Xin Yang Shi

Researchers are conducting an open, multi-center Phase I/II study to evaluate the safety, tolerability, and effectiveness of RC118 combined with Toripalimab or RC148 in patients with Claudin 18.2-positive, locally advanced unresectable or metastatic malignant solid tumors, including gastric cancer or gastro-esophageal junction cancer. The study aims to establish the maximum tolerated dose and recommended dose for Phase II, and then assess the treatment's efficacy and safety in advanced cancer cases. Participants must have tumors confirmed to express Claudin 18.2 and meet specific health criteria. The Phase I portion involves dose escalation of RC118 given every two weeks at two dose levels combined with fixed doses of Toripalimab every three weeks to find the best tolerated dose. In Phase II, patients with locally advanced or metastatic gastric or gastro-esophageal junction cancer receive RC118 with either Toripalimab or RC148, both administered every three weeks. The study includes multiple cycles of treatment, with continuous safety and response monitoring to guide dosing decisions. Participants will undergo screening to confirm eligibility, including tumor tissue analysis for Claudin 18.2 and PD-L1 expression, and assessments of organ function and performance status. During the study, researchers will track adverse events, dose-limiting toxicities, and tumor responses over 15 months. Safety will be closely monitored throughout, with follow-up visits to observe treatment effects and manage any side effects. The study includes careful evaluation of survival, tumor shrinkage, and tolerability over up to a year or more of participation.

People with end stage kidney disease (ESKD) who require dialysis have a much higher risk of developing cardiovascular disease compared to the general population, with heart problems causing over half of the deaths in this group. This trial is studying whether taking low dose aspirin daily can safely reduce cardiovascular events in these dialysis patients. The study is a Phase 4, multi-center, randomized controlled trial designed to provide clear evidence about aspirin's benefits and risks in this specific population, where existing data is limited. Participants will be randomly assigned to receive either a daily 100 mg aspirin tablet or a matching placebo. The trial uses the Chinese peritoneal dialysis and hemodialysis registry to efficiently screen and recruit patients and collect data during routine dialysis care. Follow-up visits occur every six months as part of regular clinical care, and the study will continue until enough cardiovascular events have occurred, expected to take about five years. During the study, participants will have their health monitored through routine clinic visits every six months, with data collected on cardiovascular events and safety. The main outcome measured is the number of participants experiencing major cardiovascular events over the study period. An independent board will oversee safety and study progress. The trial uses intention-to-treat analysis and aims to minimize participant burden by integrating study procedures into usual care.

Researchers are evaluating the long-term safety and effectiveness of drug-coated balloon (DCB) strategies compared to drug-eluting stent (DES) only treatment in patients with chronic total occlusion (CTO) of the coronary arteries after successful reopening of the artery. This study aims to provide high-quality evidence by directly comparing DCB alone or combined with DES (hybrid strategy) against DES-only treatment. The goal is to improve treatment strategies, reduce the use of stents, lower complication risks, and enhance patient outcomes for these complex heart artery blockages. The trial involves two groups: one receiving DCB angioplasty with possible provisional DES implantation if necessary, and the other receiving standard DES implantation. Both treatments use devices sized to the vessel diameter and cover the blocked segment plus surrounding healthy areas. DCB balloons are inflated to deliver medication, while stents are deployed with appropriate pressure to ensure vessel support. All patients receive standard medical therapy including at least 12 months of dual antiplatelet therapy and are followed for 36 months after the procedure. Participants will undergo assessments including angiographic imaging to measure late lumen loss at 9 months by a blinded core lab, as well as monitoring for clinical outcomes such as cardiac events, repeat procedures, and quality of life. An independent committee adjudicates clinical events. The study uses intention-to-treat analysis to compare safety and efficacy between groups. This comprehensive follow-up and evaluation plan aims to provide valuable insights into optimizing CTO treatment.

Primary liver cancer, particularly hepatocellular carcinoma (HCC) at BCLC stage C, is a common and serious cancer where many patients are not eligible for surgery due to advanced disease. Researchers are evaluating the effectiveness and safety of two treatments: drug-eluting bead transarterial chemoembolization (DEB-TACE) alone versus DEB-TACE followed by hepatic artery infusion chemotherapy (HAIC). This study aims to see if combining these treatments provides better outcomes for patients with unresectable advanced liver cancer. The trial compares two groups: one receiving DEB-TACE alone and the other receiving DEB-TACE followed by sequential HAIC using a FOLFOX-based chemotherapy regimen. DEB-TACE uses drug-loaded beads to block tumor blood supply and release chemotherapy slowly, while HAIC delivers chemotherapy directly into the liver artery. This combination is designed to enhance the anti-tumor effect while potentially reducing side effects. Treatment is administered in a multi-center setting with careful monitoring. Participants will be monitored from the first DEB-TACE treatment up to 36 months or until disease progression or death. Assessments include imaging scans to evaluate tumor response according to mRECIST criteria, laboratory tests, and safety evaluations. Researchers will measure progression-free survival, which is the time without tumor growth or death. Participants must cooperate with treatment, complete scheduled visits, and provide informed consent, with an estimated life expectancy of at least 3 months.

This research investigates how weight loss through a diet management mobile app and an intelligent weight scale affects cardiovascular health in obese patients with heart failure. The study focuses on patients with heart failure with reduced ejection fraction and aims to see if these tools can reduce death rates, hospital stays related to heart failure, and improve frailty and quality of life. The trial addresses a gap where current heart failure guidelines recognize obesity as a risk but lack effective interventions for this group. Participants are randomly assigned to one of two groups: one group uses a fully functional diet management app and intelligent weight scale designed to support weight loss in obese heart failure patients, while the other group uses limited-function versions of the app and scale as a comparison. Both groups use the app at every meal and the scale daily for 12 months. The trial is a multicenter, single-blind randomized controlled study. During the study, participants will visit the clinic after 12 months for checkups. Researchers will collect data on a composite cardiovascular outcome, including all-cause mortality and hospitalizations related to heart failure, tracked over one year. Adherence to app and scale use is monitored through the mobile application. The study measures the impact on heart failure frailty, quality of life, and overall cardiovascular outcomes over the trial period.

Researchers are evaluating the effectiveness and safety of Proline Plus Empagliflozin Tablets in treating adults with type 2 diabetes in real-world clinical settings. This multicenter, prospective, observational study allows the use of these tablets either alone or combined with other diabetes medications based on actual patient needs. The study aims to see how well the treatment controls blood sugar and its impact on patients with various health conditions related to diabetes. Participants prescribed Proline Plus Empagliflozin Tablets for the first time will follow dosing guidelines starting at one tablet once daily with meals, with the option to increase the dose to two tablets daily if needed and tolerated. The study includes a screening period up to 14 days before starting treatment, followed by treatment visits at 12, 24, and 48 weeks. During these visits, clinical examinations and assessments are done as needed, without interfering with usual care. Participants will have their baseline health recorded, including physical exams and medication use, and will be monitored for any side effects. Quality of life will be measured using the EQ-5D score, and cognitive function will be assessed for those aged 50 or older. The main outcome measured is blood sugar control at 24 weeks, with additional evaluations for kidney, heart, eye health, and cognitive changes. The total participation time spans up to 48 weeks with multiple visits.

Researchers are conducting a multicenter, prospective, observational real-world study across 200 hospitals in China to examine treatment patterns for chronic hepatitis B (CHB). The study aims to compare patient outcomes under various therapies to provide evidence-based data that can help optimize CHB treatment and follow-up, with the ultimate goal of advancing a functional cure for chronic hepatitis B. The focus includes monitoring the incidence of hepatocellular carcinoma (HCC) associated with hepatitis B. Participants receive treatments including entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF), or Peginterferon α-2b injection. The study follows both patients currently on these therapies and those initiating or re-initiating Peginterferon α-2b therapy. These treatments are assessed in routine clinical practice settings without intervention from the study team. Throughout the study, patients are monitored from week 4 up to week 240 for the development of HBsAg-associated hepatocellular carcinoma (HCC) and overall HCC incidence. Researchers collect data on treatment effectiveness and safety as part of the observational follow-up. Participants provide informed consent and are observed under real-world conditions to evaluate long-term outcomes and risks associated with chronic hepatitis B and its treatments.

Researchers are evaluating the safety and effectiveness of starting direct oral anticoagulants (DOACs) early versus later in patients who have acute ischemic stroke related to atrial fibrillation and who have undergone emergency endovascular therapy (EVT). This multicenter, prospective, open-label randomized controlled trial focuses on different timings to begin DOAC therapy to improve outcomes and reduce risks after stroke. Patients will be randomly assigned to one of two groups: the early anticoagulation group, which starts DOACs within four days of symptom onset, and the delayed anticoagulation group, which begins DOACs between 5 and 14 days after symptom onset. The study observes these treatment timings after emergency EVT for stroke, assessing their effects on patient safety and stroke recurrence. Participants will be monitored closely for 90 days after treatment to assess outcomes including recurrent ischemic stroke, symptomatic intracranial hemorrhage, and death from any cause. Evaluations include clinical assessments and imaging such as CT or MRI to detect hemorrhagic changes. Researchers will also review medical history, stroke severity, and treatment adherence. The study involves follow-up visits and data collection to ensure thorough safety and efficacy analysis over the three-month period.

Researchers are evaluating the safety and effectiveness of starting direct oral anticoagulants (DOACs) early versus delaying their start in patients who have had an acute ischemic stroke related to atrial fibrillation and developed bleeding in the brain after emergency endovascular treatment. This is a multicenter, open-label, randomized controlled trial focusing on different timings for beginning DOAC therapy to improve patient outcomes after stroke. Participants are assigned to one of two groups: early anticoagulation, where DOACs are started within 4 weeks after stroke symptoms begin, or delayed anticoagulation, where DOACs are started between 4 to 8 weeks after symptom onset. The study compares these two approaches to understand which timing is safer and more effective in managing stroke patients who experienced hemorrhagic transformation after treatment. During the study, patients will be monitored for a composite outcome including recurrent ischemic stroke, symptomatic brain bleeding, and death from any cause within 90 days. Researchers will conduct assessments and follow patients closely during this period to evaluate the effects of the timing of anticoagulant initiation. Participants will be followed up for 90 days to track these outcomes and assess safety and efficacy.

Researchers are evaluating the safety and effectiveness of TQB2922 combined with TAS-102, with or without bevacizumab, in adults aged 18 to 75 who have RAS/BRAF wild-type advanced colorectal cancer that cannot be removed by surgery or has spread to other parts of the body. This phase Ib/II multicenter open clinical trial focuses on patients whose cancer has not responded to previous chemotherapy treatments including oxaliplatin, fluorouracil-based therapies, and irinotecan. The study aims to understand how well these treatments work and how safe they are for this specific group of cancer patients. The treatments under investigation include TQB2922, which is an antibody designed to block cancer growth by targeting proteins EGFR and c-Met on tumor cells, potentially killing them through immune system mechanisms. Participants will receive TQB2922 injections combined with TAS-102 tablets, and some will also receive bevacizumab. The treatments are given according to the study protocol, and participants may receive different combinations depending on the study design. The study includes separate phases that monitor the effects and safety of these drug combinations over time. Participants will be closely monitored throughout the study for any dose-limiting toxicities up to 48 weeks and for objective response rates, with evaluations expected to take up to one year. Assessments include measuring tumor response using standardized criteria and regular safety checks. The study requires patients to have measurable lesions and meet specific health and laboratory requirements. Safety follow-up and adherence to contraception guidelines for participants of childbearing potential are also part of the study procedures.