Chang Sha Shi

Researchers are evaluating the usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MR) in diagnosing primary and metastatic cancer lesions. The study focuses on detecting cancer recurrence and assessing pathological response in patients with various types of malignant tumors. This preliminary study uses histopathology and follow-up results as the gold standard to measure diagnostic performance. Participants receive an injection of the imaging agent 18F-FAPI-04 before undergoing PET/CT or PET/MR scans. These scans are used to quantify tumor uptake by measuring the maximum standard uptake value (SUVmax) and tumor-to-background ratio (TBR). The study compares the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the two imaging methods. During the study, patients with suspected or diagnosed malignant tumors undergo imaging assessments. Researchers collect imaging data and follow up with participants to confirm findings. The main outcome measured is the diagnostic performance of these imaging techniques over one year. Participants must provide informed consent, and safety monitoring is part of the study process. The age range for participants is 18 to 90 years old.

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 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.

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 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.

Researchers are conducting a Phase I randomized, parallel, open-label clinical trial to compare the bioavailability and safety of different specifications of SHR-3167 injection in healthy adults aged 18 to 55 years. The study focuses on evaluating how the drug is processed in the body and its safety profile, using healthy volunteers to ensure accurate results. Participants will receive SHR-3167 injection in various forms to examine differences in drug absorption and concentration. The study will monitor drug levels in the blood, including maximum plasma concentration and the area under the concentration-time curve, over a period from Day 1 to Day 71. The open-label design means both researchers and participants know the treatment being given. During the trial, participants will undergo physical exams, vital sign checks, electrocardiograms, chest X-rays, and laboratory tests to confirm health status. Blood samples will be taken multiple times to measure drug concentrations. Safety and tolerability will be closely observed throughout the study, which lasts about 71 days. Participants must comply with study procedures and attend all follow-ups to complete the trial successfully.

Researchers are evaluating the safety and effectiveness of a drug called B001 injection in patients who have neuromyelitis optica spectrum disorder (NMOSD) and test positive for aquaporin-4 antibodies. This study is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial designed to compare B001 with a placebo in this patient population. The goal is to assess whether B001 can reduce the time to the first NMOSD attack during the study period. Participants will receive either an intravenous dose of B001 or a matching placebo on Day 1 and Day 15 during the randomized controlled period (RCP). Both treatment groups follow the same dosing schedule to evaluate the effects of B001 compared to placebo over approximately 48 weeks. During the study, participants will be closely monitored through regular assessments to track any NMOSD attacks and overall health. Researchers will measure the time to the first NMOSD attack as the primary outcome. Safety and any side effects of the treatment will also be evaluated throughout the study period. Participants are expected to complete all required tests and follow study procedures as part of their involvement.

Researchers are evaluating the effectiveness and safety of a drug called B007 in people with generalized myasthenia gravis, a condition that affects muscle strength. This study is a Phase II/III clinical trial designed to compare B007 with a placebo to better understand its impact on daily living activities in affected patients. Participants receive either a high or low dose of B007 or a matching placebo, both given as subcutaneous injections on days 1 and 15. The study includes two groups: those treated with B007 and those given placebo, with treatment administered twice during the trial period. During the study, participants will be monitored for changes in their myasthenia gravis activities of daily living profile (MG-ADL). The main outcome measured is the proportion of participants whose MG-ADL score decreases by 2 or more after approximately 16 weeks. Safety and adherence are also tracked throughout the study.

Researchers are evaluating the safety and effectiveness of B007 in adult subjects diagnosed with pemphigus, a condition characterized by specific clinical signs. This Phase II/III clinical study aims to determine how well B007 works in treating this disease, including those newly diagnosed or experiencing a relapse. Participants receive B007 through subcutaneous injections given on day 1 and day 15. The study includes varying doses of B007 to assess treatment outcomes over time. This controlled dosing schedule allows researchers to monitor responses to the medication closely. During the study, researchers will track the proportion of subjects who achieve complete remission with minimal treatment by approximately 36 weeks. Participants are expected to follow the study protocol, which includes regular assessments to monitor treatment effects and safety. Long-term monitoring will help determine the success of B007 in managing pemphigus symptoms.