Nan Jing 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 a new molecular probe called 18F-FAPI-YQ104 that targets fibroblast activation protein (FAP) labeled with radioactive isotopes to assess its safety and effectiveness in early tumor diagnosis. This study focuses on patients with lung cancer, pancreatic cancer, neuroendocrine tumors, thyroid cancer, and melanoma. The goal is to verify how well this probe works in detecting tumors through imaging techniques. Participants will receive an intravenous injection of the 18F-FAPI-YQ104 probe followed by a PET-CT scan to examine tumor uptake of the radioactive tracer. The study involves a single imaging procedure using this novel probe. The main measurement is the maximum standardized uptake value (SUVmax) of the lesion 60 minutes after the probe injection, which helps assess tumor activity. During the study, participants will undergo imaging assessments and laboratory tests to monitor kidney and liver function, blood counts, and overall safety. Researchers will collect final pathological results for tumor confirmation and evaluate the probe's diagnostic performance. The study includes adult volunteers aged 18 to 75 years who have tumor lesions confirmed by other imaging methods. Participants are monitored for safety and adverse events throughout the study period.

Researchers are studying high-risk head and neck squamous cell carcinoma to see if using two courses of cisplatin chemotherapy alongside radiation after surgery can provide similar benefits compared to the standard three courses. This Phase 3 trial focuses on the 3-year failure-free survival rate to determine if the shorter treatment is not significantly less effective. The study also examines the effectiveness and side effects of two courses of cisplatin chemotherapy given during radiation therapy after surgery. Participants receive cisplatin chemotherapy at a dose of 100 mg/m2 by intravenous injection every three weeks, specifically on days 1 and 22, combined with intensity-modulated radiation therapy. This is compared to the standard approach of three courses given on days 1, 22, and 43. The trial is randomized and multicenter, aiming to evaluate whether fewer chemotherapy courses can maintain treatment success while potentially reducing toxicity. During the study, participants will be monitored for treatment outcomes including failure-free survival over three years. Researchers will assess treatment efficacy and toxicity, with regular medical evaluations to monitor liver, kidney, and bone marrow function. Patients must provide informed consent and meet strict eligibility requirements, including good physical function and no distant cancer spread. The study helps understand if a shorter chemotherapy regimen is a viable option for this patient group.

Researchers are evaluating treatments for Helicobacter pylori (H. pylori) infection, a bacteria that causes chronic stomach inflammation and can lead to ulcers and stomach cancer. Due to rising antibiotic resistance, finding effective and safe treatments is urgent. Vonoprazan, a new acid blocker, combined with amoxicillin has shown promising results and is recommended by the 2024 American College of Gastroenterology as a first option. This study focuses on improving a shorter 7-day treatment by adding bismuth, which may boost antibiotic effects and fight resistance. Participants will be randomly assigned to one of two treatment groups. The control group receives a 14-day regimen of vonoprazan 20 mg twice daily plus high-dose amoxicillin 1 g three times daily. The experimental group receives a 7-day treatment adding bismuth 220 mg twice daily to the same vonoprazan and amoxicillin doses. The study compares the effectiveness and safety of these regimens as first-line treatments for H. pylori infection. During the study, participants will be monitored for H. pylori eradication using a urea breath test 4 to 6 weeks after treatment ends. Researchers will also assess side effects, patient adherence, and cost-effectiveness. The trial is a phase 4, multicenter, randomized controlled study involving adults aged 18 to 70 years, with follow-up to ensure treatment success and safety.

Researchers are evaluating a new molecular imaging probe to improve early tumor diagnosis. This probe targets fibroblast activating protein (FAP) and is labeled with technetium-99m for SPECT/CT imaging. The study aims to address challenges with current small molecule FAP inhibitors that clear quickly from tumor tissue and have short retention times, by optimizing the ligand for better imaging and safety in clinical use. Participants will receive an intravenous injection of the 99mTc labeled FAPI imaging agent. After drinking 300-500 ml of water, they will undergo SPECT-CT imaging one hour later to visualize tumor uptake of the probe. This imaging method is designed to help detect tumors in patients with head and neck tumors, lung cancer, or pancreatic cancer. During the study, researchers will monitor tumor uptake of the probe one hour after administration. Participants must complete informed consent and meet health criteria including kidney and liver function tests before joining. The study will assess safety and effectiveness of the imaging agent in tumor diagnosis, with close monitoring of participants' physical condition and laboratory values throughout the process.

Researchers are evaluating treatments for patients with locally advanced or metastatic urothelial carcinoma who have not previously received systemic therapy for their advanced cancer. The study compares the effectiveness of a combination of 9MW2821, a nectin-4 antibody-drug conjugate with an MMAE payload, plus toripalimab, an anti-PD-1 antibody, against 9MW2821 alone. This is a Phase II randomized trial aimed at understanding which treatment approach may better control the disease. Participants will receive either the combination of 9MW2821 with toripalimab or 9MW2821 monotherapy. The interventions involve study drugs administered according to the trial protocol, focusing on these two treatment regimens. The study is designed to assess these therapies in patients who have measurable target lesions and meet specific health criteria. During the trial, patients will be closely monitored with regular visits including laboratory tests, assessments of treatment response, and safety evaluations. Researchers will measure outcomes such as the objective response rate over three years to evaluate treatment effectiveness. Participants are expected to adhere to contraceptive measures during and after treatment, and their overall health and side effects will be tracked throughout the study period to ensure safety.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Bladder cancer is a common urinary system cancer in China, mostly diagnosed as non-muscle-invasive bladder cancer (NMIBC), which includes stages Ta, T1, and Tis. Accurate staging has improved with multiparametric MRI and the VI-RADS scoring system. NMIBC patients have varying risks of recurrence and progression depending on tumor size, stage, and grade. Current treatments like transurethral resection of bladder tumor (TURBT) are standard, but large tumors (≥5 cm) pose treatment challenges and higher risks, leading to consideration of radical cystectomy or bladder-sparing strategies. Bladder-sparing approaches aim to preserve quality of life while controlling tumor growth, especially important given the risks and impacts of radical cystectomy. This study compares two treatment strategies for large-volume NMIBC: a bladder-sparing approach and immediate radical cystectomy. The bladder-sparing treatment involves neoadjuvant chemotherapy combined with immunotherapy, followed by maximal TURBT and a second TURBT, then mitomycin C bladder instillation therapy. The radical cystectomy arm receives surgery immediately after three cycles of neoadjuvant therapy. These interventions explore balancing effectiveness and quality of life for patients with large NMIBC tumors. Participants will be monitored for recurrence-free survival from enrollment until three years after treatment completion. The study requires regular assessments including tumor evaluations and treatment tolerance monitoring. Participants must adhere to follow-up schedules and receive bladder instillation therapy if assigned to the bladder-sparing group. Safety and treatment outcomes will be closely tracked to evaluate the feasibility and effectiveness of these treatments for large-volume NMIBC over the study duration.

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 safety, effectiveness, and behavior of a new drug combining Albumin-bound Paclitaxel with granulocytes for patients with recurrent or metastatic breast cancer. This open, single-arm study focuses on patients whose breast cancer has returned or spread and who have already received standard first-line treatments. The study aims to understand how well this drug works and how it acts in the body over a 13-month period. Selected female patients with recurrent or metastatic breast cancer will receive the Albumin-bound Paclitaxel/Granulocyte therapy. Granulocytes are separated from the patient's own blood, cultured in a laboratory with Albumin-bound Paclitaxel to create the drug, which is then infused intravenously. This approach uses the patient’s own cells combined with the medication to potentially target the cancer. Participants will be monitored for safety and response to treatment throughout the study. Researchers will assess liver, kidney, and bone marrow functions, and evaluate the patients' overall health using standard scoring systems. The study includes laboratory tests and clinical observations to track how the drug behaves and its effects on cancer progression. The total study duration for measuring primary outcomes is 13 months.