[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-ovarian-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-ovarian-cancer":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,63,87,112,139,162,188,217,249,282,307,326,346],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100644252","reirradiation-and-total-ablative-strategies-for-recurrent-gynecologic-cancer-100644252",false,"NCT07667192","Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer","REGYNERA(Dia)TION: An Ambispective International Multicenter Patient Registry of Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Malignancies","Regynera-RT","Inclusion Criteria:\n\n* \\- Age 18 years or older at the time of reirradiation or prospective enrollment.\n* Histologically confirmed gynecologic malignancy, including uterine, cervical, vaginal, vulvar, ovarian, fallopian tube, primary peritoneal, or rare gynecologic primary.\n* Documented prior radiotherapy delivered as part of previous treatment.\n* Recurrent or progressive disease for which reirradiation and\u002For total ablative strategy has been delivered, is ongoing, or is planned according to local multidisciplinary decision-making.\n* Recurrence or progression documented by imaging, clinical examination, pathology, and\u002For multidisciplinary tumor board assessment according to institutional practice.\n* Availability of minimum essential data, including prior radiotherapy information, date of reirradiation or planned reirradiation, disease extent at reirradiation, and at least one follow-up, outcome, or survival-status record for retrospective patients.\n* For prospective patients, written informed consent where required by local regulations and ethics approval.\n\nExclusion Criteria:\n\n* No evidence of prior radiotherapy.\n* No reirradiation or clinically meaningful local ablative radiotherapy component delivered or planned.\n* Insufficient minimum data preventing assignment of reirradiation date, disease extent, or survival\u002Ffollow-up status.\n* Exclusively polymetastatic disease with more than 5 active non-regional lesions treated without a meaningful local reirradiation or total ablative component, unless included in an exploratory non-core substudy approved by the steering committee.\n* Prospective refusal of consent when consent is required by local law or ethics approval.","FEMALE","18 Years",{"count":20,"type":21},500,"ESTIMATED","5 Years","OBSERVATIONAL","REGYNERA(dia)TION is an international, multicenter, ambispective observational patient registry of adults with recurrent gynecologic malignancies after prior radiotherapy who are treated or planned for reirradiation and\u002For total ablative strategies as part of routine clinical care. The registry does not assign treatment. Radiotherapy technique, dose, systemic therapy, surgery, metastasis-directed therapy, imaging, and follow-up are selected by the treating multidisciplinary team according to local standards and patient-specific factors. The registry will collect harmonized retrospective and prospective data on disease characteristics, prior radiotherapy, recurrence pattern, reirradiation or ablative treatment exposure, response, progression, survival, severe treatment-related morbidity, fistula events, and patient-reported outcomes where available.",[26,27,28,29,30,31,32,33],"Recurrent Gynecologic Cancer","Recurrent Uterine Cancer","Recurrent Cervical Cancer","Recurrent Vaginal Cancer","Recurrent Vulvar Cancer","Recurrent Ovarian Cancer","Recurrent Fallopian Tube Cancer","Primary Peritoneal Cancer",[35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"Reirradiation","Radiotherapy","Brachytherapy","External Beam Radiotherapy","Stereotactic Body Radiotherapy","Proton Therapy","Intraoperative Radiotherapy","Total Ablative Strategy","Oligometastatic Recurrence","Metastasis-Directed Therapy","Patient Registry","Radiographic Progression-Free Survival","Treatment-Related Adverse Events","Fistula","Overall survival","RECRUITING","2026-06-20",{"date":53,"type":54},"2026-06-24","ACTUAL",{"date":56,"type":54},"2026-06-11",{"date":58,"type":21},"2036-12",{"name":60,"class":61},"Affidea Nu-med Center of Oncological DIagnostics and Therapy","OTHER",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":70,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":62},"100642597","to-evaluate-the-safety-of-autologous-tumor-infiltrating-lymphocytestils-for-the-treatment-of-recurrent-ovarian-cancer-100642597","NCT07651124","To Evaluate the Safety of Autologous Tumor-infiltrating Lymphocytes(TILs) for the Treatment of Recurrent Ovarian Cancer","A Clinical Trial to Evaluate the Safety of Autologous Tumor-infiltrating Lymphocytes(TILs) for the Treatment of Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Recurrent ovarian cancer\n* There is a cancerous lesion that can be removed by biopsy or surgery.\n\nExclusion Criteria:\n\n* Patient with immunodeficiency or autoimmune diseases that may be exacerbated by immunotherapy\n* Patient deemed unsuitable by the principal investigator","20 Years",{"count":72,"type":21},6,"INTERVENTIONAL",[75],"NA","The objective of this clinical trial is to evaluate the safety of autologous tumor-infiltrating lymphocytes and to investigate their efficacy in recurrent ovarian cancer.\n\nParticipants undergo the following process:\n\nThere must be a cancerous lesion available for biopsy or surgery, and enhanced tumor-infiltrating lymphocytes are cultured from ovarian cancer tissue collected from the subject.\n\nThese are processed into human cells for administration and injected into the subject.",[31],"2026-06-15",{"date":80,"type":54},"2026-06-16",{"date":82,"type":54},"2025-04-01",{"date":84,"type":21},"2027-06-30",{"name":86,"class":61},"Yong Wha Moon",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":73,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100544205","phase-2-a-study-of-ocular-toxicity-evaluation-and-mitigation-during-treatment-with-mirvetuximab-soravtansine-in-participants-with-recurrent-ovarian-cancer-with-high-folate-receptor-alpha-expression-100544205","NCT06365853","A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression","A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Patients With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression","Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC) with high FRα expression.\n* Participant's tumor must be FRα positive (FRα high) as defined by either the VENTANA FOLR1 (FOLR-2.1) IUO Assay, or the VENTANA FOLR1 ( FOLR1-2.1) RxDx Assay (hereafter collectively termed VENTANA FOLR1 Assay) (≥ 75% cells exhibit ≥ 2+ membrane staining intensity).\n* Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor or germline) must have received poly (ADP-ribose) polymerase inhibitors (PARPi).\n* Participants must have completed prior therapy within the specified times below:\n\n  1. Systemic antineoplastic therapy ≥ 5 half-lives or 4 weeks (whichever is shorter) before first dose of MIRV;\n  2. Focal radiation completed ≥ 2 weeks before the first dose of MIRV.\n* Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia).\n* Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for ≥ 7 months after the last dose; and must have a negative pregnancy test ≤ 4 days before the first dose of MIRV.\n\nExclusion Criteria:\n\n* Participants with borderline ovarian tumor or non-epithelial histology or mixed histology including borderline or non-epithelial histology will be excluded.\n* PROC participants with primary platinum-refractory disease, defined as disease that did not respond to (complete response \\[CR\\] or partial response \\[PR\\]) or progressed within ≤ 3 months of the last dose of first line platinum-containing chemotherapy.\n* Participants with \\> Grade 1 peripheral neuropathy per National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).\n* Participants with significant active or chronic corneal disorders (for example, corneal dystrophies, degenerations, limbal stem cell deficiency), history of corneal transplantation, significant ocular inflammatory conditions (for example, active or recurrent uveitis), or other active ocular conditions requiring ongoing treatment\u002Fmonitoring, such as uncontrolled glaucoma, active diabetic retinopathy with macular edema, macular degeneration requiring treatment ≤ 90 days before first dose, presence of papilledema, best corrected visual acuity (BCVA) worse than 20\u002F70 in either eye, or monocular vision.\n* Participants receiving corticosteroid or vasoconstricting eyedrops at baseline or within 5 weeks of Cycle 1 Day 1.\n* Participants who received prior treatment with MIRV or other FRα-targeting agents. Note: Other protocol-defined inclusion and exclusion criteria may apply.",{"count":95,"type":21},100,[97],"PHASE2","The purpose of this study is to evaluate the incidence rate and severity of prespecified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer \\[PSOC\\] or platinum-resistant ovarian cancer \\[PROC\\]) with high folate receptor alpha (FRα) expression.",[31,100],"Folate Receptor-Alpha Positive","2026-06-10",{"date":103,"type":54},"2026-06-12",{"date":105,"type":54},"2024-07-29",{"date":107,"type":21},"2027-06",{"name":109,"class":110},"AbbVie","INDUSTRY",40,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":73,"phases":121,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100329062","phase-1-study-of-regn4018-ubamatamab-administered-alone-or-in-combination-with-cemiplimab-in-adult-patients-with-recurrent-ovarian-cancer-or-other-recurrent-mucin-16-expressing-muc16-cancers-100329062","NCT03564340","Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers","A Phase 1\u002F2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers","Key Inclusion Criteria:\n\n1. Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:\n\n   1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)\n   2. has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts)\n   3. documented relapse or progression on or after the most recent line of therapy\n   4. no standard therapy options likely to convey clinical benefit\n2. Adequate organ and bone marrow function as defined in the protocol\n3. Life expectancy of at least 3 months\n4. Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.\n5. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:\n\n   1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol\n   2. 1-4 prior lines of systemic therapy, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Prior treatment with anti-Programmed Cell Death (PD-1)\u002FPD-L1 therapy, as described in the protocol\n2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort)\n3. Prior treatment with a MUC16 - targeted therapy\n4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol\n5. History and\u002For current cardiovascular disease, as defined in the protocol\n6. Severe and\u002For uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen\n\nNote: Other protocol-defined Inclusion\u002FExclusion Criteria apply",{"count":120,"type":21},890,[122,97],"PHASE1","The main purpose of this study is to:\n\n* Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus\n* The study will also look at the levels of ubamatamab and\u002For cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics\n* The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus\n* To find out how safe and tolerable pretreatment is in combination with ubamatamab and to see how well it works to prevent or minimize Cytokine Release Syndrome (CRS)",[31,32,125,126,127,128],"Recurrent Primary Peritoneal Cancer","Recurrent Endometrial Cancer","Endometrial Cancer","Low-grade Serous Ovarian Cancer","2026-05-07",{"date":131,"type":54},"2026-05-08",{"date":133,"type":54},"2018-05-21",{"date":135,"type":21},"2027-05-10",{"name":137,"class":110},"Regeneron Pharmaceuticals",52,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":73,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":62},"100631031","efficacy-and-safety-of-capsulex-combined-with-cisplatin-in-platinum-resistant-recurrent-ovarian-cancer-a-single-arm-prospective-clinical-study-100631031","NCT07495384","Efficacy and Safety of CapsuleX Combined With Cisplatin in Platinum-Resistant Recurrent Ovarian Cancer: A Single-Arm Prospective Clinical Study","Inclusion criteria\n\n1. The subject can understand the informed consent, voluntarily participate and sign the informed consent;\n2. The subject is at least 18 years old on the day of signing the informed consent;\n3. Subjects with histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;\n4. Platinum resistance is defined as: a. For subjects who have only received first-line platinum-based therapy, they must have received at least four cycles of platinum-based therapy and achieved disease response (CR or PR), with disease progression occurring between\\>3 months and ≤6 months after the last platinum-based treatment; b. For subjects who have received more than two lines of platinum-based therapy, disease progression must occur within \\\u003C6 months after the last platinum-based treatment (at least two cycles).\n5. The subject must have had progression or intolerance during or after the most recent treatment;\n6. Previous 2-3 line systemic antitumor therapy, with progression within \\\u003C6 months after the last platinum treatment and ≥3 months Note: a. New adjuvant and\u002For adjuvant therapy combined as line 1 treatment; b. Maintenance therapy (including monotherapy, targeted therapy, immunotherapy, and hormone therapy in the initial combination regimen) is considered part of the initial treatment (i.e., not counted separately); c. Lack of evidence of disease progression due to drug switching caused by toxicity is not considered a single treatment line (i.e., not counted separately); d. Insufficiently evaluated treatments without efficacy assessment (≤2 treatment cycles) are not considered a single treatment line (i.e., not counted separately); e. Endocrine therapy and targeted therapy are counted as separate lines unless used as maintenance therapy;\n7. According to RECIST 1.1, the baseline should have at least 1 measurable lesion. Measurable lesions should not have been previously received Local treatment (such as radiotherapy), or evidence of disease progression after local treatment;\n8. Expected survival time is greater than or equal to 6 months;\n9. ECOG score 0 or 1;\n10. Sufficient organ\u002Fmarrow function within 7 days prior to randomization, asdefined below;\n11. Willing to provide archived or fresh tumor tissue samples (if no archived tumor tissue is available and the investigator assesses that it would be risky for the subject to retrieve primary or metastatic tumor tissue samples);\n12. Able to understand the test requirements and willing and able to comply with the test and follow-up procedures.\n\nExclusion criteria\n\n1. Primary platinum-refractory is defined as disease that has not been relieved (CR) during first-line platinum-containing chemotherapy or within 3 months after the last dose Or PR) or imaging progression;\n2. History of active central nervous system metastasis, leptomeningeal metastasis or carcinomatous meningitis with stable evaluation by the investigator Excluding brain parenchyma metastases, stability is defined by the following criteria: no related symptoms and at least one recent imaging showing a stable state; or stable for more than 1 month without symptoms after treatment, and no need to use glucocorticoids or anticonvulsants for at least 2 weeks;\n3. Received any investigational drug within 28 days prior to randomization;\n4. Five half-lives (the shorter time) within 28 days prior to randomization of other antitumor therapy or antitumor drugs Equivalent but at least 14 days); Received Chinese herbal medicine with a clear anti-tumor indication within 14 days prior to randomization;\n5. Received local palliative treatment within 14 days prior to randomization;\n6. Had major surgery (such as abdominal or thoracic surgery; not including diagnostic surgery) within 28 days prior to randomization Small operations such as puncture or infusion device implantation or biliary stent implantation), or major surgery is expected to be required during the study treat;\n7. There are obvious clinical manifestations of gastrointestinal abnormalities, including but not limited to: intestinal obstruction existed or existed within 3 months before administration Symptoms and signs of intestinal obstruction, but screening can be performed if surgery has been performed and the obstruction is completely relieved (if previously received Patients who have undergone gastrointestinal stent implantation and whose stents remain in place at the screening stage are not eligible for enrollment); within 3 months before dosing, there has been a gastrointestinal perforation, gastrostomy, or intra-abdominal abscess; within 3 months before dosing, there has been CTCAE grade ≥3 gastrointestinal bleeding, or within 1 month before randomization, there has been gastrointestinal bleeding (including melena, hematochezia, etc., if confirmed as hemorrhoidal bleeding or only positive occult blood in stool, they can be enrolled);\n8. Uncontrolled and recurrent (recurrent within 2 weeks of intervention) moderate to large pleural effusions such as the chest Subjects with water, pericardial effusion, ascites and cachexia;\n9. Other malignant tumors were combined within the previous 5 years, excluding curable squamous cell carcinoma of skin, basal cell carcinoma and non-basal infiltration Bladder cancer with lubrication, in situ prostate\u002Fcervical\u002Fbreast cancer;\n10. Past or current interstitial pneumonia\u002Fpulmonary disease requiring systemic glucocorticoid therapy, or imaging during screening The examination could not rule out suspected interstitial pneumonia\u002Fpulmonary disease;\n11. The presence of uncontrolled comorbidities, including but not limited to:\n\n    * Active HBV or HCV infection. HBsAg (+), HBV-DNA \\\u003C2500 copies\u002FmL or 500 Enrollment is allowed at IU\u002FmL; enrollment is allowed if HCV-Ab (+) and HCV-RNA test is negative;\n    * HIV infection;\n    * Known active tuberculosis;\n    * Active syphilis;\n    * There is an active or uncontrolled infection within 2 weeks prior to the randomization, and systemic antimicrobial therapy is required;\n    * Uncontrolled hypertension (systolic blood pressure ≥180mmHg, diastolic blood pressure\\> 100 mmHg) and symptomatic heart failure Full (NYHA II-IV), refractory hypokalemia, long QT syndrome, moderate to severe pulmonary hypertension;\n    * Severe arrhythmias of important medical significance, including but not limited to ventricular tachycardia, ventricular fibrillation, and apex torsion A history of transition tachycardia, complete left or right bundle branch block, second or third degree cardiac conduction block;\n    * Unstable angina or myocardial infarction within 6 months;\n    * New diagnosis of a treatable thromboembolic event within 6 months (control of stable lower extremity deep vein thrombosis or infusion Thrombosis subjects such as liquid ports are allowed to be included)\n12. The toxicity of previous anti-tumor therapy has not been restored to CTCAE≤1 grade (NCI-CTCAE v5.0); Note: Participants with stable grade CTCAE 2 toxicity related to prior anti-tumor therapy can be enrolled (defined as stable toxicity severity within 3 months before dosing, with no CTCAE grade greater than 2), such as neurotoxicity, hair loss, skin pigmentation, fatigue caused by chemotherapy, and endocrine toxicity from prior immunotherapy (e.g., thyroid dysfunction, diabetes, hyperglycemia, adrenal insufficiency);\n13. Previous history of allogeneic bone marrow or organ transplantation;\n14. History of previous allergic reactions to antibody drugs and hypersensitivity reactions;\n15. Other researchers believe that conditions that may affect the safety or compliance of treatment with the study drug, including but not limited to mental illness Class diseases, alcoholism or drug abuse, etc.",{"count":111,"type":21},[75],"This trial was designed as a single-arm, open-label, prospective clinical trial to evaluate the efficacy (ORR) and safety (AE incidence) of CapsuleX in combination with cisplatin for platinum-resistant recurrent ovarian cancer (PROC).",[31,149],"Platinum Resistance",[151,152],"CapsuleX","cisplatin","2026-03-21",{"date":155,"type":54},"2026-03-27",{"date":157,"type":54},"2025-01-17",{"date":159,"type":21},"2029-11-01",{"name":161,"class":61},"The First Hospital of Jilin University",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":73,"phases":171,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":62},"100486181","phase-1-combination-therapy-for-recurrent-ovarian-cancer-100486181","NCT05610735","Combination Therapy for Recurrent Ovarian Cancer","Combination Therapy With Liposomal Doxorubicin and Withaferin A (Ashwagandha, ASWD) in Recurrent Ovarian Cancer","Inclusion Criteria:\n\nPatients with recurrent ovarian\u002Ffallopian tube\u002Fprimary peritoneal cancer for whom liposomal Doxorubicin would be an acceptable therapeutic option will be recruited. Patients are eligible if they have received first line chemotherapy containing platinum and have become platinum resistance or have refractory disease. The patient must also meet all the following criteria:\n\n1. Signed approved informed consent document stating that they understand the investigational nature of the treatment program before entering study\n2. Female patients, age ≥ 18 years\n3. Pathological confirmed ovarian, fallopian tube, or primary peritoneal carcinoma with the one of the following histologic types: high grade papillary serous carcinoma, low grade papillary serous carcinoma, high grade mucinous carcinoma, low grade mucinous carcinoma, clear cell carcinoma, high grade endometrioid carcinoma.\n4. Received at least one line chemotherapy, which must be a platinum containing regimen and develop platinum resistance. Patients may have not received previous liposomal doxorubicin therapy, and must be considered to be eligible for single agent liposomal doxorubicin treatment.\n5. Patients may have undergone surgical cytoreduction at the time of primary diagnosis or following neoadjuvant chemotherapy. Patients who had optimal (\\\u003C1 cm residual disease) or suboptimal (\\>1 cm residual disease) following surgical cytoreduction will be included.\n\n   Patients who did not undergo surgical cytoreduction will also be included.\n6. Recurrent disease confirmed by biopsy, radiologic imaging, and\u002For elevated CA 125\n7. Patients may have received radiation therapy\n8. Life expectancy \\> 6 months\n9. Part 1: Have evaluable disease by radiologic measurements (See 11) or CA 125\n10. Part 2: Have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as \\> 1 cm on cross-sectional imaging (where the CT slice thickness is no greater than 5 mm) or at least 2 cm by standard techniques; positron emissions tomography (PET\\] and ultrasound are not permitted methods for tumor measurements under this protocol. Consult RECIST 1.1 guidance for additional information (Appendix C and Eisenhauer et al., 2009; Ref 61).\n11. Adequate organ function within 14 days prior to first WFA\u002FASWD dose or liposomal doxorubicin whichever occurs first, including the following: absolute neutrophil count (ANC) ≥ 1.5 x 103\u002FL, platelet count ≥ 100 x 103\u002FL, hemoglobin ≥ 9 g\u002FdL (≥ 5.6 mmol\u002FL), patients may receive packed RBC transfusion to achieve this level at the discretion of the investigator, total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) unless elevated secondary to conditions such as Gilbert's Disease, aspartate aminotransferase (AST) \\\u003C 3 x ULN (\\\u003C 5 x ULN in the presence of hepatic metastases), alanine aminotransferase (ALT) \\\u003C 3 x ULN (\\\u003C 5 x ULN in the presence of hepatic metastases), alkaline phosphatase \\\u003C 3.0 x ULN, calculated creatinine clearance ≥ 60 mL\u002Fmin per Cockcroft and Gault formula\n12. Satisfy one of the following:\n\n    * Females: non-pregnant and non-lactating; surgically sterile, post- menopausal, or patient\u002Fpartner compliant with a reliable contraceptive regimen, as determined by the investigator, for 4 weeks prior to screening.\n    * Patients of reproductive potential must test negative for pregnancy at screening, prior to each cycle, and must agree to use a reliable method of birth control during the study period and 6 months following completion of treatment.\n13. The patient is willing and able to comply with the study visit schedule and procedures and has geographical proximity (Investigator's discretion) that allows follow-up specified by the protocol\n14. For Part 1: Patients have discontinued all prior chemotherapies, biological therapies, and other investigational therapies for cancer for at least 4 weeks prior to study treatment and have recovered from the acute effects of therapy\n15. ECOG performance status of 0, 1, or 2\n16. Adequate ejection fraction determined by transthoracic echo or MUGA of at least 55%\n17. Patients may have received prior anthracycline or anthracenedione therapy. In this scenario, the use of prior treatments will be incorporated into the cumulative dose calculations when applicable, given a known increased risk of cardiomyopathy to 11% when the cumulative dose of liposomal doxorubicin was between 450 mg\u002Fm2 to 550 mg\u002Fm2.\n\n    \\-\n\nExclusion Criteria:\n\nPatients will be excluded from the study if they meet any of the following criteria:\n\n1. ECOG performance status 3 or 4\n2. Pregnant or breastfeeding\n3. Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before screening or 5 half-lives of study agent, whichever is longer\n4. Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Brain imaging is required for symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients\n5. Patients with known pericardial effusion\n6. Patients with active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with the study (at the discretion of the Investigator)\n7. Presence or history of malignancy other than ovarian cancer that does not include carcinoma in situ of the cervix, or non-melanoma skin cancer. In the case of other malignancies, patients may be considered for participation if the prior malignancies were diagnosed and definitively treated at least two years previously with no subsequent evidence of recurrence\n8. Presence of an underlying disease state associated with active bleeding\n9. Concurrent treatment with other anticancer drugs\n10. Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device\n11. Patients with any other medical conditions that, in the opinion of the Investigator, would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study\n12. Patients with known septicemia, severe infection, or acute hepatitis\n13. Patients with known congestive heart failure or unstable angina or those who had a myocardial infarction within the past 6 months\n14. Patients with known clinically significant pericardial disease\n15. Patients taking medications known to affect the cardiac conduction system\n16. Allergy to WFA\u002FASWD\n17. Previous treatment with liposomal doxorubicin\n18. Prior use of other anthracyclines or anthracenediones -",{"count":170,"type":21},72,[122,97],"The proposed study \"combination therapy with liposomal doxorubicin and withaferin A (Ashwagandha, ASWD) in recurrent ovarian cancer\" is focused to determine the feasibility and maximum tolerance dose of Ashwagandha with liposomal doxorubicin (DOXIL) in recurrent ovarian cancer patients. The study contains two parts. In part 1 (phase I), 18 patients with recurrent ovarian cancer eligible for DOXIL therapy will be recruited and three doses of Ashwagandha (2.0 g, 4.0 g and 8.0 g) in the form of tablets along with DOXIL will be evaluated for feasibility and tolerance of ASWD. In part 2 (phase II), 54 patients with recurrent ovarian cancer will be recruited and treated with DOXIL and Ashwagandha (dose determined from part 1) to evaluate the complete response (CR), partial response (PR), and stable disease (SD).",[31],[175,176,177,31,178],"DOXIL","Withaferin A","Ashwagandha","Combination therapy","2026-03-16",{"date":181,"type":54},"2026-03-19",{"date":183,"type":54},"2024-09-25",{"date":185,"type":21},"2028-11-30",{"name":187,"class":61},"Sham Sunder Kakar",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":73,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":207,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":4},"100627852","phase-2-iparomlimabtuvonralimab--standard-chemotherapy-and-olaparib-in-platinum-sensitive-recurrent-ovarian-cancer-100627852","NCT07454018","Iparomlimab\u002FTuvonralimab + Standard Chemotherapy and Olaparib in Platinum-Sensitive Recurrent Ovarian Cancer","A Single-Arm, Exploratory, Multicenter Study Evaluating Iparomlimab\u002FTuvonralimab Combined With Standard Chemotherapy Followed by Olaparib in Platinum-Sensitive Recurrent Ovarian Cancer","Inclusion Criteria:\n\n1. Female participants aged 18 to 75 years. Voluntarily provide written informed consent and able to comply with protocol requirements.\n2. Histologically and\u002For cytologically confirmed recurrent non-mucinous epithelial ovarian cancer (including serous carcinoma, clear cell carcinoma, endometrioid carcinoma, and carcinosarcoma).\n3. First or second recurrence after standard platinum-containing chemotherapy, with recurrence diagnosed ≥ 6 months after the last dose of platinum-containing chemotherapy (platinum-sensitive recurrence).\n4. Not suitable for surgery as assessed by the investigator.\n5. At least one measurable lesion per RECIST v1.1.\n6. ECOG performance status 0-1.\n7. If no prior BRCA1\u002F2 mutation test result is available, willing to provide tumor tissue and\u002For peripheral blood for confirmation of BRCA status (archival or fresh tumor tissue preferred; if re-biopsy poses safety risk, may be discussed with medical monitor).\n8. Prior exposure to PARP inhibitor(s) other than olaparib is allowed only if the prior PARPi exposure after first-line therapy was \\>18 months for BRCA-mutated participants or \\>12 months for BRCA wild-type participants, and recurrence occurred ≥12 months after the last PARPi dose.\n9. Estimated life expectancy ≥ 3 months.\n10. Adequate organ function: ANC ≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; hemoglobin ≥90 g\u002FL; serum albumin ≥30 g\u002FL; TSH ≤1×ULN (if abnormal, FT3\u002FFT4 within normal range); total bilirubin ≤1.5×ULN; AST\u002FALT ≤2.5×ULN (≤5×ULN if liver metastases); ALP ≤2.5×ULN; serum creatinine ≤1.5×ULN; INR ≤1.5 (if not on anticoagulation).\n11. Women of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days prior to first dose, must not be breastfeeding, and must use medically accepted contraception during study treatment and for 3 months after the end of study treatment.\n\nExclusion Criteria:\n\n1. Any active autoimmune disease or history of autoimmune disease.\n2. Mucinous ovarian cancer, sex cord-stromal tumors, or other non-eligible histologic types.\n3. Uncontrolled pleural effusion, pericardial effusion, or ascites that cannot be stabilized despite repeated drainage or other interventions per investigator judgment.\n4. Other active malignancy within 2 years prior to first dose.\n5. Central nervous system metastases or carcinomatous meningitis.\n6. Palliative radiotherapy or immunomodulatory agents (e.g., thymosin, interferon, IL-2) or antitumor Chinese patent medicines within 2 weeks prior to first dose; hormonal therapy within 1 week prior to first dose.\n7. Use of immunosuppressive agents or systemic corticosteroids for immunosuppression (prednisone \\>10 mg\u002Fday or equivalent) within 2 weeks prior to enrollment.\n8. Prior immuno-oncology therapies targeting tumor immunity (e.g., PD-1\u002FPD-L1\u002FCTLA-4 inhibitors, immune checkpoint agonists such as ICOS\u002FCD40\u002FCD137\u002FGITR\u002FOX40 antibodies, or immune cell therapy).\n9. Prior treatment with olaparib.\n10. Concomitant use of strong\u002Fmoderate CYP3A inhibitors (washout 2 weeks) or strong\u002Fmoderate CYP3A inducers (washout 5 weeks for enzalutamide\u002Fphenobarbital; 3 weeks for others).\n11. Major surgery, open biopsy, or significant traumatic injury within 4 weeks prior to first dose (except secondary cytoreductive surgery), or planned major elective surgery during the study.\n12. Live vaccine within 4 weeks prior to first dose or planned live vaccination during the study.\n13. Known primary or secondary immunodeficiency, including HIV antibody positive. Untreated chronic hepatitis B or HBV carrier with HBV DNA \\>1000 IU\u002FmL; active hepatitis C.\n14. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n15. History of interstitial lung disease or non-infectious pneumonitis.\n16. Serious infection within 4 weeks prior to first dose (e.g., sepsis, severe pneumonia, or infections requiring hospitalization).\n17. Active or clinically significant inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea requiring treatment).\n18. Severe cardiovascular or cerebrovascular disease\u002Fhistory.\n19. Peripheral neuropathy ≥ Grade 2 per NCI CTCAE v5.0.\n20. History of severe hypersensitivity reaction to other monoclonal antibodies. Pregnant or breastfeeding.\n21. Known allergy to any component of QL1706, olaparib, carboplatin, or paclitaxel formulations.\n22. Participation in another investigational drug\u002Fdevice study within 4 weeks prior to first dose.\n23. Any condition that, in the investigator's opinion, would increase risk with study treatment or interfere with study assessments or interpretation.","75 Years",{"count":197,"type":21},45,[97],"This is a prospective, open-label, single-arm, multicenter exploratory clinical study designed to evaluate the efficacy and safety of iparomlimab\u002Ftuvonralimab (QL1706), a bispecific antibody targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), in combination with standard platinum-based chemotherapy followed by olaparib in patients with platinum-sensitive recurrent epithelial ovarian cancer.\n\nEligible participants are women aged 18-75 years with histologically or cytologically confirmed non-mucinous epithelial ovarian cancer (including serous carcinoma, clear cell carcinoma, endometrioid carcinoma, and carcinosarcoma) who experience first or second recurrence at least 6 months after the last platinum-containing chemotherapy, have measurable disease per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1), an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1, and are deemed not suitable for surgery by the investigator.\n\nThe study consists of a screening period (up to 28 days), a treatment period, and a follow-up period. Treatment is administered in 3-week cycles and continues until disease progression, unacceptable toxicity, withdrawal of consent, loss of clinical benefit per investigator judgment, completion of 2 years of iparomlimab\u002Ftuvonralimab (QL1706), or other protocol-defined reasons. Safety assessments are performed regularly during treatment; a safety follow-up visit is conducted 30 (±7) days after the last dose, and survival follow-up is performed every 2 months thereafter. The primary objective is to explore the antitumor efficacy of the regimen in platinum-sensitive recurrent epithelial ovarian cancer, and the secondary objective is to characterize the safety profile of the combination strategy.",[31,201],"Platinum-sensitive Ovarian Cancer",[203,204,205,206],"Iparomlimab","Tuvonralimab","Epithelial ovarian cancer","Maintenance therapy","NOT_YET_RECRUITING","2026-03-05",{"date":210,"type":54},"2026-03-06",{"date":212,"type":21},"2026-03-01",{"date":214,"type":21},"2029-12-31",{"name":216,"class":61},"The First Affiliated Hospital of Soochow University",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":73,"phases":227,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":207,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":245,"leadSponsor":247,"locationsCount":62},"100614943","phase-3-trauma-focused-managing-cancer-and-living-meaningfully-calm-tf-for-newly-diagnosed-and-recurrent-ovarian-cancer-100614943","NCT07286162","Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF) for Newly Diagnosed and Recurrent Ovarian Cancer","Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF): A Phase III Randomized Controlled Trial of an Intervention Targeting Traumatic Stress in Patients With Advanced Ovarian Cancer","CALM-TF","Inclusion Criteria:\n\n* Newly diagnosed stage III or IV ovarian cancer OR recurrent ovarian cancer within six months of diagnosis or recurrence\n* Age 18 years or older\n* Able to speak and read English\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Significant cognitive impairment that would interfere with the ability to participate in psychotherapy or complete study questionnaires\n* Active psychosis or severe psychiatric condition requiring immediate psychiatric intervention\n* Receiving ongoing psychotherapy at the time of recruitment",{"count":226,"type":21},300,[228],"PHASE3","The goal of this clinical trial is to investigate if CALM-TF (Trauma-Focused Managing Cancer and Living Meaningfully) is effective in treating traumatic stress symptoms in women with advanced ovarian cancer. It will also learn whether the efficacy differs at new diagnosis versus at recurrence.\n\nThe main questions it aims to answer are:\n\n1. What is the effectiveness of CALM-TF in reducing traumatic stress symptoms in patients with newly diagnosed or recurrent advanced ovarian cancer, as measured at 3 and 6 months?\n2. What are the effects of CALM-TF on depression, quality of life, and patient-perceived benefit of the intervention compared to usual care alone?\n3. What are patient perceptions of their care experiences as explored through qualitative interviews?\n\nResearchers will compare CALM-TF to usual standard of care (which includes regular conversations with medical teams and meetings with social workers) to see if CALM-TF works to treat traumatic stress.\n\nParticipants will:\n\n* Receive 3-6 sessions of CALM-TF over 3-6 months (45-60 minutes each) via video call, telephone, or in-person based on preference, OR receive usual care only\n* Complete questionnaires at baseline, 3 months, and 6 months\n* Continue to receive their standard cancer care throughout the study\n* Some participants may be invited to participate in qualitative interviews at 6 months",[231,31],"Ovarian Cancer (OvCa)",[233,234,235,236,237,238,239,240],"randomized controlled trial","ovarian cancer","recurrence","newly diagnosed","CALM","Managing Cancer And Living Meaningfully","Psychotherapy","psychosocial support","2026-01-23",{"date":243,"type":54},"2026-01-27",{"date":212,"type":21},{"date":246,"type":21},"2031-12-31",{"name":248,"class":61},"University Health Network, Toronto",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":257,"minAge":18,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":73,"phases":260,"briefSummary":261,"conditions":262,"keywords":268,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":62},"100575218","phase-1-hs-10502-combination-treatment-in-patients-with-advanced-solid-tumors-100575218","NCT06769425","HS-10502 Combination Treatment in Patients With Advanced Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 Combination Treatment in Subjects With Advanced Solid Tumors","HS-10502","Inclusion Criteria:\n\n* Males or females aged 18 years or older (≥18 years).\n* Patients diagnosed with pathologically confirmed advanced solid tumors.\n* Subjects have at least one target lesion as assessed per the RECIST 1.1.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.\n* Have a life expectancy of at least 12 weeks.\n* Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i.e. condoms) from signing the informed consent to 6 months after the last dose.\n* Female subjects must have a negative pregnancy test within 7 days prior to the first dose (for subjects with tumor related abnormal elevation of human chorionic gonadotropin \\[HCG\\], an ultrasound of uterus and appendages should be performed within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for pregnancy.\n* Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.\n\nExclusion Criteria:\n\n* Have received or is currently receiving the following treatment: PARPi\u002FB7-H4\u002FB7-H3-targeted therapies;\n* Have received or is currently receiving the following treatment: PARPi\u002FB7-H4\u002FB7-H3-targeted therapies;\n* Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.\n* Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.\n* Presence of pleural\u002Fabdominal effusion requiring clinical intervention.\n* Known history of other primary malignancy.\n* Evidence of brain metastasis and\u002For cancerous meningitis\n* Inadequate bone marrow reserve or hepatic\u002Frenal functions.\n* Cardiological examination abnormality.\n* Severe, uncontrolled or active cardiovascular disorders.\n* Serious or poorly controlled diabetes.\n* Serious or poorly controlled hypertension.\n* Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.\n* Serious infections within 4 weeks prior to the first dose.\n* Have received systemic glucocorticoid therapy for more than 7 days within 28 days prior to the first dose study treatment, or require chronic (≥ 7 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation.\n* Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.\n* Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.\n* Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.\n* History of severe neurological or psychiatric disorder.\n* Pregnant or breast-feeding women or women who intend to become pregnant during the study.\n* Attenuated live vaccination within 4 weeks prior to the first dose.\n* Subjects with autoimmune disease that is active or is likely to recur.\n* Subjects with gastrointestinal fistula, visceral fistula, gastrointestinal perforation, or abdominal abscess, or with symptoms\u002Fsigns of intestinal obstruction within 6 months prior to the first dose of study drug.\n* Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.\n* Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.","ALL",{"count":259,"type":21},157,[122],"HS-10502 is a PARP1-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 Combination Treatment in subjects with advanced solid tumors.",[31,263,264,265,266,267],"HER2-negative","Advanced Breast Cancer","TNBC","Advanced Prostate Cancer","Advanced Gastric Cancer",[269,255,234,270,265,271,272],"Poly(ADP-ribose) polymerase-1 inhibitor","breast cancer","prostate cancer","gastric cancer","2025-06-18",{"date":275,"type":54},"2025-06-24",{"date":277,"type":54},"2025-05-07",{"date":279,"type":21},"2026-08-31",{"name":281,"class":110},"Jiangsu Hansoh Pharmaceutical Co., Ltd.",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":73,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":62},"100511658","phase-1-cpi-0209-plus-carboplatin-in-patients-with-platinum-sensitive-recurrent-ovarian-cancer-100511658","NCT05942300","CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer","Phase I Trial of CPI-0209 in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Patients with platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer (defined as recurrent disease \\> 6 months after completing last platinum- based chemotherapy) that are eligible to receive platinum-based chemotherapy).\n* Documented disease recurrence\u002Fprogression based on GCIG-RECIST\n* Must have had at least 1 prior line of platinum-based therapy, prior bevacizumab or PARPi use are allowed. Women with germline BRCA mutations should be considered for PARPi maintenance as standard of care treatment prior to consideration of clinical trial enrollment\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 with life expectancy of ≥ 3months\n* Adequate organ function\n\n  * Serum creatinine ≤1.5mg\u002FdL or 24-hour clearance ≥50mL\u002Fmin\n  * AST\u002FALT \\\u003C2.5x ULN (or \\\u003C5x ULN if liver metastasis are present)\n  * Total bilirubin ≤ ULN or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert's Syndrome\n  * Hemoglobin ≥9 gm\u002Fdl, Platelets ≥100,000\u002Fμl ANC ≥1500\u002Fμl\n  * INR ≤1.5\n  * Potassium, total calcium (corrected for serum albumin), magnesium, and sodium within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication\n* Must be able to swallow CPI-0209 tablet\u002Foral suspension\n* Able to provide informed consent and comply with all study protocol\n* Treated CNS metastasis allowed if treatment is completed ≥8 weeks prior to enrollment. Patients must be asymptomatic off systemic corticosteroids for at least 4 weeks after completion of radiation therapy. CNS disease must be stable or regressed on repeat imaging performed at least 4 weeks after completion of therapy.\n* Women of child-bearing potential (those who have had a menstrual cycle within the last year and have not had a tubal ligation or surgical removal of both ovaries and\u002For hysterectomy) must agree to abstain from vaginal intercourse or use and continue highly effective methods of contraception for at least 183 days after discontinuation of study treatment.\n\n  * Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n  * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.\n  * Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient.\n  * Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception.\n  * In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n\nExclusion Criteria:\n\n* Borderline or low malignant potential histology\n* Platinum-resistant disease (as defined as progressive disease (PD) within 6 months of completion of chemotherapy with a platinum agent).\n* Known hypersensitivity to any of the excipients of CPI-0209.\n* Gastrointestinal (GI) dysfunction or disease that may significantly alter the absorption of the study drugs\n* Concurrent malignancy or malignancy within 3 years prior to starting study drug with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer or per physician discretion that the previous cancer was adequately treated with curative intent and unlikely to recur (the study PI must concur with this determination).\n* History of HIV infection\n* Has an active infection requiring systemic treatment\n* Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks and contraindicate patient's participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, significant cardiac\u002Fpulmonary disease etc.)\n* Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.\n* Use of herbal supplements unless discontinued ≥7 days prior to initiation of study drug\n* Consumption of foods which are strong inducers or inhibitors of CYP3A4\u002F5 has to be discontinued 7 days prior to initiation of study drug. Patients that are unwilling to exclude Seville oranges, grapefruit juice, AND grapefruit from the diet and all foods that contain those fruits from time of enrollment to through the duration of study participation will be excluded.\n* Pregnant or breast feeding\n* Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer\n* Patient who has received radiotherapy ≤4 weeks or limited field radiation for palliation ≤2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and\u002For in whom ≥25% of the bone marrow (Ellis, 1961) was irradiated.\n* Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery).\n* Patient has not recovered from all toxicities related to prior anticancer therapies to NCI-CTCAE version 5 Grade ≤1 (Exception to this criterion: patients with any grade of alopecia, controlled endocrine toxicities and\u002For neuropathy ≤ grade 2 are allowed to enter the study).\n* Grade 3 baseline neuropathy\n* Patient with a Child-Pugh score B or C.",{"count":290,"type":21},30,[122],"This is a clinical trial using CPI-0209 in combination with Carboplatin chemotherapy followed by CPI-0209 maintenance in patients with platinum sensitive, recurrent ovarian cancer.",[31],[295,296,297],"platinum sensitive","stromal tumor microenvironment (TME)","PARP inhibitor","2025-06-16",{"date":300,"type":54},"2025-06-19",{"date":302,"type":54},"2024-01-30",{"date":304,"type":21},"2028-12-31",{"name":306,"class":61},"Lan Coffman",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":73,"phases":315,"briefSummary":311,"conditions":316,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":62},"100559129","phase-2-an-exploratory-multi-cohort-phase-ii-study-of-combination-therapy-with-ak104-and-ak112-for-recurrent-ovarian-cancer-100559129","NCT06560112","An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer","Inclusion Criteria:\n\n1. Signs the written informed consent form.\n2. Female participants who are at least 18 years of age on the day of signing informed consent with.\n3. ECOG of 0 or 1.\n4. Life expectancy ≥ 3 months.\n5. Histologically diagnosed high-grade epithelial ovarian cancer (including high-grade serous, clear cell, G3 endometrioid) that has relapsed after platinum-containing standard chemotherapy.\n\n   1. Recurrence of Platinum-sensitive (relapse ≥6 months after the end of platinum-containing therapy) who is not suitable for platinum-containing therapy after ≥ 3 lines of therapy;\n   2. Recurrence of platinum resistance , ≤3 previous lines of therapy. Note: Ovarian cancer includes ovarian cancer, fallopian tube cancer and primary peritoneal cancer in this study, unless otherwise specified.\n6. Has measurable disease based on RECIST v1.1 as determined by the site study team.\n7. Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue.\n8. Has adequate organ function.\n9. All subjects of reproductive potential must agree to use an effective method of contraception, during and for 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Other pathological types such as mucinous cancer, low-grade serous carcinoma, carcinosarcoma, sex cord stromal cell tumor, etc.\n2. Presence of central nervous system (CNS) metastases or carcinomatous meningitis.\n3. Subjects with uncontrollable pleural, pericardial, or peritoneal effusion requiring repeated drainage.\n4. Patients with other active malignancies within 3 years prior to randomization.\n5. Received systemic anti-tumor therapy within 3 weeks prior to randomization.\n6. Any prior treatments targeting the mechanism of tumor immunity.\n7. Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study.\n8. Active or potentially recurrent autoimmune disease.\n9. Subjects who require systemic treatment with glucocorticoid (\\> 10 mg\u002Fday of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization.\n10. Use of live vaccines within 4 weeks prior to randomization.\n11. Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies.\n12. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n13. Known history of interstitial lung disease or non-infectious pneumonitis.\n14. Serious infections requiring hospitalization.\n15. Presence of active infection requiring systemic therapy.\n16. Subjects with active hepatitis B and active viral hepatitis C.\n17. Active or documented inflammatory bowel diseases, active diverticulitis.\n18. Patients with clinically significant cardio-cerebrovascular disease.\n19. Unresolved toxicities from prior anticancer therapy.\n20. History of severe hypersensitivity reactions to other mAbs.\n21. Pregnant or lactating women.\n22. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.\n23. Exclusion Criteria for Chemotherapy-Related Cohorts (Cohorts 1,2,4): Known contraindications or allergy to PLD, paclitaxel or topotecan.\n24. Exclusion Criteria for AK112-Related Cohorts (Cohorts 2,3,4): Known contraindications or allergy to any component of VEGF mABs or any medical conditions that affect the safety of AK112.",{"count":314,"type":21},172,[97],[31],"2025-03-11",{"date":319,"type":54},"2025-03-12",{"date":321,"type":54},"2024-11-12",{"date":323,"type":21},"2027-05-01",{"name":325,"class":110},"Akeso",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":334,"conditions":335,"keywords":336,"overallStatus":207,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":62},"100521491","investigating-participation-patterns-among-recurrent-ovarian-cancer-patients-100521491","NCT06070285","Investigating Participation Patterns Among Recurrent Ovarian Cancer Patients","Delving Into the Patterns of Patient Engagement and Trends in Participation Within Recurrent Ovarian Cancer Clinical Trials","Inclusion Criteria:\n\n* Aged ≥ 18 years old\n* Able to comprehend the investigational nature of the protocol and provide informed consent\n* Diagnosis of recurrent ovarian cancer\n\nExclusion Criteria:\n\n* No diagnosis of recurrent ovarian cancer confirmed\n* Inability to perform regular electronic reporting\n* Patient does not understand, sign, and return consent form",{"count":20,"type":21},"Clinical trials, with a particular focus on recurrent ovarian cancer, play a crucial role in assessing the safety and efficacy of novel treatments for this condition. These trials serve as essential tools to determine whether new medications outperform traditional therapies, providing substantial evidence to support their widespread adoption.\n\nBy actively participating in recurrent ovarian cancer observational study serves pivotal role in expanding the boundaries of medical knowledge and advancing the quality of care provided to those enduring the same condition.",[31],[31],"2023-09-30",{"date":339,"type":54},"2023-10-06",{"date":341,"type":21},"2024-10",{"date":343,"type":21},"2026-10",{"name":345,"class":110},"Power Life Sciences Inc.",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":73,"phases":355,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":72},"100320929","phase-2-signal-transduction-pathway-activity-analysis-in-ovarian-cancer-100320929","NCT03458221","Signal TrAnsduction Pathway Activity Analysis in OVarian cancER","STAPOVER","Inclusion Criteria:\n\n* Female, age \\> 18 years\n* Patients with recurrent ovarian cancer who meet one of the following criteria:\n* Platinum-resistant disease, defined as disease recurrence or progression within six months of last platinum-based chemotherapy or;\n* Patient refrains from standard therapy or;\n* Asymptomatic patient who is not yet eligible for standard palliative chemotherapy but has an increase of CA125 tumour marker at two consecutive time points 28 days apart with a value of two times nadir above 35 U\u002Fml.\n* Progressive disease after at least one prior line of systemic treatment for recurrent disease.\n* Radiologically evaluable disease according to RECIST 1.1 criteria (36).\n* Ability and willingness to obtain a tumour biopsy after the last course of standard treatment and before start of the study.\n* Ability and willingness to provide written and oral consent.\n* Able to speak and understand the Dutch language.\n* WHO performance status 0-II.\n* Adequate renal and liver function to start matched targeted therapy (according to the local clinician).\n* Adequate use of contraceptives in case of patients with childbearing potential.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Patient is receiving any other anti-cancer therapy (e.g. cytotoxic or targeted drug or radiation) or is chemotherapy naïve. The required wash out period prior to start of matched targeted therapy is at least three weeks.\n* Patient is diagnosed with or treated for a second primary tumour (except non-melanoma skin tumour) one year prior to study inclusion.\n* Inability to obtain (sufficient) tumour material.\n* Previous use of the selected targeted drug as anti-cancer agent.\n* Physical condition WHO III-IV.\n* Pregnant or lactating women.\n* Simultaneous participation in another treatment-related clinical trial.\n* Patients with any other clinically significant medical condition which, in the opinion of the local clinician, makes it undesirable for the patient to participate in this study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, severe psychiatric illness, or complicated social situations.",{"count":354,"type":21},148,[97,228],"The purpose of this prospective, parallel-group, cohort study is to implement phenotype-guided targeted therapy based on functional signal transduction pathway (STP) activity in recurrent ovarian cancer patients using a novel mRNA-based assay. Existing targeted drugs with tolerable toxicity profiles are used to investigate the therapeutic value beyond their approved indication, which are deemed beneficial in the select group of patients with a relevant predominantly active functional STP, in order to improve survival and maintain quality of life.",[31,358,359],"Signal Transduction Pathway Deregulation","Therapy-Associated Cancer",[361,362,363,364],"Ovarian Cancer","Signal Transduction Pathway","Targeted therapy","Drug repurposing","2023-04-13",{"date":367,"type":54},"2023-04-18",{"date":369,"type":54},"2023-01-31",{"date":371,"type":21},"2026-10-01",{"name":373,"class":61},"Gynaecologisch Oncologisch Centrum Zuid"]