Zhong Shan Shi

Researchers are evaluating the effects of reduced-dose radiotherapy (40.2Gy) compared to conventional-dose radiotherapy (49.2Gy) on low-risk target volumes in patients with chemosensitive intermediate-stage nasopharyngeal carcinoma. This phase 3 trial includes patients who have responded well to induction chemotherapy and whose plasma EBV-DNA levels have dropped to zero or below detection limits. The goal is to see if lowering the radiation dose can maintain treatment effectiveness while reducing side effects and improving quality of life. Participants will be randomly assigned to receive either reduced-dose or conventional-dose radiotherapy targeting the CTV2 area, while both groups receive the full course of PD-1 monoclonal antibody immunotherapy. The immunotherapy consists of 12 courses given every three weeks, starting with induction chemotherapy and continuing through radiotherapy and post-radiotherapy maintenance. Induction chemotherapy includes three cycles of gemcitabine and cisplatin or alternative drugs, administered intravenously. Throughout the study, patients will be closely monitored for progression-free survival and the occurrence of significant adverse events over three years. Researchers will assess survival outcomes, side effects, and quality of life differences between the two groups. Regular evaluations include imaging, laboratory tests, and clinical assessments to ensure patient safety and treatment effectiveness during the entire follow-up period.

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.

Researchers are evaluating the tolerability, safety, and preliminary effectiveness of a treatment called T3011 in people with advanced melanoma. This study is a Phase Ib/IIa clinical trial focusing on patients who have measurable tumors and an expected survival of more than 12 weeks. The purpose is to better understand how patients respond to T3011 and to monitor any side effects that occur during the treatment. Participants will receive T3011 administered directly into their tumors every two weeks. This intratumoral injection is the main method of delivering the biological treatment. The study includes both treatment and observation periods lasting approximately two years to assess long-term safety and response rates. During the study, participants will undergo regular health evaluations, laboratory tests, and tumor assessments to track the treatment's effects and any adverse events. Researchers will monitor the incidence of treatment-emergent side effects and measure the objective response rate to determine how well the tumors respond. The total participation time is about two years, allowing for detailed observation of safety and efficacy outcomes.

Researchers are evaluating HLX10 monotherapy in a phase II clinical trial for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. These patients have experienced disease progression or intolerable side effects after standard cancer treatments. The study aims to assess the clinical effectiveness and safety of HLX10, a recombinant humanized anti-PD-1 monoclonal antibody, in this patient group. Participants will receive HLX10 as an intravenous infusion at a dose of 3 mg/kg every two weeks. Treatment will continue until the patient no longer benefits, experiences intolerable toxicity, withdraws consent, or completes up to 2 years of treatment (52 dosing periods). The study includes three periods: a 28-day screening phase, the treatment phase, and a follow-up phase that involves safety and survival monitoring. During the study, participants will undergo assessments including tumor measurements and laboratory tests to track treatment response and safety. Researchers will evaluate the overall response rate for up to 2 years. Regular monitoring will include imaging, blood tests, and collection of tumor tissue samples. Safety follow-up and survival status will be tracked after treatment ends to understand long-term outcomes and tolerability.

Researchers are evaluating the effectiveness and safety of TQB6411 for Injection in adults with advanced lung cancer. This clinical trial is designed as a Phase Ib/II study to determine the recommended Phase II dosage and to observe the objective response rate over a period of up to six months. Participants must have confirmed lung cancer with measurable lesions and meet specific health and laboratory criteria to be eligible. The treatment involves administering TQB6411 for Injection every 21 days as a cycle. The study focuses on monitoring the drug’s safety and how well it works in treating advanced lung cancer. Participants will receive this treatment while being closely observed for any side effects or responses to the therapy. During the study, participants will undergo various assessments including laboratory tests, tumor tissue sampling for immunohistochemical testing, and regular health evaluations. The main outcomes measured are the recommended dosage for Phase II and the cancer's response to treatment over six months. Participants will be monitored for safety and treatment effects throughout the study period, which includes initial treatment and follow-up assessments.

Researchers are studying the gut microbiome in people with several serious chronic diseases in China, including various cancers, hypertension, epilepsy, and kidney disease. The study aims to better understand the differences and similarities in gut microbiome patterns linked to these diseases and different regions, and how these patterns affect microbiome-based diagnostic tests. This work is important because past research has shown links between microbial imbalances and disease, but variability between studies has made it hard to draw clear conclusions. This observational study will recruit 500 patients diagnosed with each target disease and 500 healthy control participants matched by age and sex. Researchers will collect detailed information about participants' demographics, lifestyle, diet, medications, and health status. Biological samples including feces, saliva, urine, and blood will be collected for analysis. There is no active treatment or intervention; the study focuses on characterizing the microbiome and related health data. Participants will undergo assessments of their medical history and lifestyle, with sample collections to analyze microbiome and biochemical markers. Researchers will measure the baseline microbiome to identify disease-associated signatures. The study requires participants to be aged 18 to 75 and to have lived in the hospital's province for at least three years. Safety monitoring is observational, with no study treatments given. The total participant involvement includes data and sample collection for cross-sectional analysis.

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.

This research aims to assess the effectiveness and safety of lebrikizumab in adults diagnosed with perennial allergic rhinitis, a condition characterized by year-round nasal allergy symptoms. The study is a Phase 3 trial involving adult participants who have confirmed allergic reactions to indoor allergens. Researchers are investigating how lebrikizumab compares with placebo, alongside standard intranasal corticosteroid therapy, to better understand treatment options for this condition. Participants will receive either the investigational drug lebrikizumab (LY3650150) administered by subcutaneous injection, a placebo injection, or standard intranasal corticosteroid spray. The study is randomized, double-blind, and placebo-controlled, ensuring that neither participants nor researchers know who receives which treatment during the trial. Treatment and observation periods will span up to 29.5 months. During the study, participants will be monitored for changes in their nasal symptoms, specifically measuring the total nasal symptom score from the start of the study to week 16. Researchers will conduct various assessments including clinical evaluations and allergy testing to track symptom changes and treatment effects. Safety will be closely observed throughout the study duration, and participants may be followed for nearly two and a half years in total.

Researchers are evaluating pegmolesatide, a long-acting erythropoiesis-stimulating agent (ESA), in patients with renal anemia who are undergoing dialysis and have been treated with hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs). Pegmolesatide was recently approved by the National Medical Products Administration in June 2023. While previous studies showed its safety and effectiveness in dialysis patients previously treated with recombinant human erythropoietin, this trial aims to assess the safety and efficacy of switching from HIF-PHIs to pegmolesatide, as well as to establish dose conversion standards. The study is a multi-center, prospective, open-label, randomized parallel-controlled clinical trial enrolling 96 patients. Participants are divided into low-dose and high-dose Roxadustat cohorts based on their prior weekly Roxadustat dose. Each cohort is further split by hemoglobin levels and then randomized to receive different initial doses of pegmolesatide (2 mg, 4 mg, or 6 mg) administered subcutaneously every four weeks. Treatment lasts for 12 weeks, followed by a 16-week follow-up period. During the study, patients receive regular doses of pegmolesatide with dose adjustments as needed per drug instructions. Researchers will monitor hemoglobin levels from baseline to 12 and 16 weeks to evaluate treatment effects. Throughout the trial, patients undergo assessments to ensure safety and treatment adherence, with overall involvement lasting 28 weeks from the start of treatment to the end of follow-up.

This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitor.