Fu Yang Shi

Researchers are evaluating TQB2102 for injection, a new antibody-coupled drug that targets two different parts of the HER2 protein on tumor cells. This study focuses on patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. The trial aims to assess the effectiveness and safety of TQB2102 combined with benmelstobart or penpulimab, with or without chemotherapy, in this patient group. This is a Phase II randomized study sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Participants receive TQB2102 for injection and either benmelstobart or penpulimab, both given intravenously every three weeks. Chemotherapy is taken orally from Day 1 to Day 15 in each 21-day treatment cycle. There are three study groups, each involving different combinations and doses of TQB2102, benmelstobart, penpulimab, and chemotherapy. Treatment continues through multiple cycles as determined by the study protocol. During the study, participants undergo regular assessments including scans and tests to measure tumor response and disease progression. Researchers monitor outcomes like the objective response rate, progression-free survival, duration of response, overall survival, and any adverse events. The study includes follow-up periods to track safety and effectiveness, with an average observation of up to three years. Participants are closely monitored throughout the treatment and follow-up phases for their health and response to therapy.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are studying the safety and effectiveness of TQB2102 for injection in patients with HER2-positive biliary tract cancer. This includes patients with locally advanced or metastatic forms of the disease who have experienced failure of 1-2 prior systemic therapies. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. and spans phases 1 and 2 to evaluate dosing, safety, and immune response. Participants receive TQB2102, a HER2 dual-antibody-drug conjugate, by intravenous infusion every three weeks in cycles of 21 days. Treatment involves 6 to 8 cycles, with ongoing monitoring for adverse events and response to therapy. The study does not use masking or placebo controls. During the trial, participants undergo assessments for tumor response, disease control, survival, and side effects from the time of consent until 28 days after the last dose or the start of a new antitumor therapy. Follow-up includes evaluations up to 36 weeks for outcomes like progression-free and overall survival. Participants also provide tumor tissue samples for HER2 testing and are monitored for immune reactions and safety throughout the study.

Researchers are studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

Researchers are studying primary membranous nephropathy PMN, a kidney condition where harmful autoantibodies build up in the kidney filters, causing damage. This can lead to protein and blood leaking into the urine, swelling, tiredness, and high blood pressure. The study aims to compare how the laboratory-made antibody drug felzartamab works compared to the existing drug tacrolimus in treating PMN, focusing on how many participants achieve complete remission over 104 weeks. Participants will be randomly assigned to receive either felzartamab through intravenous infusions or tacrolimus as oral tablets. Those whose disease worsens or who do not improve may receive additional rescue treatment, including standard immunosuppressive therapy or felzartamab. The study includes an open-label treatment phase and a non-responder treatment phase for those needing rescue therapy. Participants will undergo up to 23 study visits during screening and treatment, which may last up to 104 weeks or 156 weeks if rescue treatment is needed. Researchers will monitor urine protein levels, kidney function, antibody levels, physical health, and side effects. Follow-up visits every 12 weeks will continue if treatment stops early to assess long-term effects and safety.

Researchers are comparing the effects and safety of two drugs, GQ1005 and Trastuzumab Emtansine T-DM1, in adults with HER2-positive breast cancer that cannot be removed by surgery or has spread to other parts of the body. This phase III trial focuses on patients who have previously been treated with trastuzumab and taxane. The study aims to understand which treatment might better manage this advanced form of breast cancer. Participants will be randomly assigned to receive either GQ1005 or T-DM1. Both drugs are given through intravenous infusions every 21 days. About 228 patients will take part, and the treatments will continue to be monitored over approximately 24 months to assess their impact on cancer progression and safety. During the study, participants will have regular assessments including scans to measure tumor size and blood tests to monitor the drugs in their system. Researchers will track how long patients live without cancer progression, overall survival, response rates, adverse events, and quality of life changes. These evaluations will help understand the benefits and risks of each treatment over time.

Hepatocellular carcinoma HCC is a serious cancer with high rates of illness and death. Surgery is the main treatment, but the cancer often returns, especially in patients with a high risk of recurrence after surgery. Researchers are studying how to lower the chance of cancer returning and improve survival, as there is currently no standard treatment after surgery. This study evaluates the safety and effectiveness of combining two drugs, donafenib and envafolimab, for patients at high risk of recurrent HCC after surgery. Participants will receive donafenib orally at 100mg twice daily and envafolimab intravenously at 300mg every three weeks. Treatment cycles range from 6 to 12 months or 8 to 16 sessions, continuing until cancer recurrence, unacceptable side effects, death, withdrawal, or completion of 16 envafolimab cycles. This is a single-arm, multicenter study designed to assess this drug combination as an adjuvant therapy after surgery. During the study, participants will be monitored for recurrence-free survival over 24 months. Researchers will also track overall survival, the rate of survival and recurrence at two years, and any adverse events during this time. Patients will undergo imaging and laboratory tests to confirm no cancer recurrence before starting treatment and will be followed closely throughout to assess treatment effects and safety.

Researchers are evaluating the use of albumin combined with endovascular therapy in patients who have suffered an acute ischemic stroke in the anterior circulation. This prospective, multicenter, open-label, randomized controlled trial aims to verify the effectiveness and safety of adding albumin to the current standard endovascular treatment for this type of stroke. The study is sponsored by Capital Medical University and focuses on patients aged 18 to 80 years with specific stroke characteristics. Participants are randomly assigned to one of two groups one receiving albumin combined with endovascular treatment and the other receiving endovascular treatment alone. Albumin is given intravenously at a dose of 0.5 gkg up to 37.5 g on the first day and then daily on the second, third, and fourth days. Both groups receive acute stroke care and secondary prevention according to American stroke guidelines. Initial assessments include CT or MRI scans to locate the stroke and rule out bleeding, along with neurological and functional scoring. Throughout the study, patients undergo various evaluations such as the National Institutes of Health Stroke Scale NIHSS, Modified Rankin Scale mRS, Alberta Stroke Program Early CT Score ASPECTS, and quality of life assessments using standardized questionnaires. Vital signs and laboratory tests are monitored at baseline, with a 90-day follow-up conducted by telephone to assess recovery and outcomes. The primary measure is the proportion of patients achieving good functional recovery at 90 days after treatment.

Researchers are establishing a standardized clinical database for patients with liver cancer, including hepatocellular carcinoma and related types, to support high-quality real-world clinical studies. This observational study is led by the Department of Hepatobiliary Surgery at the First Affiliated Hospital of the University of Science and Technology of China USTC in collaboration with multiple centers nationwide. The purpose is to collect detailed clinical information to better understand liver cancer outcomes over time. Participants will receive routine clinical treatments for liver cancer, such as surgical resection, ablation, transarterial chemoembolization TACE, hepatic arterial infusion chemotherapy HAIC, and various anti-tumor drugs including immunologic, targeted, and chemotherapy agents. The study observes and records these standard treatments without assigning interventions. The research will track these patients in a cohort database to monitor their treatment and progression. During the study, participants will be followed for up to 10 years to assess overall survival, recurrence-free survival, and survival time after cancer recurrence. Researchers will collect blood and surgical tissue samples and perform regular follow-up visits to gather clinical data and pathology results. This long-term monitoring aims to provide comprehensive insights into liver cancer progression and treatment outcomes.

Researchers are investigating the effects of amlodipine alone versus amlodipine combined with folic acid in Chinese adults aged 45 to 74 years who have H-type hypertension, specific MTHFR 677 genotypes CC or CT, elevated plasma homocysteine levels, and low serum folate. This large, multi-center, randomized, double-blind, double-dummy clinical trial aims to evaluate which treatment better reduces the risk of first ischemic stroke over five years. Participants are first screened and then enter a 2 to 4 week run-in period where they take amlodipine to assess tolerance and compliance. Afterward, eligible participants are randomized by genotype into two groups one receiving amlodipine 5mg daily with a placebo, and the other receiving amlodipine 5mg combined with 0.8mg folic acid daily with a placebo. Other blood pressure medications may be added as needed to reach target blood pressure goals. Follow-up visits occur every three months during the five-year treatment period with medication provided at each visit. Throughout the study, participants undergo interviews, clinical evaluations, and laboratory tests including genetic and blood analyses. Researchers monitor adherence, blood pressure, and cardiovascular health. The main outcome measured is the occurrence of first ischemic stroke by the end of five years. Secondary outcomes include other cardiovascular events and kidney function. Two interim analyses will be conducted during the study to assess progress and safety.