[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-metastatic":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,73],{"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":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100620463","omission-of-surgery-for-triple-negative-breast-cancer-in-complete-response-after-neoadjuvant-chemo-immunotherapy-100620463",false,"NCT07357948","Omission of Surgery for Triple-negative Breast Cancer in Complete Response After Neoadjuvant Chemo-immunotherapy","Omission of Surgery for Triple-negative Breast Cancer in Complete Response Confirmed by MRI and Macrobiopsy After Neoadjuvant Chemo-immunotherapy: a Randomized, Multicenter Phase II Trial.","OMICHIR","Inclusion Criteria:\n\n1. Sex and age: Female, aged 18 years or older.\n2. Histological type: Invasive breast carcinoma of no special type (NST).\n3. Triple-negative phenotype, defined by:\n\n   * Estrogen receptor (ER) \\\u003C 10%,\n   * Progesterone receptor (PR) \\\u003C 10%,\n   * HER2-negative status according to ASCO\u002FCAP criteria (IHC score 0-1+, or 2+ without amplification by in situ hybridization).\n4. High proliferation index: Ki-67 \\> 30%.\n5. Primary tumor classified as T2, i.e. tumor size between 2 and 5 cm on imaging at diagnosis (mammography, ultrasound, and breast MRI).\n6. No regional lymph node involvement or distant metastasis, confirmed by 18F-FDG PET-CT performed prior to neoadjuvant treatment.\n7. Completion of the full neoadjuvant chemo-immunotherapy (NCIT) protocol according to the KEYNOTE-522 regimen (≥7 cycles including pembrolizumab).\n8. Breast-conserving surgery deemed feasible based on the initial surgical assessment.\n9. Radiological complete response (rCR) on post-NCIT breast MRI, associated with a negative vacuum-assisted biopsy (VAB) of the clip-marked tumor bed, confirming the absence of residual invasive or in situ disease.\n10. Written informed consent obtained prior to any study-specific procedure.\n11. Ability of the patient to comply with the protocol requirements and scheduled follow-up.\n12. Affiliation with a national health insurance system, in accordance with French regulations.\n\nExclusion Criteria:\n\n1. Presence of regional recurrence or metastatic disease at inclusion.\n2. History of thoracic, breast, or regional lymph node irradiation, regardless of indication.\n3. Invasive lobular carcinoma, excluded due to its different response profile and increased risk of multifocal residual disease.\n4. Presence of ductal carcinoma in situ (DCIS) on diagnostic biopsy, or diffuse suspicious microcalcifications on mammography, precluding reliable assessment of complete response.\n5. Bilateral breast cancer (except for localized and treated contralateral DCIS), or history of ipsilateral or contralateral invasive breast cancer.\n6. Multifocal or multicentric disease detected on imaging (mammography, ultrasound, or breast MRI).\n7. Skin involvement or inflammatory breast cancer, identified on imaging or clinical examination.\n8. History of malignancy other than breast cancer, unless the disease has been in complete remission for ≥ 5 years and is considered at low risk of recurrence, with the exception of:\n\n   * Treated carcinoma in situ of the cervix, endometrium, or colon,\n   * Melanoma in situ,\n   * Completely excised cutaneous basal cell or squamous cell carcinoma.\n9. Severe or progressive non-malignant disease limiting life expectancy to less than 10 years, in the investigator's judgment.\n10. Presence of a high-risk germline mutation predisposing to breast cancer (including BRCA1, BRCA2, or other identified predisposition genes).\n11. Participation in another interventional clinical trial within 30 days prior to inclusion.\n12. Current pregnancy or breastfeeding.\n13. Cognitive impairment, psychiatric disorder, or social situation preventing valid informed consent or adequate understanding of the protocol, as assessed by the investigator.\n14. Individuals deprived of liberty or under legal protection (guardianship, curatorship, or similar legal status), in accordance with applicable regulations.","FEMALE","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","This clinical study aims to determine if skipping breast and axillary surgery could provide similar control of local and distant disease, with fewer complications and better quality of life, for triple-negative breast cancer patients in complete response after neoadjuvant chemo-immunotherapy.\n\nPatients will be randomised into 2 groups :\n\n* Control arm will receive the standard treatment, including surgery\n* Experimental arm will receive the standard treatment, except surgery",[27,28],"Triple Negative Breast Cancer","Non-Metastatic","NOT_YET_RECRUITING","2026-06-01",{"date":32,"type":33},"2026-06-03","ACTUAL",{"date":35,"type":21},"2026-08-01",{"date":37,"type":21},"2033-07-31",{"name":39,"class":40},"Institut Curie","OTHER",4,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100589260","a-global-integrated-personalized-stage-related-multimodal-therapeutic-approach-for-rectal-adenocarcinoma-based-on-organ-sparing-and-mininvasivity-100589260","NCT06952101","A Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity","INTERPRETE: a Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity","INTERPRETE","Inclusion Criteria:\n\n* Patients aged ≥18 yrs old\n* Patients able to sign the informed consent\n* Patients with High Risk pT1 rectal adenocarcinoma endoscopically excised\n* Patients with cT2-3aN0 rectal adenocarcinoma who has complete\u002Fmajor response to EXPERIMENTAL CRT\n* Patients with cT3b4N0-1 rectal adenocarcinoma who has complete\u002Fmajor response to STANDARD CRT\n\nExclusion Criteria:\n\n* cT2-4 any NM0 who don't reach cCR or cMR after experimental\u002Fstandard CRT\n* Pregnancy","ALL",{"count":52,"type":21},200,[24],"A phase II, single-center, non-profit, interventional study on patients affected by rectal adenocarcinoma. Patients will be stratified into three groups based on pre-treatment clinical stage. The study investigates and may propose a comprehensive, stage-specific, multimodal approach to rectal adenocarcinoma, with a focus on organ preservation even in early stages (cT1-2N0). When organ-sparing strategies are not feasible, the approach prioritizes minimally invasive techniques (laparoscopic and robotic) to reduce the physical, psychological, and quality-of-life impact on patients.",[56,57],"Rectal Adenocarcinoma","Non Metastatic",[56,59,60,61],"mininvasivity","organ sparing","surgical rectal resection","RECRUITING","2026-03-03",{"date":65,"type":33},"2026-03-05",{"date":67,"type":33},"2024-04-30",{"date":69,"type":21},"2030-12-31",{"name":71,"class":40},"Fondazione del Piemonte per l'Oncologia",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100313750","phase-2-hepatic-arterial-infusion-of-gemcitabine-oxaliplatin-for-second-line-therapy-in-non-metastatic-unresectable-intra-hepatic-cholangiocarcinoma-100313750","NCT03364530","Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma","Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma: a Multicentric Single-arm Phase II Study","GEMOXIA-02","Inclusion Criteria:\n\n* Histologically-proven intrahepatic cholangiocarcinoma previously treated by first-line systemic therapy\n* Absence of extra-hepatic metastasis or peritoneal carcinomatosis (as demonstrated by CT-scan)\n* General health status : World Health Organization Performance Status = 0, 1\n* Estimated life expectancy \\> 3 months\n* Disease that is not suitable for resection with a curative intent, as validated by a multidisciplinary committee with at least one senior hepatic surgeon\n* At least one measurable lesion according to RECIST 1.1 criteria\n* Platelets ≥100,000\u002Fmm3, polynuclear neutrophils ≥ 2000\u002Fmm3 , hemoglobin 9g\u002FdL (even transfused patients can be included)\n* Creatininemia \\\u003C 1.5 mol\u002FL\n* Creatinine clearance \\> 30 mL\u002Fmin\n* Bilirubinemia ≤2 N (after biliary drainage if necessary)\n* Aspartate and Alanine Transaminase ≤ 5 mol\u002FL\n* Reference hepatic MRI (according to the foreseen protocol) done during the 30 days preceding the 1st cycle of treatment\n* Written informed consent\n* National health insurance cover\n\nExclusion Criteria:\n\n* Patients with cholangiocarcinoma of the gallbladder or common bile duct or those with hepatocholangiocarcinoma or a Klatskin tumor\n* Patients who are eligible for surgical resection or liver transplantation\n* Extra-hepatic metastases (Pulmonary micronodules \\\u003C7mm without uptake on positron emission tomography are not a contra-indication)\n* Presence of clinical ascites\n* History of intra-arterial therapy or more than one line of systemic treatment\n* Contra-indication or grade 3-4 allergy to any of the treatment drugs Gemcitabine, Oxaliplatin (notably myelosuppression developped before the beginning of the first cycle of therapy, peripheral sensory neuropathy before the first cycle of therapy, severe renal failure)\n* Grade 2 peripheral neuropathy\n* Ongoing participation or participation within the 21 days prior to inclusion in the study in another therapeutic trial with an experimental drug\n* Concomitant systemic treatment with immunotherapy, chemotherapy or hormone therapy\n* Serious non-stabilized disease, active uncontrolled infection or other serious underlying disorder likely to prevent the patient from receiving the treatment\n* Pregnancy (beta-human chorionic gonadotropin positive), breast-feeding or the absence of effective contraception for women of child-bearing age\n* Another cancer in the 5 years preceding or at the time of inclusion in the trial (except for in situ cervical cancer or basal cell carcinoma of the skin)\n* Allergy or contra-indication to iodine contrast agents (thyrotoxicosis, allergy to the active substance or excipients)\n* Treatment with anticoagulants (heparin or AVK) that cannot be interrupted for 12 hours\n* Treatment with anti-platelets that cannot be interrupted for 5 days for aspirin or Plavix.\n* Contra-indication for use of an intra-arterial approach (severe arteriopathy)\n* Legal incapacity (persons in custody or under guardianship)\n* Deprived of liberty Subject (by judicial or administrative decision)\n* Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social or psychological reasons\n* Contraindication for the MRI : Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreign body similar to the nervous structure.",{"count":82,"type":21},40,[84],"PHASE2","We hypothesized that intra-arterial gemcitabine\u002Foxaliplatin administered as second-line treatment could strongly improve objective response rate at 4 months after inclusion in patient with non-metastatic unresectable intra-hepatic cholangiocarcinoma.",[87,88],"Cholangiocarcinoma Non-resectable","Non-metastatic","2025-12-31",{"date":91,"type":33},"2026-01-05",{"date":93,"type":33},"2018-06-11",{"date":95,"type":21},"2026-10-21",{"name":97,"class":40},"University Hospital, Montpellier",7]