Libramont Chevigny

Researchers are evaluating and comparing standard neoadjuvant treatment options for older patients, aged 70 years and above, who have high-risk stage II or stage III rectal cancer. This multicenter, open-label, randomized pragmatic clinical trial aims to study the effectiveness and safety of conventional neoadjuvant therapy versus total neoadjuvant therapy in this patient group. Participants will be randomly assigned to one of two treatment groups. The conventional arm includes either short-course radiotherapy (5 daily fractions of 5 Gy) followed by surgery or watch & wait, with optional adjuvant chemotherapy, or long-course chemoradiotherapy (25-28 fractions of 1.8-2.0 Gy combined with chemotherapy) followed by surgery or watch & wait, and optional adjuvant chemotherapy. The total neoadjuvant therapy arm involves different regimens at the investigator's discretion, including RAPIDO, RAPIDO light, and OPRA regimens, combining radiotherapy, chemotherapy, and surgery or watch & wait. Each regimen varies by radiation dose, chemotherapy duration, and sequence. During the study, participants will undergo treatments as per their assigned group. Researchers will monitor overall survival, progression-free survival, peripheral sensory neuropathy, and grade 3 or higher toxicities at 3 years after randomization. The study involves assessments of clinical response and adherence to treatment protocols. Safety and efficacy will be tracked throughout the study period to evaluate long-term outcomes for these older patients with locally advanced rectal cancer.

Researchers are evaluating treatments for patients with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer that has a PIK3CA mutation. This Phase 3 study compares the effectiveness and safety of RLY-2608 combined with fulvestrant versus capivasertib combined with fulvestrant. The study focuses on patients whose cancer returned or worsened after treatment with a CDK4/6 inhibitor. Participants will receive either RLY-2608 taken orally twice daily every day in 28-day cycles or capivasertib taken orally twice daily on days 1 through 4 each week within a 28-day cycle. All participants will also receive fulvestrant by intramuscular injection on day 1 and day 15 of the first cycle, then on day 1 of each following 28-day cycle. Treatment continues until disease progression or other criteria are met. During the study, researchers will monitor participants regularly to assess progression-free survival, which is the time from starting treatment until cancer progression or death. Assessments include radiographic imaging based on RECIST v1.1 criteria and safety evaluations. The study duration may extend up to approximately 77 months, allowing for long-term monitoring of treatment effects and safety.

Researchers are evaluating the effect of adding SBP-101 to the standard treatment of gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma who have not received prior treatment for metastatic disease. This randomized, double-blind, placebo-controlled, multicenter study aims to assess overall survival as the primary endpoint, with secondary goals including progression-free survival, radiologic response, and quality of life. The study includes approximately 600 participants and is conducted in phase 2 and phase 3 stages. Participants will be randomly assigned to receive either SBP-101 with gemcitabine and nab-paclitaxel or a placebo with gemcitabine and nab-paclitaxel. SBP-101 is given as a subcutaneous injection and is studied in combination with the chemotherapy drugs nab-paclitaxel and gemcitabine. The study also incorporates a Data Safety Monitoring Board to oversee safety, efficacy, and a planned analysis to determine if the study should continue. During the study, participants will undergo assessments including imaging scans to measure tumor response, quality of life evaluations, and safety monitoring. Overall survival will be tracked from the first dose for up to 100 weeks or until death. The study ensures participants meet specific health and laboratory criteria before enrollment and requires ongoing monitoring to evaluate treatment effects and safety throughout the trial.