Lu Zhou 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.

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 conducting a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of TQH2929 injection in patients experiencing acute flare-ups of generalized pustular psoriasis (GPP). The study aims to provide evidence on how well TQH2929, a humanized monoclonal antibody, works in managing this severe skin condition. A total of 36 patients will participate in the trial. Participants will receive either TQH2929 injections or a placebo, with the placebo containing no active substance. The treatment is administered through injection, and all subjects will use either the study drug or placebo during the trial period. This setup allows researchers to compare outcomes between the two groups under controlled conditions. During the study, participants will be closely monitored through visits and procedures to assess treatment effects and safety. Researchers will measure outcomes such as the percentage of patients achieving a pustule score of zero after one week of treatment. Female participants of childbearing age must agree to use contraception during the study and for six months afterward. The trial will also include safety monitoring for infections, immune status, and other health factors over the course of participation.

Researchers are evaluating the safety and effectiveness of TQB3909 tablets in patients who have recurrent or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This phase Ib/II clinical trial focuses on patients diagnosed according to specific criteria and aims to understand how well this treatment works and how safe it is for this population. The study investigates TQB3909, a drug designed to inhibit the B-cell lymphoma-2 (BCL-2) protein. Participants will receive TQB3909 tablets as part of the treatment regimen. The trial includes monitoring for side effects and disease response over time. The study will measure the recommended phase II dose and assess remission rates through evaluations conducted up to 34 months. Participants will be involved in assessments that include monitoring for adverse events, serious adverse events, and abnormal laboratory results. These will be tracked for up to 34 months to evaluate safety and treatment impact. The study also includes imaging tests for measurable lesions and pregnancy testing for women of childbearing potential. Overall, the trial may last up to nearly three years, with ongoing safety and effectiveness evaluations throughout.

Researchers are evaluating TQB3019 capsules, a targeted protein degrader, for safety, tolerability, pharmacokinetics, and preliminary effectiveness in people with advanced malignant tumors. This Phase I clinical trial uses a single-center, open, non-randomized, single-arm design and includes patients with recurrent or refractory hematological tumors who have measurable disease and good organ function. The trial is divided into two phases: dose escalation and dose expansion. Participants receive TQB3019 capsules orally in either a single-dose or continuous dosing regimen. The study monitors dose limiting toxicity, maximum tolerated dose, recommended Phase II dose, and maximum assessed dose. The trial also tracks adverse events and serious adverse events from the first dose up to 28 days after the last dose or until other anti-tumor treatment begins, with follow-up lasting up to about three years. Participants will undergo multiple evaluations including safety and response assessments during each 28-day treatment cycle. Researchers will monitor laboratory test results and overall response rate from the first dose until disease progression or death. Safety and tolerability are carefully observed over extended periods to understand the drug's effects. The total participation duration can last up to approximately three years depending on treatment and follow-up.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.

Researchers are evaluating the efficacy and safety of Antiwei granules for treating the common cold, specifically the wind-cold syndrome type. This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to assess how well Antiwei granules work and how safe they are for adults aged 18 to 65 who have had a recent onset of the common cold. Participants will be randomly assigned to receive either Antiwei granules or a placebo. Both groups will take oral doses of 1 sack (6g) three times daily for a total of 9 sacks over a 3-day treatment period. The study compares the effects of the active granules versus placebo on cold symptoms. During the trial, participants will be monitored closely with assessments focusing on the cure rate after 3 days of treatment. Researchers will track symptoms and safety throughout the short treatment period. The total study duration for each participant is about 3 days, during which the effectiveness and any side effects of the treatment will be recorded and analyzed.