Rancagua

Researchers are evaluating the safety and preliminary effectiveness of SAR445877, given alone or with other anticancer treatments, in adults aged 18 and older who have advanced, hard-to-remove, or metastatic solid tumors. This Phase 1/2 study includes multiple groups and aims to find appropriate doses and understand how well the treatment works, including combinations with cetuximab, ADG126, or bevacizumab. The study involves about 542 participants, including those in a Japan-specific group, reflecting a wide range of advanced solid tumor types. The study has two main parts. Part 1 focuses on dose escalation to identify safe and effective doses of SAR445877 given either every two weeks or weekly, alone or combined with other therapies. Part 2 involves expanding and optimizing doses to assess safety and early effectiveness in various tumor types and treatment combinations. Participants receive SAR445877 and other drugs by infusion. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping treatment. Participants will undergo screening for up to 28 days before starting treatment, then receive ongoing therapy with regular monitoring. Assessments include scans and tests to measure tumor response, safety evaluations for side effects including dose-limiting toxicities, and follow-up visits after treatment ends. The study tracks outcomes during treatment cycles and for up to two years in the expansion phase, with safety follow-up lasting 30 days after the last dose. Overall, the participation duration varies depending on individual course and response.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are evaluating the effect of a personalized inspiratory muscle training program on patients with tracheostomy caused by prolonged mechanical ventilation. This study focuses on improving maximum inspiratory pressure, diaphragm thickness fraction, and reducing the time needed for successful removal of the tracheostomy tube. The trial compares patients receiving this specialized training combined with standard physiotherapy to those receiving standard physiotherapy and scheduled weaning from mechanical ventilation. The goal is to improve patient recovery, reduce hospital stay, and enhance quality of life while reducing costs. Participants in the experimental group will undergo a 14-day inspiratory muscle training regimen that combines strength and endurance exercises. Training intensity will be adjusted based on their ability to disconnect from mechanical ventilation. The control group will receive standard physiotherapy and guided weaning through planned disconnection periods from the ventilator. Both groups will be monitored over the two-week period to assess differences in decannulation time and clinical outcomes. Throughout the study, researchers will measure maximal inspiratory pressure after two weeks of training. Other assessments include monitoring diaphragm function, ICU length of stay, total hospital days, and quality of life surveys. Patients will be evaluated for cooperation and consciousness levels before enrollment. Safety and progress will be closely observed to ensure optimal management and potential benefits of the inspiratory muscle training program in this patient population.

Researchers are evaluating the effectiveness and safety of Zanidatamab combined with Cisplatin and Gemcitabine, with or without an added PD-1/L1 inhibitor (either Durvalumab or Pembrolizumab), as a first treatment for people with advanced HER2-positive biliary tract cancer. This study focuses on participants whose tumors show specific HER2 markers and aims to compare this combination to standard care. It is a Phase 3 trial involving patients with locally advanced or metastatic disease who have received limited prior treatment. Participants receive Zanidatamab, Cisplatin, and Gemcitabine all through intravenous (IV) infusions. Some may also receive a PD-1/L1 inhibitor chosen by their doctor, depending on local approvals. Treatments are given as part of the first-line therapy for advanced disease. The study includes screening to confirm HER2-positive status using biopsy tissue and standard imaging to assess the cancer. The study does not include a separate extension phase but follows participants during treatment and observation. During the trial, participants are monitored for progression-free survival for up to 52 months. Researchers will assess tumor response using standard criteria and regularly check participants' health, organ function, and side effects. Women of childbearing potential must have negative pregnancy tests and use birth control, and all participants must have a good performance status. Safety assessments, including laboratory tests and monitoring for adverse events, are ongoing throughout the study to ensure participant well-being.

Gallstones are common in women and are a major risk factor for gallbladder cancer (GBC), a serious disease with limited treatment options. This research aims to improve how well we can predict the risk of GBC and detect it early by studying differences in geography, environment, lifestyle, ethnicity, gender, and molecular markers. The goal is to develop better prevention programs and improve understanding of how lifestyle and genetic factors contribute to GBC development. The study involves collecting epidemiological, clinical, and dietary information, along with samples of blood, saliva, urine, bile, feces, and gallbladder tissue. These samples will be used to identify and study new biomarkers for GBC, build a biorepository, develop a risk scoring system, and explore new treatment options. The study includes patients with gallbladder cancer or precancerous conditions and those with gallstones scheduled for gallbladder removal. Participants will provide various samples and data which researchers will use to measure the number of participants developing gallbladder cancer or dysplasia, either at the start or after examination of removed gallbladders. The project also supports training researchers and aims to help shape health policies. The study is observational and does not involve any experimental treatments, focusing instead on gathering data to improve prevention, diagnosis, and future treatments for GBC.

Researchers are evaluating the safety and effectiveness of the Motiva Flora4 Tissue Expander in women undergoing staged breast reconstruction surgery after mastectomy. This 6-month, open-label, prospective, multicenter post-marketing study will include 136 genetically female participants from six countries. The study aims to confirm the performance of this device in breast tissue expansion as part of reconstruction treatment. Participants will undergo breast tissue expansion followed by placement of a final breast implant, both using devices from the Motiva Flora4 Tissue Expander catalog. The study involves staged breast reconstruction procedures with monitoring throughout the 6-month period to assess device and procedure-related outcomes. During the study, participants will have follow-up assessments including monitoring for adverse events, evaluation of breast tissue expansion success and completion, and satisfaction measured by a 5-point Likert scale. Imaging such as MRI and CT scans may be performed if required by the surgeon. Safety and performance will be closely tracked throughout the study duration with all participants attending scheduled follow-up visits.

Researchers are evaluating the safety and effectiveness of different first-line treatments for adults with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) cancer. The study focuses on participants whose tumors have a PD-L1 combined positive score (CPS) of 1 or higher in the main group, and an exploratory group with CPS less than 1. This phase 3 trial compares a new combination therapy to the current standard treatment to see which better controls the cancer progression. Participants will receive one of two treatment combinations. One group will get trastuzumab deruxtecan (T-DXd) given intravenously every three weeks along with a fluoropyrimidine chemotherapy drug and pembrolizumab, also given intravenously every three weeks. The comparison group will receive standard chemotherapy plus trastuzumab, with or without pembrolizumab depending on the group. Chemotherapy drugs include 5-FU or capecitabine, and in some arms, cisplatin or oxaliplatin will also be given. Treatments will be delivered in cycles every three weeks. During the study, researchers will monitor participants closely through scans and other tests to measure how long it takes for the cancer to worsen or for death from any cause. Participants must provide tumor tissue samples for biomarker testing before starting treatment. Heart function and lung health will also be regularly checked to ensure safety. The main outcome measured is progression-free survival over up to 59 months after randomization, with ongoing assessments throughout the treatment period.