Zhu Hai 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 studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are evaluating TQB3107, a targeted inhibitor designed to induce cell death and stop tumor growth, in patients with advanced cancers. This Phase I clinical trial aims to assess the safety and tolerability of TQB3107 tablets, determine dose-limiting toxicities, find the maximum tolerated dose, and recommend a dose for future Phase II studies. Participants receive TQB3107 tablets following one of two dosing schedules either daily for five consecutive days each week with a two-day break per 28-day cycle, or intermittent dosing every 28 days. The study begins with an initial single fasting dose followed by a seven-day observation before continuing the dosing cycles. This design allows researchers to monitor participants closely during the first cycle to assess safety and dosing effects. During the study, participants will have regular assessments including pharmacokinetic blood sampling at multiple time points to measure drug levels, and evaluations of dose-limiting toxicities and maximum tolerated dose at the end of the first 28-day cycle. Longer-term outcomes such as response rates, disease control, progression-free survival, and overall survival will be followed for up to three years. Participants are monitored for up to 24 months for recommended dosing and safety, with comprehensive evaluations throughout the study period.

Researchers are investigating new treatments for locally advanced or metastatic urothelial cancer UC, a type of bladder cancer that has spread or cannot be removed by surgery or radiation. This trial evaluates whether sacituzumab tirumotecan sac-TMT, an experimental medicine, can help people with UC who have already been treated with specific therapies live longer compared to those who receive certain non-platinum chemotherapy options. The study is a Phase 3 randomized trial comparing sac-TMT with chemotherapy drugs selected by the investigator. Participants are assigned to one of two groups one receives sacituzumab tirumotecan at a dose of 4 mgkg every two weeks by intravenous infusion until the disease worsens or side effects become unacceptable. The other group receives one of three chemotherapy drugspaclitaxel, docetaxel, or vinflunineby intravenous infusion every three weeks, also until disease progression or unacceptable toxicity. Rescue medications may be given as needed to manage side effects according to approved guidelines. During the study, participants undergo assessments of overall survival up to about 40 months, along with other measures such as progression-free survival, response rates, duration of response, and quality of life evaluations using questionnaires. Safety is monitored by recording adverse events and treatment discontinuations. The total study participation may last several years, with regular evaluations to understand the effects and tolerability of the treatments.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are conducting a multicenter, nonrandomized, open-label Phase III clinical trial to evaluate the safety, tolerability, and pharmacokinetics of ICP-723 in patients with solid tumors. The study focuses on patients with surgically unresectable locally advanced or metastatic solid tumors, including primary central nervous system tumors. This trial aims to better understand how ICP-723 behaves in the body and its safety profile during treatment. Participants will receive ICP-723, a white, round, uncoated tablet, as the investigational drug. The study includes adolescent participants aged 12 to under 18 years and adults aged 18 years and older. The trial involves monitoring treatment-emergent adverse events for up to 12 months and determining the maximum tolerated dose within the first two months. Secondary measures include peak drug concentration and objective response rate within specified time frames. During the study, participants will undergo evaluations of safety and tolerability, including assessments of adverse events and pharmacokinetic measurements. Measurable tumor lesions will be monitored according to established criteria. Patients will need to agree to use effective birth control methods if of childbearing potential and comply with visit schedules and treatment regimens. The total participation period includes follow-up for safety and treatment response, with data collected up to 12 months.

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.

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 studying a new mucosal contouring method to predict radiation-induced oropharyngeal mucositis in patients with nasopharyngeal carcinoma NPC. This condition, which causes swallowing-induced breakthrough pain, greatly affects patients quality of life during radiotherapy. Previous prediction models using oral cavity or mucosa surface contouring were not satisfactory, so this study aims to further evaluate a method based on mucosal areas linked to breakthrough pain in a real-world, multicenter observational setting. This observational study will follow patients with locally advanced NPC undergoing radical radiotherapy or chemoradiotherapy. The study focuses on assessing how well the mucosal delineation method predicts the occurrence and severity of oropharyngeal mucositis by tracking swallowing-induced breakthrough pain. There are no investigational treatments involved instead, patients are observed and data is collected during their standard care. Participants will have their oral or oropharyngeal mucositis severity and swallowing pain recorded continuously throughout their treatment. Researchers will analyze the predictive models performance by measuring accuracy, sensitivity, specificity, and other statistical values over up to three years. The study will help improve risk assessment and early intervention for mucositis in NPC patients, with all data collected during their regular clinical visits.

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.