Xi Ning Shi

Researchers are evaluating the diagnostic effectiveness of 68Ga-PSMA PET scans compared to enhanced CT scans in detecting metastatic lesions in patients with locally advanced and advanced renal cell carcinoma. The study also aims to see if 68Ga-PSMA PET can influence treatment decisions for these patients. This prospective, multicenter trial is sponsored by Xijing Hospital and focuses on improving diagnosis and management for renal cancer with metastases. Participants in the study will receive both a 68Ga-PSMA PET scan and an enhanced CT scan simultaneously to compare their abilities to detect cancer spread. This diagnostic approach helps assess the additional value that 68Ga-PSMA PET may provide over standard CT imaging. The study does not involve any masking or placebo groups and includes only patients who meet specific clinical and imaging criteria. During the study, patients will undergo imaging within six weeks after diagnosis, and researchers will track how the 68Ga-PSMA PET results affect treatment choices. The primary measurement is the additional diagnostic value of the PSMA PET compared to CT over two years. Secondary outcomes include how often the PET scan changes treatment decisions. The study monitors patient safety and adherence, with a planned follow-up period to evaluate outcomes until December 2027.

Researchers are conducting a multi-center clinical study to assess artificial intelligence AI algorithms for measuring heart function and size using echocardiography. The study aims to compare AI measurements with those of physicians at different experience levels, evaluate the accuracy and stability of AI, and explore its use in complex heart conditions like cardiomyopathy, valve disease, and coronary heart disease. The goal is to improve diagnostic consistency and clinical workflows across medical centers. The study involves measuring cardiac chamber size and function in 1600 participants using AI, senior physicians, and intermediate physicians. All measurements are made with Mindray ultrasonic machines. AI and intermediate physician results are completed within one day after data collection, while senior physician results are completed within one month. The study will establish a standardized reference system for AI-assisted echocardiographic measurements and evaluate AIs performance in special cases. Participants will undergo echocardiographic scans with measurements of left and right ventricular size and function, Doppler ultrasound indicators, and valve annulus displacements. Researchers will analyze data to compare AI and physician measurements, assess measurement deviations, and evaluate AIs efficiency in reducing analysis time. The study will run until July 2026, with ongoing data collection and analysis across multiple centers, aiming to promote wider clinical application of AI technology for cardiovascular disease diagnosis.

Researchers are studying the prognostic value of prostate-specific membrane antigen PSMA positron emission tomography PET scans in men newly diagnosed with prostate cancer who have not yet received treatment. The goal is to understand how initial PSMA PET imaging can predict progression-free survival and to develop a prognostic tool called the PSMA-VISION score. This study addresses a gap by focusing exclusively on untreated patients at initial staging to improve risk assessment accuracy. This observational study collects data from patients who have undergone PSMA PET as their first staging method before any treatment. The study will analyze baseline PSMA PET parameters, such as SUVmax, lesion count, and metastatic stage, along with clinical variables to create and validate a prognostic model. It also compares this new model with existing tools like NCCN risk categories and the PPP nomogram, aiming to enhance prediction of progression-free and overall survival. Participants will be followed for at least two years to assess progression-free survival and up to ten years for overall survival. Researchers will gather clinical data, imaging results, and pathology reports at regular intervals to evaluate disease progression and survival outcomes. Data will be securely stored and analyzed using statistical models to develop accurate risk stratification tools for prostate cancer management.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are assessing the effectiveness and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan 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 CPS 1. The study also evaluates rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, global, multicenter trial sponsored by AstraZeneca. Participants are divided into three groups Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine capecitabine or 5-FU Arm B receives pembrolizumab, trastuzumab, and chemotherapy either 5-FU plus cisplatin or capecitabine plus oxaliplatin Arm C receives rilvegostomig, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin. Treatments are given by intravenous infusion every three weeks or oral administration twice daily for capecitabine. This setup allows comparison of different combinations to evaluate each drugs role. During the study, participants will be monitored for progression-free survival and overall survival up to about six years. Researchers will also assess response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and quality-of-life factors like eating difficulties and side-effect burden. The study involves regular assessments including tumor measurements and laboratory tests. Participation may last several years, with safety and efficacy closely followed throughout this time.

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 drug CS0159 in a Phase III clinical trial for patients with Primary Biliary Cholangitis PBC who have an inadequate response or intolerance to ursodeoxycholic acid UDCA. This randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of CS0159 in this population. The study involves approximately 135 participants and is sponsored by Cascade Pharmaceuticals, Inc. Participants will be randomly assigned in a 21 ratio to receive either 4 mg of CS0159 or a placebo once daily for up to 52 weeks. Participants who are already taking UDCA should continue their stable dose during the study if applicable. The study compares the effects of CS0159 against placebo while monitoring participants over one year. During the study, participants will undergo various assessments including laboratory tests to monitor liver function and safety. Researchers will measure the proportion of patients achieving a composite response at 52 weeks as the primary outcome. Secondary outcomes include normalization of liver enzymes and monitoring of adverse events. The total participation period lasts up to 52 weeks, with ongoing safety monitoring throughout the trial.

Researchers are evaluating the safety and effectiveness of Telitacicept in adults with active lupus nephritis, a kidney inflammation caused by lupus. This phase 2, multicenter, randomized, double-blind, placebo-controlled study compares Telitacicept to a placebo while all participants receive standard of care treatment. The research aims to understand how well Telitacicept works and how safe it is for patients with this condition. Participants will be randomly assigned to one of three groups Telitacicept 240 mg, Telitacicept 160 mg, or a placebo. Each group receives weekly subcutaneous injections along with standard therapy for 48 weeks. The study monitors participants throughout this period to observe treatment effects and safety. During the 48-week treatment, participants will undergo regular assessments including kidney function tests and monitoring for side effects. Researchers will measure the percentage of participants achieving complete renal response at week 48, along with partial response rates and any adverse events up to week 48. The study ensures careful follow-up to evaluate outcomes and participant safety over the full treatment duration.

Researchers are evaluating the effectiveness and safety of TQB3473 tablets compared to a placebo in adults with primary immune thrombocytopenia ITP who have not responded well to standard corticosteroid and other ITP treatments. This randomized, double-blind, placebo-controlled Phase III clinical trial aims to show that TQB3473 can improve the sustained platelet response rate in these patients. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants will be randomly assigned to receive either TQB3473 tablets at a dose of 600 mg once daily or a placebo once daily, both for 24 consecutive weeks. The study includes a treatment period followed by a safety follow-up period. The trial carefully monitors platelet counts and bleeding events throughout the treatment duration. During the study, participants will have regular assessments including platelet count measurements, evaluations of bleeding events, and monitoring for any adverse effects. Researchers will track the durable response rate between weeks 14 and 24, as well as response rates and effectiveness within the first 12 weeks. Safety is closely monitored from consent signing until 28 days after the last dose or the start of new ITP treatment. The total participation covers the treatment and safety follow-up periods.

Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with stomach or gastroesophageal junction GEJ cancer. This study focuses on cancers that do not have the HER2 protein but do express Claudin 18.2. The goal is to understand how well zolbetuximab works with pembrolizumab and chemotherapy compared to a placebo with pembrolizumab and chemotherapy in people with advanced or metastatic disease that cannot be removed by surgery or has spread to other parts of the body. Participants will be randomly assigned to receive either zolbetuximab or a placebo, both given via intravenous infusion every 2 or 3 weeks, alongside pembrolizumab infusions every 3 or 6 weeks. Chemotherapy will be administered using one of two regimens, CAPOX or modified FOLFOX6, over multiple cycles lasting about 42 days each. Treatment continues until the cancer worsens, side effects prevent further use, or another therapy is needed. Pembrolizumab may be given for up to 2 years. During the study, participants will visit the clinic for infusions and health monitoring, including scans to check cancer status. Medical problems and treatment side effects will be recorded. After treatment ends, participants will continue to have regular health checks and scans every 9 to 12 weeks, along with phone check-ins every 3 months. The study will measure overall survival, disease progression, response rates, and safety over several years, with up to 72 months of follow-up for some outcomes.