin, Based on Changes in CA125, in Patients With Relapsed Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer","ACTOv","Inclusion Criteria:\n\n1. Female patients aged ≥18 years\n2. ECOG performance status 0-2\n3. Histologically proven diagnosis of high grade serous or high grade endometrioid carcinoma of the ovary, fallopian tube or peritoneum\n4. Most recent regimen must have included platinum (cisplatin or carboplatin)\n5. Must have previously received a PARP inhibitor\n6. 6\\. Must have responded to most recent platinum treatment by CT or MRI or by GCIG CA125 response criteria\n7. Pre-trial CT or MRI-confirmed disease relapse ≥ 6 months after day 1 of the last cycle of platinum-containing chemotherapy (cisplatin or carboplatin) and requiring treatment with further platinum-based chemotherapy\n8. Measurable disease by RECIST v1.1 on a CT scan conducted within 28 days prior to randomisation (Patient with non-measurable disease could be eligible if they meet GCIG CA125 progression criteria)\n9. CA125 ≥ 100iU\u002Fl at screening\n10. Agree to provide additional research blood samples at the same time as blood draws prior to each carboplatin treatment, 6-weekly during surveillance and at 12- weekly follow-up visit\n11. Expected to be able to commence treatment within 28 days post randomisation\n12. Adequate bone marrow function\n13. Adequate liver function\n14. Adequate renal function\n15. Postmenopausal or women of child-bearing potential (WOCBP) must agree to have an urine or serum pregnancy test at screening for evidence of non-childbearing status and prior to trial treatment and use adequate contraception for duration of trial\n16. Willing and able to give consent and able to comply with treatment and follow up schedule\n\nExclusion Criteria:\n\n1. Non-epithelial ovarian cancer, carcinosarcoma, low-grade serous and endometrioid carcinomas, mucinous \\& clear-cell carcinomas\n2. Patients requiring treatment with combination chemotherapy regimens\n3. Patients with a known hypersensitivity to carboplatin\n4. Persisting ≥ grade 2 CTCAE v5 adverse events\u002F toxicity (except alopecia and neuropathy) from previous anti-cancer treatment.\n5. Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to randomisation.\n6. Major surgery within 14 days before anticipated start of treatment and patients must have recovered from any effects of major surgery.\n7. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicated the use of an investigation drug or puts the patients at high risk for treatment-related complications.\n8. Other psychological, psychiatric, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.\n9. Malignancy treated within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, Stage 1, grade 1 endometrial carcinoma.\n10. Patients with symptomatic uncontrolled brain or meningeal metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.\n11. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to randomisation.\n12. Pregnant or breast-feeding women are excluded. Women of childbearing potential will be excluded unless effective methods of contraception are used from signing of the informed consent, throughout the period of taking study treatment and for at least 6 months after last dose of trial drug(s).\n13. Inability to attend or comply with treatment or follow-up scheduling.",{"count":552,"type":21},80,[24],"ACTOv will compare standard 3-weekly carboplatin (AUC5), to carboplatin delivered according to an AT regimen. The AT regimen will modify carboplatin dose according to changes in the clinical-standard serum biomarker CA125 as a proxy measure of total tumour burden and an individual patient's response to the most recent chemotherapy treatment. AT could prolong sensitivity to carboplatin and extend tumour control, while simultaneously reducing chemotherapy dose and drug-induced toxicity. Carboplatin is a low cost and low toxicity drug that has an enduring and central role in ovarian cancer treatment.",[55,556,29,28,557,558,27],"Relapsed Ovarian Cancer","Endometrioid Carcinoma","High Grade Serous Carcinoma","2024-04-11",{"date":561,"type":34},"2024-04-12",{"date":563,"type":34},"2023-05-24",{"date":565,"type":21},"2027-11-01",{"name":567,"class":41},"University College, London",{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":574,"targetDuration":576,"studyType":508,"phases":4,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":68},"100509403","development-and-management-of-registry-in-patients-with-gynecologic-cancer-in-korea-100509403","NCT05912972","Development and Management of Registry in Patients With Gynecologic Cancer in Korea","Inclusion Criteria:\n\n* Female patients 18 years or older\n* Written informed consent (prospective cohort)\n* Confirmed diagnosis of cervical cancer, endometrial cancer or ovarian cancer\n\nExclusion Criteria:\n\n* Unconfirmed diagnosis of cervical cancer, endometrial cancer or ovarian cancer",{"count":575,"type":21},13500,"3 Years","The goal of this observational study is to identify and analyze the characteristics, treatment trends, prognostic factors and survival prognosis of Korean gynecologic cancer patients. Ultimately, the final goal is to contribute to the development of safe surgical methods and treatment for gynecologic cancer to improve survival rates.",[579,466,55,29,28],"Cervical Cancer","2023-06-12",{"date":582,"type":34},"2023-06-22",{"date":584,"type":34},"2022-10-21",{"date":586,"type":21},"2027-10-21",{"name":588,"class":41},"Asan Medical Center"]