Wenzhou

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

Researchers are evaluating the safety, effectiveness, and plasma pharmacokinetics of 0.002% DE-117B eye drops in Chinese adults diagnosed with primary open angle glaucoma (POAG) or ocular hypertension (OHT). This Phase III study includes both a single-arm, open-label, multi-dose pharmacokinetics cohort and a randomized, evaluator-masked, active drug-controlled multicenter cohort. Participants will stop their current intraocular pressure (IOP) lowering medications before starting the study treatments. The study treatments include daily administration of 0.002% DE-117B eye drops (one drop once daily for 7 days). The study also uses 0.005% Latanoprost eye drops as an active control in the randomized portion. There is a bridging cohort and a long-term extension follow-up phase to further assess the treatments. Participants will receive their assigned eye drops and be monitored closely throughout these phases. Participants will undergo regular eye exams including IOP measurements to assess treatment effects at week 4. Visual acuity, anterior chamber angle, and corneal thickness will also be evaluated. Safety assessments will monitor for adverse events or eye conditions. The study includes washout of previous medications, detailed eligibility screening, and long-term follow-up to evaluate both efficacy and safety over time.

Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This prospective, multi-center, single-arm study will recruit about 1000 participants from approximately 50 centers across China, focusing on patients suitable for stent angioplasty. The study will last from December 2022 to December 2030, aiming to observe real-world outcomes with this stent system. Participants will receive the NOVA stent, a sirolimus-eluting device designed specifically for intracranial artery stenosis and delivered with a rapid exchangeable balloon. The study includes ten visits: preoperative screening, operation day, and follow-ups at 30 days, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. These visits will monitor the safety and performance of the stent over both the short and long term. During the study, participants will undergo assessments including digital subtraction angiography to confirm artery stenosis, and will be monitored for stroke, death, and any need for further artery procedures. Researchers will carefully track any ischemic strokes or revascularizations related to the treated artery up to one year after the operation. Follow-up visits will continue for five years to ensure thorough observation of outcomes and safety measures.

Researchers are evaluating molecular typing approaches for treating advanced thyroid cancer in this combined retrospective and prospective real-world clinical study. The study includes patients with locally advanced, recurrent, or metastatic thyroid cancer that cannot be treated with surgery and covers various thyroid cancer types such as radioiodine-refractory differentiated thyroid cancer, medullary thyroid carcinoma, poorly differentiated, and anaplastic thyroid cancer. This Phase 4 study collects detailed clinical and molecular data to assess treatment outcomes over several years. The study involves different targeted drug treatments based on specific genetic mutations found in the tumors. Patients with BRAF V600E mutation receive dabrafenib plus trametinib with or without PD-1 antibody, those with NTRK mutations are given entrectinib or larotrectinib with or without anti-PD-1 antibody, and patients with RET fusion or RET mutation receive pralsetinib or selpercatinib with or without anti-PD-1 antibody. Medullary carcinoma patients without or with unknown RET mutation may receive anlotinib or anlotinib plus anti-PD-1 antibody. Those without the above mutations or unable to afford precision treatments receive lenvatinib plus anti-PD-1 antibody. Other targeted therapies are also provided based on individual molecular profiles. The retrospective portion covers patients treated from January 2020 to December 2023, while the prospective study enrolls patients from January 2024 to April 2027. Participants provide demographic, clinical, tumor history, medication, adverse reaction, molecular testing, and survival data. Researchers track objective response rates for up to approximately three years. Data collection includes follow-ups for survival and adverse events. This comprehensive approach aims to understand treatment effectiveness and safety in a real-world setting over extended timeframes, supporting molecularly guided therapy decisions for advanced thyroid cancer.

Researchers are investigating whether Extract of Ginkgo Biloba Leaves Tablets can help improve thinking and memory in people aged 55 years and older who have had an ischemic stroke, which is caused by a blocked blood vessel in the brain. This phase 4 clinical trial is designed to assess both the effectiveness and safety of this treatment when added to the usual care for stroke recovery. Participants must have had a mild stroke confirmed by an MRI scan and show signs of cognitive impairment. The study takes place at multiple hospitals across China. Participants will be randomly assigned to one of two groups: one group will receive Extract of Ginkgo Biloba Leaves Tablets at a dose of 240 mg daily, divided into three doses of two 40 mg tablets each, along with their standard post-stroke care for 52 weeks. The other group will receive only the standard care recommended by the Chinese Stroke Association. The trial is open-label, meaning both the researchers and participants know which treatment is given. Throughout the year-long study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and testing. Researchers will evaluate changes in cognitive function using tests such as the Montreal Cognitive Assessment, Trail Making Test, Symbol Digit Modalities Test, and Verbal Fluency Test. They will also monitor neurological impairment and any new stroke events. Follow-up phone calls will occur at 12 and 38 weeks to support ongoing monitoring and safety assessments.

Researchers are conducting a multicenter observational study to better understand the treatment outcomes for patients diagnosed with psoriasis by dermatologists in clinic settings across China. Psoriasis is a chronic, recurrent inflammatory disease influenced by genetic and environmental factors, presenting as erythematosquamous lesions and potentially affecting multiple organs. The study aims to compare the effectiveness of various treatments chosen by patients, including phototherapy, traditional systemic therapies, and biologics, in real-world clinical practice. This non-interventional study allows patients to select their preferred treatment without restrictions. Data is collected primarily through a phone application called "Psoriasis New World," enabling continuous monitoring of patient progress. The study evaluates multiple outcomes such as the Psoriasis Area and Severity Index (PASI), which measures skin lesion severity and body area involvement, along with the Physician Global Assessment, Investigator Global Assessment, Body Surface Area affected, and Dermatology Life Quality Index. Patient safety is monitored throughout, including the recording of any adverse events and laboratory tests such as liver function. Participants will be followed over six months to measure the percentage achieving complete clearance of psoriasis symptoms (PASI 100). Regular assessments of disease severity and quality of life changes will be conducted remotely via the app. Continuous safety monitoring ensures any side effects or complications are documented. This approach provides comprehensive real-world evidence on how different psoriasis treatments perform in routine clinical care.

Researchers are evaluating EVER001, a highly selective oral Bruton tyrosine kinase (BTK) inhibitor, for treating proteinuric glomerular diseases, with a focus on primary membranous nephropathy. This phase 1b/2 study aims to assess the drug's effectiveness, safety, how it moves through and affects the body in participants with this kidney condition. Participants will receive EVER001, taken orally, which is designed to selectively target BTK with minimal effects on other kinases. The trial includes a treatment period where the medication's impact is monitored closely. The study uses this targeted approach to better understand the drug's role in managing proteinuria associated with membranous nephropathy. Over 104 weeks, participants will be regularly assessed for side effects, laboratory results, vital signs, physical exams, and ECGs to monitor safety and treatment effects. Researchers will collect data on adverse events and other clinical measures to evaluate the drug's profile and participant well-being throughout the study.

Researchers are investigating the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib to treat women and men with locally advanced or metastatic estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has an ESR1 mutation. This phase 3 study includes patients who have previously received treatment with ribociclib or palbociclib and aims to evaluate the effectiveness, safety, and tolerability of these treatment combinations. Participants will be randomly assigned to receive either oral lasofoxifene at 5 mg daily combined with oral abemaciclib 150 mg twice a day, or intramuscular fulvestrant 500 mg on specific days followed by monthly doses plus oral abemaciclib 150 mg twice daily. The treatment schedules are designed to compare how well these combinations work in managing the cancer. During the study, participants will be closely monitored for progression-free survival over approximately three years. Researchers will assess the cancer's response to treatment, track any side effects, and evaluate safety and tolerability. Regular evaluations and follow-ups will ensure comprehensive data collection to understand the impact of these therapies on advanced breast cancer.

Researchers are investigating the use of neoadjuvant chemotherapy combined with Toripalimab in female patients aged 18 to 70 years with triple-negative breast cancer (TNBC). This phase II, prospective, single-arm, multi-center clinical trial aims to evaluate the pathologic complete response (PCR) rate to this treatment and monitor the types and incidences of any adverse events. Secondary objectives include observing disease-free survival (DFS), progression-free survival (PFS), and objective response rate (ORR). The treatment involves two phases of neoadjuvant chemotherapy combined with Toripalimab. The first phase includes intravenous administration of Epirubicin, Cyclophosphamide, and Toripalimab every three weeks for six weeks. The second phase involves intravenous Albumin-bound Paclitaxel with Toripalimab on the same schedule for another six weeks. After completing four cycles of neoadjuvant chemotherapy, patients undergo breast cancer radical surgery. Post-surgery, if the pathology shows a complete response, patients continue immunotherapy with Toripalimab every three weeks for one year. If not, they receive postoperative adjuvant chemotherapy combined with Toripalimab. Gene testing on biopsy tissue and blood samples for ctDNA testing are performed before and after treatment. Participants will be closely monitored throughout the study, including assessments of adverse events and treatment responses. Researchers will collect tissue and blood samples to analyze genetic markers and circulating tumor DNA. The primary outcome measure is the pathologic complete response two years after treatment. Safety, disease progression, and survival outcomes will also be evaluated. The study requires participants to comply with follow-up and treatment schedules over the course of the trial.

Researchers are evaluating the safety and effectiveness of combining nimotuzumab, toripalimab, and chemotherapy for patients with locally advanced tonsillar squamous cell carcinoma. This Phase II, prospective, single-arm study aims to determine whether this combination can improve the pathological complete response rate and overall survival compared to historical data. The study plans to enroll about 10 patients at Tangdu Hospital and includes a follow-up period of 5 years after enrollment completion. Participants receive nimotuzumab, toripalimab, nab-paclitaxel, and carboplatin administered by intravenous infusion every 3 weeks for 2 to 4 cycles. Nimotuzumab is given at 400 mg on day 1, toripalimab at 240 mg on day 1, nab-paclitaxel at 260 mg/m² on day 1, and carboplatin dosed based on kidney function also on day 1. The treatment is designed as neoadjuvant therapy before radical surgery. During the study, participants will undergo evaluations including tumor assessments by MRI imaging and laboratory tests to monitor organ function and safety. Researchers will measure the pathological complete response rate within 1 to 2 weeks after surgery. Participants' performance status and survival will also be followed for up to 5 years. Compliance with follow-up procedures and safety monitoring are important parts of the study involvement.