[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"paclitaxel\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:paclitaxel":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,44,70,96,123,154,182],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100650909","a-phase-ii-study-of-ivonescimab-combined-with-intraperitoneal-paclitaxel-in-patients-with-high-grade-metastatic-appendiceal-adenocarcinoma-aa-100650909",false,"NCT07753824","A Phase II Study of Ivonescimab Combined With Intraperitoneal Paclitaxel in Patients With High-Grade Metastatic Appendiceal Adenocarcinoma (AA)","Inclusion Criteria\n\n* Age 18 years and above. There will be no upper age restriction\n* ECOG performance status 0-2\n* Participants must have histologically confirmed diagnosis of unresectable metastatic AA. The determination of appendiceal origin may rely on pathologic features combined with clinical or radiographic evidence in the event that the appendix remains in situ.\n* Participants will have undergone no more than two prior lines of systemic therapy. The last dose of systemic therapy will have been no less than 2 weeks prior to initiation of therapy.\n* Participants must have adequate nutrition and normal bowel motility and function as evidenced by albumin \\> 3.0 and no history of intestinal bypass or diverting enterostomy.\n* Demonstrate adequate organ function as determined by the following requirements:\n\n  o Hematology\n* No use of any blood components and cell growth factor supportive therapy within 7 days prior to initiation of study treatment\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm3 (ANC ≥ 1000\u002Fmm3 for African American participants)\n* Platelet count ≥ 100 × 109\u002FL (100,000\u002Fmm3)\n* Hemoglobin ≥ 9.0 g\u002FdL.\n\n  o Kidney:\n* Creatinine clearance\\* (CrCL) ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by body surface area \\[BSA\\] is not required for eGFR). \\*CrCL or eGFR can be determined using the calculator from the National Kidney Foundation website (www.kidney.org).\n* Urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g\n\n  o Liver:\n* Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for participants with confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 x ULN\n* Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN\n* Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial thromboplastic time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to participants who are not on therapeutic anti-coagulation. Participants receiving therapeutic anti-coagulation should be on a stable dose\n* The effects of PTX and Ivonescimab on the developing human fetus are unknown. Taxane agents are known to be teratogenic. Additionally, based on Ivonescimab's mechanism of action, it may cause fetal harm if administered to a pregnant woman. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until 6 months after the last dose of Ivonescimab. (Refer to Pregnancy Assessment Policy UT MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months)\n  * History of hysterectomy or bilateral salpingo-oophorectomy\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)\n  * History of bilateral tubal ligation or another surgical sterilization procedure\n* Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Unsterilized male participants having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 6 months after last dose of Ivonescimab or chemotherapy. Male participants with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of treatment period until 6 months after last dose of Ivonescimab.\n* Female participants of childbearing age must have a negative serum pregnancy test result before enrollment and a negative urine pregnancy test on the day of first dose prior to dosing.\n* Ability to understand and the willingness to sign a written informed consent document\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria\n\n* Metastases outside the peritoneal cavity, with exception of limited metastases to the thoracic cavity and\u002For limited retroperitoneal lymphadenopathy\n* Previous surgery that would preclude safe diagnostic laparoscopy with port placement\n* Current presence of significant radiographic or clinical\u002Fradiographic manifestations of gastrointestinal obstruction. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment\n* Recent history (within the last 30 days) of large volume ascites requiring repeated paracenteses. Large-volume ascites that has resolved with prior systemic therapies is not considered Exclusionary.\n* Unresolved clinically significant toxicity of greater than or equal to NCI CTCAE v. 6.0 grade 2 attributed to any prior therapies (excluding anemia, lymphopenia, alopecia, skin pigmentation).\n* Other prior malignancy unless the participant has undergone curative therapy with no evidence of disease recurrence within 3 years prior to enrollment. The following malignancies will be allowed without the 3-year interval after adequate treatment: basal cell or squamous cell carcinoma of skin, superficial bladder cancer, in situ cervical cancer, other in situ cancers, prostate cancer with a Gleason score ≤6 that does not need therapy or other local tumors that are considered cured\n* Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period for an interventional study.\n* Palliative local therapy for non-target lesions and non-specific immunomodulatory therapy (such as interleukin, interferon, thymus peptide, tumor necrosis factor, etc.) within 2 weeks before the first dose.\n* Any prior clinically significant or active autoimmune disease requiring systemic therapy (e.g., with disease- modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy or immunomodulatory agents \\[e.g., infliximab or IVIG\\]) within 2 years prior to enrollment; however, replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n* History of major diseases before enrollment, specifically:\n\n  * Unstable angina, myocardial infarction, CHF (New York Heart Association \\[NYHA\\] classification ≥Grade 2) or unstable vascular disease (e.g., aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to enrollment, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia)\n  * History of esophageal gastric varices, severe ulcers, wounds that do not heal, fistula, intra-abdominal abscesses, or ≥ Grade 3 acute gastrointestinal bleeding within 6 months before enrollment\n  * History of any grade arterial thromboembolic event (ATE), Grade 3 and above venous thromboembolism (VTE), as specified in NCI CTCAE6.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to enrollmentAcute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment\n* Live vaccine or live attenuated vaccine within 4 weeks prior to planned enrollment, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.\n* Severe infection within 4 weeks prior to enrolment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the Investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrollment (excluding antiviral therapy for hepatitis B).\n* Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after the first dose (as determined by the Investigator). Minor local procedures within 3 days prior to enrollment (excluding central venous catheterization and port implantation).\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment, including but not limited to:\n\n  * Clinically significant gastrointestinal bleeding such as hematochezia of approximately 1 tablespoon or more per day or any episodes of melena or documented acute hemoglobin drop of more than 1 gm in 2 weeks prior to enrollment\n  * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrollment is not allowed. The use of fulldose anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits according to the medical standard of the enrolling institution.\n* Poorly controlled hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* History of non-infectious pneumonia requiring systemic corticosteroids. History of or current interstitial lung disease\n* Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent)\n* Participants with known active tuberculosis (TB) and suspected active TB need to be ruled out by clinical examination.\n* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled\n* Participants with active hepatitis B are required to have stable or declining levels of hepatitis B virus (HBV) DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for 1 month prior to enrollment. All active hepatitis C participants (hepatitis C virus \\[HCV\\] positive with HCV RNA levels above the lower limit of detection) are excluded.\n* Known hypersensitivity to any component of any of the study drugs; known history of severe hypersensitivity reactions to other monoclonal antibodies.\n* History or current evidence of any condition (medical \\[including AEs from prior anti- cancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including current substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the participant to participate, in the opinion of the treating Investigator\n* Pregnant women are excluded from this study because both paclitaxel and Ivonescimab have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued.\n* Participant is breastfeeding or plans to breastfeed during the study.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","To evaluate the safety and effectiveness of Ivonescimab combined with intraperitoneal paclitaxel (IP PTX) in patients with unresectable metastatic high-grade Appendiceal Adenocarcinoma (AA).",[25,26,27,28,29,30],"Phase II","Ivonescimab","Intraperitoneal","Paclitaxel","High Grade Metastatic","Appendiceal Adenocarcinoma","NOT_YET_RECRUITING","2026-08-13",{"date":34,"type":35},"2026-08-17","ACTUAL",{"date":37,"type":19},"2027-01-16",{"date":39,"type":19},"2032-11-28",{"name":41,"class":42},"M.D. Anderson Cancer Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":43},"100553751","predicting-peripheral-neuropathy-of-paclitaxel-for-gastric-cancer-100553751","NCT06490159","Predicting Peripheral Neuropathy of Paclitaxel for Gastric Cancer","Predicting Peripheral Neuropathy of Paclitaxel in Second-line Chemotherapy for Gastric Cancer","Inclusion Criteria:\n\n1. unresectable or recurrent Gastric cancer (GC) histologically confirmed to be primary adenocarcinoma of the stomach.\n2. age over 20 years.\n3. Eastern Cooperative Oncology Group performance status score of 0-2.\n4. written informed consent following full study information is provided to the patient.\n5. progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC.\n6. presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging.\n\nExclusion Criteria:\n\n1. Patients with a life expectancy of shorter than 3 months\n2. Patients with severe complications (angina pectoris, myocardial infarction, or arrhythmia) or uncontrollable diabetes mellitus, blood hypertension, or bleeding tendency.\n3. Patients with a history of serious allergic reactions or serious drug allergy.\n4. Patients with a clinically relevant mental disorder that prohibits response to questionnaires.\n5. Patients for whom the attending physician considered that enrollment in the study is inappropriate.","20 Years",{"count":53,"type":19},150,"OBSERVATIONAL","Although advances in chemotherapy have improved the prognosis of gastric cancer patients, many patients still suffer from adverse events. Therefore, it is necessary to establish personalized treatment by identifying patients at high risk for side effects. Although paclitaxel-based therapy is the standard second-line treatment, peripheral neuropathy is a troublesome adverse event. The purpose of this study is to establish a liquid biopsy assay to predict paclitaxel-induced peripheral neuropathy in gastric cancer patients.",[57,58,28,59],"Gastric Cancer","Chemotherapy-induced Peripheral Neuropathy","Ramucirumab","RECRUITING","2026-07-06",{"date":63,"type":35},"2026-07-07",{"date":65,"type":35},"2018-10-01",{"date":67,"type":19},"2028-06-18",{"name":69,"class":42},"City of Hope Medical Center",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":15,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":20,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100639555","oral-paclitaxel-as-neoadjuvant-therapy-in-elderly-nsclc-a-phase-ii-trial-100639555","NCT07599163","Oral Paclitaxel as Neoadjuvant Therapy in Elderly NSCLC: A Phase II Trial","A Phase II, Multicenter Clinical Study of Oral Paclitaxel Solution as Neoadjuvant Therapy in Elderly Patients With Non-Small Cell Lung Cancer","Eligibility Criteria\n\nInclusion Criteria:\n\n* Age 70-85 years, any gender\n* ECOG performance status 0-1\n* Pathologically confirmed non-small cell lung cancer (NSCLC), clinical stage IIA-IIIB (8th edition AJCC)\n* No distant metastasis, deemed resectable with curative intent\n* Negative for sensitive driver mutations including EGFR, ALK, and ROS1 by molecular pathology\n* Adequate function of major organs, defined as:\n* Bone marrow: ANC ≥1.5×10⁹\u002FL, platelet ≥100×10⁹\u002FL, hemoglobin ≥9 g\u002FdL\n* Liver function: total bilirubin ≤1.5×ULN; ALT, AST ≤2.5×ULN\n* Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin; urine protein \\\u003C +; if +, 24-h urine protein \\\u003C 500 mg\n* Normal blood glucose or well-controlled diabetes\n* Pulmonary function: baseline FEV1 ≥2 L; if FEV1 \\\u003C 2 L, postoperative predicted FEV1 \\> 800 mL confirmed by surgical evaluation\n* Cardiac function: no myocardial infarction, unstable angina, severe arrhythmia, or cardiac insufficiency within the past 1 year\n* Patients and families are fully informed and voluntarily provide written informed consent\n\nExclusion Criteria:\n\n* Previous lobectomy, radiotherapy, or systemic antitumor therapy\n* Synchronous other malignancy with \\\u003C5 years of cure (except carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin)\n* History of active autoimmune disease or requirement for systemic immunosuppressive therapy\n* Active infection requiring systemic therapy, including active tuberculosis, HIV infection, chronic hepatitis B\u002FC with active replication, or syphilis\n* Severe cardiac, hepatic, renal, or metabolic disease that cannot tolerate surgery or study treatment\n* Previous interstitial lung disease, drug-induced pneumonitis, or radiologic evidence of active interstitial lung disease\n* Uncontrolled massive pleural effusion or pericardial effusion\n* Major surgery, severe trauma, or other investigational drug therapy within 4 weeks\n* Recent vaccination with antitumor vaccines or live vaccines\n* Other conditions deemed inappropriate for enrollment or likely to affect trial outcomes by the investigator","70 Years","85 Years",{"count":80,"type":19},75,[82],"NA","This study is a multicenter, single-arm Phase II clinical trial, aiming to explore the safety and preliminary efficacy of oral paclitaxel solution combined with immune checkpoint inhibitors as a neoadjuvant regimen in elderly patients aged 70-85 years with non-small cell lung cancer (NSCLC). A total of 75 eligible elderly NSCLC patients who need neoadjuvant treatment are planned to be enrolled. The study takes Shanghai Pulmonary Hospital as the main center, Zhejiang Cancer Hospital and Guangdong Provincial People's Hospital as sub-centers, adopts a single-arm study design, and the research subjects are elderly NSCLC patients who need neoadjuvant treatment. The core indicators for efficacy evaluation include pathological complete response rate (pCR), major pathological response rate (MPR, residual tumor cells ≤10%), imaging response rate (according to RECIST 1.1 criteria), 2-year event-free survival rate (EFS), 2-year overall survival rate (OS), surgical resection rate, and R0 resection rate; safety evaluation mainly observes the incidence of adverse events. The statistical methods adopt the relevant specifications for single-arm exploratory studies. Efficacy analysis is carried out in the full analysis set and per-protocol set, and safety analysis is performed using the safety analysis set; for continuous variables, paired t-test or Wilcoxon signed-rank test is used according to the distribution; categorical variables are analyzed descriptively; for the main rate-type outcome indicators, the incidence rate and 95% confidence interval (Clopper-Pearson method) are reported; survival outcome indicators are estimated using the Kaplan-Meier method and relevant parameters are reported.",[85,86,28],"Non-Small-Cell Lung Cancer","Neoadjuvant Therapy","2026-05-19",{"date":89,"type":35},"2026-05-20",{"date":91,"type":19},"2026-06-08",{"date":93,"type":19},"2030-12-30",{"name":95,"class":42},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":104,"targetDuration":106,"studyType":54,"phases":4,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":43},"100610765","registry-of-coronary-disease-outcomes-revascularizing-with-drug-coated-balloons-100610765","NCT07231835","Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons","RECORD-DCB: Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons","RECORD-DCB","Inclusion Criteria:\n\n* Patients undergoing PCI with the Protégé paclitaxel-eluting DCB\n* Age ≥ 18 years\n* Presence of a de novo lesion or in-stent restenosis in a native coronary artery or a in a bypass graft and suitable for PCI\n* Reference vessel diameter between 2.0 - 4.5 mm\n* Patient suitable for dual antiplatelet therapy (DAPT)\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Allergy to paclitaxel",{"count":105,"type":19},3000,"5 Years","The primary aim of this registry is to systematically collect and analyze real-world data on all patients undergoing PCI with the Protégé paclitaxel-eluting DCB to evaluate procedural outcomes, long-term efficacy, and safety across various clinical indications. This registry aims to assess the clinical effectiveness of DCB therapy across diverse patient populations, including those with stable coronary artery disease (CAD) and acute coronary syndromes (ACS), as well as various lesion subsets, encompassing (but not limited to) in-stent restenosis (ISR), de novo coronary lesions, small vessel disease, bifurcation and calcified lesions, coronary bypass graft lesions, and patients at high risk of bleeding. Additionally, the study aims to identify predictors of success, complications, and optimal treatment strategies to further refine the use of DCBs.",[109,110,28,111,112,113],"Percutaneous Coronary Intervention (PCI)","Drug Coated Balloon","CAD - Coronary Artery Disease","ACS (Acute Coronary Syndrome)","Stable Coronary Artery Disease (CAD), Myocardial Infarction","2025-11-14",{"date":116,"type":35},"2025-11-17",{"date":118,"type":35},"2025-11-11",{"date":120,"type":19},"2034-09-30",{"name":122,"class":42},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":20,"phases":132,"briefSummary":133,"conditions":134,"keywords":138,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":43},"100503480","phase-2-intratumoral-gemcitabine-paclitaxel-carboplatine-and-intravenous-nivolumab-for-locally-recurrence-of-head-and-neck-cancers-100503480","NCT05835804","Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers","NIVOCHIMLOC","Inclusion Criteria:\n\n* WHO status : 0, 1 or 2.\n* Age \\> 18ans\n* Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)\n* Nivolumab treatment in second line encouring according to AMM but with insufficient efficacy\n* Possible location of the tumour by clinical examination, CT-scan\n* Metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence.\n* Neutrophils \\> 1000\u002Fmm3.\n* Platelets \\> 100 000\u002Fmm3.\n* Blood créatinine \\\u003C 15 mg\u002FL. Blood bilirubine \\\u003C 30 mg\u002FL\n* Prothrombin rate \\> 70 %.\n* Social insurance\n* Informed consent\n\nExclusion Criteria:\n\n* WHO status : 0, 1 or 2.\n* Age \\> 18ans\n* Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)\n* Nivolumab treatment in second line encouring according to AMM but with insufficient efficacy\n* Possible location of the tumour by clinical examination, CT-scan\n* Metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence.\n* Neutrophils \\> 1000\u002Fmm3.\n* Platelets \\> 100 000\u002Fmm3.\n* Blood créatinine \\\u003C 15 mg\u002FL. Blood bilirubine \\\u003C 30 mg\u002FL\n* Prothrombin rate \\> 70 %.\n* Social insurance\n* Informed consent",{"count":131,"type":19},39,[22],"Patients with locally recurrent squamous-cell carcinoma of the head and neck (SCCHN) after Chemotherapy and immunotherapy have a very poor prognosis and limited therapeutic options.\n\nIntratumoral chemotherapy (ITC) with cisplatin and epinephrine in order to increase the local cisplatin retention lead to a 50 % response rate in several studies but was given up due to the poor local tolerance with frequent necrosis of the peritumoral tissues. Gemcitabine, carboplatin and paclitaxel (GCP) are used in advanced SCCHN. These chemotherapies seem to be interesting options for intratumoral infusion: their different effect could lead to avoid chemotherapy resistance with a good tolerance profile, without tissue necrosis profile. The other major option for recurrent SCCHN is immunotherapy by Nivolumab, an anti PD-1 with a 13% mediane response rate. Nevertheless, the failure of this treatment stay unclear, but immunosuppressive action of the tumour is suspected. The presence of tumoral antigen could lead to better response to immunotherapy; association of chemotherapy and immunotherapy seems a promosing association to avoid treatment resistance as cytotoxic release tumoral antigen; it could also be associated to an abscopal effect.\n\nThe aim of the study is to evaluate the efficacy of ITC using GCP in LOCAL recurrent SCCHN treated by nivolumab.",[135,28,136,137],"Squamous Cell Carcinoma of the Head and Neck","Carboplatin","Nivolumab",[135,139,140,141,142,143,144],"local reccurence of malignant tumor","intrumoral chemotherapy","gemcitabin","paclitaxel","carboplatin","nivolumab","2025-03-18",{"date":147,"type":35},"2025-03-21",{"date":149,"type":19},"2025-11",{"date":151,"type":19},"2027-04",{"name":153,"class":42},"Centre Hospitalier Universitaire, Amiens",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":162,"minAge":16,"maxAge":77,"enrollmentInfo":163,"targetDuration":4,"studyType":20,"phases":165,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":43},"100433238","phase-3-chiauranib-plus-weekly-paclitaxel-in-patients-with-platinum-refractory-or-platinum-resistant-recurrent-ovarian-cancer-100433238","NCT04921527","Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer","A Multi-center, Double-blind, Randomized Phase III Clinical Trial of Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer","CHIPRO","Inclusion Criteria:\n\n* Willingness to sign a written informed consent document .\n* Female, age ≥18 yrs and ≤70 yrs.\n* Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.\n* Patients with platinum refractory or platinum resistant ovarian cancer:\n\n  * Platinum refractory: progression during the first platinum-based treatment or within 4 weeks after the first platinum-based primary therapy;\n  * Platinum resistant: progression during the platinum-based treatment except for platinum refractory, or within 6 months after the last receipt of platinum-based treatment (patients have received platinum containing chemotherapy at least 4 weeks);\n  * Radiological progression during the last treatment administered;\n  * no more than 1 prior treatment regimens for recurrent disease.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* At least 1 lesion can be accurately measured, as defined by RECIST1.1.\n* Laboratory criteria are as follows:\n\n  * Complete blood count: hemoglobin (Hb) ≥90g\u002FL ; absolute neutrophil count (ANC) ≥1.5×109\u002FL ; platelets ≥90×109\u002FL;\n  * Biochemistry test: serum creatinine(cr) \\\u003C1.5×ULN; total bilirubin\\\u003C1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≤2.5×ULN; (ALT,AST≦5×ULN if liver involved) ;\n  * Coagulation test: International Normalized Ratio (INR) \\\u003C 1.5, activeated partial thromboplasting time (APTT) \\\u003C1.5×ULN\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Patients received vascular endothelial growth factor(VEGF)\u002Fvascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors.\n* Patients received weekly paclitaxel therapy.\n* Has known allegies to Chiauranib, paclitaxel or any of the excipients.\n* Biological therapy, immunotherapy, hormonal therapy within 28 days prior to the first dose of study drug.\n* prior major surgery or trauma within 14 days prior to first dose of study drug and\u002For presence of any non-healing wound, fracture, or ulcer.\n* Treatment with an investigational agent\u002Finstrument within 28 days prior to first dose of study drug.\n* Any ongoing toxicity from prior anti-cancer therapy that is \\>Grade 1.\n* Patients with prior invasive malignancies in the past five years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.\n* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.\n* clinically significant central\u002Fperipheral nervous system disease.\n* Have uncontrolled or significant cardiovascular disease, including:\n\n  * Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% requiring treatment with agents during screening stage.\n  * primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al)\n  * History of significant QT interval prolongation, or Corrected QT Interval (QTc) \\> 470 ms prior to study entry\n  * Symptomatic coronary heart disease requiring treatment with agents\n  * History of hypertension treated by≥2 agents, or the Blood pressure (Bp) ≥140\u002F90 mmHg prior to study entry.\n  * Other condition investigator considered inappropriate\n* Significant intravenous or arterial thrombosis, such as cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.\n* History of active bleeding within the past 2 months, patients with bleeding potential during the screening period, or receiving anticoagulation therapy.\n* CT or MRI of the chest during the screening period shows interstitial lung disease or pulmonary fibrosis or lung inflammation that requires treatment, or within 6 months before the first dose, history of pneumonia requiring oral or intravenous steroid treatment, history of immune-associated pneumonia after treatment of PD1\u002FPDL1 inhibitor.\n* Have clinical significant gastrointestinal abnormality that would impair the ingestion, transportation or absorption of oral agents, history of gastrointestinal perforation or abdominal fistula, peptic ulcer disease within 6 months prior to first dose of study drug or GI obstruction within the past 3 months.\n* Pleural fluid, ascites or pericardial effusion with significant symptoms or required treatment of puncture or drainage during the screening period, or history of drainage for therapy within 1 months prior to first dose of study drug.\n* Screening for HIV antibody positive.\n* Screening test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with virus replication, hepatitis C antibody (HCV-Ab) positive with virus replication.\n* Active infection requiring oral or intravenous systemic antimicrobial therapy during the screening period.\n* Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study.\n* History of organ transplantation or allo-HSCT.\n* Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study.\n* Candidates with drug and alcohol abuse.\n* Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study.Pregnant or breastfeeding women.\n* Any other condition which is inappropriate for the study in the opinion of the investigators.","FEMALE",{"count":164,"type":19},454,[166],"PHASE3","This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer.",[169,170,171,28],"Ovarian Cancer","Relapsed or Refractory","Chiauranib","2024-10-17",{"date":174,"type":35},"2024-10-18",{"date":176,"type":35},"2021-12-20",{"date":178,"type":19},"2025-07-31",{"name":180,"class":181},"Chipscreen Biosciences, Ltd.","INDUSTRY",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":189,"targetDuration":191,"studyType":54,"phases":4,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100419550","european-all-comers-multicentric-prospective-registry-on-luminor-drug-eluting-balloon-in-the-superficial-femoral-artery-and-popliteal-artery-with-5-years-follow-up-100419550","NCT04743180","European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.","LUMIFOLLOW","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Rutherford Clinical Category 2-5\n* The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study, voluntarily agrees to participation, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF)\n* Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery\n* TASC II Class A to D Lesions\n* de novo lesion(s), non-stented or stented restenotic lesion(s)\n* Proximal margin of target lesion(s) starts at the ostium of the superficial femoral artery, just below the common femoral bifurcation\n* Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk (P3)\n* A patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac or common femoral inflow artery lesions); Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication\n* Successful wire crossing and pre-dilatation (1min min, with under sizing of 1mm compared to ref diameter) of the target lesion; Use of crossing devices allowed if necessary. Use of laser or atherectomy is allowed if necessary, during the index procedure. Bailout stenting is allowed if necessary, after DEB use\n* At least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography (treatment of outflow disease is NOT permitted during the index procedure)\n\nExclusion Criteria:\n\n* Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children\n* Patient is contraindicated to use Luminor Drug Eluting Balloon per the current Instructions For Use (IFU)\n* Life expectancy of \\\u003C 1year\n* Patient is currently participating in an investigational drug or other device study or previously enrolled in this study\n* Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication\n* Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel",{"count":190,"type":19},500,"60 Months","The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and\u002For long lesions\u002Focclusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.",[194,195,196,197,28],"Angioplasty","Peripheral Arterial Disease","Drug-eluting Balloon","Femoral Artery","2021-02-10",{"date":200,"type":35},"2021-02-11",{"date":202,"type":35},"2021-01-18",{"date":204,"type":19},"2026-06-30",{"name":206,"class":181},"iVascular S.L.U.",15]