Wenzhou

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This study is a prospective, multi-center, single-arm clinical trial conducted across about 50 centers in China, aiming to include 1000 participants who are suitable candidates for stent angioplasty. The trial will run from December 2022 to December 2030, focusing on patients with significant artery narrowing in the brain. All participants will receive the NOVA drug-eluting stent, which is designed to treat intracranial artery stenosis with a sirolimus-eluting coating and a rapid exchangeable balloon. The study includes ten visits starting from preoperative screening, the operation day, then follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years after the procedure. This schedule allows researchers to closely monitor the devices performance and patient outcomes over time. Participants will undergo various assessments during these visits, including evaluations for stroke, death, ischemic events, and revascularization related to the treated artery. Other measures include rates of stroke in different brain regions, transient ischemic attacks, restenosis, bleeding events, and quality of life assessments using tools like the modified Rankin Scale and EuroQol-5D. Safety, device defects, and long-term outcomes will be carefully tracked throughout the study period, which lasts up to five years after the operation.

Researchers are studying the use of molecular typing in the treatment of advanced thyroid cancer through a real-world clinical study that includes both retrospective and prospective parts. The retrospective study looks back at patients treated from January 2020 to December 2023 in 24 hospitals, gathering data on treatment history, molecular test results, adverse reactions, and survival outcomes. The prospective study will enroll patients from January 2024 to April 2027 receiving precise treatments in the same hospitals. This study aims to understand how molecular typing can guide treatment in various types of advanced thyroid cancer, including differentiated, medullary, poorly differentiated, and anaplastic forms. Participants receive targeted drug treatments based on the type of gene mutations found in their cancer. These treatments include dabrafenib plus trametinib for BRAF V600E mutation, entrectinib or larotrectinib for NTRK mutation, pralsetinib or selpercatinib for RET fusion or mutation, anlotinib for medullary carcinoma without RET mutation, lenvatinib combined with anti-PD-1 antibody for patients without specific mutations or unable to afford precision therapy, and other targeted treatments based on identified targets. The study includes several patient groups defined by cancer type and suitability for radioiodine therapy. During the study, researchers will collect and analyze clinical data, molecular test results, medication regimens, and follow-up survival information up to about three years. Key outcomes measured include objective response rate, duration and time to response, disease control rate, progression-free survival, and overall survival. Safety and adverse reactions are also monitored. The study involves ongoing data collection and follow-up to assess how molecularly guided treatments affect advanced thyroid cancer management over time.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

Researchers are evaluating whether Extract of Ginkgo Biloba Leaves Tablets can improve memory and thinking skills in people aged 55 and older who have had an ischemic stroke caused by a blocked blood vessel in the brain. This study also looks at the safety of taking these tablets alongside usual post-stroke treatments. Participants must have had a stroke confirmed by MRI within 7 to 14 days before joining the study and have mild cognitive impairment after their stroke. Participants will be randomly assigned to one of two groups one group will take 240 mg of Extract of Ginkgo Biloba Leaves Tablets daily for 12 months in addition to their usual stroke care, while the other group will receive only their usual care without the tablets. The study will take place at hospitals across China and will last for 52 weeks for each participant. Throughout the study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and tests, including brain scans, cognitive assessments such as the Montreal Cognitive Assessment and other neuropsychological tests, and evaluations of neurological function. Follow-up phone calls will occur at 12 and 38 weeks to monitor health and any new stroke events. Researchers will measure changes in thinking, memory, cognitive speed, verbal skills, and neurological status to understand the tablets effects and safety over time.

Psoriasis is a chronic, recurring inflammatory disease influenced by genetics and environmental factors, marked by skin lesions that can affect multiple organs. Researchers are evaluating the effectiveness of different treatments chosen by patients in real-world clinical settings, comparing phototherapy, traditional systemic therapies, and biologics among Chinese psoriasis patients. This observational study aims to gather real-world evidence under routine care without intervention. Patients diagnosed with psoriasis by dermatologists choose their preferred treatments, which may include phototherapy, traditional systemic drugs, or biologics. The study does not assign treatments but observes outcomes as patients follow their chosen therapies. Data collection is supported through a phone application called Psoriasis New World, and the study includes multiple centers. Participants will be assessed regularly for treatment effectiveness using measures such as the Psoriasis Area and Severity Index PASI, Physician and Investigator Global Assessments, Body Surface Area affected, and Dermatology Life Quality Index. Adverse events and laboratory tests, including liver function, will be monitored throughout up to 12 months. The primary outcome is the percentage of patients achieving complete skin clearance PASI 100 at 6 months, with additional follow-up evaluations at 12 months.

Researchers are evaluating the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for treating pre- and postmenopausal women and men with locally advanced or metastatic estrogen receptor positive ERhuman epidermal growth factor 2 negative HER2- breast cancer who have an ESR1 mutation and have previously been treated with ribociclib or palbociclib. The study aims to compare the effectiveness, safety, and tolerability of these two treatment combinations. Participants are randomly assigned to one of two groups one receives 5 mg daily oral lasofoxifene plus oral abemaciclib 150 mg twice a day the other receives fulvestrant 500 mg via intramuscular injections on Days 1, 15, and 29 and then monthly thereafter, combined with oral abemaciclib 150 mg twice a day. This open-label study assesses these treatments over approximately three years. During the trial, participants will be monitored through regular assessments including tumor measurements, survival tracking, quality of life questionnaires, and evaluation of adverse events. Researchers will measure progression-free survival as the primary outcome and also track response rates, overall survival, treatment duration, and time to chemotherapy. Brain metastases patients meeting specific criteria are allowed, and safety is closely observed throughout the study period which may last up to about three years.

Researchers are evaluating the use of Toripalimab combined with neoadjuvant chemotherapy as an adjuvant treatment for triple-negative breast cancer TNBC. This phase II, prospective, single-arm, multi-center clinical trial aims to assess the pathologic complete response PCR rate along with the types and frequency of side effects. Secondary objectives include monitoring disease-free survival, progression-free survival, and objective response rate in participants. The treatment involves two phases of neoadjuvant chemotherapy combined with Toripalimab administered intravenously every three weeks. The first phase includes Epirubicin, Cyclophosphamide, and Toripalimab for six weeks, followed by Albumin-bound Paclitaxel plus Toripalimab for another six weeks. After four treatment cycles, participants undergo radical breast cancer surgery. Postoperative therapy depends on pathology results if PCR is achieved, immunotherapy with Toripalimab continues every three weeks for one year if not, chemotherapy combined with Toripalimab continues. Gene testing on biopsy tissue and blood samples for ctDNA testing are also performed before and after treatment. During the study, participants will have regular assessments including pathology evaluation and monitoring of side effects. Researchers will track treatment response and survival outcomes over two to three years. The total involvement includes neoadjuvant treatment, surgery, postoperative therapy, and follow-up to evaluate treatment effectiveness and safety. Careful monitoring ensures adherence and collection of important biological samples for ongoing analysis.

Researchers are evaluating the effectiveness and safety of combining nimotuzumab, toripalimab, and chemotherapy to treat patients with locally advanced tonsillar cancer. This prospective, single-arm Phase II study aims to see if this combination can improve the pathological complete response rate and overall survival compared to historical data. Approximately 10 patients will be enrolled with a follow-up period extending up to five years after enrollment to monitor long-term outcomes. Participants receive nimotuzumab 400 mg, toripalimab 240 mg, nab-paclitaxel 260 mgm, and carboplatin through intravenous infusions every three weeks for 2 to 4 cycles. Each infusion lasts at least 60 minutes with careful monitoring for reactions. After 2 to 4 cycles of this neoadjuvant combination therapy, patients undergo endoscopy and imaging evaluation around day 42 to assess response. Throughout the study, participants will have assessments including pathological examination within 1 to 2 weeks after radical surgery to measure the pathological complete response rate, surgical margins, and major pathological response. Radiological response rates are evaluated after completing two treatment cycles, and functional status is assessed before surgery and at 1 month, 6 months, and 1 year post-surgery or concurrent chemoradiotherapy. Disease-free survival will be followed for up to 72 months. Participants must comply with study procedures and follow-up visits during this period.