Nujiang Lisu Autonomous Prefecture

Researchers are evaluating BB-1705, an antibody-drug conjugate, in patients with locally advanced or metastatic solid tumors that have progressed after standard treatments. This Phase I study has two parts a dose-escalation phase to find the safest and most effective dose, and a cohort expansion phase to further assess safety, how the drug moves through the body, and its early anti-tumor effects. BB-1705 is given as an intravenous infusion every three weeks for up to eight cycles. During the dose-escalation phase, different doses are tested to find the maximum tolerated dose, followed by a cohort expansion phase where selected doses are given to more patients to monitor safety and preliminary effectiveness. The study is open label and non-randomized. Participants will have regular visits for safety checks, blood tests, and tumor assessments using imaging every 6 to 9 weeks for up to two years. Researchers will closely track side effects, drug levels, immune responses, tumor response, and progression-free survival. The total study duration includes treatment cycles and follow-up for adverse events and clinical outcomes.

Heat stroke is a serious condition caused by an imbalance between heat production and loss in the body, often triggered by exposure to hot, humid environments or intense exercise. It is characterized by a core body temperature above 40C and brain dysfunction, often leading to damage in multiple organs. The severity depends on the highest temperature reached and how long the body remains overheated. Rapidly lowering body temperature can stop cell damage, reverse organ problems, and improve recovery. However, there is currently no standardized method for emergency teams to manage body temperature effectively in these patients. This study evaluates a new early in-hospital temperature management protocol developed to guide rapid cooling and precise temperature control for heat stroke patients. The protocol includes early detection, selection of cooling methods, target temperature management, and ongoing monitoring. Patients in the experimental group will be treated using this protocol, while data from patients treated with previous standard methods between 2021 and 2022 will be collected retrospectively as a comparison. Participants admitted with heat stroke will be closely monitored for their cooling rate and body temperature within the first 30 minutes and at two hours. Researchers will also track survival rates in the hospital and at three months, along with any complications that arise. The total observation period for outcomes extends to three months, helping evaluate the protocols impact on patient recovery and safety over time.

Researchers are evaluating the safety and effectiveness of the Lifetech Concave Supra-arch Branched Stent-Graft System for treating aortic arch diseases such as aortic arch aneurysms and penetrating aortic ulcers. This study is designed as a prospective, multicenter, single-group clinical trial to assess this device in patients needing intervention for these conditions, focusing on outcomes related to surgery and long-term vessel health. The study involves the use of the Concave Supra-arch Branched Stent-Graft System for endovascular treatment, where the stent-graft is placed inside the aorta to manage the disease. The procedure targets patients with specific anatomical criteria regarding the aorta and branch vessels. The study includes a detailed monitoring schedule with assessments at surgery, before discharge, and follow-ups at 6 months, 12 months, and up to 5 years to track treatment success and complications. Participants will undergo evaluations including imaging and clinical assessments to monitor technical success, vessel patency, aneurysm size changes, complications like endoleaks or stent migration, adverse events, and mortality related to the aorta and overall health. The study monitors safety closely during the perioperative period and long-term. Participants will be followed for up to five years to assess the outcomes and safety of the device after treatment.

Researchers are comparing two treatment approaches for patients with diabetes and significant three-vessel coronary artery disease CAD that does not involve the left main artery. This randomized study aims to evaluate outcomes between imaging- and physiology-guided state-of-the-art percutaneous coronary intervention PCI and coronary artery bypass grafting CABG. The trial focuses on how these methods affect major cardiac and cerebrovascular events in this patient group. Participants will receive either PCI guided by advanced imaging and physiological assessments, including intravascular ultrasound IVUS or optical coherence tomography OCT, and tools like fractional flow reserve FFR or instantaneous wave-free ratio iFR, along with modern drug-eluting stents and optimal medical therapy, or they will undergo standard CABG surgery. Both treatments are delivered under careful clinical protocols, and patients will be followed up extensively to assess various health outcomes. During the study, participants will be monitored for major adverse events over two years and other cardiovascular outcomes over five years. Assessments include hospitalization duration, rehospitalization rates, changes in functional class, quality of life questionnaires, medication use, and healthcare costs. The study aims to provide comprehensive data on the effectiveness and safety of these two revascularization strategies, with participants involved in clinical follow-ups and evaluations throughout the study period.

This trial investigates the clinical benefits of Clifutinib compared to salvage chemotherapy in Chinese patients aged 18 and older with relapsed or refractory FLT3-mutated acute myeloid leukemia AML. The study aims to evaluate overall survival and the effectiveness of Clifutinib based on complete remission rates. It is an open-label, randomized Phase III study involving multiple centers. Participants are randomly assigned in a 21 ratio to receive either Clifutinib or one of several salvage chemotherapy regimens, which are pre-selected before randomization. Clifutinib is given orally once daily in continuous 28-day cycles, while chemotherapy options include low-dose cytarabine, azacitidine, decitabine, Ara-CIDA, or FLAG-IDA, each administered in 28-day cycles with specific dosing schedules. Treatment continues until criteria for discontinuation are met. During the study, participants undergo a screening period up to 28 days prior to treatment start. After treatment ends, there is an end-of-treatment visit within 7 days and a 30-day safety follow-up. Long-term follow-up visits occur every 90 days. Researchers assess overall survival from randomization until death from any cause over up to 5 years and measure remission rates within at least 4 months of follow-up. Safety monitoring continues throughout the study period.

Researchers are evaluating a new chemotherapy drug called JSKN003 in people with recurrent or metastatic breast cancer that is HER2-low and cannot be removed by surgery. This phase III clinical trial compares JSKN003 to chemotherapy drugs chosen by doctors in patients who have already tried and not responded to one or two previous chemotherapy treatments. The study aims to assess the safety and effectiveness of JSKN003 in this group of patients. Participants are randomly assigned to one of two groups one group receives JSKN003 alone given by intravenous infusion, while the other group receives one chemotherapy drug selected by their doctor from options like capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The choice of the chemotherapy drug for the control group is made before randomization. Treatment schedules follow the study protocol at multiple centers. During the study, participants will have regular assessments including scans to measure tumor progression and other tests to evaluate response and overall survival, monitored for up to about three years after enrollment. Researchers will track progression-free survival as the main outcome, along with overall survival, response rate, and duration of response. Safety and side effects will also be closely monitored throughout the study.

Researchers are evaluating the effectiveness and safety of GP681 tablets compared to a placebo for preventing influenza infection after exposure. The study focuses on households where the first patient is confirmed to have influenza and where other household members have not received an influenza vaccine in the past six months and do not show signs of infection. This Phase III trial aims to understand if GP681 can reduce the spread of influenza within these households during the influenza season. Participants are divided randomly into two groups one group receives a single oral dose of GP681 tablets 40mg and the other receives a matching placebo. The main study period lasts up to 10 days during which multiple respiratory swabs are taken from household contacts to detect influenza virus infection. Symptoms are also monitored closely during this time to assess the presence and severity of influenza. Participants will undergo symptom assessments and respiratory swabs through Day 10 to monitor infection status and symptom severity. Researchers track the proportion of household members who become infected and develop moderate to severe symptoms, as well as the timing of symptom onset and infection. Safety and adherence to study procedures, including maintaining health diaries, are also monitored throughout the study duration.