Chang 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.

Researchers are evaluating how well Orelabrutinib combined with bendamustine and rituximab works compared to bendamustine and rituximab alone in patients with mantle cell lymphoma who have not received previous treatment. This is a Phase 3, randomized, double-blind, placebo-controlled study focused on assessing both the safety and effectiveness of these treatments in this patient group. Participants will be randomly assigned to receive either Orelabrutinib orally along with bendamustine and rituximab injections, or a placebo instead of Orelabrutinib plus the same bendamustine and rituximab injections. Treatment will continue according to the study protocol until disease progression or other reasons for stopping treatment occur. The study compares the results between these two groups over time. During the study, patients will be monitored for side effects and the main outcomes include dose-limiting toxicity measured over 28 days and progression-free survival tracked for approximately 7 years. Various assessments will be done to evaluate the treatment response and safety. The total duration and follow-up allow researchers to understand long-term effects and disease control in participants.

Researchers are evaluating the long-term safety of subcutaneous guselkumab in children with moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis. This Phase 3, open-label study aims to monitor the safety of this treatment over an extended period in a pediatric population. Participants will receive guselkumab through subcutaneous injections. The study includes those who have completed the initial pediatric guselkumab dosing and have benefited from continued therapy as judged by their doctor. The study focuses on long-term treatment, with safety assessed by tracking adverse events for up to 6 years and 9 months. During the study, children will be regularly monitored for treatment-emergent adverse events. Parents or guardians will provide consent, and children able to understand will give assent. Researchers will collect data to assess safety throughout the treatment period, ensuring careful observation of participants' health and responses to guselkumab.

Researchers are investigating whether different oxygen concentration protocols during embryo culture affect term live birth rates and offspring health in women undergoing assisted reproductive technology. This prospective, randomized controlled trial compares constant (5%) oxygen concentration with sequential (5%-2%) oxygen concentration in embryo culture. The study is motivated by concerns about telomere shortening in offspring, which is linked to premature aging and health issues, and the role of oxygen tension in regulating telomere length. Participants will be randomly assigned to one of two groups: constant (5%) oxygen concentration or sequential (5%-2%) oxygen concentration during blastocyst culture. These protocols will be used in the embryo culture process before blastocyst transfer. The trial will be conducted at five centers, including the Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University. Women wishing to undergo blastocyst transplantation will be involved in the study. Researchers will collect data on live birth rates, perinatal complications, and offspring health status for each group. The main outcome measured is term live births within three years. Data will be statistically analyzed to compare the effects of the two oxygen concentration protocols on pregnancy and child health outcomes.

Researchers are conducting a Phase 1/2a trial to assess the safety and tolerability of DB-1303/BNT323 in people with advanced solid tumors that express HER2. The study focuses on patients with HER2-positive or HER2-expressing malignant solid tumors that are advanced, unresectable, recurrent, or metastatic, and have not responded to standard treatments or have no available standard treatments. This multicenter, open-label study includes an initial dose-escalation phase followed by a dose expansion phase to explore safety, tolerability, and preliminary efficacy of the treatment.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

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 safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are evaluating the effectiveness and safety of two treatment combinations for elderly patients newly diagnosed with multiple myeloma who are not planning to undergo stem cell transplant initially. The study compares daratumumab, lenalidomide, and dexamethasone (DRd) with a modified regimen of bortezomib, lenalidomide, and dexamethasone (VRd-lite). The main goals are to measure how long patients survive without disease progression and the rate of minimal residual disease negativity. Participants can choose between the two treatment options. Daratumumab is given intravenously weekly for the first 8 weeks, then every two weeks for 16 weeks, and finally every 4 weeks in later cycles. Bortezomib is administered by injection once a week during each 28-day cycle for 8 cycles. Both groups receive lenalidomide orally for 21 days of each cycle and dexamethasone twice a week. After initial treatment, all participants continue lenalidomide maintenance until the disease worsens or side effects become unacceptable. During the study, participants undergo regular evaluations including tests for disease progression and minimal residual disease status at various time points up to approximately 5 to 8 years. Safety is monitored throughout. The study involves ongoing assessments such as laboratory tests and clinical evaluations to track treatment response, side effects, and overall health during and after therapy.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.