Pu Yang Shi

Researchers are evaluating the effectiveness and safety of TQB2102 injection compared to a combination of docetaxel, trastuzumab, and pertuzumab in treating adults with HER2 positive recurrent or metastatic breast cancer. This Phase III, randomized, open-label, multicenter trial aims to compare these treatments in patients who have not received systemic anti-tumor therapy during their recurrence or metastasis stage, except for limited first-line endocrine therapy. Participants must have HER2 positive invasive breast cancer confirmed by pathology and measurable lesions. Participants are randomly assigned to one of two treatment groups in equal numbers. One group receives TQB2102, a next-generation HER2 Antibody-Drug Conjugate, while the other group receives docetaxel combined with trastuzumab and pertuzumab as a positive control. The study monitors the patients during treatment and collects data on tumor response and progression. During the study, participants undergo regular assessments including imaging to measure tumor size and progression according to RECIST 1.1 criteria. Researchers track the objective response rate and progression-free survival for up to approximately 30 months. Safety and adverse events are monitored throughout the trial, and participants must have good compliance and major organ function to continue. The study includes long-term follow-up to assess treatment outcomes and tolerability.

Researchers are evaluating the safety and effectiveness of TQB3702 tablets combined with immunochemotherapy in treating B-cell lymphoma. This phase II clinical trial focuses on patients with specific types of B-cell lymphoma, including relapsed or refractory indolent B-cell lymphoma and diffuse large B cell lymphoma (DLBCL). Participants must meet diagnostic criteria according to the 2022 World Health Organization standards and have measurable disease. The treatment involves administering TQB3702 tablets, a tyrosine kinase inhibitor, together with a chemotherapy regimen designed to inhibit tumor cell growth, suppress DNA synthesis, induce cancer cell death, enhance immune function, and inhibit blood vessel formation that supports tumors. The study monitors patients throughout the treatment period to assess the combined therapy's impact on lymphoma. Participants will be closely observed during the study to evaluate their response to treatment, including overall response rate and complete response rate over a period of up to two years. Researchers will perform regular assessments of organ function, tumor measurements, and safety monitoring. Women of childbearing potential and men must agree to use contraception during the study and for six months afterward. The trial includes follow-up to ensure participant safety and treatment effectiveness over time.

Researchers are evaluating the efficacy and safety of a new antibody-coupled drug called TQB2102 for injection in patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. This Phase II study focuses on how TQB2102 works in combination with Benmelstobart Injection or Penpulimab Injection, with or without chemotherapy, to target HER2 proteins on tumor cells and potentially improve treatment outcomes. The study aims to assess the Objective Response Rate (ORR) over about one year of participation. The treatments being studied include TQB2102 combined with Benmelstobart and chemotherapy or TQB2102 combined with Penpulimab and chemotherapy. TQB2102 is designed to bind more effectively to tumor cell HER2 proteins, while Benmelstobart and Penpulimab are antibodies that may help the immune system target cancer cells. Different dosing regimens of TQB2102 (6 mg or 7.5 mg) are being evaluated, and chemotherapy may be included depending on the treatment group. Participants will be monitored through regular evaluations during the study, which lasts approximately one year. Researchers will measure tumor response and safety outcomes, including lab tests and imaging to confirm measurable lesions according to RECIST 1.1 criteria. The study also involves reviewing previous PD-L1 expression test results or collecting tumor tissue for testing. Safety is closely observed, and participants must meet specific health criteria to join and continue in the trial.

Researchers are conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of WS016 for treating hyperkalemia, a condition characterized by high potassium levels in the blood. The trial includes adults aged 18 years and older with serum potassium levels between 5.0 and 6.5 mmol/L. The study consists of two parts: Part A is a randomized, double-blind, placebo-controlled trial, and Part B is an open-label extension for eligible participants from Part A. In Part A, participants are first randomly assigned in a 5:1 ratio to receive either oral WS016 at a 12g dose or a placebo three times a day for 48 hours, totaling six doses. Following this corrective phase, those with normal potassium levels are re-randomized into one of four groups to receive WS016 at 6g, 12g, or 18g, or placebo once daily for 28 days. Participants who finish or discontinue Part A due to potassium level changes and meet eligibility criteria can join Part B, receiving WS016 once daily for 11 months. The dose in Part B starts at 12g and may be adjusted based on ongoing potassium monitoring. Throughout the study, researchers measure serum potassium levels, focusing on average levels during the 28-day maintenance phase. Participants will undergo regular blood tests and health assessments to monitor potassium and overall safety. The study also includes tracking any side effects and adjusting treatment as needed. The total duration for participants entering Part B may extend up to nearly a year, including the initial phases and the long-term extension.

Researchers are evaluating the long-term safety and effectiveness of drug-coated balloon (DCB) strategies compared to drug-eluting stent (DES) only treatment in patients with chronic total occlusion (CTO) of the coronary arteries after successful reopening of the artery. This study aims to provide high-quality evidence by directly comparing DCB alone or combined with DES (hybrid strategy) against DES-only treatment. The goal is to improve treatment strategies, reduce the use of stents, lower complication risks, and enhance patient outcomes for these complex heart artery blockages. The trial involves two groups: one receiving DCB angioplasty with possible provisional DES implantation if necessary, and the other receiving standard DES implantation. Both treatments use devices sized to the vessel diameter and cover the blocked segment plus surrounding healthy areas. DCB balloons are inflated to deliver medication, while stents are deployed with appropriate pressure to ensure vessel support. All patients receive standard medical therapy including at least 12 months of dual antiplatelet therapy and are followed for 36 months after the procedure. Participants will undergo assessments including angiographic imaging to measure late lumen loss at 9 months by a blinded core lab, as well as monitoring for clinical outcomes such as cardiac events, repeat procedures, and quality of life. An independent committee adjudicates clinical events. The study uses intention-to-treat analysis to compare safety and efficacy between groups. This comprehensive follow-up and evaluation plan aims to provide valuable insights into optimizing CTO treatment.

Researchers are evaluating the safety and effectiveness of TQB2825 injection combined with immunochemotherapy in adults aged 18 to under 80 years with untreated or relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This phase Ib/II clinical trial aims to measure treatment responses such as objective response rate, complete response rate, progression-free survival, duration of response, and overall survival. Safety outcomes include dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose. The study involves two treatment combinations: TQB2825 injection with the R-CHOP regimen and TQB2825 injection with GemOx. The R-CHOP regimen includes rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone. TQB2825 is a bispecific antibody that targets CD20 on tumor cells and CD3 on T cells. Participants receive these treatments according to their disease status, with untreated patients receiving TQB2825 plus R-CHOP, and relapsed or refractory patients receiving TQB2825 plus GemOx. During the study, participants undergo evaluations including imaging scans to measure tumor lesions, laboratory tests, and monitoring for adverse effects. Researchers track treatment safety and effectiveness from baseline for up to two years, focusing on toxicity and maximum tolerated dose. Women of childbearing potential and men must use effective contraception during and for 12 months after the study. Participant involvement includes regular assessments to monitor disease status and treatment safety throughout the study period.

The study population are patients with acute anterior circulation large vessel occlusion stroke and planned to undergo endovascular treatment. All participants are randomly assigned in a 1:1 ratio to the tocilizumab group or the placebo group. In tocilizumab group, participants will receive tocilizumab combined endovascular treatment. And in placebo group, participants will receive placebo combined endovascular treatment. All participants will be visited immediately postoperatively, at 24 hours, 7 days, and 90 days after randomization.

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.

This trial investigates the effects of TQA2225/AP025, a recombinant human FGF21-Fc fusion protein, in adults with Non-Alcoholic Steatohepatitis (NASH). It is a randomized, double-blind, placebo-controlled Phase II study designed to evaluate the safety and effectiveness of two different doses (25mg and 50mg) of this drug compared to a placebo. Participants have a confirmed diagnosis of NASH based on liver biopsy and imaging, and the study aims to assess changes in liver health over time. Participants receive either 25mg or 50mg of TQA2225/AP025 or a matching placebo, and the treatment is administered during the study period. The trial compares the impact of these doses on liver fibrosis and inflammation, as measured by liver biopsy scores and imaging results. The study includes a treatment duration of 48 weeks, during which the drug's effect on liver tissue is closely monitored. During the study, participants undergo liver biopsies at baseline and after 48 weeks to evaluate liver changes. Additional assessments include MRI scans to measure liver fat content, laboratory tests to monitor liver enzymes and kidney function, and safety evaluations. Researchers will track participants' adherence to the treatment and monitor any side effects or changes in health status throughout the 48-week period.

Researchers are evaluating the safety and effectiveness of JS107 compared to investigator-selected therapies for patients with advanced gastric or gastroesophageal junction adenocarcinoma that is positive for CLDN18.2 and negative for HER2. This Phase III, multicenter, randomized, controlled, open-label study focuses on patients who have already received at least one prior systemic treatment, including fluorouracil and platinum, and have disease progression. The main goals are to measure progression-free survival and overall survival. Participants will be randomly assigned to receive either JS107 or one of the investigator's chosen therapies, which may include irinotecan, paclitaxel, or docetaxel. Treatment will continue until disease progression confirmed by blinded independent central review, death, loss to follow-up, withdrawal of consent, or study termination by the sponsor. Both groups will follow their assigned treatment schedules throughout the study. During the study, patients will undergo regular assessments to monitor treatment response and safety. Researchers will use imaging according to RECIST v1.1 criteria to measure tumor changes and track progression-free survival up to 2 years, as well as overall survival for up to 5 years. Safety and tolerability will be closely observed, and participants will be followed for survival outcomes throughout the study duration.