Bo Zhou Shi

Researchers are evaluating the effectiveness of QL1074 compared with a placebo in achieving kidney response after 52 weeks of treatment in people with active lupus nephritis. The study focuses on whether adding QL1074 to standard care, which includes mycophenolate mofetil (MMF) and corticosteroids, can reduce disease activity. Participants must have a diagnosis of lupus nephritis confirmed by clinical and biopsy evidence and meet established criteria for active kidney inflammation. Participants will receive either QL1074 at a fixed dose of 23.7 mg twice daily or a matching placebo, alongside background therapy with MMF and an initial course of intravenous methylprednisolone followed by tapering oral corticosteroids. The study includes provisions to adjust or interrupt QL1074 dosing based on safety concerns such as blood pressure and kidney function. Treatment will continue for 52 weeks, during which participants will be monitored closely. During the study, participants will undergo various assessments including urine tests to measure protein levels as an indicator of kidney function, and safety evaluations to monitor side effects. The main outcome measured is the number of participants who achieve complete kidney remission by week 52. The study will also track safety and tolerability of the treatment over the full duration, with participants committed to the 52-week treatment period and follow-up.

Researchers are establishing a standardized clinical information database for liver cancer patients through a collaborative effort led by the Department of Hepatobiliary Surgery at the First Affiliated Hospital of the University of Science and Technology of China (USTC). This database aims to support high-quality real-world clinical studies and research on hepatocellular carcinoma and related liver cancers. Participants may receive routine treatments such as surgical operations including resection, ablation, transarterial chemoembolization (TACE), and hepatic arterial infusion chemotherapy (HAIC). They might also be treated with various anti-tumor drugs including immunologic, targeted, and chemotherapy medications. Treatments and clinical data are collected to enrich the database for future research. During the study, participants will provide blood samples and postoperative pathology residual samples and will be followed over time to monitor their health and treatment outcomes. The primary outcome measured is overall survival over 10 years. Participants must be willing to comply with follow-up visits and provide informed consent, ensuring comprehensive data collection for long-term analysis.

Researchers are evaluating the effects of two treatments in people with H-type hypertension who have specific genetic types (MTHFR 677 CC or CT), elevated plasma homocysteine levels, and low serum folate. This large, phase 4 clinical trial involves 32,000 Chinese men and women aged 45 to 74 years. The study aims to compare the risk of first ischemic stroke over a five-year period between the two treatment groups. Participants will be divided into groups based on their MTHFR genotype and randomly assigned to receive either amlodipine tablets (5mg once daily) or amlodipine combined with folic acid tablets (5.8mg once daily). The study includes a screening period, a 2 to 4-week run-in phase to check tolerance and compliance to amlodipine, and a five-year randomized treatment phase. Additional blood pressure medications may be added if needed to maintain target blood pressure levels. During the study, participants will have visits every three months for drug distribution and monitoring. Researchers will collect blood samples, conduct clinical evaluations, and gather data on medication adherence and health outcomes. The primary outcome measured is the first occurrence of ischemic stroke by the end of five years. Safety and efficacy will be assessed, with two interim analyses planned at years three and four.

Researchers are studying the effects of three different treatment approaches on the risk of first ischemic stroke in Chinese men and women with hypertension and a specific genetic type called MTHFR 677 TT genotype. This large, phase 4 clinical trial will include 24,000 participants aged 45 to 74, and will compare the impact of amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate (5-MTHF). The goal is to evaluate which treatment strategy might better prevent the first ischemic stroke over five years. The study has three main periods: screening, run-in, and randomized treatment. During screening, participants provide consent and undergo interviews, clinical evaluations, and lab tests to confirm eligibility. The run-in period lasts 2 to 4 weeks, where participants take amlodipine (5 mg once daily) to assess tolerance and compliance. After this, eligible participants are randomly assigned to one of three groups: amlodipine only, amlodipine plus folic acid, or amlodipine plus folic acid and 5-MTHF. Treatments are taken orally once daily for five years. Additional antihypertensive medications may be added as needed to keep blood pressure controlled. Participants will visit the research centers every three months for follow-up, medication distribution, and monitoring. Researchers will check blood pressure, collect biological samples, and assess compliance and safety throughout the five-year treatment. The study’s main outcome is the occurrence of a first ischemic stroke by the end of the fifth year. Two interim analyses are planned at years three and four to evaluate ongoing results while maintaining study integrity.

Researchers are evaluating the effectiveness and safety of TQB2102 for injection, a HER2 dual-antibody-drug conjugate, in patients with HER2 negative recurrent or metastatic breast cancer. This Phase II clinical trial focuses on individuals whose cancer has returned or spread and who are not suitable for surgery or radiation aimed at a cure. Participants must have measurable tumors, adequate organ function, and have experienced disease progression or intolerance to previous treatments, including chemotherapy or targeted therapies. Participants will receive TQB2102 for injection as the study treatment. The trial monitors the response to this drug over a period of up to 24 months. Female participants of childbearing age must agree to use contraception during the study and for six months afterward, and males must also agree to avoid pregnancy during this time. The study excludes individuals with recent surgeries, uncontrolled illnesses, certain lung diseases, recent other cancer treatments, or allergies to the investigational drug. Throughout the study, participants will undergo regular evaluations to assess tumor response according to standardized criteria. The primary outcome measured is the objective response rate, which will be assessed for up to two years from the start of the study. Safety monitoring and adherence to treatment protocols will be conducted continuously to ensure participant well-being and accurate study results.

Researchers are evaluating gastrointestinal bleeding in patients with acute coronary syndrome (ACS) who have undergone Percutaneous Coronary Intervention (PCI) and require long-term dual antiplatelet therapy (DAPT). Helicobacter pylori (Hp) infection is a common risk factor for gastrointestinal bleeding in these patients. This open-label, randomized, controlled phase 4 trial compares the effects of a novel dual eradication therapy using Vonoprazan combined with amoxicillin against routine proton pump inhibitor (PPI) treatment with pantoprazole on bleeding events in ACS patients with Hp infection and coronary stents. The study plans to enroll 2600 patients, randomly assigning 1300 to each group. The test group will receive a 14-day course of Vonoprazan 20 mg twice daily plus amoxicillin 1 g three times daily for Hp eradication, followed by 6 months of monitoring. The control group will receive pantoprazole 40 mg daily for 6 months. All patients will continue their DAPT regimen, which includes aspirin plus either clopidogrel or ticagrelor, as determined by their doctor. Hp infection will be confirmed using urea breath tests and antibody detection, and eradication success will be retested about 12 weeks after treatment. Participants will be monitored for gastrointestinal bleeding and adverse reactions over 6 months. Follow-up visits will include breath tests for Hp, safety visits for adverse event reporting, and documentation of treatment adherence. The primary outcome is the incidence of gastrointestinal bleeding within 6 months after PCI. This trial aims to provide evidence on whether Vonoprazan-based dual eradication therapy is a safe and effective alternative to routine PPI treatment in reducing bleeding risk in this high-risk patient group.

Researchers are evaluating the efficacy and safety of TQC2731 injection in adults with severe asthma that is not well controlled. This is a Phase III, multicenter, randomized, double-blind, placebo-controlled trial involving 660 participants aged 18 to 75 years. The study focuses on those who have had asthma diagnosed for at least a year and have experienced multiple asthma exacerbations in the past year despite using high-dose inhaled corticosteroids and other asthma medications. Participants are randomly assigned in equal numbers to receive either TQC2731 injection at a dose of 420 mg every four weeks or a placebo injection with no active drug. Both treatments are given by subcutaneous injection. The study treatment lasts for 52 weeks, during which the effects of blocking the Thymic Stromal Lymphopoietin (TSLP) protein by TQC2731 are assessed. Throughout the study, participants will be monitored for asthma exacerbations and other health outcomes. Researchers will regularly evaluate safety and treatment effects over the full 52-week period. The primary outcome measured is the annual rate of asthma exacerbations from the first day of dosing through completion. Participants' medication use, symptom control, and adverse events will also be tracked to assess treatment impact and safety.

Researchers are evaluating treatments for adults with acute spontaneous supratentorial intracerebral hemorrhage (ICH) of 20 mL or more. The study compares early minimally invasive surgery combined with thrombolysis (eMIST) against the best medical management. This multicenter trial is designed to adaptively assess outcomes using a randomized, open-label approach with blinded evaluation of results. The main goal is to improve functional recovery measured by a utility-weighted modified Rankin Scale at 180 days after treatment. Participants are randomly assigned to one of two groups: one receiving early minimally invasive catheter evacuation surgery along with up to ten doses of urokinase administered through the catheter placed in the hemorrhage area, and the other receiving the best available medical care without surgery. The intervention must start within 4 hours after randomization, which itself must occur within 8 hours of stroke symptom onset or the last known well time. The study includes an adaptive design to reassess sample size after 250 patients complete 180-day follow-up. Throughout the study, patients undergo assessments including head CT scans before randomization to confirm eligibility. Functional improvement is tracked using the utility-weighted modified Rankin Scale at 180 days. Safety and effectiveness of treatments are monitored during the trial, which includes long-term follow-up to evaluate outcomes. Participants or their legal representatives provide informed consent prior to enrollment.