Su Zhou Shi

Hepatitis B virus (HBV) infection is a major global health concern, with chronic infection increasing the risk of liver cirrhosis, liver cancer, and death. Researchers aim to better understand which factors influence the long-term outcomes of chronic HBV infection in a broad group of Chinese patients. This study is an observational cohort designed to collect detailed data on epidemiology, clinical status, biology, virology, immune response, and treatments to identify these important factors. Participants with chronic HBV infection, defined by positive hepatitis B surface antigen (HBsAg) for at least 6 months, will be included in this real-life cohort. There are no specific treatment interventions or experimental therapies involved, as the study focuses on observing and collecting comprehensive patient data over time. During the study, researchers will track patient health outcomes for up to 20 years, including loss of viral antigens (HBeAg and HBsAg), development of liver cirrhosis, liver failure, liver cancer (hepatocellular carcinoma), and mortality. The long-term follow-up will involve monitoring clinical and laboratory parameters to understand disease progression and outcomes in this patient population.

This will be a confirmatory, prospective, open-label, single-arm, multi-centre study in a Chinese patient population. The study is designed to evaluate the safety, tolerability, sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed Tomography (PET/CT) imaging to non-invasively detect Clear Cell Renal Cell Carcinoma (ccRCC). The multi-centre study will be conducted in mainland China in adult patients with Indeterminate Renal Masses (IRM), who are scheduled for partial or total nephrectomy as part of their standard of care. Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET/CT imaging. The study involves a single administration of 37 MBq (±10%) of 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, in mainland Chinese participants (ZIRCON-CP). This is consistent with the confirmatory, prospective, multinational clinical trial ZIRCON (ClinicalTrials.gov ID: NCT03849118). This study consists of seven visits. Imaging will then be conducted 5±2 days post administration. The partial/total nephrectomy will then be performed at institutional discretion any time following the PET/CT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory. On Day 5±2 post study drug administration, an abdominal PET/CT imaging will be obtained. In patients, in which unexpected evidence for disseminated disease is observed, PET/CT imaging may be extended to complete whole body imaging(vertex of skull to toe) at the discretion of the investigator. Image data analyses will be performed by a central imaging vendor. For participants who were nephrectomised within 28 days post administration, the final study visit will be conducted on Day 42 (±7 days). For participants with nephrectomy between 28 and 90 days post administration, the final study visit will be performed 35 days (±7 days) after surgery. Image data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or Magnetic Resonance Imaging \[MRI\]), will be used to assess test performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth. The duration of this study is expected to be about 12 months, with a follow-up of 4 months. The study duration for a single participant will be approximately between 4 - 6 months. No interim analysis is planned for this study.

Researchers are evaluating TQB2934, a special antibody designed to treat multiple myeloma, a type of malignant plasma cell tumor. TQB2934 is a double-specific antibody that binds to both the CD3 receptor on T cells and the BCMA antigen on cancerous plasma cells. This binding helps recruit and activate T cells to attack and kill the cancer cells. The study is a Phase 1 clinical trial focusing on the safety and pharmacokinetics of this treatment in adults with multiple myeloma. The treatment involves subcutaneous injections of TQB2934. The antibody works by activating T cells to release substances that kill BCMA-positive target cells. The study monitors participants over time to assess how the drug is processed in the body, including measures like peak drug concentration and elimination half-life within 120 hours after administration. The trial also tracks adverse events for up to 24 months. Participants will undergo various laboratory tests and assessments to meet study requirements and monitor their health throughout the trial. Researchers will evaluate pharmacokinetics, including peak time, drug concentration, and clearance, as well as safety by recording any adverse events. The study includes careful monitoring of participants' condition and treatment responses, with follow-up lasting up to two years to ensure comprehensive safety data collection.

Researchers are evaluating the effects of adding SG301 injection to pomalidomide and dexamethasone in adults with relapsed or refractory multiple myeloma who have had at least one prior treatment including lenalidomide and a proteasome inhibitor. This phase III, randomized, placebo-controlled, double-blind study aims to compare SG301 combined with pomalidomide and dexamethasone against placebo combined with these drugs. The study includes two stages: a dose exploration phase to determine the recommended dose of SG301, followed by a randomized controlled phase to assess treatment outcomes. Participants will receive SG301 or placebo as an intravenous infusion weekly for 8 weeks, then every two weeks thereafter. All participants will take pomalidomide capsules orally at 4 mg once daily on days 1 through 21 of each 28-day cycle. Dexamethasone will be given orally or intravenously at 40 mg on days 1, 8, 15, and 22 of each 28-day cycle, with a reduced dose for participants with low body mass index. The study treatment continues through these cycles, with dosing and treatment monitored carefully. Participants will be monitored for adverse events from the first dose through about 30 days after the last dose, with follow-up lasting up to approximately 4 years. Disease progression and survival will be tracked regularly, with assessments every 4 weeks initially and then every 8 weeks after randomization. The study includes evaluations of organ function, disease status, and safety to gather comprehensive data on the treatments' impact and participant well-being throughout the trial period.

Researchers are investigating a treatment for elderly patients aged 65 and older with advanced triple-positive breast cancer, a group that typically has low physical status and struggles to tolerate harsh chemotherapy. The study aims to confirm the safety and effectiveness of a combination therapy involving Darcilide, an AI (aromatase inhibitor such as letrozole, anastrozole, or exemestane), and Pyrrotinib. Pyrrotinib is a small molecule tyrosine kinase inhibitor with proven efficacy in HER2-positive breast cancer, while Darcilide is a newly optimized CDK4/6 inhibitor developed in China that has shown promising results in combination with AI therapy. The treatment plan involves administering Darcilide orally once daily for 21 days followed by 7 days off within a 28-day cycle. The aromatase inhibitor can be letrozole, anastrozole, or exemestane, given orally once daily. Pyrrotinib is started at 240 mg daily, with a possible increase to 320 mg if tolerated, also given orally within 30 minutes after breakfast for 21 days per cycle. Prophylactic antidiarrheal medications are recommended alongside Pyrrotinib. Participants will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. Participants undergo a screening period of up to 28 days before starting treatment cycles every 28 days. Imaging assessments are performed regularly according to RECIST 1.1 criteria, with evaluations made by investigators. Safety checks occur at the end of treatment and 28 days post-treatment. Follow-up includes monitoring for adverse events until recovery, documenting tumor progression or death, and survival tracking until death, withdrawal, or study end. The primary outcome measured is progression-free survival over 29 months.

Researchers are investigating HMPL-506, an oral drug, in a Phase 1 clinical study for patients with hematological malignancies such as relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and multiple myeloma (MM). The study has two phases: dose escalation and dose expansion, aiming to determine the safest and most effective dose. Approximately 60 to 132 patients are expected to participate, including those with specific genetic mutations or rearrangements related to these blood cancers. In the dose escalation phase, patients receive increasing doses of HMPL-506 orally once daily in 28-day cycles to identify the maximum tolerated dose and recommended Phase 2 dose. Initial doses start at 50 mg daily, with potential escalation based on safety and efficacy data. The dose expansion phase enrolls patients into three cohorts based on disease type and genetics, treating them with the recommended dose in 28-day cycles until disease progression, intolerable side effects, or other defined reasons to stop. Participants will undergo regular safety monitoring, including evaluation of dose-limiting toxicities, serious adverse events, and response to treatment. Tumor response is assessed every cycle for the first six cycles and then every two cycles thereafter, with follow-up lasting up to 42 months. Additional assessments include bone marrow biopsies, laboratory tests, and performance status evaluations. The study tracks participants until disease progression, withdrawal, or study completion to evaluate HMPL-506's safety and preliminary effectiveness.

Researchers are evaluating the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) injection for treating upper limb spasticity in adults with unilateral hemiplegia caused by stroke. This randomized, double-blind, multi-center phase II/III study focuses on adults aged 18 to 75 years who have experienced at least 3 months since stroke onset and exhibit functional impairments in hygiene, dressing, limb position, or pain due to spasticity. Participants will receive a single intramuscular injection of either Recombinant Botulinum Toxin Type A (YY001) at doses between 200 to 400 units, BOTOX® at 200 units, or a placebo prepared with 0.9% Sodium Chloride. The study monitors effects at 4 weeks after treatment, comparing the changes in muscle tone using the Modified Ashworth Scale among the groups. During the study, participants' disability levels, treatment adherence, and any side effects will be assessed. Oral antispasticity medication and physical or occupational therapy, if ongoing, must be stable before enrollment. Safety monitoring includes exclusion of individuals with allergies to study drugs, recent botulinum toxin use, fixed limb contractures, or other medical conditions that increase risk. The study spans screening, treatment, and follow-up to ensure thorough evaluation of outcomes and safety.

Researchers are evaluating the safety and tolerability of B019 injection in patients with relapsed or refractory B-cell acute lymphoblastic leukemia. This phase 1 clinical study aims to gather preliminary data on how well patients tolerate this treatment and to monitor its safety over approximately two years. The study includes participants aged 3 to 25 years who have documented CD19/CD22 tumor expression and meet specific health criteria. Participants will receive B019 through intravenous infusion, with doses ranging from 1.0x10^6 to 10.0x10^6 CAR T cells per kilogram of body weight. The study focuses on assessing the treatment-emergent adverse events and serious adverse events to understand the safety profile of B019. The treatment is given under close medical supervision, and participants must agree to use effective contraception if applicable. Throughout the study, researchers will monitor patients for side effects, overall health, and treatment responses. This includes regular assessments of liver, kidney, lung, and heart functions, as well as ongoing documentation of any adverse events over about two years. Participants and their guardians will provide informed consent and commit to follow-up visits and evaluations to ensure their safety and collect necessary data for the study's outcomes.

Researchers are evaluating the safety and effectiveness of TQB3909 tablets in patients who have recurrent or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This phase Ib/II clinical trial focuses on patients diagnosed according to specific criteria and aims to understand how well this treatment works and how safe it is for this population. The study investigates TQB3909, a drug designed to inhibit the B-cell lymphoma-2 (BCL-2) protein. Participants will receive TQB3909 tablets as part of the treatment regimen. The trial includes monitoring for side effects and disease response over time. The study will measure the recommended phase II dose and assess remission rates through evaluations conducted up to 34 months. Participants will be involved in assessments that include monitoring for adverse events, serious adverse events, and abnormal laboratory results. These will be tracked for up to 34 months to evaluate safety and treatment impact. The study also includes imaging tests for measurable lesions and pregnancy testing for women of childbearing potential. Overall, the trial may last up to nearly three years, with ongoing safety and effectiveness evaluations throughout.

Researchers are evaluating the effectiveness and safety of special defocusing lenses designed to slow down the progression of myopia in children and adolescents aged 8 to 13 years. This study includes 156 participants who meet specific vision and health criteria. The trial is randomized, double-blind, and controlled, aiming to compare different types of lenses over a 12-month period while monitoring eye health and any side effects. Participants are divided into three groups to wear different lenses for one year: microstructure lens A with a low defocus ratio, microstructure lens B with a high defocus ratio, or standard aspherical single-light lenses as a control. All lenses must be worn regularly, with follow-up visits scheduled to check eye health and collect subjective feedback on lens comfort and performance. Throughout the study, regular eye examinations including cycloplegic subjective refraction are performed to assess changes in vision. Researchers observe the condition of the eyes, record any adverse events, and measure the primary outcome of change in spherical lens value after 12 months of wearing the lenses. Safety and effectiveness are closely monitored during the study to ensure participant well-being.