Shangluo

Researchers are evaluating the safety and effectiveness of two antibiotic treatments, omadacycline and moxifloxacin, in Chinese adults with community-acquired bacterial pneumonia (CABP). This Phase 3b study is designed as a bridging trial to confirm whether omadacycline works as well as moxifloxacin in this specific population, building on results from a global CABP trial. Participants will receive either omadacycline or moxifloxacin through intravenous or oral routes. The treatments are given as a course, with details on dosing schedules not specified. The study compares these two drugs directly to assess their clinical efficacy and safety in treating CABP. During the study, participants will be monitored and evaluated for their clinical response at 18 months after therapy. Researchers will assess symptoms, vital signs, and overall health related to pneumonia to determine treatment success. Safety and efficacy data collected throughout the study will help understand how well each drug performs in this 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.

Researchers are evaluating the safety and effectiveness of a combination treatment using selinexor, azacitidine, and venetoclax for adults newly diagnosed with acute myeloid leukemia (AML) who have not received prior treatment. This Phase 2, prospective, single-arm, multi-center clinical trial aims to understand how well this combination works specifically for patients who are either not suitable for intensive chemotherapy or who refuse it. The study focuses on measuring the percentage of participants who achieve complete remission from the start of the study up to about two years or until death. The treatment regimen involves giving selinexor orally at 60 mg on days 3, 10, and 17; azacitidine intravenously at 75 mg/m2 on days 1-3, 8-9, and 15-16; and venetoclax orally starting with 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-14. Each cycle lasts 28 days. Participants may proceed to receive a transplant at any time after achieving complete remission. Those who do not undergo transplant will continue treatment until their disease worsens or side effects become unacceptable. During the study, participants will be closely monitored through various evaluations to assess treatment response and safety. Researchers will track remission status, disease progression, and any adverse effects. The total study period involves treatment cycles and follow-up lasting up to approximately two years. This ongoing monitoring helps determine the overall benefit and risks of the combination therapy for AML patients who are treatment naive.

Researchers are evaluating the effects of two different inhaled oxygen concentrations on lung function in older patients undergoing laparoscopic gastrointestinal surgery under general anesthesia. This multicenter, prospective, randomized controlled clinical study involves patients aged 65 years and older at 19 centers in China. The aim is to compare low oxygen concentration (40%) versus high oxygen concentration (80%) during surgery using a lung-protective ventilation strategy. Participants will be randomly assigned in a 1:1 ratio to receive either 40% or 80% fraction of inspired oxygen (FiO2) during surgery. The total gas flow rate will be set at 2 liters per minute. All patients will have ventilation managed with tidal volumes of 6-8 ml/kg, positive end-expiratory pressure (PEEP) of 6-8 cmH2O, and a respiratory rate adjusted to maintain carbon dioxide levels between 35-45 mmHg. Lung recruitment maneuvers will be performed after intubation and before extubation. Patients are expected to be extubated in the operating room. During the study, researchers will assess the oxygenation index 48 hours after surgery as the primary outcome. Secondary outcomes include pulmonary complications within seven days after surgery and mortality rates within 30 days. The study plans to enroll 1098 patients. Safety and lung function will be closely monitored through these measures during the postoperative period.

Researchers are investigating whether immediate allogeneic hematopoietic stem cell transplantation (HSCT) is as effective as HSCT performed after bridging therapy in patients with higher-risk myelodysplastic syndrome (HR-MDS). This phase 2 randomized controlled trial aims to compare these two approaches to better understand treatment timing for this condition. The study plans to enroll 236 patients with HR-MDS, defined by specific risk scores, and will continue until at least 124 disease-related events occur. Participants are randomly assigned in equal numbers to either the immediate HSCT group, where they receive direct allogeneic HSCT, or the bridging therapy group. Those in the bridging therapy group will first undergo one to two cycles of therapy using hypomethylating agents alone or combined with chemotherapy, such as azacitidine plus venetoclax, or targeted therapies like IDH1 inhibitors if eligible. After bridging therapy, these patients proceed to allogeneic HSCT. During the study, researchers will monitor participants for disease-free survival over two years following transplantation. Assessments include evaluating performance status, organ function, and eligibility for transplantation. Safety and effectiveness will be observed through clinical follow-ups, with the overall goal of determining the best timing for HSCT in HR-MDS patients. Participants must be adults with adequate health status to join and will be followed throughout the study period.

Researchers are investigating the effectiveness and safety of PM8002, a bispecific antibody targeting PD-L1 and VEGF, combined with Paclitaxel as a second-line treatment for small cell lung cancer (SCLC). This phase III, open-label, randomized study compares this combination to standard chemotherapy options, including Topotecan or Paclitaxel, in patients whose cancer has progressed after first-line platinum-containing chemotherapy. The study aims to improve outcomes for patients with advanced SCLC. Participants will be randomly assigned to receive either PM8002 with Paclitaxel or the investigator's choice of chemotherapy (Topotecan or Paclitaxel). Paclitaxel is given as a 175 mg/m2 intravenous infusion on Day 1 every three weeks, while Topotecan is administered as 1.25 mg/m2 per day via intravenous infusion on Days 1 through 5 every three weeks. PM8002 dosing follows a predefined schedule. The study involves multiple centers and evaluates these treatments as second-line therapy. During the study, participants will undergo regular assessments to monitor overall survival for up to approximately 32 months from the first patient enrolled. Researchers will evaluate safety and treatment effects through clinical examinations, tumor measurements following RECIST v1.1 criteria, and tests of organ function. The study also includes monitoring for adverse events and ensures participants have a life expectancy of at least 12 weeks, adequate organ function, and an ECOG performance score of 0 or 1 to participate.

Researchers are evaluating the efficacy and safety of Fresubin Support Drink compared to Enteral Nutrition Emulsion (TPF-T) in patients with gastrointestinal cancer undergoing surgical resection. This prospective, randomized, open-label, active-controlled, multi-center clinical trial aims to demonstrate non-inferiority between the two nutrition products during the perioperative period. The study involves up to 350 patients randomly assigned in a 1:1 ratio to either the Fresubin Support Drink group or the control group receiving Enteral Nutrition Emulsion. Participants will receive either the Fresubin Support Drink or the control product before surgery, with daily intake adjusted to meet recommended energy levels. After surgery, from day 1 to day 8, patients will gradually increase their intake of the assigned nutrition product to reach the recommended energy amount. Both groups follow the same schedule for nutritional support throughout the perioperative phase. During the study, researchers will assess changes in serum prealbumin levels from baseline to the close-out visit (post-operation days 5 to 8). Additional evaluations include albumin, C-reactive protein (CRP), immunology parameters, vital signs, nutrition- and safety-related laboratory tests, patient compliance, and monitoring of adverse events. The study involves regular assessments to track these outcomes and ensure patient safety and adherence to the treatment regimen.