Wei Hai Shi

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.

This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitor.

Researchers are evaluating the preliminary effectiveness of TQB2825, a bispecific antibody targeting CD3 and CD20, combined with chemotherapy in adults with relapsed or refractory diffuse large B-cell lymphoma. This Phase II clinical trial focuses on patients who have already undergone at least one systemic treatment and are not suitable for stem cell transplantation. The study seeks to measure the complete response rate at one year to better understand this combination therapy's potential benefits. Participants receive TQB2825 injection along with chemotherapy drugs gemcitabine hydrochloride and oxaliplatin. The treatment targets lymphoma cells and aims to improve outcomes for patients with measurable disease confirmed by imaging and pathology. The medication is administered in cycles, with dosing and schedules designed to maximize treatment impact while monitoring safety. During the study, participants will undergo regular assessments including physical exams, laboratory tests, and imaging such as PET-CT scans to monitor disease status and treatment effects. Researchers will track response rates, side effects, and overall health over time, ensuring participant safety and collecting detailed data to evaluate the therapy's effectiveness. The study includes follow-up visits and ongoing monitoring throughout the treatment period and beyond.

Researchers are evaluating the progression-free survival of D-1553 Tablet compared to Docetaxel Injection in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have a KRAS G12C mutation and have not responded to prior standard therapies. This phase III, randomized, controlled, double-blind study uses progression-free survival as the main outcome, assessed by an Independent Review Committee based on RECIST 1.1 criteria. The goal is to understand how these treatments perform in this specific patient group after prior therapy failure. Participants will be randomly assigned to receive either D-1553, a KRAS inhibitor taken as a tablet, or Docetaxel, an anti-tumor drug given as an injection that affects microtubules in cancer cells. The treatments are delivered according to the study protocol, with the study being conducted at multiple centers. The study compares the effects of these two treatments in managing NSCLC with the KRAS G12C mutation. During the study, participants will undergo regular assessments including tumor evaluations based on RECIST 1.1 to monitor disease progression. The primary outcome measure is progression-free survival from baseline up to three years. Safety and overall health will be monitored throughout the study to track any side effects or changes. Participants are expected to comply with the study requirements and provide necessary samples for mutation confirmation and ongoing monitoring over the study period.

Stroke is the second leading cause of death worldwide, with ischemic stroke being the most common type. The current best treatment for acute ischemic stroke is intravenous thrombolysis using recombinant tissue plasminogen activator (rt-PA) given within 4.5 hours of symptom onset. However, some patients experience stroke progression or early blood vessel reocclusion after thrombolysis, which worsens neurological function and outcomes. This is believed to be caused by increased platelet activation after thrombolysis, which peaks within the first 2 hours. This clinical trial is testing whether starting oral aspirin early after intravenous thrombolysis can improve functional outcomes without causing more bleeding problems. Patients are randomly assigned to receive either 300 mg aspirin tablets or matching placebo tablets as soon as possible after enrollment. If swallowing is difficult, tablets can be crushed and given through a nasogastric tube. Both groups receive best medical management according to guidelines. The study is a Phase 3, multicenter, randomized, placebo-controlled trial. Participants will be followed for 90 days after stroke to measure their functional recovery using the modified Rankin scale (mRS). Researchers will check if patients have a good outcome defined as an mRS score of 0 or 1 at 90 days. During the study, patients undergo assessments including neurological exams and imaging to confirm eligibility and monitor safety. The trial aims to determine if early aspirin treatment after thrombolysis is safe and can help prevent neurological decline and improve recovery.

Researchers are investigating the effectiveness and safety of oral minocycline compared to placebo in patients who have experienced an acute spontaneous intracerebral hemorrhage within 48 hours of symptom onset. This phase III clinical trial is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled study aiming to improve recovery outcomes in this patient population. An additional goal is to assess the impact of minocycline on markers of venous neuroinflammation at various times after the hemorrhage. A total of 1192 participants will be randomly assigned in equal numbers to receive either minocycline capsules containing 50 mg of minocycline hydrochloride or matching placebo capsules for five days. All participants will also receive standard medical care based on current guidelines. The study includes three phases: screening and baseline, treatment, and follow-up. Participants will be evaluated at several time points including screening/baseline, 72 ±12 hours, 7 ±1 days, 90 ±7 days, and 180 ±7 days after randomization, as well as during any relevant events. Researchers will measure the primary outcome of disability and functional status using the modified Rankin Scale score (mRS) at 90 days post-randomization, aiming for scores between 0 and 3. Throughout the study, assessments and interviews will monitor safety, efficacy, and treatment adherence.

Researchers are evaluating the effectiveness and safety of Prunella oral liquid for treating benign thyroid nodules in adults aged 18 to 65 years. This phase 4, multicenter, randomized, double-blind, placebo-controlled study involves 234 participants across several centers in China. Eligible patients have solid thyroid nodules measuring between 1 and 3 cm with specific ultrasound characteristics and confirmed benign status by biopsy, along with normal thyroid hormone and antibody levels. Participants are randomly assigned to one of four groups: two groups receive either a regular or double dose of Prunella oral liquid, and two groups receive matching placebo doses at the same volumes. All treatments are taken orally twice daily for 9 months. Follow-up visits are scheduled at 3, 6, 9, and 12 months to monitor treatment effects and safety. Throughout the study, participants undergo thyroid ultrasound to measure nodule volume and size, blood tests to assess thyroid function and antibodies, and quality of life surveys. The main outcome is the change in thyroid nodule volume after 9 months. Additional assessments include nodule diameter, number, thyroid volume, and safety monitoring for adverse events, laboratory changes, and discontinuations due to side effects.

Researchers are evaluating the long-term safety, effectiveness, and immune response of two doses of TQH2722 injection in adults with severe chronic sinusitis, with or without nasal polyps. This multicenter, randomized Phase II expansion trial focuses on people aged 18 to 75 who have previously participated in a related TQH2722 study. The study aims to better understand how TQH2722, a fully human monoclonal antibody that affects certain cell signals, may help manage chronic sinusitis over extended periods. Participants receive either 300mg or 600mg doses of TQH2722 injection. The trial continues from prior treatment phases, allowing participants who completed earlier parts of the study or withdrew for reasons other than side effects related to TQH2722 to enroll. During the study, participants maintain stable doses of nasal glucocorticoids, specifically Mometasone furoate nasal spray, if they had been using other nasal steroids before screening. The study includes careful monitoring of safety and treatment effects over a long-term period. Throughout the study, participants undergo assessments for adverse events and treatment effects up to 32 weeks. Safety is closely monitored, including laboratory tests and clinical evaluations. Researchers track any new or worsening symptoms and measure immune response to TQH2722. Participants agree to use effective contraception during the study and avoid family planning for six months from consent through the last dose. This comprehensive approach helps ensure participant safety while collecting important data on long-term treatment with TQH2722.

This research investigates how weight loss through a diet management mobile app and an intelligent weight scale affects cardiovascular health in obese patients with heart failure. The study focuses on patients with heart failure with reduced ejection fraction and aims to see if these tools can reduce death rates, hospital stays related to heart failure, and improve frailty and quality of life. The trial addresses a gap where current heart failure guidelines recognize obesity as a risk but lack effective interventions for this group. Participants are randomly assigned to one of two groups: one group uses a fully functional diet management app and intelligent weight scale designed to support weight loss in obese heart failure patients, while the other group uses limited-function versions of the app and scale as a comparison. Both groups use the app at every meal and the scale daily for 12 months. The trial is a multicenter, single-blind randomized controlled study. During the study, participants will visit the clinic after 12 months for checkups. Researchers will collect data on a composite cardiovascular outcome, including all-cause mortality and hospitalizations related to heart failure, tracked over one year. Adherence to app and scale use is monitored through the mobile application. The study measures the impact on heart failure frailty, quality of life, and overall cardiovascular outcomes over the trial period.

Researchers are evaluating the safety and effectiveness of TQB2450 injection combined with anlotinib and chemotherapy compared to TQB2450 injection combined with chemotherapy alone in people with advanced non-small cell lung cancer (NSCLC) that has not responded to first-line chemotherapy combined with immunotherapy. This phase II clinical trial aims to explore biomarkers related to treatment effects, mechanisms of action, resistance, and safety in this patient group. The study involves two treatment groups: one receiving TQB2450 with anlotinib capsules and docetaxel chemotherapy, and the other receiving TQB2450 with placebo anlotinib capsules and docetaxel chemotherapy. TQB2450 is a monoclonal antibody that targets PD-L1 to help restore immune activity, while anlotinib inhibits multiple receptors involved in tumor growth. Docetaxel is a chemotherapy drug used to treat tumors. Participants receive these treatments in a controlled, randomized, double-blind setting. Participants will be involved for up to 48 weeks, during which researchers will monitor progression-free survival as the primary outcome. Assessments include tumor measurements, safety evaluations, and biomarker studies to understand treatment effects and resistance. The trial also includes careful monitoring of organ function, tumor tissue analysis, and compliance checks to ensure participant safety and data quality throughout the study period.