Wei Hai Shi

Researchers are evaluating the effectiveness and safety of TQB2102 for injection compared to a standard chemotherapy regimen called TCbHP in patients with HER2-positive breast cancer. This phase III, randomized, open-label, multi-center study focuses on neoadjuvant treatment, which is therapy given before surgery. The study aims to measure the total pathological complete response and other outcomes such as event-free survival and overall survival. Participants receive either TQB2102 for injection at 6 mgkg by intravenous infusion every 3 weeks for 8 cycles or a combination of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin given intravenously every 3 weeks for 6 cycles. The study monitors participants throughout the treatment period and collects data on tumor response and side effects. During the study, participants will undergo assessments including tumor response evaluations by independent review and investigators, safety monitoring for adverse events, and laboratory tests. Follow-up will continue for up to 50 months after the start of the study to observe long-term outcomes. Participants are expected to comply with contraceptive use requirements and attend all scheduled visits for treatment and evaluations.

Researchers are evaluating the preliminary effectiveness of TQB2825 combined with chemotherapy in adults with diffuse large B-cell lymphoma that has returned or not responded to previous treatments. This phase II clinical trial focuses on patients who have relapsed or refractory disease and are not suitable for stem cell transplantation, aiming to understand how well this combination works in this group. Participants receive a combination treatment that includes TQB2825 injection, gemcitabine hydrochloride for injection, and oxaliplatin for injection. The treatment cycles last 21 days, with careful monitoring of drug levels and response. The study measures various outcomes such as complete response rate after one year, overall survival up to three years, and other markers related to treatment effectiveness and safety. During the trial, participants undergo regular assessments including scans, laboratory tests, and evaluations of response and side effects. Researchers collect detailed pharmacokinetic data at specific time points during treatment cycles. The study also monitors the presence of anti-drug antibodies over two years. Participants health is observed throughout treatment and follow-up periods to evaluate both the response and safety of the therapy.

Researchers are evaluating the progression-free survival of D-1553 Tablet compared to Docetaxel Injection in patients with KRAS G12C mutation-positive locally advanced or metastatic non-small cell lung cancer NSCLC who have not responded to prior standard therapy. This phase III, randomized, controlled, double-blind study aims to assess progression-free survival as the primary endpoint, with other outcomes measured over up to three years. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants will receive either the experimental D-1553 Tablet or the active comparator Docetaxel Injection, each administered in 21-day treatment cycles. D-1553 is a KRAS inhibitor, while Docetaxel is an anti-tumor drug that works by affecting microtubule dynamics. The study design includes a quadruple masking and random allocation to ensure unbiased results. During the study, participants will undergo evaluations of progression-free survival, overall survival, response rates, disease control, and patient-reported outcomes over a period of up to three years. Safety assessments include monitoring adverse events and laboratory tests from consent through 30 days after the last dose. Pharmacokinetic parameters such as time to maximum plasma concentration and half-life will be measured during specific cycles. The total participation duration depends on individual treatment response and follow-up.

Acute ischemic stroke is a leading cause of death worldwide, and intravenous thrombolysis with recombinant tissue plasminogen activator rt-PA within 4.5 hours of symptom onset is the most effective treatment currently available. However, some patients experience stroke progression and early reocclusion after thrombolysis, which can worsen neurological outcomes. This trial evaluates whether early antiplatelet therapy with oral aspirin, given soon after thrombolysis, can improve recovery without increasing bleeding risks. The study randomly assigns patients to receive either early oral aspirin within 3 hours of starting intravenous thrombolysis or a placebo, alongside the best medical care based on current guidelines. Aspirin is administered as a 300 mg dose, either chewed or given via nasogastric tube if swallowing is difficult. The trial includes a control group receiving placebo under similar conditions to compare outcomes. This is a Phase 3, multicenter, quadruple-blind, randomized clinical trial. During the study, participants will be closely monitored for neurological status and functional recovery using the modified Rankin scale at 30 and 90 days after stroke, as well as other assessments like NIH Stroke Scale scores within the first week. Researchers will track early neurological changes and safety outcomes such as intracranial hemorrhage. Follow-up will include evaluations at multiple time points up to 90 days post-stroke to determine the effects of early antiplatelet treatment on stroke recovery.

Researchers are evaluating the efficacy and safety of oral minocycline in patients who have experienced an acute spontaneous intracerebral hemorrhage within 48 hours of onset. This prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial aims to improve patient outcomes and explore the effects of minocycline on venous neuroinflammation in this condition. Participants will be randomly assigned to receive either minocycline or a matching placebo for 5 days alongside standard medical care. The minocycline group will take an initial dose of 200 mg immediately after randomization, followed by 100 mg every 12 hours for a total of 10 doses. Those with swallowing difficulties may receive the medication through a nasal feeding tube. The trial includes screening, treatment, and follow-up phases with visits scheduled at screening, 72 hours, 7 days, 90 days, and 180 days after randomization. During the study, participants will undergo assessments including neurological evaluations and imaging at specified time points. Researchers will measure outcomes such as the modified Rankin Scale score at 90 days, changes in neurological scores, inflammation markers, and stroke recurrence. Safety and efficacy will be monitored through these evaluations, with total participation lasting up to 180 days post-randomization.

Researchers are evaluating the efficacy and safety of Prunella oral liquid in adults with benign thyroid nodules. This phase 4, multicenter, randomized, double-blind, placebo-controlled trial aims to provide post-marketing reevaluation data on this treatment. Eligible participants have thyroid nodules confirmed benign by biopsy and normal thyroid hormone and antibody levels. The study includes 234 subjects recruited across multiple centers in China and focuses on changes in nodule volume and related health measures over time. Participants are randomly assigned to one of four groups receiving either a regular or double dose of Prunella oral liquid or a matching placebo at the same doses. Treatment lasts for 9 months, with follow-up visits scheduled at 3, 6, 9, and 12 months. Dosing is oral, twice daily, and the study includes monitoring for treatment effects and safety measures. During the study, participants undergo thyroid ultrasound examinations and blood tests to assess nodule size, thyroid function, antibody levels, and quality of life through questionnaires. Researchers track changes in nodule volume and diameter as primary and secondary outcomes, along with safety assessments such as adverse event monitoring and laboratory tests. The total participation duration spans up to 12 months, with thorough evaluations at specified intervals to understand treatment impact and safety.

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 Phase II, multicenter, randomized trial aims to expand understanding of TQH2722s role in managing this condition over an extended period. Participants receive either 300mg or 600mg of TQH2722 injection every two weeks until week 22, combined with daily use of Mometasone furoate nasal spray at doses of 100-200 mcg until week 32. The study includes two parts A and B, with similar treatment schedules and follow-up visits to monitor the treatment effects. During the study, participants undergo regular assessments including monitoring for treatment-emergent adverse events up to 32 weeks. Researchers measure changes in sinus imaging scores, smell identification tests, symptom scores, nasal polyp sizes, and immune responses. Safety evaluations include laboratory tests and monitoring for serious adverse events. The total study duration includes treatment and follow-up visits over approximately 32 weeks.

Obesity greatly increases the risk of heart failure, and current treatments like caloric restriction, exercise, medications, or surgery may not be suitable for obese patients with heart failure. This research aims to study whether a combined approach using a diet management app and an intelligent weight scale can help obese patients with heart failure and reduced ejection fraction lose weight and improve their heart condition. The trial compares the effectiveness of a fully functional app and scale versus a limited-function version to assess their impact on heart failure outcomes and overall quality of life. Participants are randomly assigned to two groups one using a fully featured diet management app and intelligent weight scale with various monitoring tools and health metrics, and the other using a limited version of both. The full app tracks food intake, exercise, weight, and provides dietary analysis and recommendations, while the full scale measures body composition and vital signs. The limited versions offer fewer features. Participants use the app at every meal and weigh themselves daily for 12 months. During the study, participants will visit the clinic at 12 months for checkups. Researchers will evaluate outcomes such as a composite of death and heart failure hospitalizations over one year, changes in quality of life related to heart failure, and weight change. The trial includes monitoring of heart failure frailty and quality of life assessments at baseline, 3 months, and 1 year, with ongoing safety and condition tracking throughout the study period.

Researchers are comparing the safety and effectiveness of TQB2450 injection combined with anlotinib and chemotherapy versus TQB2450 injection combined with chemotherapy alone in people with advanced non-small cell lung cancer NSCLC who have not responded to first-line chemotherapy combined with immunotherapy. The study also aims to explore biomarkers related to treatment effectiveness, mechanisms of action or resistance, and safety. This is a randomized, double-blind, phase II clinical trial conducted by Tianjin Medical University Cancer Institute and Hospital. Participants receive treatment every three weeks. One group receives TQB2450 1200 mg intravenously on day 1, anlotinib oral capsules on days 1 to 14, and docetaxel chemotherapy 60 mg per square meter intravenously on day 1. The other group receives TQB2450 and docetaxel chemotherapy with a placebo instead of anlotinib. Treatment is given in cycles of three weeks. During the study, participants will be monitored through various assessments including tumor measurements to evaluate progression-free survival up to 48 weeks. Other outcomes include overall response rate, disease control rate, overall survival, and duration of response. Safety and tolerability will be closely observed. The total duration of participation varies, with follow-up continuing until disease progression or death.

Researchers are evaluating the safety and effectiveness of combining two drugs, iparomlimab and tuvonralimab QL1706, with chemotherapy to treat adults with HER2-negative, low PD-L1 expressing, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. This phase II trial focuses on patients whose cancer cannot be removed by surgery or has spread to other parts of the body. The study aims to understand how well this combination works and its safety profile in this specific group of patients. Participants will receive iparomlimab and tuvonralimab at a dose of 5 mgkg by intravenous drip on the first day of each 3-week cycle until disease progression or unacceptable side effects occur. They will also receive XELOX chemotherapy, which includes oxaliplatin given intravenously at 130 mgm2 on day 1 of each 3-week cycle for the first 6 cycles, and capecitabine tablets taken orally twice daily from days 1 to 14 of each cycle. This treatment continues until disease progression or intolerable toxicity. The study is a single-arm trial, meaning all participants receive this combination treatment. During the trial, researchers will monitor participants for progression-free survival over 12 months after the last participant joins, along with overall survival, response rates, duration of response, disease control rate, and safety through adverse event tracking for up to about 2 years. Participants will undergo regular assessments to measure tumor response and side effects. The total study period includes these follow-up evaluations to understand the treatments impact and safety profile comprehensively.