Dingxi

Researchers are evaluating the effectiveness and safety of 68Ga-PSMA-11 PET/CT or PET/MRI scans in detecting biochemical recurrence of prostate cancer in Chinese male patients. This prospective, open-label, single-arm, multicenter phase 3 study focuses on patients who have experienced a rise in PSA levels after radical prostatectomy or radical radiotherapy. The study aims to assess how accurately 68Ga-PSMA-11, a new tracer called Illuccix®, identifies recurrent prostate cancer compared to histopathology, PSA monitoring, and conventional imaging over a 12-month period. Participants receive a single intravenous dose of 68Ga-PSMA-11 ranging from 111 to 259 MBq administered over 3 to 5 minutes. PET/CT or PET/MRI scans are then performed between 50 and 100 minutes after the injection. These imaging procedures help detect tumor recurrence at the patient level. The study does not mention additional treatment or comparator groups. It is conducted across multiple centers in China, focusing on this specific patient population. During the study, participants undergo scheduled PET scans and clinical monitoring including PSA measurements and follow-up imaging to confirm the presence of recurrent tumors. The main outcome measured is the positive predictive value of the imaging tests for detecting prostate cancer recurrence confirmed by biopsy, clinical markers, or imaging over one year. Safety and tolerability of the tracer and imaging procedures are also observed to ensure participant well-being throughout the study.

Researchers are conducting a multicenter, randomized, double-blind, placebo-positive controlled phase 3 clinical trial to evaluate the efficacy, safety, and pharmacokinetics of TRD303 solution for postoperative pain relief in patients undergoing abdominal surgery. The main goal is to assess how well TRD303 controls pain after surgery, with additional focus on its safety and how the body processes the drug. Participants receive either TRD303 solution, ropivacaine hydrochloride, or 0.9% sodium chloride as part of the study. TRD303 is applied by smearing the wound and injecting it at the incision sites after the peritoneum is sutured but before closing the surgical incision. The injection volume for the main incision is around 2.5 mL, with adjustments for multiple incisions. Ropivacaine hydrochloride and sodium chloride are also injected locally around the incision after peritoneal suture and irrigation. During the study, participants' pain intensity will be measured over 72 hours at rest to evaluate the treatment's effectiveness. Researchers will also monitor safety and pharmacokinetics throughout the trial. Participants will be adults aged 18 to 80 years undergoing elective abdominal surgery, and their pain, safety, and drug processing will be carefully tracked during this period.

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.

This trial is focused on adults with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer. It compares the length of time participants remain free from disease progression when treated with amivantamab combined with chemotherapy regimens (mFOLFOX6 or FOLFIRI) versus cetuximab combined with the same chemotherapy regimens. The study is a randomized, open-label Phase 3 clinical trial designed to evaluate progression-free survival over a period of up to 4 years and 2 months. Participants receive either amivantamab with chemotherapy drugs including 5-fluorouracil, leucovorin calcium or levoleucovorin, oxaliplatin, or irinotecan hydrochloride, or cetuximab with the same chemotherapy regimens (mFOLFOX6 or FOLFIRI). Treatments are administered as first-line therapy for their colorectal cancer. The trial assesses how these treatments affect disease progression and survival. During the study, participants will be monitored regularly through assessments and evaluations to measure progression-free survival. Researchers will gather data via blinded independent central review to ensure unbiased assessment of disease status. Participants are followed up for safety and treatment efficacy over the study duration, which may last over four years.

Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in adults with Alcohol Use Disorder (AUD) and hazardous alcohol use. This Phase 3, multicenter, randomized, double-blind study aims to understand if brenipatide can help participants reduce or stop drinking. The study lasts approximately 56 weeks and focuses on changes in drinking patterns using the Timeline Followback Method (TLFB). Participants will receive either brenipatide (LY3537031) or a placebo, both administered by subcutaneous injection. Participants who cannot self-inject will have assistance from a trained support person. They are expected to store and use the blinded study drug as directed, maintain electronic and paper diaries, and complete questionnaires throughout the study. During the study, participants will have scheduled visits to monitor their progress, including assessments of drinking behavior and safety evaluations. Researchers will measure changes in alcohol use patterns up to 56 weeks. Participants must be motivated to reduce or stop drinking and be available for all study visits and procedures. Safety and adherence will be closely monitored throughout the trial.

Researchers are evaluating the safety and effectiveness of brenipatide compared to a placebo for adults with moderate-to-severe Alcohol Use Disorder (AUD). This phase 3 study aims to better understand if brenipatide can help reduce drinking in this population. Participants will be followed for about 56 weeks to gather comprehensive information. Participants will receive either brenipatide (LY3537031) or a placebo, both given by subcutaneous injection. The study involves a randomized, double-blind design, meaning neither the participants nor the researchers know who receives which treatment during the trial. This method helps provide reliable results about the effects and safety of brenipatide. During the study, participants will attend scheduled visits, self-inject the study drug, and complete electronic and paper diaries as well as questionnaires. Researchers will monitor changes in drinking patterns using the Timeline Followback Method for up to 56 weeks. Safety monitoring and regular assessments will be performed throughout the study to track participants' health and adherence.

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are evaluating the efficacy of claseprubart (DNTH103) compared to placebo in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) in this Phase 3 study. The goal is to assess how well claseprubart works in treating this condition, which involves nerve inflammation leading to muscle weakness and sensory problems. The study consists of multiple periods: Part A is an open-label phase lasting up to 13 weeks where all participants receive claseprubart. Those who respond move to Part B, a randomized, double-blind, placebo-controlled phase lasting up to 52 weeks, where participants receive either claseprubart or placebo by infusion or injection. After Part B, eligible participants may join an optional open-label extension for up to 104 weeks. A safety follow-up period of 40 weeks follows the treatment phases. Participants will undergo various assessments including neurological evaluations and disease activity scoring. Researchers will monitor the time from the first dose to disease relapse as the main outcome. Additional safety and efficacy measures will be tracked throughout all study periods. Total participation may last over two years including extension and follow-up phases.

Colorectal cancer is a common and increasing health concern in China, with its incidence growing faster than the global average. Screening and early diagnosis for colorectal cancer and its precancerous lesions are important to reduce its disease burden. While previous studies focused on high-risk groups, most colorectal cancers occur in average risk individuals, highlighting the need for better screening methods for this population in China. This trial aims to compare three colorectal cancer screening approaches in average risk adults. Participants will be randomly assigned to one of three groups: one group will receive a colonoscopy once at the start of the study, a second group will have annual Fecal Immunochemical Tests (FIT) for four years with positive results leading to colonoscopy, and a third group will have annual FIT plus blood tests based on cfDNA methylation for four years, with positive results also leading to colonoscopy. Suspicious lesions found during colonoscopies will be removed and examined. After the initial four-year screening phase, all participants will be followed long-term. During the study, fecal, blood, and tissue samples will be collected. Participants will be monitored annually during the screening phase and regularly throughout the follow-up period. The primary outcome measured is the mortality rate from colorectal cancer over ten years. The study plans to enroll at least 60,300 eligible adults aged 45 to 74 in China, assessing the effectiveness of these screening strategies to guide future colorectal cancer screening policies.

Researchers are conducting a multicenter observational study to better understand the treatment outcomes for patients diagnosed with psoriasis by dermatologists in clinic settings across China. Psoriasis is a chronic, recurrent inflammatory disease influenced by genetic and environmental factors, presenting as erythematosquamous lesions and potentially affecting multiple organs. The study aims to compare the effectiveness of various treatments chosen by patients, including phototherapy, traditional systemic therapies, and biologics, in real-world clinical practice. This non-interventional study allows patients to select their preferred treatment without restrictions. Data is collected primarily through a phone application called "Psoriasis New World," enabling continuous monitoring of patient progress. The study evaluates multiple outcomes such as the Psoriasis Area and Severity Index (PASI), which measures skin lesion severity and body area involvement, along with the Physician Global Assessment, Investigator Global Assessment, Body Surface Area affected, and Dermatology Life Quality Index. Patient safety is monitored throughout, including the recording of any adverse events and laboratory tests such as liver function. Participants will be followed over six months to measure the percentage achieving complete clearance of psoriasis symptoms (PASI 100). Regular assessments of disease severity and quality of life changes will be conducted remotely via the app. Continuous safety monitoring ensures any side effects or complications are documented. This approach provides comprehensive real-world evidence on how different psoriasis treatments perform in routine clinical care.