Fu Yang Shi

Researchers are evaluating the efficacy and safety of a new antibody-coupled drug called TQB2102 for injection in patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. This Phase II study focuses on how TQB2102 works in combination with Benmelstobart Injection or Penpulimab Injection, with or without chemotherapy, to target HER2 proteins on tumor cells and potentially improve treatment outcomes. The study aims to assess the Objective Response Rate (ORR) over about one year of participation. The treatments being studied include TQB2102 combined with Benmelstobart and chemotherapy or TQB2102 combined with Penpulimab and chemotherapy. TQB2102 is designed to bind more effectively to tumor cell HER2 proteins, while Benmelstobart and Penpulimab are antibodies that may help the immune system target cancer cells. Different dosing regimens of TQB2102 (6 mg or 7.5 mg) are being evaluated, and chemotherapy may be included depending on the treatment group. Participants will be monitored through regular evaluations during the study, which lasts approximately one year. Researchers will measure tumor response and safety outcomes, including lab tests and imaging to confirm measurable lesions according to RECIST 1.1 criteria. The study also involves reviewing previous PD-L1 expression test results or collecting tumor tissue for testing. Safety is closely observed, and participants must meet specific health criteria to join and continue in the trial.

Researchers are evaluating the safety and effectiveness of two antibiotic treatments, omadacycline and moxifloxacin, in Chinese adults with community-acquired bacterial pneumonia (CABP). This Phase 3b study is designed as a bridging trial to confirm whether omadacycline works as well as moxifloxacin in this specific population, building on results from a global CABP trial. Participants will receive either omadacycline or moxifloxacin through intravenous or oral routes. The treatments are given as a course, with details on dosing schedules not specified. The study compares these two drugs directly to assess their clinical efficacy and safety in treating CABP. During the study, participants will be monitored and evaluated for their clinical response at 18 months after therapy. Researchers will assess symptoms, vital signs, and overall health related to pneumonia to determine treatment success. Safety and efficacy data collected throughout the study will help understand how well each drug performs in this patient group.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating the safety and effectiveness of TQB2102 for injection, a HER2 dual-antibody-drug conjugate, in treating patients with HER2-positive biliary tract cancer. This study focuses on patients aged 18 to 75 years who have advanced or metastatic biliary tract cancer confirmed by specific tests and who have failed 1-2 prior systemic therapies. The trial is conducted in Phase 1 and Phase 2 stages to determine the recommended dose and assess adverse events. Participants receive TQB2102 injections as part of the treatment. This study includes a screening period to confirm eligibility, followed by treatment cycles where participants are monitored closely. Women of reproductive age and men must agree to use effective contraception during and for six months after the study. The study also excludes patients with certain medical conditions, recent treatments, or prior anti-HER2 therapies depending on the stage. During the study, participants undergo tumor evaluations, safety assessments, and laboratory tests to monitor the drug's effects and side effects. Researchers collect data on adverse events from the time participants consent until 28 days after the last dose or start of new antitumor therapy. The study period includes up to 24 weeks to establish the recommended dose and long-term monitoring to ensure participant safety and treatment adherence.

Researchers are evaluating the effects of felzartamab in adults with Immunoglobulin A nephropathy (IgAN), a kidney disease caused by the buildup of abnormal IgA antibodies in the kidneys. This buildup leads to inflammation and damage, causing protein to appear in the urine. The study aims to understand how felzartamab influences proteinuria and kidney function, while also assessing the safety and how the body processes this treatment. This is a Phase 3, randomized, double-blind, placebo-controlled study focusing on adults with IgAN. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous (IV) infusions. Neither the participants nor the researchers will know which treatment is given. The treatment period lasts 24 weeks followed by an 80-week follow-up period. In total, participants will attend 17 study visits over about 2 years to receive infusions and participate in study activities. During the study, participants will undergo assessments including urine tests to measure protein levels, kidney function evaluations, and safety monitoring. Researchers will track changes in proteinuria from the start of the study to Week 36 as the main outcome. Additional measurements will include kidney function, clinical endpoints, and the study of how felzartamab is processed by the body. Participant safety and long-term effects will be monitored throughout the study and follow-up periods.

Researchers are studying the effects and safety of felzartamab, a laboratory-made monoclonal antibody, in adults with primary membranous nephropathy (PMN), a condition where harmful autoantibodies build up in the kidney filters causing damage. This damage leads to protein leaking into the urine, swelling, tiredness, and high blood pressure, which can progress to kidney failure if untreated. The study aims to compare felzartamab to tacrolimus, a standard oral medication, to see how well each helps achieve complete remission of proteinuria and maintains kidney function over 104 weeks. Participants will be randomly assigned to receive either felzartamab through intravenous infusions or tacrolimus tablets by mouth. The study includes a screening period of up to 42 days before treatment begins. If a participant's kidney function worsens, proteinuria increases, or the disease relapses without improvement, rescue treatment options are available. Those stopping treatment early will have follow-up visits every 12 weeks until week 104. Participants without rescue treatment will continue in the study for up to 104 weeks, while those needing rescue treatment may stay for up to 156 weeks, with a total of up to 23 study visits. Throughout the study, researchers will monitor how many participants achieve complete remission, how long remission lasts, and the development of antibodies against felzartamab. They will also assess the drug's safety, how it is processed in the body, and its effects on participants' tiredness and overall physical health. Regular evaluations, including laboratory tests and patient-reported outcomes, will help understand the treatment impact and safety over the long term.

Researchers are evaluating the safety and effectiveness of combining donafenib and envafolimab as an additional treatment for patients with hepatocellular carcinoma (HCC) who have a high risk of cancer returning after surgery. HCC is a serious liver cancer with high rates of illness and death, and while surgery is a key treatment, many patients experience recurrence. Currently, there is no standard therapy to prevent cancer from coming back after surgery, so this study explores a new combination therapy to address this need. The study involves giving patients envafolimab, an immunotherapy drug administered intravenously at a dose of 300 mg every three weeks, along with donafenib, a targeted therapy taken orally at 100 mg twice daily. This is a single-arm, phase II study conducted at multiple centers. Patients receive this combination after surgery to assess the treatment's impact on preventing cancer recurrence. The study focuses on those with high-risk features such as large tumors, multiple tumors, or portal vein cancer thrombus. Participants will be followed and monitored for up to 24 months to observe recurrence-free survival. During the study, researchers will conduct various assessments including imaging to confirm no metastasis before treatment, routine blood tests, liver and kidney function tests, and monitor adverse effects. The goal is to carefully evaluate both the benefits and safety of this adjuvant therapy in reducing cancer recurrence after surgery.

Researchers are evaluating the use of albumin combined with endovascular treatment in patients who have acute ischemic stroke affecting the anterior circulation. This phase 3, multicenter, open-label clinical trial aims to verify the safety and effectiveness of adding albumin to reperfusion therapy for these patients. The study enrolls adults aged 18 to 80 years who have had a large vessel occlusion stroke and meet specific clinical criteria. Participants are randomly assigned to one of two groups: one group receives albumin together with endovascular therapy, and the other group receives endovascular therapy alone. Albumin is administered intravenously at a dose of 0.5 g/kg (up to 37.5 g) on the first day and then daily on days two, three, and four. All patients receive standard acute stroke treatment and secondary prevention according to current American stroke guidelines. Initial evaluations include brain imaging (CT or MRA) to locate the blockage and check for bleeding, as well as laboratory tests and stroke severity scoring. Throughout the study, vital signs and neurological assessments are recorded. After 90 days from randomization, patients are followed up by telephone to assess recovery using quality of life scales and functional outcomes. The main measure of success is the proportion of patients achieving a good functional status or returning to their baseline level at 90 days. Safety and efficacy are carefully monitored during this period to understand the impact of albumin therapy in this patient population.

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.