Foshan

Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target Human Epidermal Growth Factor Receptor 2 HER2 in patients with locally advanced or metastatic non-small cell lung cancer who have HER2 gene abnormalities. This Phase 2 study aims to assess the effectiveness and safety of TQB2102, which combines targeted antibody action with a potent drug payload that is normally too toxic for general use. Participants receive TQB2102 through intravenous infusion every three weeks, with each treatment cycle lasting 21 days. Some participants will receive TQB2102 alone, while others will receive TQB2102 combined with Benmelstobart, another intravenous drug targeting programmed death ligand-1 PD-L1. Both treatments are given over multiple cycles to evaluate their effects. During the study, participants will be closely monitored through various assessments including measuring tumor response over up to eight months, tracking survival, and recording any adverse events from the start of treatment until 28 days after the last dose. Researchers will also check for immune responses to the drug at several points during and after treatment. The total participation may last up to 18 months to gather comprehensive safety and effectiveness data.

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating zorifertinib as a first-line treatment for patients with advanced non-small cell lung cancer NSCLC that has mutations in the EGFR gene and has spread to the central nervous system CNS. This prospective study involves multiple centers and compares the survival benefits and safety of zorifertinib to other similar drugs called EGFR tyrosine kinase inhibitors EGFR-TKIs. The study aims to better understand how well zorifertinib works and its clinical value in this patient group. Participants are divided into three groups those receiving first-line zorifertinib who meet criteria of the EVEREST study, those receiving zorifertinib but not meeting EVEREST criteria, and those receiving other anti-tumor drugs chosen by their doctors excluding zorifertinib. The EVEREST study is an open-label trial comparing zorifertinib to gefitinib or erlotinib. Treatments are given as prescribed by clinicians, with monitoring of safety and dosage adjustments as needed. During the study, participants will be followed for up to 36 months, with assessments every 8 weeks to measure overall survival, progression-free survival, intracranial progression, response rates, and adverse events. Researchers will track dose changes and monitor safety outcomes over time. The study collects clinical data to evaluate the effectiveness and tolerability of the treatments in patients with EGFR-mutant advanced NSCLC and CNS metastases.

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Chronic kidney disease CKD involves damage to the kidneys structure or function and affects a significant portion of the population in China, with a prevalence of 10.8%. CKD not only leads to severe kidney failure requiring treatments like dialysis but also raises the risk of cardiovascular diseases, placing a heavy burden on individuals and the healthcare system. This research aims to improve understanding of CKD occurrence, progression, treatment, prognosis, and risk factors in the Chinese population through a large-scale, real-world observational study. The study is a multi-center, prospective observational registry involving participants from various centers across mainland China. It collects and integrates standardized data to efficiently analyze CKD patterns and outcomes. The study includes both CKD patients and individuals with risk factors such as hypertension, diabetes, or hyperlipidemia, as well as healthy participants, to allow broad representation and subgroup analysis. The study is designed to cover a large sample size and account for potential loss to follow-up. Participants will be observed over up to 5 years to monitor the development of CKD in non-CKD individuals and the progression of disease in those with CKD. Researchers will track changes in kidney function, albuminuria levels, and composite endpoints including disease progression and mortality. Data collection includes clinical assessments and laboratory measurements to evaluate disease markers and outcomes. The study offers long-term monitoring to better understand CKD dynamics and inform prevention and control strategies.

Researchers are evaluating the real-world effectiveness of Repatha combined with standard of care SOC compared to SOC alone in Chinese adults with established atherosclerotic cardiovascular disease ASCVD. The study focuses on the risk of major cardiovascular events such as cardiovascular death, heart attack, stroke, hospitalization for unstable angina, or coronary revascularization. This observational study aims to understand how these treatments work when used according to local clinical practice. Participants are divided into two groups based on treatment decisions made independently of the study enrollment those receiving Repatha with SOC and those receiving SOC alone. The study observes these participants over a period of up to 72 months to assess outcomes. Treatment choices follow local guidelines and approved labels, ensuring minimal impact on routine care. During the study, participants undergo regular monitoring for cardiovascular events and changes in cholesterol levels, including low-density lipoprotein cholesterol LDL-C. Researchers also track adverse events and reactions throughout the follow-up period. Participants remain under usual care, and data collection occurs alongside routine clinical visits, with a total participation time of up to six years.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the efficacy and safety of GB491 combined with Letrozole compared to placebo combined with Letrozole in treating patients with hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2- locally advanced or metastatic breast cancer. This study focuses on patients who have not previously received systemic antitumor therapy for this condition and aims to provide new treatment insights. Participants are randomly assigned to one of two groups one receives GB491 at 150 mg orally twice daily along with Letrozole 2.5 mg orally once daily, while the other receives a placebo twice daily with the same Letrozole dose. Treatment cycles last 28 days, and the study is designed as a randomized, double-blind, placebo-controlled phase III trial. During the study, participants will be closely monitored for progression-free survival assessed by investigators using RECIST v1.1 criteria over approximately 60 months. Additional measures include overall survival, response rates, duration of response, disease control rates, clinical benefit rates, and the frequency and severity of adverse events. Regular assessments ensure safety and treatment adherence throughout the study period.