Nantong

Researchers are evaluating the efficacy and safety of TQB6411 for Injection in adults with advanced lung cancer. This phase IbII clinical trial focuses on patients aged 18 to 75 years who have lung cancer confirmed by histology or cytology and meet specific health criteria. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and aims to determine the recommended phase II dosage and measure response rates over time. Participants will receive TQB6411 for Injection as the treatment, administered in cycles every 21 or 28 days. The study includes monitoring for response rates, disease control, duration of relief, progression-free survival, overall survival, adverse events, and the presence of anti-drug antibodies. Blood samples will be collected at specified cycles and timepoints before and after dosing to assess drug levels and immune responses. During the study, participants will be evaluated for tumor response using recognized criteria and undergo laboratory tests to monitor safety and drug effects. The study duration includes follow-ups up to three years for overall survival assessment. Participants will be regularly monitored for side effects and treatment efficacy to ensure comprehensive data collection throughout the trial period.

This trial investigates TQ05105 tablets in adults with intermediate or high-risk myelofibrosis, a type of bone marrow cancer. It includes two groups one studying how the drug behaves in the body in participants with different levels of kidney function, and another assessing the drugs safety and effect in those who have not responded well or cannot tolerate previous Janus kinase JAK inhibitor treatments. The study is a phase II, open-label, single-arm, multicenter trial. Participants receive TQ05105 tablets in 28-day treatment cycles. The first group focuses on pharmacokinetics to guide dosing for normal to moderate kidney impairment. The second group evaluates the drugs safety and potential benefits in participants with spleen enlargement and prior JAK inhibitor therapy that was ineffective or intolerable. Treatment continues with regular dosing and monitoring. During the study, participants undergo assessments including measurements of spleen volume reduction and various pharmacokinetic parameters such as drug concentration over time. Safety is monitored through recording adverse events during treatment and up to 4 weeks after the last dose. Additional outcomes include symptom assessments, survival rates, and blood transfusion needs. The study lasts up to several years, with primary measurements at 24 weeks and extended follow-up averaging three years.

Researchers are studying the effectiveness and safety of combining RC108 with Furmonertinib compared to Furmonertinib alone for treating patients with a specific type of advanced or recurrent non-small cell lung cancer NSCLC that has both EGFR mutations and MET positivity. This phase II clinical trial aims to better understand how these treatments work together for this condition. The trial involves two groups one receiving RC108 combined with Furmonertinib, and the other receiving Furmonertinib alone. Participants have unresectable locally advanced or recurrent metastatic NSCLC with certain EGFR mutations and MET positivity. Treatment and monitoring occur over several months, with careful evaluation of drug effects and safety. Participants will undergo tests for tumor response, survival rates, and disease control over a period of up to 45 months. Researchers will collect tissue samples, monitor side effects, and assess drug levels and immune responses. The study includes regular check-ins to measure how well the cancer responds and to track any adverse events or reactions.

Researchers are evaluating the combination of acalabrutinib and obinutuzumab in people with previously untreated chronic lymphocytic leukemia CLL. This study aims to assess how well this treatment works and its safety for patients who meet specific clinical criteria for needing treatment. The study is led by The First Affiliated Hospital with Nanjing Medical University and is designed as a single-arm, prospective trial. Participants will receive acalabrutinib capsules taken by mouth once daily in 28-day cycles for up to 24 months, unless side effects or disease progression occur first. Along with acalabrutinib, obinutuzumab will be given intravenously following a specific schedule for up to 6 cycles. Dose adjustments are possible based on tolerance. The study includes screening, treatment, and follow-up phases to monitor participants throughout their involvement. During the study, participants will undergo regular evaluations including blood tests and clinical assessments to monitor their response to treatment and safety. Researchers will measure outcomes such as progression-free survival at 24 months, overall survival, response rates, and any side effects experienced. Participants will be followed for up to 24 months to assess these outcomes and support safety monitoring throughout the treatment period.

Researchers are evaluating RC148, both alone and in combination with other therapies, in patients with locally advanced unresectable or metastatic malignant solid tumors. The study includes Phase I, which focuses on assessing safety, tolerability, and determining the maximum tolerated dose and recommended Phase II dose of RC148. Phase II primarily evaluates the effectiveness of RC148 in combination with other treatments, along with safety and pharmacokinetics, while also exploring biomarker correlations with treatment outcomes. Participants receive RC148 as an intravenous infusion either alone or combined with drugs such as docetaxel, RC48, RC88, or bevacizumab. Dosing schedules vary by treatment group, with infusions administered every 2 or 3 weeks depending on the combination. Phase I involves dose escalation with observation for dose-limiting toxicities over 28 days after the first treatment. Phase II includes multiple arms targeting different cancer types with specific combination therapies. Throughout the study, participants undergo regular assessments including monitoring for adverse events, physical exams, laboratory tests, and imaging to measure tumor response using RECIST criteria. Pharmacokinetic and pharmacodynamic evaluations, as well as immunogenicity tests, are conducted. The trial lasts up to 15 months, covering safety and efficacy outcomes. Researchers also collect tumor samples for biomarker analysis and monitor participants for long-term treatment effects and tolerability.

This research aims to study the safety and tolerability of an oral drug called ABSK061 in patients with advanced solid tumors. The trial is an open-label phase 1 study that starts with dose escalation to find the maximum tolerated dose or maximum administered dose. The study includes patients with solid tumors who have progressed on or cannot tolerate standard treatments. The expansion phase focuses on specific tumor types with certain genetic changes and further evaluates safety and antitumor activity. During the dose escalation phase, patients receive a single dose of ABSK061 on the first day of cycle 1, followed by twice-daily dosing for the rest of the 28-day cycle and subsequent cycles. The dose is adjusted based on safety data using a Bayesian optimal interval design. In the expansion phase, patients receive the drug at the recommended dose for repeated 28-day cycles. Some regions may enroll a small number of local patients first to confirm safety before full expansion. Participants will undergo regular assessments including monitoring for dose-limiting toxicities and adverse events over about six months. Researchers will also measure drug levels and antitumor responses such as objective response rate, duration of response, disease control rate, and progression-free survival. Eligibility involves performance status, life expectancy, organ function, and specific tumor genetic tests. Safety monitoring continues throughout the study, which lasts several months per participant.

Psoriasis is a chronic, recurring inflammatory disease influenced by genetics and environmental factors, marked by skin lesions that can affect multiple organs. Researchers are evaluating the effectiveness of different treatments chosen by patients in real-world clinical settings, comparing phototherapy, traditional systemic therapies, and biologics among Chinese psoriasis patients. This observational study aims to gather real-world evidence under routine care without intervention. Patients diagnosed with psoriasis by dermatologists choose their preferred treatments, which may include phototherapy, traditional systemic drugs, or biologics. The study does not assign treatments but observes outcomes as patients follow their chosen therapies. Data collection is supported through a phone application called Psoriasis New World, and the study includes multiple centers. Participants will be assessed regularly for treatment effectiveness using measures such as the Psoriasis Area and Severity Index PASI, Physician and Investigator Global Assessments, Body Surface Area affected, and Dermatology Life Quality Index. Adverse events and laboratory tests, including liver function, will be monitored throughout up to 12 months. The primary outcome is the percentage of patients achieving complete skin clearance PASI 100 at 6 months, with additional follow-up evaluations at 12 months.

Researchers are evaluating the efficacy and safety of fospropofol disodium for injection during painless endoscopic diagnosis and treatment, including gastrointestinal endoscopy and colonoscopy, in adults aged 50 to 65 years. This multicenter, randomized, double-blind, controlled clinical study compares fospropofol disodium with propofol to find an appropriate anesthesia method that improves patient comfort, stabilizes anesthesia induction, and reduces adverse events like hypoxemia and cardiovascular complications. Participants are randomly assigned to one of two groups one receives slow intravenous sufentanyl plus fospropofol disodium at 8 mgkg completed within 60 seconds, and the other receives slow intravenous sufentanyl plus propofol at 2 mgkg completed within 60 seconds. Two fixed anesthesiologists administer the drugs. The study focuses on sedation success, anesthesia induction duration, and incidence of hypoxemia, among other safety and effectiveness measures. During the trial, participants undergo painless gastrointestinal procedures while researchers monitor sedation success, total drug doses, intraoperative vital signs, body movements, injection pain, and recovery quality at intervals up to 30 minutes after awakening. The study also tracks hemodynamic stability and adverse reactions to assess the overall safety profile. The total study duration exceeds two years, with careful follow-up to support rapid recovery and reduce hospitalization costs.

This research aims to evaluate whether the inhaled anesthetic desflurane provides heart protection and reduces the chance of serious major cardiac events after coronary artery bypass graft CABG surgery compared to the intravenous anesthetic propofol. Cardiac surgery carries high risks of severe complications that influence patient outcomes, and current evidence on the benefits of inhaled anesthetics in this setting is inconsistent. The study is a large, national, multi-center, randomized controlled trial enrolling elective CABG patients to determine the best anesthesia approach for reducing complications and mortality. Participants will be randomly assigned to one of two groups one receiving inhaled desflurane anesthesia maintained at 0.5-2 MAC with specific timing protocols during surgery, and the other receiving total intravenous anesthesia with propofol infusion at 3-8 mgkgh without inhaled anesthetics. Desflurane is given with careful dosing to maximize cardioprotective effects, including protocols for wash-in and wash-out if needed. Propofol is administered via targeted infusion or manual adjustment. Both groups undergo routine induction before anesthesia maintenance. During the study, participants will be closely monitored for major cardiac events and death within 30 days after surgery. Researchers will also track complications such as pulmonary, kidney, and neurological issues, length of ventilation and ICU stay, hospital readmissions, and mortality up to 90 days. Assessments include clinical evaluations and outcomes related to cardiac surgery recovery. The study lasts through hospitalization and includes follow-up for up to one year for some measures to understand long-term effects and safety.

Metallo--lactamase-producing carbapenem-resistant Gram-negative bacteria MBL-CR-GNB are a serious global health threat due to their ability to break down almost all -lactam antibiotics. Current inhibitors like avibactam cannot stop metallo--lactamases, limiting treatment options. Researchers are studying the combination of ceftazidime-avibactam with aztreonam, which works together to fight these infections. This phase 4 clinical trial aims to compare different infusion methods for this combination in patients with complicated infections caused by MBL-CR-GNB. Participants will receive either a 3-hour simultaneous intravenous infusion of ceftazidime-avibactam 2.5g and aztreonam 2g every 8 hours, or a sequential infusion where ceftazidime-avibactam is given over 2 hours followed by aztreonam over 1 hour every 8 hours. The study is randomized and double-blinded, comparing the effects of these two dosing schedules. Both methods are being evaluated for their ability to reach effective drug levels and their impact on infection outcomes. During the trial, researchers will monitor patients for clinical cure rates within 14 days, microbiological eradication, and any adverse events. Assessments include genotypic testing to confirm bacterial resistance, clinical evaluations, and safety monitoring. The study will follow patients through their treatment period, with careful tracking of infection response and potential side effects to determine if one infusion method offers advantages over the other.