Xi An Shi

Researchers are evaluating the use of 3D-printed biodegradable breast implants for personalized breast reconstruction in female patients with newly diagnosed primary breast cancer aged 18 to 70 years. This phase 2, prospective, multicenter, controlled clinical study compares cosmetic effects, quality of life, and safety of 3D-printed implants with traditional breast-conserving surgery and traditional silicone prosthesis breast reconstruction. The study aims to determine whether patients unsuitable for breast-conserving surgery might benefit from the new implant approach and to identify any medical issues related to its use. The study has three groups: the experimental group receives breast reconstruction using 3D-printed biodegradable implants designed from 3D MRI breast tissue models and printed with polycaprolactone. The control groups undergo either traditional breast-conserving surgery or breast reconstruction with silicone implants. Each surgical approach involves tumor resection with negative margins, lymph node procedures, and postoperative management including radiotherapy and systemic therapy as appropriate. Postoperative monitoring includes wound care and complication recording. Participants undergo preoperative assessments including patient-reported outcomes and MRI imaging, then regular postoperative follow-up with ultrasound and MRI scans at scheduled intervals up to 24 months. Quality of life and cosmetic satisfaction are measured using the BREAST-Q V2.0 scale. Telephone follow-ups occur monthly, with in-person visits every three months. The primary outcome is postoperative cosmetic effects and quality of life assessed one year after surgery.

Researchers are evaluating the diagnostic accuracy of 68Ga-PSMA PET scans compared with enhanced CT scans in detecting metastatic lesions in patients with locally advanced and advanced renal cell carcinoma. The study also aims to determine whether the use of 68Ga-PSMA PET can influence treatment decisions for these patients. This is a prospective, multicenter study focusing on patients with stage III or IV renal cell carcinoma as defined by the 2017 AJCC TNM staging system. Participants will undergo 68Ga-PSMA PET / CT imaging within 6 weeks after their renal cell carcinoma diagnosis. This diagnostic test is being studied for its potential impact on clinical decision-making in renal cancer management. The trial aims to assess the additional diagnostic value of 68Ga-PSMA PET compared to standard CT imaging. During the study, patients will be monitored over a 2-year period to evaluate the diagnostic effectiveness of the 68Ga-PSMA PET. Researchers will collect data on imaging results and observe any changes in treatment plans based on PET findings. Safety and kidney function will also be considered, especially since renal impairment or ongoing hemodialysis are exclusion factors. Participants will provide informed consent before joining the study.

Researchers are evaluating the use of 99mTc-H7ND SPECT/CT imaging to assess treatment response and predict the effectiveness of follow-up therapy in patients with non-small cell lung cancer (NSCLC). This prospective, controlled, single-center study focuses on patients with NSCLC confirmed by cytology or pathology who cannot undergo surgery due to recurrence, metastasis, or other conditions, and who have completed 2 to 4 cycles of first-line therapy with stable disease (SD) as assessed by RECIST 1.1 criteria. Participants are divided into two groups: one group undergoes 99mTc-H7ND SPECT/CT imaging while the other does not. In the imaging group, positive results are defined by lesions with uptake greater than normal liver, dividing patients into SD+ and SD- subgroups. Treatment decisions for SD- patients involve continuing the original or maintenance therapy, while SD+ patients receive either ongoing original treatment or second-line therapy based on multidisciplinary team discussion. During the study, repeat visits occur at 8-12 weeks and again 12 weeks after the baseline assessment to monitor disease control rate (DCR). Researchers collect clinical data and imaging to evaluate treatment stability and predict subsequent treatment efficacy. Safety and adherence are monitored, and participants are followed to assess outcomes related to disease progression and treatment response.

Researchers are investigating the use of a radioactive probe called 99mTc-P137 that targets prostate specific membrane antigen (PSMA) for diagnosing prostate cancer. This study aims to evaluate the effectiveness of this probe combined with SPECT/CT imaging to improve early detection, accurate tumor staging, treatment decisions, and prognosis for prostate cancer patients. The study uses clinical surgical specimens and pathological diagnosis as the standard for comparison to assess the diagnostic and prognostic value of 99mTc-P137 imaging. Participants will receive an injection of the 99mTc-P137 tracer, followed by SPECT/CT scans approximately two hours after injection. This imaging approach is designed to optimize the clinical diagnosis process by providing clear images of prostate cancer lesions. The study is prospective, focusing on patients suspected of having prostate cancer who are planned for surgical resection or biopsy, ensuring final pathological results will be available. During the study, participants will undergo assessments including clinical laboratory tests (blood routine, biochemical, and serum PSA) within one month before the study, and at least two other imaging examinations such as CT, MRI, PET/CT, SPECT/CT, or ultrasound. Researchers will analyze the imaging results alongside clinical data to evaluate the probe's accuracy. Safety and cooperation during the study are monitored, and participants provide informed consent. The total duration and follow-up details are based on the availability of pathology and imaging data.

Researchers are evaluating TQB2934, a special antibody designed to treat multiple myeloma, a type of malignant plasma cell tumor. TQB2934 is a double-specific antibody that binds to both the CD3 receptor on T cells and the BCMA antigen on cancerous plasma cells. This binding helps recruit and activate T cells to attack and kill the cancer cells. The study is a Phase 1 clinical trial focusing on the safety and pharmacokinetics of this treatment in adults with multiple myeloma. The treatment involves subcutaneous injections of TQB2934. The antibody works by activating T cells to release substances that kill BCMA-positive target cells. The study monitors participants over time to assess how the drug is processed in the body, including measures like peak drug concentration and elimination half-life within 120 hours after administration. The trial also tracks adverse events for up to 24 months. Participants will undergo various laboratory tests and assessments to meet study requirements and monitor their health throughout the trial. Researchers will evaluate pharmacokinetics, including peak time, drug concentration, and clearance, as well as safety by recording any adverse events. The study includes careful monitoring of participants' condition and treatment responses, with follow-up lasting up to two years to ensure comprehensive safety data collection.

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 efficacy and safety of a drug called B007 compared to Cyclosporin in treating Primary Membranous Nephropathy, a kidney condition confirmed by biopsy. This study is a multicenter, randomized, controlled, open-label trial in phase II/III, focusing on patients aged 18 to 80 years with certain kidney function levels and proteinuria. Participants will receive either B007 via subcutaneous injections on days 1 and 15 or oral Cyclosporin capsules dosed at 3.5 mg per kg per day. The study includes screening to confirm eligibility, treatment administration, and monitoring for approximately two years to evaluate overall remission rates. Throughout the trial, participants will be monitored with laboratory tests to meet study standards and ensure safety. Researchers will assess kidney function, protein levels in urine, and remission rates over about two years. Safety will be followed closely, including checking for allergies, infections, and adherence to the treatment protocol.

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.