Linyi

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 investigating treatments for metastatic pancreatic ductal adenocarcinoma mPDAC in this randomized, double-blind, placebo-controlled, multicenter phase III clinical trial. The study aims to compare overall survival between patients receiving a combination of TQB2868 injection, anlotinib hydrochloride capsules, and chemotherapy versus those receiving placebo combined with chemotherapy. This trial evaluates whether adding TQB2868, a dual antibody targeting PD-L1 and TGF-beta, to standard treatment may impact survival outcomes in patients with advanced pancreatic cancer. Participants are randomly assigned to one of two groups. The experimental group receives TQB2868 injection plus anlotinib hydrochloride capsules combined with gemcitabine hydrochloride injection and paclitaxel for injection. The control group receives a placebo injection combined with anlotinib hydrochloride capsules and the same chemotherapy drugs. Treatments are given as first-line therapy for metastatic disease, with dosing and administration schedules based on the trial protocol. The study includes an approximately two-year period for measuring overall survival as the primary outcome. During the trial, participants will undergo regular assessments including imaging scans to evaluate tumor response, laboratory tests, and monitoring for adverse events. Secondary outcomes include progression-free survival, objective response rate, disease control rate, duration of response, and time to tumor recurrence, observed over about one year. Safety is closely monitored until 28 days after the last treatment. The total participation time varies depending on individual outcomes and follow-up schedules.

Researchers are evaluating TQB6411 Injection in adults with recurrent or metastatic Esophageal Cancer who have previously not responded to PD-1PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. The study includes Phase Ib to assess tolerance and safety, and Phase II to evaluate the effectiveness of TQB6411 Injection in this participant group. Participants will receive TQB6411 Injection administered in treatment cycles of either 21 or 28 days. The study follows a single group model where all participants receive the investigational drug. The research aims to determine the recommended dose for Phase II, monitor adverse events, and assess progression-free survival over 24 months. Participants will be involved in treatment and regular assessments including laboratory tests, tumor measurements according to RECIST v1.1, and biomarker analysis using tumor tissue samples. The study measures include response rates, survival outcomes, and drug concentration in plasma. Safety monitoring continues for up to 24 months, and participants must comply with study procedures and contraception requirements during and after the study.

Researchers are studying the safety and effectiveness of starting direct oral anticoagulants DOACs early versus delaying their start in adults who have had an acute ischemic stroke related to atrial fibrillation and received emergency endovascular therapy EVT. This trial is a multicenter, randomized controlled study designed to compare different timings for beginning DOAC treatment after stroke. Participants are randomly assigned to one of two groups. One group will begin taking any DOAC within 96 hours 4 days of stroke onset, while the other group will start DOAC treatment between 5 and 14 days after stroke onset. The study compares these two approaches to see which timing is safer and more effective. During the study, participants will be monitored for outcomes including recurrent ischemic stroke, symptomatic brain bleeding, and death over 90 days. Researchers will also assess other events like venous clots, heart attacks, and overall quality of life. Follow-up visits and assessments will track these health outcomes and safety measures throughout the study period, which lasts up to one year for some outcomes.