Nan Jing Shi

Chronic hepatitis B virus HBV infection is a major global health issue that can lead to serious liver problems such as cirrhosis, liver cancer, and death. This observational study aims to gather detailed information from a broad group of Chinese patients with chronic HBV infection to better understand the factors that influence disease outcomes. The study involves creating a comprehensive database of clinical, epidemiological, biological, virological, immunologic, and treatment-related data from patients with chronic HBV infection. There are no drug interventions instead, participants are monitored as part of this long-term cohort. Participants will be followed over many years, with researchers tracking outcomes like loss of hepatitis B antigens, development of cirrhosis, liver failure, liver cancer, and mortality. Regular assessments will collect relevant health information to help identify the factors linked to disease progression. The study is planned to continue until 2030, providing extensive long-term data on chronic HBV infection.

Researchers are evaluating the safety and effectiveness of a new molecular probe called 18F-FAPI-YQ104, which targets fibroblast activation protein FAP, for early tumor diagnosis. This observational study focuses on patients with lung cancer, pancreatic cancer, neuroendocrine tumors, and thyroid cancer. The goal is to verify how well this probe works in detecting tumors during clinical use. Participants will receive an intravenous injection of the 18F-FAPI-YQ104 probe followed by a PET-CT examination to capture detailed images of tumor lesions. The study will observe the probes uptake in tumor sites, measured by SUVmax values 60 minutes after administration. No additional treatment is given instead, the study monitors the imaging results to assess the probes diagnostic potential. During the study, participants will undergo PET-CT scans and other imaging tests such as CT or MRI. Researchers will evaluate the images to measure tumor activity and probe uptake. Safety assessments include checking kidney and liver function, blood counts, and monitoring for allergic reactions. The study will last from April 2025 to March 2026 and includes adults aged 18 to 75 years who have confirmed tumors and meet health criteria.

Researchers are evaluating whether giving 2 courses of cisplatin chemotherapy along with postoperative radiotherapy is as effective as 3 courses in treating patients with high-risk head and neck squamous cell carcinoma after surgery. This phase 3 randomized trial focuses on patients with advanced stages III and IV of this cancer type who have undergone radical surgery but have high-risk factors such as extracapsular invasion or positive surgical margins. The main goal is to compare the 3-year failure-free survival rates between the two treatment approaches. Participants will be assigned to one of two groups. One group receives intensity-modulated radiotherapy totaling more than 66 Gy, given once daily five days a week, combined with cisplatin chemotherapy at 100 mgm2 through intravenous injection on days 1 and 22 2 courses. The other group receives the same radiotherapy schedule plus 3 courses of cisplatin chemotherapy on days 1, 22, and 43. Both treatments are delivered under medical supervision to assess outcomes and side effects. During the study, participants will undergo regular assessments to evaluate failure-free survival, overall survival, distant metastasis-free survival, locoregional recurrence-free survival, and quality of life over a 3-year period. Safety and treatment tolerability will also be monitored. The trial includes close follow-up visits and evaluations to measure the effects of the different chemotherapy schedules combined with radiotherapy on cancer control and patient well-being.

This trial investigates the use of 40 Hz flicker light stimulation to address insomnia in patients with Parkinsons disease PD, a condition marked by motor and non-motor symptoms including sleep disturbances. Current drug treatments for PD-related insomnia may not be sufficient and can cause side effects, so this study explores a non-drug method that may influence brain activity related to sleep regulation. Approximately 30 patients with PD and significant insomnia symptoms will participate in this randomized, single-blind, controlled study. Participants will be randomly assigned to one of two groups one receiving 40 Hz flicker light stimulation and the other receiving 100 Hz control light. Both groups will receive the light for 30 minutes each night at bedtime for seven consecutive nights, alongside their stable Parkinsons medication. The flicker light is delivered using a specialized device with parameters adjusted for safety and comfort. The study focuses specifically on this PD insomnia group within a larger parent protocol. Throughout the trial, participants will complete sleep assessments including the Parkinsons Disease Sleep Scale-2 PDSS-2, sleep quality questionnaires, and sleep diaries. Objective sleep measures such as total sleep time and awakenings will be collected using polysomnography when possible. Other non-motor symptoms will also be evaluated. Safety will be monitored through adverse event tracking, vital signs, and checking for any visual discomfort. The primary outcome is the change in PDSS-2 score from baseline to Day 7, with additional follow-up assessments conducted at Day 28.

Researchers are evaluating the effectiveness and safety of a 7-day treatment combining vonoprazan, high-dose amoxicillin, and bismuth VAB-7 to treat Helicobacter pylori infection. This infection can cause chronic stomach inflammation and increase risks for ulcers, lymphoma, and gastric cancer. The study compares this shorter regimen with the standard 14-day vonoprazan and high-dose amoxicillin dual therapy VA-14 due to concerns about antibiotic resistance and the need for more effective treatments. Participants are randomly assigned to one of two groups. The experimental group receives vonoprazan 20 mg twice daily, amoxicillin 1 g three times daily, and bismuth 220 mg twice daily for 7 days. The control group receives vonoprazan 20 mg twice daily and amoxicillin 1 g three times daily for 14 days. The study explores whether adding bismuth can improve eradication rates in a shorter treatment course. During the study, researchers monitor participants for Helicobacter pylori eradication using a urea breath test conducted 4 to 6 weeks after treatment. They also assess patient adherence, adverse events during treatment days, and cost-effectiveness. Follow-up assessments occur shortly after treatment completion to evaluate safety and compliance. The total study duration for each participant varies based on their assigned treatment group.

Researchers are evaluating the effectiveness of combining 9MW2821 with toripalimab compared to using 9MW2821 alone in patients with locally advanced or metastatic urothelial carcinoma who have not yet received systemic treatment for their advanced cancer. This randomized phase II trial aims to improve first-line treatment options for this condition, which includes urothelial carcinoma of the bladder, renal pelvis, and ureter. Participants will be assigned to receive either the combination of 9MW2821, a nectin-4 antibody-drug conjugate with MMAE payload, plus toripalimab, an anti-PD-1 antibody, or 9MW2821 monotherapy. The study treatments will be given according to protocol, with no masking or blinding. The trial includes a planned 3-year period to assess treatment response and safety. Throughout the study, participants will undergo regular assessments including evaluations of tumor response using RECIST v1.1 criteria, safety monitoring, and immunogenicity tests over three years. Researchers will measure outcomes such as the objective response rate and other efficacy endpoints. Participants must be able to follow study visits, treatment, and laboratory procedures, with contraceptive measures maintained until 180 days after the last dose. The overall participation spans from screening through treatment and follow-up over the study duration.

Bladder cancer is a common urinary system cancer, with a significant number of patients diagnosed with non-muscle-invasive bladder cancer NMIBC. NMIBC varies in risk based on tumor size, stage, and grade, and while surgery is primary treatment, residual tumors and recurrence are concerns, especially for larger tumors. This research aims to explore bladder-sparing treatment strategies for large-volume NMIBC, balancing quality of life with cancer control outcomes. The study compares two approaches a bladder-sparing set and immediate radical cystectomy. The bladder-sparing method involves neoadjuvant chemotherapy combined with immunotherapy, followed by maximal transurethral resection of bladder tumor TURBT and a second TURBT, then mitomycin C bladder instillation therapy. The radical cystectomy group undergoes surgery immediately after three cycles of neoadjuvant therapy. Participants will be monitored from enrollment through three years after treatment, focusing on recurrence-free survival as the main outcome. Progression-free survival is also measured. Regular follow-up will assess tumor status and safety. The study includes adults aged 18 to 80 who can tolerate chemotherapy and immunotherapy and are willing to comply with study requirements, including ongoing evaluations and bladder instillation therapy.

Researchers are evaluating TQB2934, a special antibody designed to target multiple myeloma, a cancer affecting plasma cells. This antibody binds to T cells and cancer cells to activate the immune system to attack the disease. The study is a Phase 1 clinical trial focusing on safety and the bodys handling of the drug in patients with malignant plasma cell tumors. The study involves giving TQB2934 as a subcutaneous injection at doses of 40mg or 60mg. Treatment cycles occur once weekly during the first three cycles, then every two weeks for cycles four to six. If patients achieve a partial remission or better after six cycles, dosing continues every four weeks. Each treatment cycle lasts 28 days. Participants will undergo various assessments including blood tests to measure drug levels and immune response over 120 hours after each dose. Researchers will monitor adverse events for up to 24 months and evaluate treatment responses such as remission rates and survival outcomes. The total study participation includes treatment and long-term safety follow-up lasting up to two years.

Researchers are evaluating H1710 for Injection in adults with advanced solid tumors in this phase Ia clinical study. The study aims to assess the safety, tolerability, and how the drug behaves in the body. Participants included have advanced solid tumors that have not responded to or are not suitable for standard treatments. Participants will receive H1710 for Injection according to the study protocol. This single-group trial involves administering the drug and monitoring its effects. The study will track adverse events, dose limiting toxicities, and determine the maximum tolerated dose as well as the recommended dose for future studies over a period of up to 18 months. During the study, participants will undergo evaluations including safety assessments, laboratory tests, and imaging to measure tumor response using RECIST criteria. Researchers will measure drug concentration levels and other pharmacokinetic parameters. The study also monitors disease control, response duration, and progression-free survival. The total participation may last up to approximately 18 months, with regular visits to monitor health and treatment effects.

Researchers are evaluating if combining the medicines calderasib and subcutaneous pembrolizumab can more effectively treat people with non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study aims to find out whether patients receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a Phase 3 clinical trial focusing on first-line treatment for advanced or metastatic nonsquamous NSCLC. Participants are assigned to one of two groups. One group receives subcutaneous pembrolizumab plus berahyaluronidase alfa every 6 weeks for up to 18 cycles about 2 years along with oral calderasib until treatment discontinuation criteria are met. The other group receives the same pembrolizumab and berahyaluronidase alfa regimen plus chemotherapy with pemetrexed and either carboplatin or cisplatin infusions during the early cycles. Treatment continues based on individual response and tolerability. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess progression-free survival, overall survival, response rates, and quality of life using questionnaires and symptom scores over several years. Safety will be monitored through adverse event reporting. The trial lasts up to about 7 years with ongoing evaluation of health outcomes and side effects to understand the impact of these treatment combinations.