Nantong

Researchers are evaluating the effectiveness and safety of TQB6411 for Injection in adults with advanced lung cancer. This clinical trial is designed as a Phase Ib/II study to determine the recommended Phase II dosage and to observe the objective response rate over a period of up to six months. Participants must have confirmed lung cancer with measurable lesions and meet specific health and laboratory criteria to be eligible. The treatment involves administering TQB6411 for Injection every 21 days as a cycle. The study focuses on monitoring the drug’s safety and how well it works in treating advanced lung cancer. Participants will receive this treatment while being closely observed for any side effects or responses to the therapy. During the study, participants will undergo various assessments including laboratory tests, tumor tissue sampling for immunohistochemical testing, and regular health evaluations. The main outcomes measured are the recommended dosage for Phase II and the cancer's response to treatment over six months. Participants will be monitored for safety and treatment effects throughout the study period, which includes initial treatment and follow-up assessments.

Researchers are evaluating the effectiveness and safety of combining RC108 with Furmonertinib compared to using Furmonertinib alone for first-line treatment in adults aged 18 to 75 years with EGFR-mutated, MET-positive, unresectable locally advanced or recurrent metastatic non-small cell lung cancer (NSCLC). This Phase II trial aims to provide new options for patients whose cancer cannot be removed by surgery or treated with radiation. The study also looks at how the body processes RC108 and whether the immune system reacts to it when given with Furmonertinib. Participants will be randomly assigned to receive either the combination of RC108 and Furmonertinib or Furmonertinib alone. Treatments are taken as medications, and the study monitors patients over time to compare their responses. The study includes patients who have not received previous systemic therapy for their advanced or recurrent disease. Tumor tissue samples are collected for testing, and participants must have measurable cancer lesions. During the study, participants will undergo regular assessments including physical exams, performance status evaluation, and tumor measurements according to RECIST criteria. Researchers will track the objective response rate over 24 months to determine how well the treatments work. Safety will be closely monitored along with patient survival and overall health. Participants are expected to use effective contraception if of childbearing potential and will be followed for treatment effects and side effects throughout the study period.

Researchers are evaluating the combination of acalabrutinib and obinutuzumab in Chinese patients with previously untreated chronic lymphocytic leukemia (CLL). This single-arm, prospective study aims to assess the effectiveness and safety of these treatments in managing CLL, focusing on progression-free survival over 24 months. Participants must have active disease meeting specific criteria and be suitable for treatment based on established guidelines. Participants will receive acalabrutinib orally at 100 mg once daily in 28-day cycles. Obinutuzumab is given intravenously with a dosing schedule starting at 100 mg on Day 1 and escalating to 900 mg on Day 2, then 1000 mg on Days 8 and 15 of the second cycle, and 1000 mg on Day 1 of subsequent cycles for a total of six 28-day cycles. The study includes a screening phase, treatment phase, and follow-up phase to monitor response and safety. During the study, participants will undergo various evaluations including laboratory tests and clinical assessments to track disease status and treatment effects. Researchers will monitor blood counts, liver and kidney function, and symptoms, ensuring participants meet the criteria for safety and efficacy. The main outcome measured is the progression-free survival rate at 24 months, with ongoing follow-up to assess long-term outcomes and adverse effects.

Researchers are studying RC148 in patients with locally advanced unresectable or metastatic malignant solid tumors. The Phase I part focuses on assessing the safety, tolerability, and determining the maximum tolerated dose or maximum administered dose of RC148. It also evaluates the drug's pharmacokinetics, pharmacodynamics, immunogenicity, and early signs of effectiveness. In Phase II, the study primarily looks at how well the RC148 combination treatments work, while also continuing to monitor safety, tolerability, drug behavior, and immune response. Biomarker correlations with treatment effects will also be explored during the trial. The study treatments include RC148 given alone or combined with other drugs such as docetaxel, RC48, RC88, or a combination of RC148 with bevacizumab and RC88. RC148 is given by intravenous infusion on Day 1 of each cycle, with cycle lengths of either 2 or 3 weeks depending on the combination. Docetaxel, RC48, RC88, and bevacizumab are also administered intravenously on Day 1 of their respective cycles. These treatment regimens are studied in different groups of patients based on tumor type and prior treatments. Participants will be involved in treatment cycles with close monitoring for side effects and dose-limiting toxicities during the first 28 days of treatment. Safety is tracked up to 28 or 90 days after the last dose. Effectiveness is evaluated over 15 months using criteria such as tumor response rates and progression-free survival. Before treatment, patients provide tumor samples for biomarker testing. Regular assessments include imaging scans, laboratory tests, and physical exams to monitor health, treatment response, and side effects throughout their participation.

Researchers are evaluating the safety, tolerability, and pharmacokinetics of ABSK061 in patients with advanced solid tumors in this open-label Phase 1 study with expansion. The study begins with dose escalation of oral ABSK061 to identify the maximum tolerated or administered dose. The expansion phase will further assess safety and tolerability of ABSK061 at the recommended dose among selected tumor types, specifically urothelial carcinoma and cholangiocarcinoma with FGFR2/3 genetic alterations. Preliminary antitumor activity will also be evaluated. During the dose escalation part, patients receive a single dose of ABSK061 on the first day of cycle 1, followed by twice-daily dosing for the rest of the cycle and subsequent 28-day cycles. The starting dose is 5 mg twice daily. In the expansion phase, patients take ABSK061 orally at the recommended dose for repeated 28-day cycles. For some regions, a few local patients may first receive the drug at this dose to confirm safety before full expansion enrollment. Participants will undergo screening assessments including blood tests for organ and bone marrow function before starting treatment. Researchers will monitor dose-limiting toxicities at the end of cycle 1 and track adverse events throughout about half a year. The study measures safety, tolerability, and preliminary antitumor effects. Patients will be followed closely during treatment cycles with evaluations to ensure compliance and safety.

Researchers are conducting a multicenter observational study to better understand the treatment outcomes for patients diagnosed with psoriasis by dermatologists in clinic settings across China. Psoriasis is a chronic, recurrent inflammatory disease influenced by genetic and environmental factors, presenting as erythematosquamous lesions and potentially affecting multiple organs. The study aims to compare the effectiveness of various treatments chosen by patients, including phototherapy, traditional systemic therapies, and biologics, in real-world clinical practice. This non-interventional study allows patients to select their preferred treatment without restrictions. Data is collected primarily through a phone application called "Psoriasis New World," enabling continuous monitoring of patient progress. The study evaluates multiple outcomes such as the Psoriasis Area and Severity Index (PASI), which measures skin lesion severity and body area involvement, along with the Physician Global Assessment, Investigator Global Assessment, Body Surface Area affected, and Dermatology Life Quality Index. Patient safety is monitored throughout, including the recording of any adverse events and laboratory tests such as liver function. Participants will be followed over six months to measure the percentage achieving complete clearance of psoriasis symptoms (PASI 100). Regular assessments of disease severity and quality of life changes will be conducted remotely via the app. Continuous safety monitoring ensures any side effects or complications are documented. This approach provides comprehensive real-world evidence on how different psoriasis treatments perform in routine clinical care.

Researchers are examining the current use and influencing factors of Bruton's Tyrosine Kinase inhibitors (BTKi) in treating patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) in China. Since BTKi has become the standard treatment for these conditions, this multicenter retrospective cross-sectional study aims to gather large-scale real-world data to better understand treatment patterns and identify factors that may affect therapy effectiveness or patient outcomes. The study focuses on patients who have been treated with BTKi drugs, which include Orelabrutinib, Ibrutinib, Zanubrutinib, and Acalabrutinib, between February 2023 and February 2024. It collects data from multiple centers to assess how these medications are being used in real practice and seeks to explore more suitable treatment approaches based on observed trends and outcomes. Participants' characteristics related to BTKi treatment will be analyzed up to one year. The study involves reviewing patient records to evaluate treatment status and related factors. This observational approach helps researchers understand how BTKi therapies are applied and their real-world impact, with the goal of improving future treatment strategies for CLL/SLL patients in China.

Researchers are evaluating whether the inhaled anesthetic desflurane provides heart protection and reduces severe postoperative major cardiac events compared to propofol in patients undergoing coronary artery bypass graft (CABG) surgery. CABG is a common, high-risk cardiac surgery with significant rates of postoperative complications and mortality. The study aims to clarify conflicting evidence on the benefits of inhaled versus intravenous anesthetics in cardiac surgery, focusing on desflurane's potential advantages over propofol. Participants are randomly assigned to one of two anesthesia maintenance groups: the desflurane group uses inhaled desflurane adjusted to maintain 0.5-2 MAC, with specific intraoperative strategies to maximize heart protection, including maintaining at least 1 MAC for 30 minutes and timing discontinuation before cardiopulmonary bypass; the propofol group receives total intravenous anesthesia with propofol infusion at 3-8 mg/kg/h, with no inhaled anesthetics allowed. The trial involves elective isolated CABG procedures. During the study, researchers monitor patients for major cardiac events and death within 30 days after surgery. Assessments include tracking postoperative complications and overall outcomes related to heart health. The study is a large-scale, national, multi-center randomized clinical trial aiming to identify the optimal anesthesia method to improve cardiac surgery prognosis, with participant involvement lasting through 30 days postoperatively for outcome evaluation.

Metallo-b2-lactamase-producing carbapenem-resistant Gram-negative bacteria (MBL-CR-GNB) are a major global threat because they can break down nearly all b2-lactam antibiotics. Current b2-lactamase inhibitors do not work against these bacteria. The combination of aztreonam, which is stable against these enzymes, and avibactam, which blocks other enzymes, has shown promising antibacterial effects. This study explores whether different ways of infusing ceftazidime-avibactam with aztreonam affect treatment success for infections caused by these bacteria. Participants will receive ceftazidime-avibactam 2.5g every 8 hours with aztreonam 2g every 8 hours. One group will get both drugs infused together over 3 hours, while another group will receive ceftazidime-avibactam infused over 2 hours followed by aztreonam over 1 hour. The study compares these two infusion methods to see if there are differences in drug effectiveness, cure rates, bacteria elimination, or side effects. During the study, researchers will monitor participants for clinical cure after 14 days. They will assess how well the infections respond to treatment and check for any adverse events. The study is designed to provide data on the best infusion method for this drug combination in treating complicated infections caused by MBL-CR-GNB, with participants ranging from 18 to 100 years old.

Researchers are investigating the effectiveness and safety of oral minocycline compared to placebo in patients who have experienced an acute spontaneous intracerebral hemorrhage within 48 hours of symptom onset. This phase III clinical trial is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled study aiming to improve recovery outcomes in this patient population. An additional goal is to assess the impact of minocycline on markers of venous neuroinflammation at various times after the hemorrhage. A total of 1192 participants will be randomly assigned in equal numbers to receive either minocycline capsules containing 50 mg of minocycline hydrochloride or matching placebo capsules for five days. All participants will also receive standard medical care based on current guidelines. The study includes three phases: screening and baseline, treatment, and follow-up. Participants will be evaluated at several time points including screening/baseline, 72 ±12 hours, 7 ±1 days, 90 ±7 days, and 180 ±7 days after randomization, as well as during any relevant events. Researchers will measure the primary outcome of disability and functional status using the modified Rankin Scale score (mRS) at 90 days post-randomization, aiming for scores between 0 and 3. Throughout the study, assessments and interviews will monitor safety, efficacy, and treatment adherence.