Heng Shui Shi

Researchers are evaluating the efficacy and safety of SPH5030 tablets in adults with Her2-positive or Her2-mutated biliary tract or colorectal cancer. This phase II clinical study focuses on patients with metastatic, unresectable, or advanced forms of these cancers who have specific genetic markers and meet certain health criteria. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd and aims to better understand treatment outcomes in this group. Participants will receive SPH5030 tablets orally once daily at a dose of 600 mg. The study is open-label and single-arm, meaning all participants receive the same treatment without a placebo group. The treatment period and follow-up span approximately two years, during which multiple outcome measures will be assessed. During the study, participants will undergo regular evaluations to monitor tumor response, duration of remission, disease control, progression-free survival, overall survival, and any adverse events related to treatment. Researchers will also assess safety through clinical and laboratory tests. The total involvement for each participant is about two years, allowing for detailed observation of treatment effects and tolerability.

Researchers are evaluating the effectiveness of early treatment with BXOS110 injection in reducing disability for patients who have had an acute ischaemic stroke. This phase 3 clinical trial compares BXOS110 to a placebo to better understand its safety and impact when given within three hours of stroke onset. The study includes adults aged 18 to 85 diagnosed with acute ischaemic stroke, with specific neurological and functional criteria for participation. Participants are randomly assigned to one of two groups one receiving a single intravenous infusion of BXOS110 at a dose of 3.0 mgkg up to 300 mg, and the other receiving a placebo infusion of the same volume and dose schedule. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know which treatment is given. The trial consists of a screening and baseline phase, a treatment phase with immediate administration of the study drug, followed by a follow-up period with evaluations on days 2, 3, 10 or at discharge, day 30, and day 90 after treatment. Throughout the study, participants undergo assessments to measure disability and neurological function, including the modified Rankin Scale mRS, NIH Stroke Scale NIHSS, Barthel Index BI, and EQ-5D quality of life questionnaire. The main outcome measured is the proportion of patients achieving an mRS score of 0 to 2 on day 90, indicating good recovery. Safety and efficacy are monitored closely during follow-up visits and at discharge. The total study duration includes screening, treatment, and a 90-day follow-up period to assess outcomes and safety.

Researchers are evaluating whether Extract of Ginkgo Biloba Leaves Tablets can improve memory and thinking skills in people aged 55 and older who have had an ischemic stroke caused by a blocked blood vessel in the brain. This study also looks at the safety of taking these tablets alongside usual post-stroke treatments. Participants must have had a stroke confirmed by MRI within 7 to 14 days before joining the study and have mild cognitive impairment after their stroke. Participants will be randomly assigned to one of two groups one group will take 240 mg of Extract of Ginkgo Biloba Leaves Tablets daily for 12 months in addition to their usual stroke care, while the other group will receive only their usual care without the tablets. The study will take place at hospitals across China and will last for 52 weeks for each participant. Throughout the study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and tests, including brain scans, cognitive assessments such as the Montreal Cognitive Assessment and other neuropsychological tests, and evaluations of neurological function. Follow-up phone calls will occur at 12 and 38 weeks to monitor health and any new stroke events. Researchers will measure changes in thinking, memory, cognitive speed, verbal skills, and neurological status to understand the tablets effects and safety over time.

Researchers are evaluating the safety and effectiveness of LT3001 for treating acute ischemic stroke. This phase II multicenter study compares LT3001 at high and low doses to a placebo, aiming to understand how well LT3001 works and how safe it is for patients who have suffered this type of stroke. The study is led by Shanghai Pharmaceuticals Holding Co., Ltd and involves participants aged 18 to 80 years. Participants will receive LT3001 or placebo through intravenous infusion. The study uses a randomized, double-blind, placebo-controlled design with parallel groups. Treatment must begin within 24 hours after stroke onset. The trial evaluates multiple outcomes, including stroke severity and daily living abilities at various time points up to 90 days after the first dose. During the study, participants will undergo neurological assessments using scales like the NIH Stroke Scale, Modified Rankin Scale, and Barthel Index at several days after treatment. The main safety measure is the occurrence of adverse events, monitored for about two years. Participants will be closely followed to assess recovery progress and any side effects over time.

Researchers are evaluating the effectiveness and safety of the KPCXM18 injection at different doses for treating acute ischemic stroke. This phase 2 clinical trial uses a multicenter, randomized, double-blind, parallel, placebo-controlled design to compare treatments. The goal is to provide evidence for future studies and understand how the drug behaves in the body through population pharmacokinetic analysis. Participants are assigned to one of three groups a low-dose KPCXM18 injection group receiving 60 mg twice daily, a high-dose group receiving 100 mg twice daily, or a placebo group. All treatments are given by intravenous infusion every 12 hours for about 12 days. Researchers will observe and compare the effects of these doses against placebo to assess benefits and safety. During the study, participants will be monitored closely with assessments including the Modified Rankin Scale to measure disability at days 12, 30, and 90. Additional evaluations include stroke severity using the NIH Stroke Scale and daily functioning by the Barthel Index. The trial spans about three months of follow-up after treatment, with safety and effectiveness tracked throughout. Participants will be involved in regular visits to measure their recovery progress and any side effects.

Gastric cancer is a significant health challenge worldwide, and this research aims to develop a new Artificial Intelligence AI system to predict how well tumors respond to combined chemotherapy and immunotherapy before surgery. The study focuses on patients with locally advanced gastric cancer receiving standard neoadjuvant chemo-immunotherapy. The goal is to create a tool that helps doctors personalize treatment plans by predicting tumor response more accurately. Participants will receive standard neoadjuvant chemotherapy combined with approved PD-1 inhibitors, chosen by their treating physician, in a real-world clinical setting. Researchers will collect preoperative contrast-enhanced CT scans, pathological tissue slides, and biological samples like blood and tumor tissue. These will be analyzed using advanced deep learning methods to build and validate a multimodal AI model predicting pathological complete response. During the study, patients will undergo baseline assessments and postoperative pathological evaluations about five months apart. Researchers will monitor the accuracy of the AI model in predicting tumor response, including the rate of complete tumor disappearance after surgery. They will also track disease-free survival for up to three years. The study involves collecting imaging, tissue, and blood samples, as well as clinical data, to support AI development and patient monitoring throughout the treatment process.