Shangluo

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.

This research aims to evaluate the safety and effectiveness of combining selinexor with azacitidine and venetoclax in adults newly diagnosed with acute myeloid leukemia AML who have not received prior treatment. The study is a prospective, single-arm, multi-center clinical trial focusing on patients who are either ineligible for or refuse intensive chemotherapy. It is designed to gather data on how well this combination works and its safety profile in this patient group. Participants will receive selinexor orally at 60 mg on days 3, 10, and 17 azacitidine intravenously at 75 mgm2 on days 1-3, 8-9, and 15-16 and venetoclax orally starting at 100 mg on day 1, increasing to 200 mg on day 2, and 400 mg on days 3-14 within each 28-day treatment cycle. Those who achieve complete remission may undergo a transplant at any time, while others will continue treatment until the disease progresses or unacceptable side effects occur. During the study, participants will be closely monitored for treatment response and safety through assessments including remission rates up to about two years. Secondary measures include overall survival, response rates, minimal residual disease negativity, and recurrence-free survival over approximately four years. The total participation time varies based on individual outcomes, with ongoing evaluations to track effectiveness and side effects throughout the study period.

Researchers are evaluating the effects of different inhaled oxygen concentrations on lung function in older patients undergoing laparoscopic gastrointestinal surgery under general anesthesia. This multicenter, prospective, randomized controlled study compares low oxygen concentration 40% and high oxygen concentration 80% during surgery in patients aged 65 and older. The study aims to understand how these oxygen levels impact lung function and postoperative recovery. Participants will be randomly assigned to one of two groups one receiving 80% oxygen and the other receiving 40% oxygen after anesthesia induction. Both groups will follow a lung-protective ventilation strategy with specific respiratory parameters. Manual lung recruitment maneuvers will be performed after intubation and before extubation. Blood samples for gas analysis will be collected within 48 hours after surgery to assess outcomes. During the study, participants will be closely monitored with respiratory assessments and blood gas analyses, focusing on the oxygenation index 48 hours post-surgery. Secondary measures include pulmonary complications within 7 days and mortality within 30 days. The study involves multiple centers and plans to enroll 1098 subjects. The total duration of participation includes the surgical procedure and follow-up assessments up to 30 days after surgery.

Researchers are evaluating the effectiveness of immediate allogeneic hematopoietic stem cell transplantation HSCT compared to HSCT performed after bridging therapy in patients with higher-risk myelodysplastic syndrome HR-MDS. This phase 2, multicenter, randomized controlled trial seeks to determine if starting HSCT right away is not worse than delaying it until after initial treatment, helping to guide optimal timing for transplantation in this patient group. Participants will be randomly assigned to one of two groups the immediate HSCT group, where patients receive direct allogeneic HSCT or the bridging therapy group, where patients first undergo one to two cycles of bridging therapy before HSCT. Bridging therapy may include hypomethylating agents alone or combined with chemotherapy, such as azacitidine and venetoclax, and targeted therapies like IDH1 inhibitors for eligible patients. The study will continue until at least 124 events occur, ensuring sufficient data to assess outcomes. During the study, researchers will monitor participants for disease-free survival over two years after HSCT as the primary outcome. Secondary measures include the proportion of patients undergoing HSCT at various time points, complete remission rates, overall survival, leukemia-free survival, quality of life assessments, and molecular clearance rates over two years. Participants will be closely followed with clinical evaluations and laboratory tests throughout the study duration, which extends through at least two years post-treatment to fully assess outcomes and safety.

Researchers are conducting a prospective, multicenter, open-label, randomized controlled trial to compare two treatment strategies for adults with acute myocardial infarction AMI who have mild coronary artery narrowing. The study aims to determine if standard medical therapy alone is not worse than using drug-eluting stent DES implantation combined with standard therapy. This trial will include 2,000 patients with ST-segment elevation myocardial infarction STEMI or non-ST-segment elevation myocardial infarction NSTEMI from multiple centers in China. Participants will be randomly assigned to one of two groups one receiving guideline-recommended standard medical therapy alone, which includes dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other related medications and the other receiving DES implantation plus the same standard medical therapy. The study also includes a functional substudy with 120 participants assessing coronary microvascular dysfunction using pressure wire tests. The enrollment period is planned for 36 months, with a follow-up of at least 12 months after randomization and continued monitoring until study completion. During the study, participants will undergo coronary angiography and assessments of vessel function. Researchers will monitor for target lesion failure TLF, defined as cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization, over a median follow-up of 30 months. Additional outcomes include all-cause death, stroke, rehospitalization for heart conditions, and quality of life measures. The study tracks these outcomes through regular follow-up visits to evaluate the safety and effectiveness of the treatment approaches.