He Fei 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.

Researchers are evaluating the safety and diagnostic accuracy of [18F]FT8 PET imaging in people with AL amyloidosis, a condition where abnormal protein deposits affect the heart and other organs. This study compares the new imaging method to established clinical tests like echocardiography, MRI, and lab tests to see if [18F]FT8 can better visualize and distinguish AL amyloidosis from other types. The focus is on proving [18F]FT8's ability to specifically bind to amyloid deposits in heart tissue. Participants will receive a single intravenous injection of [18F]FT8 followed by a PET/CT scan to capture images of their organs. The uptake of [18F]FT8 in tissues will be measured using a standardized uptake value during the scan on day 1. Before and after the scan, clinical assessments including physical exams, tests of heart, liver, and kidney function, and lab work will be performed to monitor health and safety. Throughout the study, researchers will closely monitor safety from the time of injection up to seven days afterward. Participants will undergo detailed evaluations including cardiac function assessment and other laboratory tests to support diagnosis and track any changes. The total involvement includes initial screening, the imaging procedure, and follow-up safety assessments to ensure participant well-being and gather comprehensive diagnostic data.

Researchers are evaluating a new imaging tracer called [18F]NIDF to detect abnormal tau protein buildup in the brains of people with neurodegenerative diseases, including Alzheimer's disease and other tau-related conditions. This tracer is designed to bind more strongly and specifically to tau neurofibrillary tangles compared to existing imaging agents, potentially improving diagnosis. The study focuses on assessing the safety and effectiveness of [18F]NIDF PET imaging in living human subjects. Participants will receive an injection of the [18F]NIDF tracer, followed by a single PET/CT scan on the first day to visualize tau pathology in the brain. Researchers will monitor how the tracer distributes throughout the body during this scan and observe participants for any safety concerns from the time of injection up to seven days afterward. Throughout the study, participants will be closely evaluated for safety and the tracer's diagnostic performance. The main measurements include safety assessments within one week after injection and analyzing the tracer's distribution during the PET/CT scan. Participants may include healthy individuals as well as those diagnosed with probable Alzheimer's disease or other causes of dementia, with study involvement spanning from consent through post-injection monitoring.

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 studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are evaluating new treatment options for adults with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This study compares the safety and effectiveness of adding calderasib and cetuximab, both targeted therapies, to a standard chemotherapy regimen called mFOLFOX6. The goal is to see if this combination can help patients live longer without their cancer growing or spreading compared to current treatments that may include mFOLFOX6 with or without bevacizumab. The study has two parts. It involves treatment with calderasib taken as an oral tablet, cetuximab given according to standard procedures, and mFOLFOX6 chemotherapy combining oxaliplatin, leucovorin/levofolinate calcium, and 5-fluorouracil. Some participants may receive bevacizumab or a bevacizumab biosimilar as part of the comparison. The treatments are given following approved dosing schedules. This design allows researchers to assess the safety and tolerability of these drug combinations in treating this type of colorectal cancer with the KRAS G12C mutation. Participants will be monitored for side effects, treatment tolerability, and cancer progression over a period that may last up to about 44 months. Researchers will track outcomes such as how many participants experience dose-limiting toxicities or adverse events, how many stop treatment due to side effects, and progression-free survival time. Assessments include health evaluations, laboratory tests, and imaging to observe cancer status. This long-term follow-up aims to understand both safety and effectiveness of the treatment combinations.

Researchers are evaluating the safety and tolerability of QT-019B, a universal allogeneic CAR-T cell therapy targeting CD19 and BCMA, in adults aged 18 to 65 with refractory systemic lupus erythematosus (SLE). This Phase I/IIa open-label study aims to determine the recommended dose (RD) of QT-019B and includes subjects who have not responded well to standard treatments including glucocorticoids, immunosuppressants, and biologics. The study plans to enroll 18-24 participants and focuses on those who meet specific diagnostic and disease severity criteria for refractory SLE. The study consists of two phases: dose escalation and dose expansion. Initially, subjects receive a QT-019B cell injection at Dose A (1×10^6/kg) with a 14-day waiting period before enrolling more subjects at this dose level. Depending on observed dose-limiting toxicities (DLTs) within 28 days post-injection, the Safety Review Committee (SRC) may escalate the dose to Dose B (3×10^6/kg), add more subjects at the current dose, reduce the dose, or stop the study. This careful dose adjustment process ensures close monitoring of participant safety. Participants will be observed for adverse events from the time of QT-019B administration through Day 28, including monitoring for dose-limiting toxicities within the first 28 days. Evaluations include checking important organ functions such as bone marrow, liver, and kidney health. The study also requires use of contraception during treatment and for 12 months after. Overall, the study involves careful follow-up to assess safety and tolerability of the investigational therapy in this patient population with refractory SLE.

Researchers are evaluating the safety, tolerability, and preliminary effectiveness of GO306 Recombinant Oncolytic Vaccinia Virus Injection in adults with advanced solid tumors that have not responded to standard treatments. This early stage Phase 1 study uses a single-arm, open-label, dose-escalation design and includes two parts. Part 1 focuses on determining the maximum tolerated dose (MTD) through single doses, while Part 2 explores repeated doses in specific tumor types to identify the recommended Phase 2 dose (RP2D) and optimal dosing schedule. In Part 1, participants receive a single intratumoral or intracavitary injection of GO306 at escalating dose levels: low (3.0 x 10^7 PFU), medium (3.0 x 10^8 PFU), or high (1.0 x 10^9 PFU). Each dose level includes 3 subjects. Part 2 involves multiple doses of GO306 at the RP2D level given weekly or every two weeks to about 20 subjects with specific tumor types. The study monitors pharmacokinetics, viral shedding, immunogenicity, and immunological changes related to GO306 treatment. Participants will undergo evaluations including safety assessments for adverse events up to 6 months after treatment, dose-limiting toxicity monitoring for 21 days post-first injection, and pharmacodynamic assessments. Tumor lesions are evaluated by imaging per RECIST 1.1 criteria. Laboratory tests and performance status are assessed before treatment to confirm eligibility. Follow-up includes monitoring serious adverse events and tolerability, with an expected survival time of at least 3 months. The study duration and procedures ensure careful observation of treatment effects and participant safety throughout.

Researchers are investigating HMPL-506, an oral drug, in a Phase 1 clinical study for patients with hematological malignancies such as relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and multiple myeloma (MM). The study has two phases: dose escalation and dose expansion, aiming to determine the safest and most effective dose. Approximately 60 to 132 patients are expected to participate, including those with specific genetic mutations or rearrangements related to these blood cancers. In the dose escalation phase, patients receive increasing doses of HMPL-506 orally once daily in 28-day cycles to identify the maximum tolerated dose and recommended Phase 2 dose. Initial doses start at 50 mg daily, with potential escalation based on safety and efficacy data. The dose expansion phase enrolls patients into three cohorts based on disease type and genetics, treating them with the recommended dose in 28-day cycles until disease progression, intolerable side effects, or other defined reasons to stop. Participants will undergo regular safety monitoring, including evaluation of dose-limiting toxicities, serious adverse events, and response to treatment. Tumor response is assessed every cycle for the first six cycles and then every two cycles thereafter, with follow-up lasting up to 42 months. Additional assessments include bone marrow biopsies, laboratory tests, and performance status evaluations. The study tracks participants until disease progression, withdrawal, or study completion to evaluate HMPL-506's safety and preliminary effectiveness.

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.