Tacheng Prefecture

Researchers are evaluating the safety and initial effectiveness of T3011, a herpesvirus injection, combined with PD-1/PD-L1 inhibitors in adults with advanced solid tumors. This phase Ib/IIa clinical trial focuses on patients who have measurable tumors and a good performance status, aiming to understand how well this combination treatment is tolerated and how it impacts tumor response. Participants receive T3011 through injections directly into the tumor every two weeks. Alongside this, PD-1/PD-L1 inhibitors are given by intravenous infusion at a dose of 3 mg/kg every two weeks. The study includes high, middle, and low doses of T3011 to monitor different effects. This multi-center, single-arm trial does not include a comparison group and spans roughly two years. Throughout the study, researchers will monitor treatment-emergent side effects and measure how tumors respond to the therapy over about two years. Participants will undergo regular laboratory tests and pregnancy tests for women of childbearing potential. Safety assessments, including monitoring for adverse events and overall treatment tolerability, will be conducted. The study requires participants to comply with all procedures and follow-up visits during this period.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.