He Chi Shi

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus (HPV) vaccine called Hansenulapolymorpha in Chinese women aged 18 to 45 years. This Phase III randomized, blinded, placebo-controlled trial involves 13,500 women divided into three age groups: 18-26, 27-35, and 35-45 years. The study aims to assess the incidence of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) associated with various HPV types after vaccination. Participants receive either the 11-valent HPV vaccine or a placebo through intramuscular injections in the upper arm deltoid muscle. The vaccination schedule includes three doses given at 0, 2, and 6 months. The trial compares the vaccine's effects against placebo across the different age groups, following strict immunization timing. During the study, women attend follow-up visits and provide information through diary cards and contact forms. Researchers monitor safety, immune responses, and HPV-related cervical changes, including CIN2+ occurrences one month after the third dose. The trial also includes pregnancy testing before vaccination and requires effective contraception during the study. Total participation includes vaccination and follow-up over approximately six years to evaluate long-term outcomes.

Researchers are evaluating the effects of Tislelizumab, an anti-PD-1 monoclonal antibody, in adults with previously treated locally advanced unresectable or metastatic solid tumors that have either mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H). This Phase 2, single-arm, multi-center, open-label study aims to assess the efficacy and safety of this treatment in these specific tumor types. Participants must have measurable disease and have already received prior therapy for their advanced cancer. Participants will receive Tislelizumab as monotherapy. The study is designed to monitor the treatment's impact on tumor response over time. The dosing schedule and administration details are consistent with the use of this antibody therapy. The study focuses on patients with MSI-H or dMMR solid tumors who have limited treatment options due to the advanced stage or unresectability of their cancer. Throughout the study, participants will be closely monitored, including assessments by an Independent Review Committee using standardized tumor evaluation criteria (RECIST Version 1.1) for up to two years. Researchers will evaluate the objective response rate to the treatment as the primary outcome. Participants will also undergo evaluations of organ function, performance status, and safety monitoring to ensure appropriate management of any side effects or complications during the study period.