Zhu Hai Shi

Researchers are evaluating the effects of reduced-dose radiotherapy (40.2Gy) compared to conventional-dose radiotherapy (49.2Gy) on low-risk target volumes in patients with chemosensitive intermediate-stage nasopharyngeal carcinoma. This phase 3 trial includes patients who have responded well to induction chemotherapy and whose plasma EBV-DNA levels have dropped to zero or below detection limits. The goal is to see if lowering the radiation dose can maintain treatment effectiveness while reducing side effects and improving quality of life. Participants will be randomly assigned to receive either reduced-dose or conventional-dose radiotherapy targeting the CTV2 area, while both groups receive the full course of PD-1 monoclonal antibody immunotherapy. The immunotherapy consists of 12 courses given every three weeks, starting with induction chemotherapy and continuing through radiotherapy and post-radiotherapy maintenance. Induction chemotherapy includes three cycles of gemcitabine and cisplatin or alternative drugs, administered intravenously. Throughout the study, patients will be closely monitored for progression-free survival and the occurrence of significant adverse events over three years. Researchers will assess survival outcomes, side effects, and quality of life differences between the two groups. Regular evaluations include imaging, laboratory tests, and clinical assessments to ensure patient safety and treatment effectiveness during the entire follow-up period.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating HLX10 monotherapy in a phase II clinical trial for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. These patients have experienced disease progression or intolerable side effects after standard cancer treatments. The study aims to assess the clinical effectiveness and safety of HLX10, a recombinant humanized anti-PD-1 monoclonal antibody, in this patient group. Participants will receive HLX10 as an intravenous infusion at a dose of 3 mg/kg every two weeks. Treatment will continue until the patient no longer benefits, experiences intolerable toxicity, withdraws consent, or completes up to 2 years of treatment (52 dosing periods). The study includes three periods: a 28-day screening phase, the treatment phase, and a follow-up phase that involves safety and survival monitoring. During the study, participants will undergo assessments including tumor measurements and laboratory tests to track treatment response and safety. Researchers will evaluate the overall response rate for up to 2 years. Regular monitoring will include imaging, blood tests, and collection of tumor tissue samples. Safety follow-up and survival status will be tracked after treatment ends to understand long-term outcomes and tolerability.

Researchers are investigating new treatment options for people with locally advanced or metastatic urothelial cancer, a type of bladder cancer. This trial focuses on comparing a medicine called sacituzumab tirumotecan (sac-TMT) with certain non-platinum chemotherapy drugs. The goal is to find out if sac-TMT can help people live longer after their cancer has worsened following previous treatments, including immunotherapy, chemotherapy, and targeted therapy. This is a Phase 3 randomized, open-label study. Participants receive either sacituzumab tirumotecan or one of the chemotherapy drugs vinflunine, docetaxel, or paclitaxel through intravenous (IV) infusions. Rescue medications may also be given to manage side effects, based on the investigator’s judgment and approved treatment guidelines. The study compares these treatments to evaluate their effects on the cancer and survival. During the trial, participants will be closely monitored with regular assessments to measure overall survival, the main outcome of the study, over about 40 months. Researchers will check participants' health, cancer progression, and organ function, and collect tumor tissue samples when possible. Safety and side effects will be tracked throughout the study to understand the treatments’ impacts and support participant well-being.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

This clinical trial is studying adults and adolescents with advanced solid tumors or primary central nervous system tumors that cannot be removed by surgery or have spread to other parts of the body. The study aims to evaluate the safety, tolerability, and how the body processes ICP-723, a drug being tested for these tumors. The trial is a phase I/II, open-label study conducted at multiple centers to gather detailed information about the effects of ICP-723 in these patients. Participants will receive ICP-723, an uncoated white, round tablet, as the investigational treatment. The study includes both adult and adolescent groups, with dosing and treatment monitored for safety and tolerability. The trial will assess the maximum tolerated dose within the first 2 months and continue to monitor for treatment-emergent adverse events throughout a 12-month period. Throughout the study, participants will undergo regular evaluations including physical exams, performance status assessments, and tumor measurements using standard criteria. Researchers will closely monitor safety by tracking adverse events and pharmacokinetic data. Participants are expected to follow the treatment and visit schedule, with safety and treatment effects observed for up to one year after starting ICP-723.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Chronic kidney disease (CKD) includes various conditions that cause damage to the kidneys or reduce their function. CKD affects about 10.8% of the population in China, making it a major health concern due to its high prevalence and associated risks, including progression to kidney failure and increased cardiovascular problems. This study aims to better understand CKD in China by investigating its occurrence, progression, treatment, and related risk factors using real-world patient data from multiple centers. The research is a multi-center, prospective, observational study involving a large and diverse group of participants from mainland China. It uses a standardized data network for efficient collection and analysis of patient information. The study includes people diagnosed with CKD, those at risk due to conditions like hypertension or diabetes, and healthy individuals, allowing for broad and detailed analysis. The study does not involve specific treatments but focuses on observing patients over time. Participants will be followed for up to 5 years to monitor the development or progression of CKD and related health outcomes. Researchers will collect and analyze clinical data and track kidney function and disease status over this period. This long-term observation aims to provide valuable insights into CKD prevention and management, helping to reduce the disease burden in China.

Radiation-induced oropharyngeal mucositis, which causes swallowing-induced breakthrough pain, is a common and challenging side effect for patients with nasopharyngeal carcinoma (NPC) undergoing radiotherapy. Existing predictive models using oral cavity or mucosa surface contouring methods have shown unsatisfactory results in predicting the occurrence and severity of this condition. To address this, researchers are evaluating a mucosal delineation method based on areas causing swallowing-induced breakthrough pain, which preliminary results suggest may predict radiation-induced oropharyngeal mucositis more effectively in locally advanced NPC. This research is a prospective, multicenter, real-world observational study aimed at further assessing the predictive accuracy of this new mucosal contouring method. Participants are patients with NPC undergoing radical radiotherapy or chemoradiotherapy. The study follows these patients throughout their treatment, collecting complete and continuous records of oral and oropharyngeal mucositis grading, as well as self-reported swallowing-induced breakthrough pain. During the study, researchers monitor participants up to three years to evaluate the performance of the predictive model using the area under the curve (AUC) measurement. Data collection includes clinical assessments of mucositis severity and detailed pain reports to understand the link between radiation dose, mucosal injury, and breakthrough pain. This long-term observation aims to improve risk assessment and early intervention for radiation-induced oropharyngeal mucositis, potentially enhancing treatment outcomes and patient quality of life.

Researchers are evaluating the effectiveness of a house dust mite (HDM) sublingual immunotherapy (SLIT) tablet compared to a placebo in Chinese participants aged 12 to 65 years who have HDM allergic rhinitis or rhinoconjunctivitis, with or without asthma. This phase III trial aims to assess symptom control by measuring the total combined rhinitis score over the last 4 weeks of treatment. The study is designed as a randomized, double-blind, placebo-controlled, multi-site trial conducted in China. Participants will receive either the HDM SLIT-tablet, taken once daily, or a matching placebo tablet daily during the treatment period, which lasts between 24 and 28 weeks. The HDM SLIT-tablet is also known as Acarizax or Odactra. The study compares these two groups to evaluate the tablet's efficacy in reducing allergy symptoms. Throughout the study, participants will be monitored for symptom severity using the total combined rhinitis score during a primary efficacy assessment period of 4 weeks, starting 24 weeks after treatment begins. Safety and lung function will also be assessed to ensure participants meet eligibility and to monitor responses. The total participation time includes screening, treatment, and assessment phases lasting up to 28 weeks.