Qianxinan Buyei And Miao Autonomous Prefecture

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 investigating BNT3212, alone and combined with pumitamig (BNT327), in adults with advanced solid tumors who have no remaining standard treatment options. This first-in-human, open-label study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and early signs of effectiveness of these treatments. The study includes multiple phases to carefully explore dosing and potential benefits while monitoring participant safety. The study is divided into four parts: Part A tests increasing doses of BNT3212 alone, Part B expands these doses in specific tumor types, Part C tests dose escalation of BNT3212 combined with pumitamig, and Part D expands this combination in select patient groups. Treatments are given by intravenous infusion, with doses adjusted or expanded based on ongoing safety and efficacy data. This stepwise approach helps identify the recommended doses for future studies. Participants will be closely monitored throughout the study period, which may last up to around 31 months, including follow-up after the last dose. Researchers will track side effects, treatment interruptions, and responses to therapy. Assessments include imaging for tumor measurements, laboratory tests for organ function, immune response evaluations, and overall health status. Safety observations continue up to 90 days post-treatment to ensure participant well-being.

Researchers are evaluating the safety and effectiveness of two types of treatments using the InterVapor System for patients with severe emphysema. This study compares precise subsegmental treatment versus segmental treatment. Participants must have severe emphysema and meet specific lung function and health criteria to join the study. Participants will be assigned to either the experimental group, receiving treatment in at least two subsegments of different lung segments, or the control group, treated in at least one full lung segment. Both groups will have procedures spaced at least 6 weeks and no more than 6 months apart, with treatment volumes limited per procedure and cumulatively. All participants will continue receiving optimal medical therapy following GOLD guidelines throughout the study. After the second procedure, participants will have follow-up visits at 1, 3, 6, and 12 months. During these visits, lung function tests, high-resolution CT scans, 6-minute walk tests, and various health questionnaires will be conducted. Researchers will monitor improvements in lung function and record any adverse events to assess safety and treatment impact over time.

Researchers are evaluating the safety and effectiveness of two antibiotic treatments, omadacycline and moxifloxacin, in Chinese adults with community-acquired bacterial pneumonia (CABP). This Phase 3b study is designed as a bridging trial to confirm whether omadacycline works as well as moxifloxacin in this specific population, building on results from a global CABP trial. Participants will receive either omadacycline or moxifloxacin through intravenous or oral routes. The treatments are given as a course, with details on dosing schedules not specified. The study compares these two drugs directly to assess their clinical efficacy and safety in treating CABP. During the study, participants will be monitored and evaluated for their clinical response at 18 months after therapy. Researchers will assess symptoms, vital signs, and overall health related to pneumonia to determine treatment success. Safety and efficacy data collected throughout the study will help understand how well each drug performs in this patient group.

Researchers are evaluating GH2616 Tablet in a Phase Ia/Ib clinical trial involving adults with advanced solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of GH2616. Phase Ia focuses on dose escalation using a "3+3" design with eight ascending-dose groups, while Phase Ib expands dosing to evaluate safety and efficacy in patients whose tumors have specific genetic changes such as TP53 mutation and whole-genome doubling (WGD+). GH2616 Tablets are taken orally throughout the study. Phase Ia involves sequential dose escalation across eight cohorts to identify safe dosage levels. Phase Ib includes two to three dose expansion cohorts based on Phase Ia results, focusing on patients with TP53 mutation and WGD+ tumors. Both phases are open-label and conducted at multiple centers. Participants will undergo various assessments including safety monitoring, blood tests, and tumor evaluations to track adverse events and treatment effects over two years. Researchers will measure the number of participants reporting adverse or serious adverse events and count dose-limiting toxicities. Participants need to meet specific health and tumor-related criteria and will be followed closely to evaluate tolerability and preliminary anti-tumor activity of GH2616.

Researchers are evaluating treatments for women with hormone receptor-positive, HER2-negative advanced breast cancer that has returned or worsened after endocrine therapy. This phase II, open, multicenter clinical trial involved 118 patients who previously received CDK4/6 inhibitors. The study tested combinations of drugs to find effective therapies for this type of breast cancer. Participants are treated with entinostat tablets taken orally once a week and fulvestrant given by injection on specific days within 28-day cycles. One group receives only entinostat and fulvestrant, while another group receives these two drugs plus anlotinib, taken orally daily for two weeks followed by a one-week break in 21-day cycles. Treatment continues until the disease progresses, unacceptable side effects occur, or patients choose to stop. During the study, patients have tumor response evaluations every 8 weeks using standard criteria until progression or treatment change. Safety checks happen throughout treatment, with visits within a week and around a month after the last dose for follow-up. The main outcome measured is the objective response rate observed over up to two years. The study ends when all patients experience progression, finish treatment, or if the study is stopped early for other reasons.

Researchers are evaluating if fecal microbiota transplantation (FMT) can help treat gastrointestinal symptoms caused by chemotherapy or targeted therapy in patients with gastrointestinal cancers. This phase 1 observational study focuses on patients with advanced gastrointestinal tumors who experience side effects like diarrhea, constipation, vomiting, or nausea during cancer treatment. The main goal is to assess how FMT affects these symptoms in patients undergoing chemotherapy or targeted therapy. Participants receive FMT starting from their fourth cycle of chemotherapy or targeted therapy. The treatment involves taking capsules containing about 40 grams of donor intestinal bacteria. These capsules are swallowed orally in doses of about 2 to 3 capsules every 3 to 5 minutes, totaling 40 capsules per dose, with three doses given during the fourth, sixth, and eighth treatment cycles (weeks 3, 9, and 15 after the study starts). The study evaluates treatment effectiveness every two cycles. During the study, participants will be monitored for gastrointestinal symptoms and overall safety. Researchers will assess the incidence and improvement of side effects at 8 weeks after FMT treatment. Patients are followed for at least 15 weeks, with regular evaluations including laboratory tests to ensure organ function and ongoing assessments of side effects. Participants must be able to swallow the capsules and complete follow-up visits to help researchers understand the impact of FMT on cancer treatment side effects.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of JMT203 in patients with cancer cachexia, a condition often occurring in people with cancers such as colorectal, non-small cell lung, and pancreatic cancer. This open-label, multicenter Phase I study involves two parts: Phase Ia focuses on dose-escalation and dose-expansion to find the maximum tolerated dose and recommended dose for further study, while Phase Ib examines preliminary efficacy and determines the recommended Phase 2 dose. Participants receive JMT203, an anti-GFRAL monoclonal antibody, through subcutaneous injections once every three weeks for a total of 12 weeks. Phase Ia includes monitoring for dose-limiting toxicities and adverse events up to 90 days after the last dose, while Phase Ib observes changes in body weight over a 12-week period. The study is designed to carefully assess the response to different dosing levels and expand cohorts based on cancer type. Throughout the study, participants undergo various assessments including safety evaluations, laboratory tests, and monitoring for adverse events. Researchers measure outcomes such as incidence and severity of side effects, dose-limiting toxicities, and changes in body weight. Participants are followed closely during and after treatment to evaluate the study drug's safety and potential effectiveness, with total involvement lasting up to several months depending on the phase and dosing schedule.

Researchers are evaluating the effectiveness and safety of switching between two targeted treatment strategies, HP plus chemotherapy and HPy plus chemotherapy, in female patients with HER-2 positive advanced or metastatic breast cancer. This observational, multicenter study plans to enroll about 600 patients across approximately 20 research centers nationwide. Patients with newly diagnosed stage IV disease or recurrent metastatic breast cancer who have not received trastuzumab before, as well as those with brain metastases, will be analyzed separately and excluded from the overall analysis. Participants will be naturally assigned in equal groups to either switch from HP plus chemotherapy to HPy plus chemotherapy or vice versa. If the first-line treatment fails, patients will switch to the alternative regimen for second-line treatment. Treatment will continue until disease progression, intolerable toxicity, or other reasons require stopping, with the number of treatment cycles recorded. If patients develop intolerance to taxanes, other chemotherapy options such as vinorelbine, capecitabine, or eribulin may be used. After chemotherapy or treatment discontinuation, maintenance therapy may be given based on clinical needs until progression or toxicity occurs. During the treatment period, patients will be followed every two cycles to collect clinical data including disease status, lab tests, drug use, other medications, and side effects. After treatment, survival follow-up will occur every three months for up to three years to record survival status. The primary outcome measured is progression-free survival assessed by investigators using RECIST 1.1 criteria over 60 months. This design allows close monitoring of treatment effects and patient safety throughout the study.

This research aims to evaluate the safety and effectiveness of TAK-279 in people with moderately to severely active Crohn's disease, a long-term condition that causes inflammation anywhere in the gut. The study seeks to determine if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. Participants will be assessed using endoscopy to check the level of bowel inflammation. Participants will be randomly assigned to one of four groups: three different doses of TAK-279 or a placebo. They will receive the assigned treatment capsules for a total of 52 weeks (1 year). The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given unless needed for urgent medical reasons. The trial will be conducted at multiple centers worldwide and involves 15 clinic visits. Throughout the study, participants will undergo assessments including endoscopy to measure treatment response based on the Simple Endoscopic Score for Crohn's Disease at week 12. Safety will also be monitored over approximately 60 weeks, including a 4-week safety follow-up period after treatment ends. Researchers will compare the medical problems experienced and how well participants tolerate the treatments.