Xi Ning Shi

Researchers are evaluating the diagnostic accuracy of 68Ga-PSMA PET scans compared with enhanced CT scans in detecting metastatic lesions in patients with locally advanced and advanced renal cell carcinoma. The study also aims to determine whether the use of 68Ga-PSMA PET can influence treatment decisions for these patients. This is a prospective, multicenter study focusing on patients with stage III or IV renal cell carcinoma as defined by the 2017 AJCC TNM staging system. Participants will undergo 68Ga-PSMA PET / CT imaging within 6 weeks after their renal cell carcinoma diagnosis. This diagnostic test is being studied for its potential impact on clinical decision-making in renal cancer management. The trial aims to assess the additional diagnostic value of 68Ga-PSMA PET compared to standard CT imaging. During the study, patients will be monitored over a 2-year period to evaluate the diagnostic effectiveness of the 68Ga-PSMA PET. Researchers will collect data on imaging results and observe any changes in treatment plans based on PET findings. Safety and kidney function will also be considered, especially since renal impairment or ongoing hemodialysis are exclusion factors. Participants will provide informed consent before joining the study.

This research aims to verify the accuracy, stability, and clinical usefulness of artificial intelligence (AI) algorithms for measuring heart function through echocardiography. The study involves collaboration with multiple medical centers and focuses on comparing AI measurements with those done manually by physicians of different experience levels. It also explores whether AI can reduce the time needed for echocardiogram analysis and improve clinical workflows, while assessing AI's performance in complex heart conditions such as cardiomyopathy and valve disease. The study collects echocardiographic data using Mindray ultrasonic machines, with AI and physicians at each center measuring key heart parameters including left and right ventricular size and function. AI and intermediate doctors complete measurements within one day of data collection, while senior physicians at the main research unit finalize their assessments within one month. The goal is to establish a standardized reference system for AI in ultrasound measurement and promote its use across various medical institutions. Participants aged 18 to 80 years with specific heart conditions or normal hearts are involved. Researchers measure heart chamber sizes and functions through echocardiography, comparing AI and physician results for consistency and accuracy. The study also monitors how AI-assisted measurements could optimize diagnosis time and medical resource use. The total duration of participant involvement depends on data collection and measurement timelines, with ongoing analysis to support AI's clinical application in cardiovascular care.

Researchers are investigating the prognostic value of initial staging using prostate-specific membrane antigen (PSMA) positron emission tomography (PET) in men with newly diagnosed, untreated prostate cancer. This study aims to develop a prognostic tool called the PSMA-VISION score to predict progression-free survival (PFS), and to compare this tool with existing prognostic models. The study addresses the current need for clear risk assessment specifically in treatment-nafve patients, as earlier studies included mixed patient groups with varied disease stages and treatment histories, which may limit accuracy. Participants will undergo PSMA PET imaging as part of their initial cancer staging before starting any treatment. The study will collect baseline PSMA PET parameters, such as lesion counts and metastatic stage, alongside clinical and pathological information. These data will be used to create and validate the PSMA-VISION score. The study will follow patients for at least two years to track progression-free survival and overall survival, comparing the new score to established tools like the NCCN risk categories and PPP nomograms. During the study, data will be collected repeatedly every 3 to 6 months and securely stored in a central database. Researchers will monitor progression-free survival over two years and evaluate the predictive accuracy of the PSMA-VISION score. Additional analyses will explore correlations with clinical features and early disease progression. This study plans to enroll approximately 1000 men and will use statistical methods to validate the prognostic value of PSMA PET imaging in this specific patient group.

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are evaluating the effectiveness and safety of BGB-16673 compared to the investigator's choice of treatment (either bendamustine plus rituximab or high-dose methylprednisolone plus rituximab) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with covalent Bruton tyrosine kinase inhibitors. CLL and SLL are blood cancers that cause enlarged lymph nodes, spleen, or liver and symptoms such as night sweats, weight loss, and fever, leading to a shorter life expectancy. Participants will be randomly assigned to receive either oral BGB-16673 or the investigator's choice of intravenous bendamustine plus rituximab or high-dose methylprednisolone plus rituximab. About 150 participants in Mainland China and Taiwan will take part in this Phase 3, open-label, randomized study. During the study, researchers will measure how long participants live without their disease worsening, known as progression-free survival, over approximately 23 months. Participant health and disease status will be monitored through imaging, laboratory tests, and clinical assessments to evaluate treatment effects and safety.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the safety and effectiveness of Telitacicept in adults with active proliferative lupus nephritis, a serious kidney inflammation caused by lupus. This phase 2, multicenter, randomized, double-blind, placebo-controlled trial compares Telitacicept to a placebo alongside standard care treatments. The study focuses on adult patients aged 18 to 75 years with biopsy-confirmed active lupus nephritis and positive lupus-related antibodies, aiming to improve kidney response over 48 weeks. Participants will be randomly assigned to receive one of two doses of Telitacicept (240 mg or 160 mg) or a placebo once weekly for 48 weeks, all in addition to their standard of care treatment, which includes high-dose corticosteroids and mycophenolate mofetil or other mycophenolate forms. The study ensures that all participants continue their induction therapy for active renal disease alongside the investigational or placebo treatment. Throughout the study, participants will undergo regular assessments including laboratory tests to monitor kidney function and lupus activity. The main outcome measured is the percentage of participants who achieve a complete renal response at 48 weeks. Safety will also be closely monitored to evaluate any adverse effects. The total study duration for each participant is 48 weeks of treatment with follow-up evaluations.

Researchers are evaluating the effect of TQB3473 tablets, a selective Spleen tyrosine kinase (Syk) inhibitor, compared to placebo in adults with primary immune thrombocytopenia (ITP) who have previously received standard corticosteroid therapy and failed or relapsed after at least one standard ITP treatment. This Phase III randomized, double-blind, placebo-controlled study aims to demonstrate that TQB3473 improves the sustained platelet response rate in this population. The study includes a treatment period followed by a safety follow-up period. Participants are randomly assigned to receive either TQB3473 tablets or a matching placebo. The treatment duration includes a 24-week randomized double-blind period during which platelet counts and durable response rates are closely monitored. The placebo contains no active substance, allowing comparison of effects with the active treatment. After the treatment phase, participants enter a safety follow-up period to monitor ongoing effects and adverse events. During the study, participants will have multiple assessments including platelet count measurements to evaluate response to treatment. Researchers will track durable platelet response defined by platelet counts of 50×10^9/L or higher during weeks 14 to 24. Safety evaluations and monitoring for adverse reactions will occur throughout the treatment and follow-up periods. The total participation time covers screening, treatment, and follow-up phases, ensuring comprehensive evaluation of treatment effects and safety.

Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with locally advanced, unresectable, or metastatic stomach or gastroesophageal junction (GEJ) cancer. This study focuses on cancer cells that are HER2-negative but positive for the Claudin 18.2 protein and PD-L1, exploring how well zolbetuximab helps the immune system attack the tumor alongside immunotherapy and chemotherapy. The trial is a phase 3, randomized, double-blind study designed to compare the overall survival of participants receiving zolbetuximab with pembrolizumab and chemotherapy versus those receiving a placebo with pembrolizumab and chemotherapy. Participants receive study treatment in 6-week cycles, with zolbetuximab or placebo given by infusion every 2 or 3 weeks. Chemotherapy regimens include either CAPOX (capecitabine tablets and oxaliplatin infusion) or mFOLFOX6 (infusions of 5-fluorouracil, folinic acid, and oxaliplatin) administered on schedules matching the cycles. Pembrolizumab is infused every 3 or 6 weeks. Treatment continues until cancer worsens, is not tolerated, or another therapy is needed, with pembrolizumab given for up to 2 years. After initial cycles, some chemotherapy drugs are adjusted to only include oral capecitabine or certain infusions. During the study, participants visit the clinic for treatments, health checks, and scans to monitor cancer changes and side effects. Researchers also track medical problems related to the treatments and may collect tumor samples if cancer worsens. After stopping treatment, participants have follow-up visits and scans every 9 to 12 weeks, along with telephone check-ins every 3 months. The primary outcome measured is overall survival up to 72 months, with ongoing monitoring to evaluate safety and treatment effects.