[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institut Bergonié\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":492},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,44,68,93,117,141,165,193,219,245,272,302,327,349,371,396,417,443,469],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100637923","effect-of-hypnosis-in-the-management-of-anxiety-and-chemo-induced-symptoms-in-adolescents-and-young-adults-with-sarcoma-or-germ-cell-tumor-and-in-young-women-with-breast-cancer-100637923",false,"NCT07614620","Effect of Hypnosis in the Management of Anxiety and Chemo-induced Symptoms in Adolescents and Young Adults With Sarcoma or Germ Cell Tumor and in Young Women With Breast Cancer","Effect of Hypnosis in the Management of Anxiety and Chemo-induced Symptoms in Adolescents and Young Adults With Sarcoma or Germ Cell Tumor and in Young Women With Breast Cancer.","HYPNO-AJA2","Inclusion Criteria:\n\n1. Newly diagnosed patients receiving initial care and follow-up at the Institut Bergonié during treatment:\n\n   1. Adolescents or young adults (AJA) aged 15 to 39 with soft tissue or bone sarcoma or a germ cell tumor (testicular, ovarian),\n   2. Young women aged 15 to 49 with breast cancer.\n2. Treatment with neoadjuvant chemotherapy based on anthracyclines and\u002For alkylating agents.\n3. Treatment administered as:\n\n   1. Inpatient for patients with soft tissue or bone sarcoma or a germ cell tumor (testicular, ovarian),\n   2. Outpatient or day hospital for female patients with breast cancer.\n4. Dated and signed informed consent (if the patient is a minor, consent must also be signed by the legal guardians).\n5. Patient enrolled in a social security program in accordance with current regulations.\n\nExclusion Criteria:\n\n1. Known contraindications to hypnosis (psychotic disorders, mental disorders, confusion, deafness, severe cognitive impairment, etc.)\n2. Patients who have already undergone hypnosis sessions within 6 months prior to enrollment.\n3. Geographic, social, or psychological factors rendering the patient unable to comply with the study's follow-up and procedures.\n4. Patients who are deprived of their liberty or subject to a legal protection measure (guardianship, conservatorship, judicial protection, or family authorization).","ALL","15 Years","49 Years",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"NA","The HYPNO-AJA 2 study is a prospective single-center interventional clinical trial conducted at the Institut Bergonié to evaluate the effectiveness of hypnosis in reducing anxiety and chemotherapy-related symptoms in adolescents, young adults (AYAs), and young women undergoing cancer treatment. The study focuses on patients aged 15-39 with sarcoma or germ cell tumors and women aged 15-49 with breast cancer receiving neoadjuvant chemotherapy.\n\nCancer treatment in AYAs is frequently associated with high levels of psychological distress, particularly anxiety related to chemotherapy sessions, invasive procedures, and repeated hospitalizations. Previous studies suggest that hypnosis may help reduce anxiety, pain, nausea, and emotional distress in oncology patients, but evidence remains limited in AYA populations and specific cancer types such as sarcoma, germ cell tumors, and breast cancer. HYPNO-AJA 2 aims to address this gap by assessing the feasibility, safety, and therapeutic value of hypnosis during chemotherapy.\n\nThe study's primary objective is to determine whether hypnosis can significantly reduce anxiety symptoms during chemotherapy. Secondary objectives include evaluating its effects on nausea and vomiting, pain, medication consumption (anxiolytics and antiemetics), quality of life, body image perception, and patient satisfaction.\n\nThe trial will include 70 participants divided into two cohorts:\n\n* 35 hospitalized patients with sarcoma or germ cell tumors;\n* 35 outpatients with breast cancer treated in a day hospital setting.\n\nEligible participants must be newly diagnosed, treated at Institut Bergonié, and receiving chemotherapy based on anthracyclines and\u002For alkylating agents. Patients with contraindications to hypnosis, severe psychiatric or cognitive disorders, recent hypnosis exposure, or inability to comply with follow-up procedures are excluded.\n\nThe intervention consists of a hypnosis session performed during the second chemotherapy cycle by a specialized oncology nurse trained in Ericksonian hypnosis and pain management. Sessions will last between 30 and 60 minutes and take place in a private and comfortable environment. The hypnosis procedure includes a preparatory discussion, hypnotic induction, progressive return to normal consciousness, and debriefing adapted to the patient's needs.\n\nAnxiety levels will be assessed using a Visual Analog Scale (VAS-Anxiety) before and after chemotherapy cycles 1, 2, and 3. Cycle 2 includes hypnosis, whereas cycles 1 and 3 do not. The primary endpoint is the difference in anxiety levels after cycle 2 compared with cycle 3. Secondary outcomes will evaluate chemotherapy-induced nausea and vomiting using the PRO-CTCAE system, pain intensity, medication use, quality of life through the EORTC QLQ-C30 questionnaire, body image changes using the Body Image Scale, and satisfaction with hypnosis sessions.\n\nThe planned enrollment period is 18 months, with a total study duration of 24 months and individual patient participation lasting approximately six months. Statistical analyses will compare anxiety scores after chemotherapy with and without hypnosis using paired statistical tests. Based on preliminary results from the earlier HYPNO-AJA-1 pilot study, the sample size is expected to provide more than 90% statistical power to detect clinically meaningful reductions in anxiety.\n\nThe investigators expect hypnosis to improve patients' psychological well-being, reduce symptom burden and medication use, enhance quality of life and body image acceptance, and strengthen the therapeutic relationship between patients and caregivers. More broadly, the study may support the integration of hypnosis into supportive oncology care pathways as a low-cost, non-pharmacological intervention adapted to young cancer patients.",[28,29,30,31],"Sarcoma","Germ Cell Tumor of Testis","Ovarian Tumor","Breast Cancer","NOT_YET_RECRUITING","2026-05-22",{"date":35,"type":36},"2026-05-29","ACTUAL",{"date":38,"type":22},"2026-09-15",{"date":40,"type":22},"2028-12",{"name":42,"class":43},"Institut Bergonié","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100625662","evaluation-of-quality-of-life-after-facial-hyaluroic-acid-injections-following-treatment-for-breast-cancer-100625662","NCT07425548","Evaluation of Quality of Life After Facial Hyaluroic Acid Injections Following Treatment for Breast Cancer.","JOUVENCE","Inclusion Criteria:\n\n1. Women ≥ 18 years old and ≤ 50 years old.\n2. Non-menopausal status at time of diagnosis of breast cancer (self-reporting).\n3. Patient with breast cancer (uni or bilateral):\n\n   1. treated at the Institut Bergonié by chemotherapy (+\u002F- targeted\u002Fimmunotherapy) and surgical treatment (conservative or not) and\u002For hormone therapy and\u002For radiotherapy\n   2. who completed their treatment at least 6 months ago including end of treatment with Herceptin but with the exception for ongoing hormone therapy\n   3. in complete remission\n4. Non-immunosuppressed patient.\n5. Voluntarily signed and dated written informed consent prior to any study specific procedure.\n6. Patient affiliated to a social security in compliance with Article 1121-11 of the French Public Health Code.\n\nExclusion Criteria:\n\n1. Patients with a history of or declared autoimmune disease or immune system deficiency or undergoing immunosuppressive treatment. A 6-month washout is required.\n2. Patients undergoing or planning to undergo peeling treatment or laser\u002Fultrasound-based or botox treatment or hyaluronic acid injections during the study or having had one of these treatments in the 6 months preceding the study.\n3. Patients showing cutaneous disorders, inflammation or infection (acne, herpes labialis, scars…) at the treatment site or near to this site.\n4. Patients having a known hypersensibility to lidocaine and\u002For amide local anaesthetic agents or hyaluronic acid and\u002For proteins from gram-positive bacteria, or with a history of severe allergy or anaphylactic shock.\n5. Patients with a history of streptococcal disease (recurrent sore throat, rheumatic fever)\n6. Patients with autoimmune or cardiac diseases (i.e. heart conduction disorders) and\u002For undergoing treatment for heart diseases (beta-blockers).\n7. Patients with hepatocellular insufficiency and\u002For undergoing treatment for liver disease.\n8. Patients suffering from epilepsy not controlled by a treatment or porphyria.\n9. Patients with a tendency to develop hypertrophic scars.\n10. Patients with severe, ongoing and\u002For uncontrolled disease that may pose a health risk to the patient during the study and\u002For may have an impact on the study assessments.\n11. Patients receiving or planning to receive high dose Vitamin E, aspirin, anti-inflammatories, or anti-coagulant during the week preceding each injection\n12. Patients receiving any long-term medical treatment or any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the patient at undue risk.\n13. Patients under guardianship\u002Ftutorship.\n14. Pregnant women or breastfeeding mothers.","FEMALE","18 Years","50 Years",{"count":55,"type":22},22,[25],"Breast cancer, the most common cancer in women, is increasingly managed as a chronic disease thanks to therapeutic advances. However, treatments such as chemotherapy and hormonotherapy often induce premature menopause in younger women, leading to skin aging, atrophy, and distressing symptoms that negatively affect quality of life. These cutaneous effects are frequently overlooked despite their psychological and social impact. Hyaluronic acid injections, already well established in aesthetic and reconstructive medicine, may offer a safe, minimally invasive option to restore skin quality, improve self-esteem, and enhance overall well-being in breast cancer survivors. This study aims to assess their efficacy and safety in this specific population.",[31,59],"Aesthetic Improvement of the Skin","2026-04-15",{"date":62,"type":36},"2026-04-16",{"date":64,"type":22},"2026-04",{"date":66,"type":22},"2027-09",{"name":42,"class":43},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100570291","convertases-and-pancreatic-cancer-cohort-of-patients-treated-for-pancreatic-adenocarcinoma-100570291","NCT06705335","Convertases and Pancreatic Cancer: Cohort of Patients Treated for Pancreatic Adenocarcinoma","Convertases and Pancreatic Cancer. New Therapeutic and Prognostic Approach: Cohort of Patients Treated for Pancreatic Adenocarcinoma (CONVERCAP)","CONVERCAP","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Pancreatic adenocarcinoma (suspected on radiological assessment or histologically proven):\n\n   1. Indication for biopsy of metastasis(es) performed as part of standard care for patients who already have a histologically confirmed diagnosis of pancreatic cancer.\n   2. Indication for pancreatic surgery or metastasis(es) carried out as part of standard care for patients with a suspicion of pancreatic cancer on radiological assessment or who already have a confirmed histological diagnosis of pancreatic cancer.\n3. Whatever the stage of the disease.\n4. Whatever the type of treatment proposed (systemic, surgery, radiotherapy, etc.).\n5. Patient who has never received systemic treatment or advanced radiotherapy.\n6. WHO 0-1-2.\n7. Life expectancy \\> 3 months.\n8. Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).\n9. Patient affiliated to a social security scheme in compliance with Article 1121-11 of the French Public Health Code.\n\nExclusion Criteria:\n\n1. Indication for biopsy for primary diagnosis of pancreatic cancer\n2. No indication for treatment of pancreatic cancer.\n3. Adjuvant\u002Fneoadjuvant chemotherapy completed less than 6 months ago in the case of patients with recurrent disease.\n4. Patient already included in the study.\n5. Geographical, social or psychological factors rendering the patient unable to undergo study monitoring and procedures.",{"count":77,"type":22},50,"OBSERVATIONAL","This is a prospective, single-centre, observational study. The analysis of samples of pancreatic tumours and\u002For metastases taken during biopsy or surgery will lead to the determination of the level of expression of convertases in patients with pancreatic cancer and could be used as an additional prognostic means reinforcing those currently used.",[81],"Pancreas Cancer",[83],"Convertases","RECRUITING",{"date":86,"type":36},"2026-04-20",{"date":88,"type":36},"2026-03-27",{"date":90,"type":22},"2029-01",{"name":42,"class":43},1,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":101,"minAge":52,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":92},"100569885","clinical-and-dosimetric-study-of-patients-treated-with-177lu-psma-617-for-prostate-cancer-100569885","NCT06700057","Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.","Optimisation and Safety of an Innovative Nuclear Medicine Treatment: Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.","DOSIPROSTATE","Inclusion Criteria:\n\n1. Patient aged 18 and over.\n2. Patient with indication for or having started or completed treatment with 177Lu-PSMA-617 since 01\u002F11\u002F2023:\n\n   1. Progressive, metastatic, castration-resistant prostate cancer,\n   2. overexpressing prostate specific membrane antigen (PSMA)\n   3. treated with taxane chemotherapy and at least one 2nd generation hormone therapy (apalutamide, enzalutamide, darolutamide, abiraterone-prednisone).\n3. Patient able to lie still for 1 hour for image acquisition.\n4. Patient's place of residence \\\u003C 2 hours' drive from the Institut Bergonié.\n5. Patient has not expressed any opposition to the use of his\u002Fher medical data for research purposes.\n\nExclusion Criteria:\n\nNone","MALE",{"count":77,"type":22},"Single-centre, retrospective and prospective observational study. This study aims to evaluate the dose delivered by radiation to the tumour and organs at risk, as a factor predicting response and the appearance of toxicities. Dosimetric calculations are made for each treatment using scintigraphic images acquired following injection of 177Lu-PSMA-617.",[105,106],"Prostate Cancer","Metastasis",[108],"Radiopharmaceutical drug","2026-01-28",{"date":111,"type":36},"2026-01-30",{"date":113,"type":36},"2023-11-01",{"date":115,"type":22},"2027-12-31",{"name":42,"class":43},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":92},"100388544","phase-3-cryoablation-in-combination-or-not-with-pembrolizumab-and-pemetrexed-carboplatin-in-1st-line-treatment-for-patients-with-metastatic-lung-adenocarcinoma-100388544","NCT04339218","Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma","Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in First-line Treatment for Patients With Metastatic Lung Adenocarcinoma: A Randomized Phase III Study","CRYOMUNE","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed non-small lung adenocarcinoma.\n2. Metastatic disease.\n3. Treatment with pembrolizumab in combination with pemetrexed-carboplatin as per market authorization.\n4. At least two target lesions (RECIST1.1), measurable with CT or MRI :\n\n   1. One target lesion that is amenable for accurate repeated measurements,\n   2. One target lesion (15-40 mm) that is amenable for cryoablation treatment including lung, kidney, adrenal, soft tissue and lytic bone lesions. Liver and sclerotic bone lesions are not allowed to be treated by cryoablation.\n5. Age ≥ 18.\n6. Performance status ≤ 2.\n7. Women of childbearing potential must have a negative serum pregnancy test prior to registration.\n8. Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia)\n9. Patients with a social security in compliance with the French law (Loi Jardé).\n10. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n11. Voluntarily signed and dated written informed consents prior to any study specific procedure.\n\nExclusion Criteria:\n\n1. Squamous cell tumors and other than adenocarcinoma.\n2. Prior systemic treatment for advanced non-small cell lung cancer (except adjuvant therapy after complete resection).\n3. Current or prior use of immunosuppressive medication including any use of oral glucocorticoids, within 21 days before the first dose of pembrolizumab.\n4. Known contra-indication and\u002For hypersensitivity to PD1\u002FPD-L1 antagonist and\u002For cytotoxic therapy.\n5. Known contra-indication to cryoablation.\n6. Abnormal coagulation contraindicating biopsy.\n7. Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma or incidentally discovered good prognosis prostate cancer (T stage \\\u003C pT3 and Gleason ≤ 7).\n8. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.\n9. Subjects who participated in an investigational drug or device study within 28 days prior to study entry.\n10. Known infection with HIV, hepatitis B, or hepatitis C.\n11. Females who are pregnant or breast-feeding.\n12. Men or women refusing contraception.\n13. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.\n14. Previous enrolment in the present study.\n15. Individuals deprived of liberty or placed under legal guardianship.",{"count":126,"type":22},214,[128],"PHASE3","This study aims to compare the one-year survival benefit of the association of cryoablation-pembrolizumab-pemetrexed-carboplatin versus pembrolizumab-pemetrexed-carboplatin in metastatic lung adenocarcinoma patients.\n\nThis is a multicenter, prospective, open-labeled, 2-arm comparative randomized (1:1) phase III trial.\n\nPatients will be randomized with a 1:1 ratio into:\n\n* Arm A (experimental arm): cryoablation of one visceral lesion or bone metastasis excluding liver and sclerotic bone metastases combined with pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization.\n* Arm B (standard arm): pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization.\n\nPembrolizumab and pemetrexed-carboplatin will be prescribed and administered at the dose recommended by market authorization.\n\nCryoablation treatment should be performed within 6 weeks after the first administration of pembrolizumab. No treatment switching permitted.",[131,132],"Lung Adenocarcinoma","Cryotherapy Effect",[134],"Lung adenocarcinoma, immunotherapy, cryoablation",{"date":111,"type":36},{"date":137,"type":36},"2020-08-28",{"date":139,"type":22},"2028-08-27",{"name":42,"class":43},{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":51,"minAge":4,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":92},"100557648","deep-learning-for-histopathological-classification-and-prognostication-of-gynaecologic-smooth-muscle-tumours-100557648","NCT06540846","Deep Learning for Histopathological Classification and Prognostication of Gynaecologic Smooth Muscle Tumours","STUMP","Inclusion Criteria:\n\n* Patients with a diagnosis of uterine smooth muscle tumors (leiomyomas, smooth muscle tumors of uncertain malignancy and leiomyosarcomas), registered in the RRePS database and\u002For treated at Institut Bergonié or one of the participating centers.\n* Histopathological material available (kerosene blocks and\u002For slides).\n* The follow-up (outcome) is required for each LMS\u002F STUMP.\n\nExclusion Criteria:\n\n* na",{"count":149,"type":22},392,"Smooth muscle tumors of the uterus that do not fit the diagnostic criteria of benignity (such as leiomyomas) or malignancy (such as leiomyosarcomas) are called STUMP (smooth muscle tumor of uncertain malignant potential). A potential solution to this problem could be the application of predictive models using artificial intelligence (AI) to aid in the histopathological classification and prognosis of gynecological smooth muscle tumors. Deep learning using convolutional neural networks represents a specific class of machine learning, in which predictive models are trained by considering small groups of pixels in digital images and iteratively identifying salient features. In this study, we aim to develop deep learning models capable of accurately subclassifying and predicting the prognosis of gynecological smooth muscle tumors, based on histopathological features of hematoxylin and eosin (H\\&E) slides. The aim is to develop a diagnostic and prognostic algorithm to help pathologists better classify and diagnose uterine smooth muscle tumors and predict their clinical course.",[152],"Stump",[154,155,156],"algorithm","diagnostic","pronostic","2026-01-13",{"date":159,"type":36},"2026-01-15",{"date":161,"type":36},"2023-12-01",{"date":163,"type":22},"2026-12",{"name":42,"class":43},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},"100269625","cinsarc-signature-and-correlation-with-hemotherapy-efficacy-in-soft-tissue-sarcomas-a-biomarker-study-100269625","NCT02789384","CINSARC Signature and Correlation With Hemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study.","Prognostic Value of the CINSARC (Complexity Index in Sarcoma) Signature and Correlation With Chemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics )","NEOSarcomics","Inclusion Criteria:\n\n1. Histologically confirmed soft-tissue sarcoma by central review, except if the diagnosis was already confirmed by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) Network,\n2. Available archived frozen tumor tissue sample or patient consenting to undergo a biopsy of the tumour for research purpose,\n3. Non-metastatic disease, for which the use of chemotherapy to \"downstage\" the sarcoma prior to surgery, is assumed to result in better local tumor control by the multidisciplinary sarcoma team of one of the French reference centers involved in this study,\n4. Age ≥ 18 years,\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,\n6. Measurable disease according to RECIST v1.1 outside any previously irradiated field,\n7. Neoadjuvant anthracycline-based chemotherapy proposed as the best option by the multidisciplinary sarcoma team of one of the French reference centers involved in this study,\n8. No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,\n9. Voluntarily signed and dated written informed consents prior to any study specific procedure,\n10. Patients with a social security in compliance with the French Law relating to biomedical research (Article 1121-11 of French Public Health Code).\n\nExclusion Criteria:\n\n1. Pathological diagnosis different from a soft-tissue sarcoma,\n2. Histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, rhabdomyosarcoma,\n3. Previous treatment for the sarcoma,\n4. Contra-indication precluding the administration of chemotherapy as assessed by the investigator,\n5. Participation to a study involving a medical or therapeutic intervention in the last 30 days,\n6. Previous enrolment in the present study,\n7. Pregnant or breast feeding women,\n8. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.",{"count":174,"type":22},205,[25],"This is a prospective observational biomarker study including patients with non-metastatic, soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option by the multidisciplinary sarcoma team of one of the participating centers.",[178],"Soft-tissue Sarcomas",[180,181,182,183,156],"soft-tissue sarcomas","CINSARC","biomarker","efficacy","2025-11-24",{"date":186,"type":36},"2025-12-02",{"date":188,"type":36},"2016-06",{"date":190,"type":22},"2027-12",{"name":42,"class":43},10,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":101,"minAge":52,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":205,"conditions":206,"keywords":207,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":192},"100465909","phase-2-randomized-phase-ii-trial-on-short-term-darolutamide-concomitant-to-radiation-therapy-for-patients-with-intermediate-unfavorable-risk-prostate-cancer-100465909","NCT05346848","Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer","A Randomized Non-comparative Phase II Multicentric Trial on Short Term Darolutamide (ODM-201) Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer","DARIUS","Inclusion Criteria:\n\n1. Age ≥ 18,\n2. Histological diagnosis of prostate malignancy cancer\n3. Cancer without loco-regional or distant metastasis (tumor assessment must comprise at least Pelvic MRI AND thoraco-abdomino-pelvic contrast-enhanced CT-Scan AND Bone Scintigraphy. (Note that additional assessment by PET-Scan is allowed as per investigator judgement),\n4. Unfavorable intermediate risk prostate cancer diagnosis defined by the NCCN Guidelines.\n\n   One of the following criteria is sufficient to define an unfavorable intermediate risk prostate cancer:\n   * Gleason = 7 (4+3)\n   * ≥ 50% of thecore of biopsies need to be positive for adenocarcinoma\n\n   If these criteria are not being identified, two or three of the following criteria are necessary to define unfavorable intermediate risk prostate cancer:\n   * PSA value between 10-20 ng\u002Fml\n   * Gleason 7 (3+4) or 6\n   * T2b (clinical or radiological) Note: patients with iT3a can be included only if gleason score is 6 and PSA less than 20 .\n5. Patients newly diagnosed with an unfavorable intermediate risk prostate cancer according to the protocol criteria or previously diagnosed with low risk (Gleason score \\\u003C 6, clinical stage \\\u003C T2a, and PSA\\\u003C 10) prostate cancer progressing to eligible risk disease according to the protocol criteria within 30 days before registration\n6. Patients must have a life expectancy of at least 5 years,\n7. Performance status ECOG ≤ 2,\n8. Patients without contra-indications to EBRT as per physician judgement,\n9. Patients with adequate organ function defined by all the following laboratory values\n10. Available archived paraffin-embedded tumor sample for research purpose,\n11. Patients with a social security in compliance with the french law,\n12. Voluntary signed and dated written informed consent prior to any study specific procedure,\n13. Men must agree to use an effective method of contraception throughout the treatment period and for one week after discontinuation of treatment.\n\nExclusion Criteria:\n\n1. Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation,\n2. Patients with Gleason score ≥8,\n3. Patients with PSA \\>20 ng\u002Fml,\n4. Presence of loco-regional or distant metastasis,\n5. Contra-indications to MRI and to contrast-enhanced CT-scan,\n6. Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng\u002FdL or below the normal range for the institution.\n7. Previous prostate cancer treated by androgen deprivation, chemotherapy, surgery, or radiotherapy,\n8. Patients with previous orchiectomy\n9. Patients actively receiving or having received within 6 months prior enrollment any concurrent androgens, anti-androgens, estrogens, or progestational agents,\n10. Patients having received ketoconazole, finasteride or dutasteride within 30 days of inclusion,\n11. Previous and current malignancies other than prostate cancer within the last 5 years with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, acute lymphoblastic leukemia, non-muscle invasive bladder cancer,\n12. Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection),\n13. History of cerebrovascular accident (within the last 6 months)\n14. Impaired cardiac function as defined in the Protocol\n15. Uncontrolled hypertension\n16. Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of study drug,\n17. Major surgery within 4 weeks prior enrolment except pelvic lymph-nodes dissection,\n18. Known hypersensitivity to any involved study drug or of its formulation components, to natural gonadotrophin releasing hormone or its analogues\n19. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome\n20. Men who are not using an effective method of contraception as previously described\n21. Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES,\n22. History of non-compliance to medical regimens or inability to grant consent,\n23. Patient unable to follow and comply with the study procedures because of any geographical, social or psychpsychological reasons,\n24. Individuals under judicial protection or deprived of liberty.\n25. Inability to swallow or to give subcutaneous or intramuscular injections.",{"count":202,"type":22},62,[204],"PHASE2","Randomized non-comparative phase II trial to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer.",[105],[208,209,210],"unfavorable intermdiate risk prostate cancer","androgen deprivation therapy","radiation therapy","2025-10-01",{"date":213,"type":36},"2025-10-02",{"date":215,"type":36},"2023-02-24",{"date":217,"type":22},"2030-02",{"name":42,"class":43},{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":236,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":244,"locationsCount":192},"100453255","phase-2-combination-of-pembrolizumab-and-cabozantinib-in-patients-with-advanced-sarcomas-100453255","NCT05182164","Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas","PEMBROCABOSARC","Inclusion Criteria:\n\n1. Histology: undifferentiated pleomorphic sarcoma (stratum 1), bone osteosarcoma (stratum 2), bone or extraskeletal or Ewing sarcoma (stratum 3),\n2. Advanced non resectable \u002F metastatic disease,\n3. Recurrent disease or progression after standard therapy,\n4. Documented progression according to RECIST criteria.\n5. Have provided tissue of a tumor lesion from \\\u003C 3 months old archival tissue sample obtained on locally advanced disease, or metastatis with no subsequent treatment since or from a newly obtained core or excisional biopsy,\n6. No more of three previous lines of systemic therapy for advanced disease,\n7. Age ≥ 18 years,\n8. Eastern Cooperative Oncology Group ≤ 1,\n9. Measurable disease according to RECIST v1.1 outside any previously irradiated field. At least one site of disease must be uni-dimensionally ≥ 10 mm,\n10. Life expectancy \\> 3 months,\n11. Participant must have advanced disease and must not be a candidate for other approved therapeutic regimen known to provide significant clinical benefit based on investigator judgement,\n12. No symptomatic central nervous system disease,\n13. No chronic use of glucocorticoids.\n14. Adequate hematological, renal, metabolic and hepatic function,\n15. No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,\n16. At least three weeks since last chemotherapy, immunotherapy and two weeks for any other pharmacological treatment and\u002For radiotherapy,\n17. Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment (excluding alopecia of any grade, non-painful peripheral neuropathy grade ≤ 2 and endocrine-related grade ≤ 2 requiring treatment or hormone replacement) (according to NCI-CTCAE, version 5.0). For patients previously treated by radiotherapy, they must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis,\n18. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication. Both women and men must agree to use 2 medically acceptable methods of contraception throughout the treatment period and for 6 months after discontinuation of treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥ 1 year,\n19. Voluntary signed and dated written informed consents prior to any specific study procedure,\n20. Patients with a social security in compliance with the French Law.\n\nExclusion Criteria:\n\n1. Previous treatment with Pembrolizumab or Cabozantinib,\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumabor any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways),\n3. Evidence of progressive or symptomatic central nervous system or leptomeningeal metastases,\n4. Men or women of childbearing potential who are not using an effective method of contraception; women who are pregnant or breast feeding, men or women who are planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment,\n5. Participation to a study involving a medical or therapeutic intervention in the last 21 days,\n6. Previous enrolment in the present study,\n7. Patient unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons,\n8. Patient unable to swallow,\n9. Known hypersensitivity to any involved study drug or of its formulation components,\n10. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy is not considered a form of systemic treatment and is allowed.\n11. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment,\n12. History of idiopathic pulmonary fibrosis, history of non-infectious pneumonitis that required steroids, current pneumonitis\u002Finterstitial lung disease, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted,\n13. Has 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.\n14. Has a known history of HIV infection and\u002For of active TB (Bacillus Tuberculosis),\n15. Treatment with anticoagulants such as anti-Vitamin K, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel),\n16. Previous allogenic bone marrow transplant or solid organ transplantation,\n17. Has an active infection requiring systemic treatment at study entry,\n18. The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms within 28 days before treatment. Note: if initial QTcF is found to be \\> 500 ms, two additional ECGs separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is ≤ 500 ms, the subject meets eligibility in this regard,\n19. The subject requires chronic concomitant treatment of strong CYP3A4 inducers\n20. The subject has experienced any of the following: Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment, Hemoptysis of ≥ 2.5 mL of red blood within 3 months before the first dose of study treatment, Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment, The subject has radiographic evidence of cavitating pulmonary lesion(s), The subject has tumor in contact with, invading or encasing any major blood vessels, or The subject has evidence of tumor invading the GI tract, or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib.\n21. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions which are fully described in the study protocol: Cardiovascular disorders, Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation, Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy,\n22. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n23. Has an history or current evidence of any condition, therapy, or laboratory abnormality that might counfound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n24. The subject is planning to have oral surgery\u002Finvasive dental procedure within the projected duration of the study, starting with the screening visit through 3 months after the last dose of study treatment or had such a procedure within 3 months of first dose of study treatment.",{"count":227,"type":22},119,[204],"Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.",[231,232,233,234,235],"Soft Tissue Sarcoma Adult","Advanced Soft-tissue Sarcoma","Ewing Sarcoma","Osteosarcoma","Undifferentiated Pleomorphic Sarcoma",[237,238],"soft-tissue sarcoma","immune checkpoint inhibitor",{"date":240,"type":36},"2025-10-07",{"date":242,"type":36},"2022-04-25",{"date":190,"type":22},{"name":42,"class":43},{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":255,"briefSummary":256,"conditions":257,"keywords":260,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},"100382323","circulating-dna-to-improve-outcome-of-oncology-patient-a-randomized-study-100382323","NCT04258137","Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study","Circulating DNA to Improve Outcome of Oncology PatiEnt: A Randomized Study - COPE Study","COPE","Inclusion Criteria:\n\n1. Age ≥ 18 years,\n2. Histology: colorectal cancer, non-small cell lung cancer,\n3. Locally advanced\u002Funresectable and\u002For metastatic solid tumor,\n4. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 2 (Appendix 1),\n5. Measurable disease according to RECIST 1.1 (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1). At least one site of disease must be uni-dimensionally \\> 10 mm,\n6. No previous systemic treatment for advanced disease,\n7. Availability of suitable paraffin embedded (FFPE) archive tumor material or at least one target lesion that can be biopsied for research purpose,\n8. Eligible to first-line systemic therapy,\n9. Patient with a social security in compliance with the French law,\n10. Voluntary signed and dated written informed consent prior to any study specific procedure.\n\nExclusion Criteria:\n\n1. Inability to swallow,\n2. Major problem with intestinal absorption,\n3. Previous allogeneic bone marrow transplant,\n4. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer,\n5. Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV),\n6. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol,\n7. Individuals deprived of liberty or placed under guardianship,\n8. Pregnant or breast feeding women,\n9. Previous enrolment in the present study,\n10. Any contraindication to first-line systemic therapy.",{"count":254,"type":22},332,[25],"COPE is a biology driven protocol with 2 independent, multicentric, two-arm non-comparative randomized (2:1) phase II trials in 2 distinct populations: colorectal cancer patients and non-small-lung cancer patients.\n\nFor each phase II trial, patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B:\n\n* Arm A (Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis)\n* Arm B (Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging).",[258,259],"Colorectal Cancer","Non Small Cell Lung Cancer",[261,262,263,264],"advanced","metastatic","liquid biopsy","genetic profiling",{"date":213,"type":36},{"date":267,"type":36},"2020-09-04",{"date":269,"type":22},"2027-12-01",{"name":42,"class":43},6,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":290,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":300,"locationsCount":301},"100356029","phase-2-atezolizumab-combined-with-bdb001-and-immunogenic-radiotherapy-in-patients-with-advanced-solid-tumors-100356029","NCT03915678","Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors","AGADIR","Inclusion criteria:\n\n1. histologically confirmed pancreatic cancer, virus-associated tumors \\[including papillomaviruses-related cancers (cervical, head and neck, and nasal), Epstein-Barr virus (nasopharyngeal carcinoma) and Kaposi's sarcoma-associated herpes virus), non-small cell lung cancer, soft-tissue sarcomas, bladder cancer, triple negative breast cancer. For population 4, diagnosis must be confirmed by the RRePS Network as recommended by the French NCI. For population 2, papillomavirus-related cancers must be eligible whatever the genotype but in case of viral genotype is not available, IHC p16 positive must be provided, hepatocellular carcinoma must be confirmed by Hepatite B or C infection, HHV-8 and Epstein-Barr virus related cancers must be confirmed by molecular analysis,\n2. Metastatic disease,\n3. Age ≥ 18 years,\n4. ECOG ≤ 1,\n5. At least two lesions: one extra cerebral lesion that can be treated by radiotherapy and one site of disease that must be uni-dimensionally ≥ 10 mm considered as measurable according to RECIST v1.1. This lesion will not be treated by radiotherapy, however, note that lesion(s) that will be treated by radiotherapy will also be considered as measurable. Note that the largest size of the metastases to be irradiated will be 3cm and at that previous irradiation of these lesions is not allowed,\n6. Life expectancy \\> 6 months,\n7. At least one tumor site that can be biopsied for research purpose. Tumor lesion in close proximity to vascular structures such as large vessels, aneurysm or pulmonary arteriovenous malformation will not be considered for biopsy,\n8. Availability of archived paraffin-embedded tumor tissue for research purpose,\n9. Participant must have advanced disease and must not be a candidate for other approved therapeutic regimen known to provide significant clinical benefit based on investigator judgement,\n10. Participants who received prior anti-PD-1\u002FL1 therapy must fulfill the following requirements - population 3 and population 5 only\n\n    * Have achieved a complete response, partial response or stable disease and subsequently had disease progression while still on anti-PD-1\u002FL1 therapy\n    * Have received at least two doses of an approved anti-PD-1\u002FL1 therapy (by any regulatory authority)\n    * Have demonstrated disease progression as defined by RECIST v1.1 within 18 weeks from the last dose of the anti- PD-1\u002FL1 therapy.\n11. Adequate hematological, renal, metabolic and hepatic functions\n12. No prior or concurrent malignant disease needing an active treatment,\n13. At least three weeks since last chemotherapy, immunotherapy or any other pharmacological treatment and\u002For radiotherapy,\n14. Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment, excluding alopecia of any grade and non-painful peripheral neuropathy grade ≤ 2,\n15. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to inclusion.\n16. Both women and men must agree to use an effective method of contraception throughout the treatment period and for five months after discontinuation of treatment.\n17. Voluntary signed and dated written informed consents prior to any specific study procedure,\n18. Participants with a social security in compliance with the French law.\n\nExclusion criteria:\n\n1. Previous treatment with a TLR agonist\n2. Evidence of progressive or symptomatic central nervous system (CNS) or leptomeningeal metastases,\n3. Women who are pregnant or breast feeding,\n4. Participation in a study involving a medical or therapeutic intervention in the last 30 days,\n5. Known hypersensitivity to CHO cell products or to any involved study drug or of its formulation components,\n6. History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins,\n7. Treatment with systemic immunosuppressive medications including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to inclusion.\n8. Major surgical procedure, open biopsy or significant traumatic injury within 28 days before inclusion,\n9. Any of the following cardiac criteria: congestive heart failure ≥ New York Heart Association (NYHA) class 2, unstable angina, new-onset angina, myocardial infarction less than 6 months before inclusion, uncontrolled cardiac arrhythmias, known left ventricular ejection fraction (LVEF) \\\u003C50%, previously experience of pericardial disorder\n10. Individuals deprived of liberty or placed under legal guardianship,\n11. Prior organ transplantation, including allogeneic stem cell transplantation,\n12. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver and inherited liver disease,\n13. History of intra-abdominal inflammatory process within the last 12 months such as, but not limited to, diverticulitis, peptic ulcer disease or colitis.\n14. History of autoimmune disease including, but not limited to systemic lupus erythematosus (SLE), Sjögren's syndrome, glomerulonephritis, multiple sclerosis, rheumatoid arthritis, vasculitis, systemic immune activation, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Guillain-Barré syndrome, Bell's palsy.\n15. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n16. Poorly controlled Type II diabetes mellitus defined as a screening fasting plasma glucose ≥160 mg\u002FdL (or 8.8 mmol\u002FL).\n17. Severe infections within 2 weeks prior to inclusion, including but not limited to SARS-Cov-2 infection, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n18. Received therapeutic oral or IV antibiotics within 2 weeks prior to inclusion.\n19. Participant has spinal cord compression not definitively treated with surgery and\u002For radiation or previously diagnosed and treated spinal cord compression without evidence that disease is clinically stable at least 14 days prior to inclusion.\n20. Administration of a live, attenuated vaccine within 4 weeks before the start of study medication .\n21. Has known active hepatitis B or hepatitis C,known history of Human Immunodeficiency or known acquired immunodeficiency syndrome, known history of tuberculosis\n22. Patients with current retinal disorder confirmed by retinal examination (external ocular examination, routine slit lamp biomicroscopy of anterior ocular structures and evaluation of the anterior and posterior chamber,\n23. Patients who wear contact lenses unable to replace them with glasses.",{"count":280,"type":22},247,[204],"Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.",[284,285,286,259,287,288,289],"Solid Tumor, Adult","Pancreatic Cancer","Virus-associated Tumors","Melanoma","Bladder Cancer","Triple Negative Breast Cancer",[291,292,293,294],"Immunotherapy","Radiotherapy","Oncology","Metastatic",{"date":296,"type":36},"2025-10-06",{"date":298,"type":36},"2021-03-31",{"date":190,"type":22},{"name":42,"class":43},11,{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":317,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":326,"locationsCount":192},"100347536","phase-3-benefit-of-intensified-peri-operative-chemotherapy-within-high-risk-cinsarc-patients-with-resectable-soft-tissue-sarcomas-100347536","NCT03805022","Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas","Phase III Trial Investigating the Potential Benefit of Intensified Peri-operative Chemotherapy With in High-risk CINSARC Patients With Resectable Soft-tissue SARComas","CIRSARC","Inclusion Criteria :\n\n1. Histologically confirmed soft-tissue sarcoma by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network, as recommended by the French NCI,\n2. Grade 2 or 3 according to the FNCLCC grading system,\n3. Available archived tumour sample for research purpose,\n4. Non-metastatic and resectable disease,\n5. No prior treatment for the disease under study,\n6. Age ≥ 18 years,\n7. Life expectancy ≥ 3 months,\n8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,\n9. Patients must have measurable disease (lesion in previously irradiated field can be considered as measurable if progressive at inclusion according to RECIST 1.1) defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm or ≥ 15mm in case of adenopathy,\n10. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for one year after discontinuation of treatment. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier. Subjects of childbearing potential are those who have not been surgically sterilized (e.g., vasectomy for males and hysterectomy for females) or have not been free from menses for ≥ 1 year,\n11. Voluntarily signed and dated written informed consents prior to any study specific procedure,\n12. Patients with a social security in compliance with the French law.\n\nExclusion Criteria :\n\n1. Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clearcell sarcoma, embryonal and alveolar rhabdomyosarcoma,\n2. Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,\n3. Any other contraindication to anthracycline, ifosfamide or dacarbazine chemotherapy,\n4. Participation to a study involving a medical or therapeutic intervention in the last 28 days,\n5. Known infection with HIV, hepatitis B, or hepatitis C,\n6. Females who are pregnant or breast-feeding,\n7. Other medical conditions may interfere with the conduct of the study and, in the judgment of the investigator, would make the patient inappropriate for entry into this study,\n8. Individuals deprived of liberty or placed under legal guardianship,\n9. Unwillingness or inability to comply with the study protocol for any reason.\n\nAdditional criteria for randomization :\n\n1. High-risk CINSARC signature,\n2. No more than two cycle of neo-adjuvant anthracycline-based chemotherapy before randomization.",{"count":311,"type":22},351,[128],"The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +\u002F- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).",[315,316],"Non-metastatic Soft-tissue Sarcoma","Resectable",[318,319,320,316,321],"Solid tumor","Phase III trial","Soft-tissue sarcoma","Non-metastatic",{"date":213,"type":36},{"date":324,"type":36},"2019-02-14",{"date":40,"type":22},{"name":42,"class":43},{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":340,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":92},"100313182","circulating-tumor-dna-after-neoadjuvant-chemotherapy-100313182","NCT03357120","Circulating Tumor DNA After Neoadjuvant Chemotherapy","Detection of Circulating Tumoral DNA Mutations (Sequential Assessment) Following Neoadjuvant Chemotherapy for Breast Cancer: Clinical Validity (ALIENOR Study)","ALIENOR","Inclusion Criteria :\n\n1. Age ≥ 18 years (no age limit).\n2. Women or men.\n3. Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy):\n\n   1. Locally advanced tumor known to be inoperable from the start:\n\n      * cT4a, b, c, d whatever the cN\n      * or cN2 or cN3 whatever the cT.\n   2. Operable tumors:\n\n      * cT2cN1 or cT3cN0 or cT3N1,\n      * or cT2cN0 for which ganglionic invasion has been proven by cytology or histology.\n4. Lack of clinically or radiologically detectable metastases in the initial diagnosis before the neoadjuvant chemotherapy (M0).\n5. Unilateral or bilateral breast cancer. Multifocality is accepted.\n6. Patients who received 6 to 8 cycles of neoadjuvant chemotherapy.\n7. Preoperative radiation therapy allowed.\n8. Breast surgery performed and pathology report of a non-complete histological response (i.e. all the different results of ypT0 \u002Fis ypN0).\n9. Signed informed consent.\n10. Patients affiliated to a French social security scheme in accordance with Article 1121-11 of the French Code of Public Health.\n11. Possible inclusion in another interventional research (surgical, radiotherapy or drug study).\n\nExclusion Criteria :\n\n1. cT2cN0 tumor without cytological or histological lymph node involvement.\n2. Progression during neoadjuvant chemotherapy.\n3. Exclusive neoadjuvant hormone therapy.\n4. Complete blood transfusion within 120 days prior to 1st sampling.\n5. History of invasive cancer regardless of the time elapsed since the diagnosis of this cancer, including a history of contralateral invasive breast cancer. However, patients who have been treated for in situ breast cancer, basocellular skin cancer or cervical cancer treated in situ are eligible.\n6. Patient unable to follow and comply with research procedures for geographical, social or psychological reasons.\n7. Patient deprived of liberty or subject to a legal protection measure.",{"count":336,"type":22},180,[25],"Trial assessing the prognostic value of ctDNA mutations from samples taken sequentially in patients with invasive breast cancer initially treated with neoadjuvant chemotherapy and whose tumor is not in complete histological response.",[31],[31,341,342],"Neoadjuvant chemotherapy","Circulating tumor DNA",{"date":213,"type":36},{"date":345,"type":36},"2017-10-06",{"date":347,"type":22},"2028-10",{"name":42,"class":43},{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":23,"phases":359,"briefSummary":360,"conditions":361,"keywords":363,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":92},"100312067","high-intensity-focused-ultrasound-treatment-of-breast-tumors-brifu-study-100312067","NCT03342625","High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study","High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study (Breast Resection By HIFU)","BRIFU","Inclusion Criteria :\n\n1. Histologically proven infiltrating ductal carcinoma with the analysis of hormone receptors, tumor grade, Her-2 expression.\n2. T0 lesion, unifocal or plurifocal, with or without micro-calcifications associated, measuring 15 mm maximum major axis on ultrasound.\n3. Clinical N0.\n4. Bra cup size greater than or equal to B.\n5. Markable and identifiable lesion in MRI.\n6. Indication of partial or total mastectomy in case of multifocal lesions or extensive calcification associated with axillary surgery.\n7. Breast assessment performed by a referent radiologist: Mammography, ultrasound, clinical examination.\n8. No contraindication to MRI.\n\nExclusion Criteria :\n\n1. Infiltrating lobular carcinoma and Pure ductal carcinoma in situ.\n2. Bilateral lesion.\n3. Non-detectable MRI lesions, within 10 mm of the skin, greater than 15 mm on ultrasound.\n4. Unifocal palpable tumor.\n5. Cup size bra equal to A.\n6. Cutaneous lesion on the breast to be treated by HIFU.\n7. Impossibility of ventral decubitus immobility, extended arm, during 1 hour.\n8. Pregnant or postpartum patient.\n9. Patient participating in another interventional clinical trial within 30 days of enrollment and during the trial.",{"count":358,"type":22},15,[25],"Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.",[362],"Breast Cancer Female",[364],"High intensity focused ultrasound",{"date":213,"type":36},{"date":367,"type":36},"2018-06-07",{"date":369,"type":22},"2027-01",{"name":42,"class":43},{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":385,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":395},"100250123","bergonie-institut-profiling--fighting-cancer-by-matching-molecular-alterations-and-drugs-in-early-phase-trials-100250123","NCT02534649","Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials","BIP","Inclusion Criteria:\n\n1. Age ≥ 18 years,\n2. Histology: solid malignant tumor or hematological malignancy,\n3. Deleted MSA9\n4. Deleted MSA9,\n5. Deleted MSA9,\n6. Deleted MSA9,\n7. Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code),\n8. Voluntary signed and dated written informed consent prior to any study specific procedure.\n\nExclusion Criteria:\n\n1. Deleted MSA9\n2. Deleted MSA9\n3. Deleted MSA9\n4. Deleted MSA9\n5. Deleted MSA9\n6. Deleted MSA9\n7. Deleted MSA9\n8. Deleted MSA9\n9. Individuals deprived of liberty or placed under guardianship\n10. Pregnant or breast feeding women,\n11. Previous enrolment in the present study.",{"count":379,"type":22},10000,[25],"This is a biology driven, monocentric study designed to identify actionable molecular alterations in cancer patients with advanced disease.\n\nIn this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling.\n\nPatients included in the BIP study and for whom a targetable genomic alteration had been identified might be subsequently included in an early phase trials running at Institut Bergonie or another French hospital.",[383,384],"Solid Tumor","Hematological Malignancy",[386,387,388],"Molecular profiling","Genomic alteration","Advanced cancer",{"date":213,"type":36},{"date":391,"type":36},"2015-12",{"date":393,"type":22},"2029-12",{"name":42,"class":43},7,{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":4,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":404,"conditions":405,"keywords":406,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":92},"100277625","bergonie-institute-breast-cancer-database-100277625","NCT02893761","Bergonie Institute Breast Cancer Database","Inclusion Criteria:\n\n* Breast cancer\n* Aged 18 years and over\n* First treatment at Bergonie Institute\n\nExclusion Criteria:\n\n\\-",{"count":403,"type":22},30000,"A database of breast cancer patients was established at Institute Bergonié since the 90s , to assess patients' survival, assess practice, search for prognostic factors.",[31],[407,408],"breast cancer","survival","2025-09-22",{"date":411,"type":36},"2025-09-23",{"date":413,"type":36},"1990-01",{"date":415,"type":22},"2050-12",{"name":42,"class":43},{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":425,"targetDuration":427,"studyType":78,"phases":4,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":442},"100360815","national-clinical-and-biological-sarcoma-database--an-initiative-of-the-french-sarcoma-group-100360815","NCT03978039","National Clinical and Biological Sarcoma Database : An Initiative of the French Sarcoma Group","The \"BCB-sarcomes\" Database: the Database of the French Sarcoma Group Dedicated to the Collection of Clinical and Biological Data for All Sarcomas","BCB-Sarcomes","Inclusion criteria :\n\n* Diagnosis of sarcoma\n* Diagnosis in a French Comprehensive Cancer Center\n* Any age",{"count":426,"type":22},150000,"10 Years","The BCB SARCOMES database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (French expert network dedicated to the management of bone sarcomas \\[RESOS\\] \u002F French expert network dedicated to the pathology of sarcomas \\[RREPS\\]), dedicated to systematic review of mesenchymal tumor diagnostics nationwide; the second is clinical (RESOS \u002F French expert clinical network for sarcomas \\[NETSARC\\]), collecting multidisciplinary tumor boards (MDTB) data of patients nationwide, and the third (CONTICABASE \u002F BONE \u002F GIST) is dedicated to collecting patients longitudinal\u002Ffollow up data, with a focus on treatments of every events, and a catalogue of associated samples.\n\nPrimary objectives of BCB-SARCOMES are the following: description of the patterns of care and treatment outcomes, assessment of the prognostic factors of patients' outcomes.\n\nWith the financial support of the French National Cancer Institute \\[Institut National du cancer \\[INCa\\]).",[28],[431,432,408,433],"patterns of care","access to care","experts' network","2025-08-28",{"date":436,"type":36},"2025-09-04",{"date":438,"type":36},"2010-01-01",{"date":440,"type":22},"2035-12-31",{"name":42,"class":43},3,{"id":444,"slug":445,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":23,"phases":453,"briefSummary":454,"conditions":455,"keywords":457,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":92},"100507551","phase-2-medi5752-in-patients-with-mature-tertiary-lymphoid-structures-solid-tumors-100507551","NCT05888857","MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.","A Multicentric Phase II Trial Evaluating MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.","TAYLOR","Inclusion Criteria:\n\n1. Histologically confirmed solid tumor\n2. IO-naïve patients (cohort A) OR patients with secondary resistance to PD1\u002FPDL1 inhibitors (cohort B),\n3. Patients in cohort B:\n\n   1. have to be diagnosed previously treated with PD-L1\u002FPD-1 inhibitors (investigational or approved),\n   2. must have experienced initial clinical benefit (stable disease or better) from checkpoint inhibitor therapy for at least 4 months in which there was at least one interval scan prior to 4 months demonstrating no progression of disease.\n4. Presence of mature tertiary lymphoid structures (TLS) by IHC as described in protocol section 3.2.4. Except if presence of TLS has been already confirmed by Biopathological platform at Bergonié Institute, presence of TLS should be confirmed by central review based on FFPE tumor tissue sample,\n5. Advanced unresectable or metastatic solid disease,\n6. Measurable disease according to RECIST v1.1\n7. At least one tumor site that can be biopsied for research purpose,\n8. Age ≥ 18 years,\n9. Body weight \\> 35 kg,\n10. ECOG ≤ 1,\n11. Life expectancy \\> 3 months,\n12. Adequate hematological, renal, metabolic, hepatic and cardiac functions:\n13. Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment. Note that no more than three lines of systemic treatment for metastatic disease are allowed and that patients with oncogenic addiction must have progressed on prior approved regimens),\n14. Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia of any grade (according to the NCI-CTCAE, version 5.0),\n15. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry.\n16. Women and men must agree to use at least one medically highly effective method of contraception from screening, throughout the treatment period\n17. Voluntary signed and dated written informed consents prior to any specific study procedure,\n18. Patients with a social security in compliance with the French law.\n\nExclusion Criteria:\n\n1. Any anticancer treatment within 21 days or 5 half-lives (whichever is shorter) prior to start of study treatment,\n2. Whole brain radiotherapy within 14 days prior to start of study treatment,\n3. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.\n4. Stereotactic radiosurgery within 7 days prior to start of study treatment,\n5. Major surgery within 4 weeks prior to start of study treatment or still recovering from prior surgery\n6. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding,\n7. History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study\n8. Prior or concurrent malignant disease\n9. Any prior Grade ≥ 3 imAE while receiving immunotherapy or any unresolved imAE \\> Grade 1\n10. For subjects who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 : Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy, must not have experienced a ≥ grade 3 imAE or an immune-related neurologic or ocular AE of any grade while receiving prior immunotherapy, must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, must not have experienced recurrence of an AE if rechallenged, and must not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day\n11. Symptomatic or actively progressing central nervous system metastases.\n12. History of leptomeningeal disease or cord compression\n13. Uncontrolled or symptomatic hypercalcemia\n14. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n15. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiomyopathy of any etiology, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, history of myocardial infarction within the past 12 months, cardiac arrhythmia, ILD, serious chronic gastrointestinal conditions associated with diarrhea,\n16. Cerebrovascular accident within 6 months prior to enrolment,\n17. Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.\n18. Active or history of autoimmune disease immune deficiency or inflammatory disorders, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, sarcoidosis syndrome, rheumatoid arthritis, hypophysitis, uveitis, inflammatory bowel disease, diverticulitis antiphospholipid antibody syndrome, Wegener granulomatosis, Graves'disease, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis,\n19. History of idiopathic pulmonary fibrosis, organizing pneumonia drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening CT scan.\n20. Evidence of the following infections: active infection including tuberculosis, HIV, active hepatitis B or C or A\n21. Any contraindication to biopsy for the research,\n22. Participation to a study involving a medical or therapeutic intervention in the last 30 days,\n23. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,\n24. Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia,\n25. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment.\n26. Prior allogeneic stem cell or solid organ transplantation,\n27. Treatment with a live, attenuated vaccine within 30 days prior to initiation of study treatment\n28. Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic Immunosuppressive medication during study treatment,\n29. History of severe allergic anaphylactic reaction to chimeric or humanized antibodies or fusion proteins,\n30. Known hypersensitivity to Chinese hamster ovary cell products, to any component of the MEDI5752 formulation or to any human globulin therapy.",{"count":452,"type":22},102,[204],"Multicentric, prospective, multi-indication, single-treatment arm, open-label phase II trial assessing the efficacy of MEDI5752",[456],"Advanced Solid Tumor",[458,459,460],"tertiary lymphoid structure","solid tumor","immunotherapy","2025-08-11",{"date":463,"type":36},"2025-08-13",{"date":465,"type":22},"2025-09",{"date":467,"type":22},"2028-09",{"name":42,"class":43},{"id":470,"slug":471,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":23,"phases":479,"briefSummary":480,"conditions":481,"keywords":483,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":491},"100429610","phase-2-bintrafusp-alfa-and-doxorubicin-hydrochloride-in-treating-patients-with-advanced-sarcoma-100429610","NCT04874311","Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma","Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST Study","TRUST","Inclusion Criteria:\n\n1. Histologically confirmed soft-tissue sarcoma with unknown translocation (including the following histologies but not limited to undifferentiated pleomorphic sarcomas, dedifferentiated liposaromas or leiomyosarcomas). Diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de référence en pathologie des sarcomes et des viscères) as recommended by the French NCI (Institut National du Cancer, Inca).\n2. Metastatic or unresectable locally advanced disease,\n3. No previous systemic treatment for advanced\u002Fmetastatic disease,\n4. For TLS status: available archived FFPE (Formalin-Fixed Paraffin-Embedded) tumor tissue sample or tumor material newly obtained by biopsy. Except if TLS analysis have been already performed by Biopathological platform at Bergonié Institute, presence or absence of TLS should be confirmed by central review based on FFPE tumor tissue sample (archived or newly obtained by biopsy for research purpose),\n5. Age ≥ 18 years,\n6. ECOG ≤ 1,\n7. Life expectancy \\> 3 months,\n8. Patients must have measurable disease defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension as \\> 10 mm with spiral CT scan.,\n9. Patient must comply with the collection of tumor biopsies and biomarkers study. Tumors must be accessible for biopsy,\n10. Adequate hematological, renal, metabolic and hepatic function\n11. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization. Serum or urine pregnancy test must be repeated within 72 hours prior to receiving the first dose of study medication,\n12. Both women and men must agree to use a highly effective method of contraception throughout the treatment period and for at least two months after discontinuation of treatment for women and four months for men.\n13. No prior or concurrent malignant disease diagnosed or treated in the last 3 years except for superficial\u002Fnon-invasive bladder cancer, or basal or squamous cell carcinoma in situ treated with curative intent; b. endoscopically resected GI cancers limited to the mucosal layer without recurrence in \\> 1 year,\n14. Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia and vitiligo of any grade and non-painful peripheral neuropathy grade ≤ 2) according to to NCI-CTCAE, version 5.0,\n15. Voluntarily signed and dated written informed consent prior to any study specific procedure,\n16. Patients with a social security in compliance with the French law.\n\nExclusion Criteria:\n\n1. Previous treatment with doxorubicin, daunorubicin, epirubicin, idarubicin and\u002For any other anthracyclines or anthracediones at the maximum cumulative dose or any approved or investigational treatment targeting PD1, PD-L1 or TGFB1,\n2. Known central nervous system malignancy (CNS),\n3. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding,\n4. Participation to a study involving a medical or therapeutic intervention in the last 30 days,\n5. Previous enrolment in the present study,\n6. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,\n7. Known hypersensitivity to any involved study drug or any of its formulation components,\n8. Any history of anaphylaxis, or recent, within 5 months, history of uncontrollable asthma,\n9. Individuals deprived of liberty or placed under legal guardianship,\n10. Any of the following cardiac criteria:\n\n    1. Mean resting corrected QT interval (QTcF) ≥ 470 msec, obtained from three consecutive ECGs,\n    2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG,\n    3. LVEF ≤ 50% per CTCAE v5 by MUGA or echocardiogram\n    4. Any factors increasing the risk of QTc prolongation or arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years old or any concomitant medication known to prolong the QT interval,\n    5. Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris, uncontrolled hypertension, congestive heart failure NYHA Grade ≥2, ventricular arrhythmias requiring continuous therapy, supraventricular arrhythmias including atrial fibrillation, which are uncontrolled, haemorrhagic or thrombotic stroke, including transient ischaemic attacks, cerebral vascular accident\u002Fstroke or any other central nervous system bleeding\n11. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:\n12. History of bleeding diathesis or recent major bleeding event ,\n13. Prior organ transplantation including allogenic stem-cell transplantation, except transplants that do not require immunosuppression,\n14. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection requiring systemic therapy, drug-induced interstitial lung disease or subject has had a history of drug-induced pneumonitis that has required oral or IV steroids, and\u002For other diseases, which in the opinion of the investigator might impair the subject's tolerance for the study or ability to consistently participate in study procedures,\n15. Active infection including tuberculosis ,\n16. Has known active hepatitis B or hepatitis C,\n17. Has a known history of Human Immunodeficiency Virus infection,\n18. Receipt of live attenuated vaccine within 30 days prior to the first dose of treatment. Note: Patients, if enrolled, should not receive live vaccine within 30 days prior to the first dose of treatment, whilst receiving study treatments and up to 30 days after the last dose. Seasonal flu vaccines that do not contain a live virus are permitted,\n19. Patients with current or history of deep vein thrombosis within 6 months prior to randomization,\n20. Any contraindication to biopsy for the research,\n21. Any other contraindication to Doxorubicin administration,.\n22. Patients with oral anticoagulation therapy based on Vitamin K antagonist.\n23. Prior mediastinal radiation.",{"count":478,"type":22},80,[204],"This study encompasses two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin",[232,482],"Metastatic Soft-tissue Sarcoma",[458,237,484,460],"advanced\u002Fmetastatic",{"date":463,"type":36},{"date":487,"type":36},"2022-03-01",{"date":489,"type":22},"2027-07",{"name":42,"class":43},8,""]