Pu Yang Shi

Researchers are evaluating the effectiveness and safety of a new drug called TQB2102 for Injection compared to a combination treatment of docetaxel, trastuzumab, and pertuzumab in adults with HER2 positive recurrent or metastatic breast cancer. This Phase III trial involves multiple centers and randomizes participants into two groups to compare these treatments. The study aims to better understand how well TQB2102 works and its safety profile in this patient population. Participants receive treatments through intravenous infusions every 21 days. One group is treated with TQB2102, a next-generation HER2 Antibody-Drug Conjugate, while the other group receives docetaxel combined with trastuzumab and pertuzumab following specific dosing schedules. Docetaxel is given once every three weeks for six cycles, trastuzumab starts with a loading dose followed by maintenance doses every three weeks, and pertuzumab is administered with an initial loading dose followed by maintenance doses every three weeks with observation after infusions. The study compares these two treatment approaches over the course of the trial. During the study, participants will undergo regular evaluations including imaging to assess tumor response, blood tests to monitor drug levels and immune responses, and tracking of any side effects or adverse events. The primary outcomes measured are the objective response rate and progression-free survival up to about 30 months. Secondary outcomes include overall survival, duration of remission, and detailed safety assessments up to around 52 months. The study also involves monitoring specific antibodies related to the drug and other laboratory markers to understand treatment effects fully.

Researchers are evaluating the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for treating B-cell lymphoma. This Phase II clinical trial focuses on patients diagnosed with specific types of B-cell lymphoma, including relapsed or refractory indolent B-cell lymphoma and diffuse large B-cell lymphoma DLBCL. The study aims to assess how well this combination therapy works and its overall safety. Participants will receive TQB3702 tablets at a dose of 200 mg every 4 weeks as one treatment cycle. Alongside this, they will undergo chemotherapy cycles every 3 or 4 weeks, with a total of 6 to 12 cycles of combination therapy. The chemotherapy regimen is designed to inhibit tumor cell growth, suppress DNA synthesis, induce cancer cell death, support immune function, and prevent new blood vessel formation that supports tumors. During the trial, participants will be closely monitored for treatment response and safety. Researchers will measure overall and complete response rates up to 2 years, as well as adverse events, progression-free survival, duration of response, and overall survival up to death from any cause. The study includes assessments from baseline through combination therapy completion and follow-up periods lasting up to 2 years. This comprehensive monitoring helps understand both the immediate and longer-term effects of the treatment.

Researchers are evaluating TQB2102 for injection, a new antibody-coupled drug that targets two different parts of the HER2 protein on tumor cells. This study focuses on patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. The trial aims to assess the effectiveness and safety of TQB2102 combined with benmelstobart or penpulimab, with or without chemotherapy, in this patient group. This is a Phase II randomized study sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Participants receive TQB2102 for injection and either benmelstobart or penpulimab, both given intravenously every three weeks. Chemotherapy is taken orally from Day 1 to Day 15 in each 21-day treatment cycle. There are three study groups, each involving different combinations and doses of TQB2102, benmelstobart, penpulimab, and chemotherapy. Treatment continues through multiple cycles as determined by the study protocol. During the study, participants undergo regular assessments including scans and tests to measure tumor response and disease progression. Researchers monitor outcomes like the objective response rate, progression-free survival, duration of response, overall survival, and any adverse events. The study includes follow-up periods to track safety and effectiveness, with an average observation of up to three years. Participants are closely monitored throughout the treatment and follow-up phases for their health and response to therapy.

Researchers are evaluating the dose-effect relationship of TQH3906 capsules compared to placebo in treating active Psoriatic Arthritis PsA. This Phase II, randomized, double-blind, placebo- and active drug-controlled clinical trial aims to measure the proportion of participants achieving a 20% improvement in arthritis symptoms by Week 12, using the American College of Rheumatology ACR20 criteria as the primary endpoint. Participants are randomly assigned to receive one of several oral treatments daily from Day 1 to Day 85 either 24 mg or 16 mg of TQH3906 capsules, placebo capsules matching TQH3906, or 5 mg tofacitinib citrate tablets. The treatments are administered in the morning while fasting, with tofacitinib also taken at bedtime. This study evaluates efficacy and safety across these groups over 12 weeks of treatment. During the study, participants are assessed at multiple timepoints for improvements in arthritis symptoms ACR20, ACR50, ACR70 and psoriasis severity PASI 75 and PASI 90. Blood samples are collected to evaluate drug levels and immune markers at baseline and Weeks 2, 4, 8, and 12. Safety is monitored continuously through adverse event reporting up to 28 days after the last dose. The total study duration per participant is approximately 12 weeks of treatment plus follow-up.

Researchers are evaluating the efficacy and safety of TQH3906, a Tyrosine Kinase 2 TYK2 inhibitor, in treating systemic lupus erythematosus SLE, an autoimmune disease. This randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial aims to assess how well TQH3906 works and its safety profile in adults diagnosed with SLE based on established criteria. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants are randomly assigned to one of three groups 16 mg TQH3906 capsule, 24 mg TQH3906 capsule, or placebo. All treatments are taken orally once daily for 48 weeks. The trial compares these doses to placebo to understand TQH3906s impact on disease activity. The study uses a parallel design and includes a quadruple masking method to keep participants and researchers unaware of group assignments. During the study, participants undergo regular assessments including clinical evaluation of disease activity using the Systemic Lupus Erythematosus Responder Index 4 SRI-4, lupus activity indices, and joint assessments up to week 48. Safety is monitored throughout, and background lupus medications must remain stable during the trial. The primary outcome measure is the percentage of participants achieving SRI-4 response by week 32, with additional secondary measures assessing remission, low disease activity, and symptom improvements. Participation lasts up to 48 weeks with scheduled visits and monitoring.

Researchers are evaluating the drug WS016 in adults with hyperkalemia, a condition characterized by elevated potassium levels in the blood. This Phase 3 clinical trial aims to study the effectiveness and safety of WS016 through a two-part design including a corrective phase to quickly reduce potassium levels and a maintenance phase to keep potassium normal. An open-label extension phase is also included to assess longer-term treatment effects. In Part A, participants are first randomized to receive either oral WS016 12g or placebo three times daily for 48 hours during the corrective phase. Those who achieve normal potassium levels are then re-randomized to receive WS016 at doses of 6g, 12g, or 18g, or placebo once daily for 28 days in the maintenance phase. Part B is an open-label extension lasting 11 months, where participants receive WS016 starting at 12g daily, with dose adjustments based on potassium levels. Participants will have regular blood tests to monitor serum potassium and other health measures throughout the study. Researchers will track potassium levels during the maintenance phase and corrective phase to assess drug effects. Safety and tolerability will be monitored, and participants completing or discontinuing the maintenance phase may continue treatment in the extension phase. Overall participation can last up to nearly a year depending on enrollment in Part B.

Researchers are evaluating the long-term effectiveness and safety of drug-coated balloon DCB strategies, including DCB alone or combined with drug-eluting stents DES, compared to DES-only treatment in patients with chronic total occlusion CTO of coronary arteries after successful reopening. This multicenter randomized controlled trial aims to fill the gap in direct comparative data between DCB and DES treatments for CTO, with the goal of optimizing treatment strategies, reducing stent use, lowering complication risks, and improving patient outcomes. Participants will be randomly assigned to either the DCB group, which involves balloon angioplasty with drug coating and possible provisional DES implantation if needed hybrid strategy, or the DES-only group receiving standard drug-eluting stent placement. Both groups receive standard medical therapy including at least 12 months of dual antiplatelet therapy DAPT. The study includes a 9-month primary endpoint assessment and a 36-month follow-up period to monitor long-term outcomes. During the study, patients will undergo angiographic evaluation for late lumen loss at 9 months, assessed by an independent laboratory using quantitative coronary angiography. Clinical events such as target lesion failure, cardiac death, myocardial infarction, and repeat revascularization will be monitored up to 36 months. Patient-reported outcomes like angina status and quality of life, as well as intravascular imaging and safety parameters, will also be collected. Overall participation spans over three years with regular follow-up visits to assess treatment effects and safety.

Researchers are evaluating the safety and effectiveness of TQB2825 injection combined with immunochemotherapy in people with untreated or relapsedrefractory diffuse large B cell lymphoma DLBCL. This study includes both Phase 1b and Phase 2 stages and aims to measure outcomes such as the objective response rate, complete response rate, progression-free survival, duration of response, overall survival, and safety indicators like dose-limiting toxicity and maximum tolerated dose. Participants receive one of two treatment combinations TQB2825 injection plus the R-CHOP regimen which includes Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone or TQB2825 injection combined with Gemcitabine and Oxaliplatin GemOx. Each treatment cycle lasts 21 days. The study evaluates these treatments over these cycles to assess their effects on lymphoma. During the study, participants will undergo regular assessments including imaging scans, laboratory tests, and safety monitoring to track treatment response and side effects. Researchers will observe participants for up to two years to evaluate dose-limiting toxicity and maximum tolerated dose, and up to five years to assess overall survival. The study also tracks adverse events and serious adverse events throughout. Participation involves multiple visits for treatment and follow-up evaluations until study completion.

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.

This research aims to evaluate the safety and effectiveness of TQA2225AP025, 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 assess how well two different doses of this treatment work in managing NASH, a liver condition characterized by fat buildup and inflammation. Participants will receive either 25mg or 50mg of TQA2225AP025 or a matching placebo, given by weekly subcutaneous injections for 48 weeks. The study includes two experimental groups receiving the different doses, and all treatments are administered under blinded conditions to assess the treatment effects accurately. During the study, participants will undergo liver biopsies at the start and after 48 weeks to measure changes in liver condition using the NASH CRN scoring system. Safety will be closely monitored by tracking any adverse events throughout the treatment period. The study is expected to provide detailed information on both the treatment impact on liver health and its safety profile over nearly a year of participation.