Zhong Shan Shi

Researchers are studying patients with low-risk intermediate-stage nasopharyngeal carcinoma who have responded well to induction chemotherapy and have undetectable levels of plasma EBV-DNA. The trial compares two doses of radiotherapy targeting a specific low-risk area to evaluate their effects on survival, side effects, and quality of life. This phase 3 randomized study aims to find out if lower-dose radiotherapy can maintain treatment success while reducing toxicities related to treatment. Participants receive either reduced-dose radiotherapy 40.2Gy or conventional-dose radiotherapy 49.2Gy to the low-risk target volume called CTV2. Both groups undergo full-course immunotherapy with the PD-1 monoclonal antibody Tislelizumab, administered every three weeks, totaling 12 courses through induction, radiotherapy, and maintenance phases. Induction chemotherapy using a cisplatin-based regimen is given before radiotherapy. Treatment continues until toxicity, progression, withdrawal, or completion of planned courses. During the study, patients will be monitored for progression-free survival and serious adverse events over three years. Secondary measures include metastasis-free survival, relapse-free survival, overall survival, tumor response rates, and quality of life assessments using standard questionnaires over three years. Safety and effectiveness will be evaluated through imaging, laboratory tests, and clinical evaluations. The study enrollment includes adults aged 18 to 75 years, and the follow-up will provide information on long-term outcomes and treatment impact.

Researchers are evaluating the tolerability, safety, and early effectiveness of T3011 in adults with advanced melanoma. This clinical study is designed as a phase IbIIa trial to understand how participants with measurable melanoma lesions respond to this treatment. The study is led by Shanghai Pharmaceuticals Holding Co., Ltd and focuses on treatment outcomes over approximately two years. Participants receive T3011 delivered directly into the tumor every two weeks. This treatment period is followed by ongoing monitoring to assess responses and any side effects. The trial includes a single group of participants all receiving T3011, without a comparison placebo or alternative treatment group. Throughout the study, participants undergo various assessments including laboratory tests and evaluations of tumor response. Researchers measure treatment-emergent adverse events and objective response rate as primary outcomes, along with disease control rate, remission duration, progression-free survival, and overall survival as secondary outcomes. The total study duration is approximately two years, during which safety and efficacy are closely monitored.

Researchers are evaluating the efficacy and safety of TQB6411 for Injection in adults with advanced lung cancer. This phase IbII clinical trial focuses on patients aged 18 to 75 years who have lung cancer confirmed by histology or cytology and meet specific health criteria. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and aims to determine the recommended phase II dosage and measure response rates over time. Participants will receive TQB6411 for Injection as the treatment, administered in cycles every 21 or 28 days. The study includes monitoring for response rates, disease control, duration of relief, progression-free survival, overall survival, adverse events, and the presence of anti-drug antibodies. Blood samples will be collected at specified cycles and timepoints before and after dosing to assess drug levels and immune responses. During the study, participants will be evaluated for tumor response using recognized criteria and undergo laboratory tests to monitor safety and drug effects. The study duration includes follow-ups up to three years for overall survival assessment. Participants will be regularly monitored for side effects and treatment efficacy to ensure comprehensive data collection throughout the trial period.

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 evaluating the use of pegmolesatide, a long-acting erythropoiesis-stimulating agent ESA, in patients with renal anemia who are currently treated with hypoxia-inducible factor prolyl hydroxylase inhibitors HIF-PHIs. This trial aims to explore the safety and effectiveness of switching from HIF-PHIs to pegmolesatide, addressing the current need for longer-acting and safe medications. The study is a multi-center, prospective, open-label, randomized parallel-controlled trial enrolling 96 dialysis chronic kidney disease patients with anemia. Participants are divided into two groups based on their current weekly Roxadustat dose a low-dose cohort 210 mg and a high-dose cohort >210 mg and 360 mg. Within each cohort, patients are randomly assigned to receive pegmolesatide at different initial doses 2 mg, 4 mg, or 6 mg administered subcutaneously once every 4 weeks. The dose may be adjusted according to the drugs instructions. The treatment period lasts 12 weeks, followed by a 16-week follow-up period. During the study, researchers will monitor hemoglobin levels and other blood parameters at various intervals to assess the effects of pegmolesatide. Patients will undergo assessments including hemoglobin tests, red blood cell counts, and safety monitoring for adverse events. The primary measurement is the change in mean hemoglobin levels from baseline to 12 and 16 weeks. The total participation time for each patient is 28 weeks, including treatment and follow-up.

Researchers are evaluating the real-world effectiveness and safety of Trastuzumab Deruxtecan T-DXd in patients with unresectable or metastatic HER2-positive or HER2-low breast cancer. This observational study focuses on patients who have previously received anti-HER2 treatments or systemic therapy and aims to understand treatment outcomes, patient characteristics, and tolerability over time. The study is sponsored by Daiichi Sankyo and collects detailed clinical and patient-reported data to provide insights into treatment patterns and safety. Participants are grouped into two cohorts those with HER2-positive breast cancer who have had one or more anti-HER2 regimens, and those with HER2-low breast cancer who have received prior systemic therapy or experienced early recurrence after adjuvant chemotherapy. All participants are starting or have recently started T-DXd treatment according to approved labeling in China. The study observes these patients from the start of treatment until study end, death, withdrawal, loss to follow-up, or closure. During the study, researchers will track time to next treatment or death, treatment duration, dosing changes, safety events, and patient-reported tolerability using questionnaires and symptom diaries. Follow-up lasts up to 36 months with ongoing data collection on clinical characteristics, treatment patterns, and safety management. This design allows for a comprehensive view of how T-DXd performs in routine clinical practice for this patient population.

Respiratory syncytial virus RSV is a common and serious respiratory infection that affects infants worldwide, often leading to hospitalization and severe complications like pneumonia. This trial aims to evaluate the safety and effectiveness of AK0529, a drug targeting the RSV fusion protein to prevent virus spread, in hospitalized infants aged 1 to 24 months with moderate to severe RSV infection. The study is a randomized, double-blind, placebo-controlled phase III trial conducted across multiple centers in China. Participants will be randomly assigned to receive either AK0529 or a placebo. The medication is given orally twice daily for five days, with doses adjusted based on the infants weight. The study includes a screening period of 36 hours before treatment, followed by the 5-day treatment phase and a 9-day safety follow-up. Dosing will be monitored closely, and samples will be collected to assess viral levels and drug impact. Throughout the study, infants will be regularly evaluated using the Wang bronchiolitis clinical score to monitor respiratory symptoms. Nasopharyngeal samples will be taken for virological testing at multiple points during and after treatment. Safety assessments will include monitoring for adverse events, vital signs, blood oxygen levels, physical exams, laboratory tests, and heart monitoring via ECG. Total participation is expected to last up to 17 days.

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 patients with non-valvular atrial fibrillation who are scheduled to have a combined procedure involving atrial fibrillation ablation and left atrial appendage LAA occlusion. This prospective, multi-center, randomized controlled trial aims to compare two methods for selecting the size of the LAA occluder device during the procedure. The study is sponsored by the First Affiliated Hospital of Shantou University Medical College and seeks to evaluate the accuracy of size selection using two imaging approaches. Participants are randomly assigned to one of two groups the CT group, where the LAA occluder size is chosen based on preoperative cardiac CT measurements, and the DSA group, where size selection is guided by intraoperative digital subtraction angiography DSA measurements. Both methods are used after completing the atrial fibrillation ablation. The trial measures various outcomes including the accuracy of occluder size selection during the procedure, procedural success, procedure-related times, and incidence of major adverse events within three months after the procedure. Participants will have clinical follow-ups before hospital discharge and at three months after surgery, with telephone follow-ups conducted annually for up to five years. The study monitors procedure success, device-related leaks at three months, and any major adverse events related to the device or procedure. The total participation duration can extend up to five years, allowing careful assessment of both immediate and longer-term outcomes.

Researchers are evaluating the effectiveness of postoperative adjuvant therapy with EGFR-TKIs based on minimal residual disease MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer NSCLC. This multicenter, prospective clinical study aims to explore whether MRD-guided treatment improves disease-free survival, with primary endpoints including the 3-year disease-free survival rate and median disease-free survival time. All participants will have their peripheral blood tested for MRD within one week and one month after surgery. Those with positive MRD results will receive icotinib as adjuvant treatment until their MRD turns negative, after which they enter a drug withdrawal observation period. If MRD becomes positive again, icotinib treatment resumes. Detection of the EGFR T790M mutation will lead to switching treatment to osimertinib. Participants with negative MRD results initially will be monitored regularly and start osimertinib treatment if MRD turns positive, followed by drug withdrawal once MRD is negative again. Participants will undergo MRD assessments at specified intervals, including every 12 weeks after surgery. Researchers will track disease progression, survival rates, and overall survival up to 100 months. The study includes careful monitoring of participants health status, laboratory tests, and treatment adherence. This approach aims to personalize treatment based on MRD status and provide close follow-up to assess outcomes and safety over an extended period.