Zhaotong

This research observes patients who have received Siltartoxatug Injection, a drug used for preventing tetanus after injuries. The study aims to document wound conditions and evaluate the clinical outcomes of tetanus prevention in a large real-world setting. It also focuses on monitoring safety by recording any side effects or serious adverse reactions from the treatment. Participants receive Siltartoxatug Injection following their injury as part of routine care. The study collects detailed information about their injury and wound status at enrollment. There is no comparison group; all participants are observed after receiving this treatment. Participants are followed for 90 days after receiving the injection. During this time, researchers assess whether tetanus develops and track any adverse events. The study uses selective safety data collection to monitor reactions to the drug. This follow-up period helps determine both the effectiveness and safety of the tetanus prevention approach using Siltartoxatug.

Researchers are evaluating simmitinib combined with irinotecan liposome for treating advanced esophageal squamous cell carcinoma. This phase II trial aims to assess the safety and effectiveness of this combination, study the drug's behavior in the body, and explore the relationship between biomarkers and treatment response. The study includes patients whose cancer has progressed after first-line standard therapy. The study has two main stages. The first is a dose escalation phase using a rapid titration and "3+3" design to find the maximum tolerated dose and observe dose-limiting toxicities of simmitinib plus irinotecan liposome. The second stage is a randomized controlled trial where participants are assigned equally to one of three groups: simmitinib plus irinotecan liposome, irinotecan liposome alone, or irinotecan alone. Treatments are given every two weeks at specified doses. Participants will be monitored from the start of treatment through the dose escalation phase and for up to two years during the randomized phase. Safety is assessed by tracking adverse events and dose-limiting toxicities. Effectiveness is measured by the objective response rate over two years. Other evaluations include biomarker analysis and pharmacokinetics. Patients must attend scheduled visits for clinical assessments and laboratory tests throughout the study.

Researchers are evaluating the safety, tolerability, and effectiveness of valemetostat tosylate combined with DXd antibody-drug conjugates (ADCs) in patients with advanced solid tumors, including HER2-positive gastric cancer, non-squamous non-small cell lung cancer (NSCLC), and unresectable or metastatic HER2 low breast cancer. This Phase 1b study aims to determine the recommended dose for further study and to assess treatment effects in these patient groups. The study has two parts: Part 1 involves dose escalation where valemetostat is given orally once daily, combined with either T-DXd or Dato-DXd administered by intravenous infusion every three weeks on Day 1 of each 21-day cycle. After identifying the recommended dose, Part 2 will expand to further evaluate safety and tolerability of this combination treatment. Participants will undergo regular assessments including imaging scans every 6 weeks during the first year and every 12 weeks thereafter to evaluate tumor response. Safety will be monitored from screening through 40 days after the last dose. Researchers will track adverse events and dose-limiting toxicities during the treatment cycles, which last 21 days each. Follow-up may continue for up to approximately 5 years to observe long-term outcomes.

Researchers are investigating CNSI-Fe, an innovative anti-cancer drug developed by Sichuan Yingrui Pharmaceutical Technology Co., Ltd., which uses iron (Fe2+) and nanocarbon particles to trigger tumor cell death through the ferroptosis pathway. This study focuses on patients with advanced solid tumors, including various types such as lung, pancreatic, thyroid, colorectal, cervical, and vulva cancers. The trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary effectiveness of CNSI-Fe delivered directly into tumors. This follows an earlier Phase I trial that showed promising safety and disease control results across different dose groups, with plans to explore higher doses. The trial includes a Phase Ib/IIa study with several periods: screening, treatment, and follow-up. During treatment, participants receive CNSI-Fe injections into 1 to 3 eligible tumor lesions every two weeks, for a total of 4 doses, with possible extension if benefits outweigh risks. Safety checks occur before each dose and two weeks after the last dose. Tumor response is assessed multiple times during and after treatment using modified criteria focusing on injected lesions. The study prohibits other investigational cancer therapies but allows symptom control treatments. Participants will undergo evaluations including tumor imaging, laboratory tests, and sample collection at specific times. Safety monitoring continues during a 28-day follow-up after treatment ends. Those with disease progression are followed every 6 weeks until further therapy, death, or study end. The main outcome measured is the occurrence and severity of treatment-related side effects during the 12-week treatment. This study's duration and procedures aim to provide comprehensive data on CNSI-Fe's clinical profile in advanced solid tumor patients.

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 evaluating the effectiveness and safety of early PCSK9 inhibitor therapy in adults aged 18 to 80 years who have experienced a large-artery atherosclerotic ischemic stroke. This prospective multicenter cohort study compares patients treated with evolocumab plus statin therapy to those receiving statin therapy alone. The study aims to assess early neurological improvement, lipid-lowering effects, 90-day functional outcomes, recurrent cardio-cerebrovascular events, and safety outcomes. Participants will be assigned to one of two groups based on their prescribed treatment in routine care. The treatment group will receive evolocumab injections of either 140 mg every two weeks or 420 mg monthly, combined with daily statin therapy, for 90 days. The comparison group will receive daily statin therapy alone for the same duration. The study plans to enroll approximately 1000 participants, with about 500 in each group. Participants will be assessed at the start of the study, on Day 7 or at hospital discharge, Day 30, and Day 90 after stroke onset. Evaluations include clinical and imaging examinations, neurological assessments, and safety monitoring. The primary measure is the proportion of participants achieving a favorable functional outcome at 90 days. Safety follow-up continues through Day 90, even if evolocumab treatment is stopped.

Researchers are conducting a phase II clinical trial to evaluate the safety, tolerability, and preliminary effectiveness of JS207 in patients with advanced non-small cell lung cancer (NSCLC) who have experienced disease progression after platinum-based chemotherapy and immunotherapy. This study focuses on patients with locally advanced or metastatic NSCLC that cannot be treated with surgery or radical radiochemotherapy. The goal is to understand how JS207 performs in this group who have limited treatment options. Participants receive one of several treatment combinations: JS207 injection alone at 10mg/kg or other dosages; JS207 combined with docetaxel at 75mg/m2 every three weeks; or JS207 combined with JS004 injection at 200mg every three weeks. These treatments are given in cycles spaced three weeks apart, and the study monitors their effects over time. During the trial, researchers will assess the objective response rate over 1.5 years to measure treatment effectiveness. Participants will undergo regular evaluations to monitor safety and tolerability. The study includes adults aged 18 to 75 years, and various assessments will be conducted to track disease status and adverse effects throughout the treatment period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of FS-8002 alone and in combination therapy for patients with advanced solid tumors. This open, single-arm Phase I clinical trial focuses on patients who have not responded to or cannot tolerate standard treatments. The study aims to understand how the drug behaves in the body and its potential benefits in this patient group. Participants will receive FS-8002 injections every three weeks. In addition, they may receive Toripalimab injections and chemotherapy chosen by the investigator, also administered every three weeks. Treatment continues until disease progression, unacceptable side effects, death, loss of follow-up, voluntary withdrawal, or study end. This approach allows researchers to assess the combined effects of these therapies over time. Throughout the study, participants will be closely monitored for safety and side effects for up to two years. Key outcomes include the maximum tolerated dose, recommended dose, dose-limiting toxicities, adverse events, and serious adverse events. Patients will undergo regular evaluations to track the disease and treatment effects. The total participation time is approximately two years, ensuring thorough assessment of safety and preliminary efficacy.