Zhaotong

Researchers are observing patients who receive Siltartoxatug Injection, also known as Sintetol4, to prevent tetanus following injury. This large-sample, real-world registry aims to document injury and wound conditions and evaluate clinical outcomes related to tetanus prevention. The study focuses on collecting safety information and any adverse reactions after receiving the injection. Participants in this observational study receive Siltartoxatug Injection as part of their tetanus prophylaxis after injury. The study does not involve randomization or comparison groups but follows patients over time to monitor outcomes. A key part of the study is the follow-up at 90 days after administration to assess whether tetanus develops and to record any safety events. During the study, patient injury details and wound conditions will be carefully noted. Safety data will be selectively collected to identify any adverse reactions or serious events linked to Siltartoxatug use. The main outcome measure is the occurrence of tetanus within 90 days post-injection. Participants are followed for this 90-day period to evaluate treatment outcomes and safety.

Researchers are evaluating MRG007 ARR-217 in an open-label, multi-center phase I trial involving patients with unresectable locally advanced or metastatic solid tumors. The study aims to assess the safety, tolerability, efficacy, and pharmacokinetics of MRG007 in this patient population, including those with colorectal, gastric, or pancreatic cancers who have failed or are intolerant to standard therapies. This research is sponsored by ArriVent BioPharma, Inc. and involves dose escalation, confirmation, and expansion phases. Participants receive MRG007 alone or in combination with Bevacizumab according to the study protocol. The trial uses a sequential study model without randomization or masking. Treatment administration follows specific dosing schedules outlined in the protocol, with evaluations of dose-limiting toxicities and adverse events conducted from baseline through 30 days post-treatment. Objective response rates and other efficacy measures are monitored up to 24 months after starting treatment. Throughout the study, participants undergo evaluations including tumor assessments by RECIST criteria, performance status scoring, and laboratory tests to monitor organ and coagulation functions. Safety is closely tracked via serious and treatment-related adverse events. Pharmacokinetic parameters such as Tmax, Cmax, and antibody responses are also measured. Participants may be followed for up to two years to assess treatment response, disease control, progression-free survival, and overall survival.

Researchers are evaluating the efficacy and safety of ZL-1310 compared to Investigators Choice Therapy in adults with relapsed Small Cell Lung Cancer SCLC. This phase 3, randomized, open-label study aims to compare treatment responses and overall survival between these two therapies in participants who have previously received platinum-based systemic therapy or tarlatamab. Participants are randomly assigned to receive either ZL-1310 as a single-agent drug or Investigators Choice Therapy, which includes Topotecan, Lurbinectedin, or Amrubicin. The study follows a parallel design and monitors participants during treatment and follow-up periods lasting up to 27 months to assess various outcomes. During the study, participants undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, brain metastases response evaluations, and quality of life measurements using validated questionnaires. Safety is closely monitored by tracking treatment-emergent adverse events. Participants are expected to comply with study procedures, including tumor biopsies or providing archived tissue samples, and the total study duration may extend to nearly three years.

Researchers are evaluating CNSI-Fe, an innovative anti-cancer drug containing Fe2 loaded on carbon nanoparticles, in people with advanced solid tumors. CNSI-Fe works by regulating a cell death process called ferroptosis and aims to improve cancer treatment through intratumoral injections. This Phase IbIIa study follows an initial Phase I trial where different doses showed promising safety and disease control in various advanced solid tumor patients. Participants will receive CNSI-Fe injections directly into 1 to 3 tumor lesions every two weeks for a total of 4 doses, with the possibility of additional doses if the benefits outweigh risks. The study includes a screening period, treatment period, and follow-up phase. Tumor response and safety will be closely monitored, and injections will stop or switch lesions based on tumor shrinkage or disappearance. During the study, participants will undergo safety checks before each dose and tumor evaluations at specified intervals, including before the third dose, after the fourth dose, and every six weeks thereafter. Follow-up includes safety monitoring 28 days after the last dose and regular checks for disease progression until new treatment, death, or study end. Samples will be collected at scheduled visits to assess safety, drug levels, and anti-tumor effects.

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 effectiveness and safety of early PCSK9 inhibitor therapy in adults aged 18 to 80 who have experienced a large-artery atherosclerotic ischemic stroke. The study compares patients treated with evolocumab plus statin therapy to those receiving statin therapy alone, focusing on neurological improvement, lipid reduction, functional outcomes at 90 days, recurrent cardiovascular events, and safety. Participants will be assigned to one of two groups based on their routine clinical care one group will receive evolocumab injections 140 mg every 2 weeks or 420 mg monthly plus daily statins for 90 days, while the other group will receive only daily statin therapy for the same period. The study is conducted across multiple centers and includes baseline, day 7 or hospital discharge, day 30, and day 90 visits for assessments. During the study, participants will undergo evaluations including neurological scales and lipid measurements at scheduled visits. Researchers will monitor functional outcomes using the modified Rankin Scale at 90 days, track early neurological changes, recurrent events, and mortality. Safety follow-up continues through day 90 even if evolocumab treatment stops. Total participation spans approximately 90 days post-stroke onset.

Researchers are evaluating the safety, tolerability, and early effects of JS207 in adults with advanced non-small cell lung cancer NSCLC who have experienced disease progression after receiving platinum-based chemotherapy and immunotherapy. This phase II trial aims to assess how well JS207 works alone or combined with other treatments in this setting. Participants receive one of three treatments JS207 with docetaxel chemotherapy every three weeks, JS207 with JS004 antibody every three weeks, or JS207 alone at 10mgkg or another dose. These groups allow comparison of different combinations to explore potential benefits and safety profiles. During the study, participants will be monitored for tumor response, disease control, duration of response, progression-free survival, overall survival, and any adverse effects or laboratory abnormalities. These outcomes will be assessed over periods ranging from 1.5 to 2 years to gather comprehensive information about treatment effects and safety.

Researchers are conducting an open, single-arm Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary effectiveness of FS-8002, alone and in combination with Toripalimab Injection and chemotherapy, in patients with advanced solid tumors. This study aims to better understand how these therapies work and their potential impact on patients who have not responded to or cannot tolerate standard treatments. Participants will receive FS-8002 injection every three weeks, either alone or combined with Toripalimab Injection, with some also receiving chemotherapy chosen by their doctor. Treatment continues until the patient experiences disease progression, unacceptable side effects, death, loss of follow-up, voluntary withdrawal, or the study ends. The study includes a dose escalation phase with six dose groups involving 42 patients to determine the best dose levels. Throughout the study, participants will be closely monitored with regular assessments of drug levels in the blood, side effects, and tumor responses using recognized criteria. Researchers will evaluate multiple outcomes including maximum tolerated dose, dose-limiting toxicities, adverse events, and various measures of tumor control and patient survival over one to two years. Participants will have ongoing evaluations during treatment and follow-up periods to track safety and effectiveness.

Researchers are evaluating a monitoring system based on cerebral autoregulation function in patients who have undergone mechanical thrombectomy for acute ischemic stroke due to large vessel occlusion in the anterior circulation. This multicenter, prospective, interventional diagnostic accuracy study aims to explore whether this monitoring can predict poor neurological outcomes shortly after the procedure. The study follows participants for up to 90 days to assess these outcomes. Participants who achieve successful recanalization after mechanical thrombectomy will undergo bedside cerebral autoregulation monitoring immediately after the procedure. This involves continuous near-infrared spectroscopy NIRS to track cerebral oxygen saturation and simultaneous noninvasive or invasive blood pressure measurement for 25-30 minutes. A carotid compression test is also performed to dynamically assess cerebral autoregulation. The cerebral oxygenation index COx is calculated from these measurements to determine the status of autoregulation. During the study, participants will be monitored closely after thrombectomy with cerebral oxygenation and blood pressure recordings, as well as the carotid compression test. Researchers will measure neurological outcomes using scales such as the Modified Rankin Scale up to 90 days after enrollment, and early neurological improvement at around 24 hours. The study includes various assessments and follow-ups to evaluate the predictive value of cerebral autoregulation monitoring for adverse neurological events after stroke treatment.