Saint Malo

Researchers are studying patients with metastatic colorectal cancer (mCRC) who have a specific BRAFV600E mutation. This rare subtype of mCRC has poor prognosis and resistance to current treatments, especially in tumors with microsatellite stability or proficient mismatch repair. The study aims to collect detailed clinical data and biological samples to better understand treatment outcomes, resistance, and survival in real-world settings. Participants will provide blood samples and tumor tissue samples to support various research goals. The study will evaluate circulating tumor DNA during different lines of metastatic treatment to predict treatment response and resistance. It will also analyze the immune environment of BRAFV600E mCRC tumors and study specific subgroups with mismatch repair deficiencies. Clinical management data will be collected to inform future therapeutic approaches. During the study, patients will be monitored regularly with blood sample collections of 30 mL at each time point. Researchers will gather information about treatments, survival, and biological markers over time. The main outcome measured is overall survival from diagnosis up to five years. Patients must be able to comply with study procedures and provide informed consent. The study aims to improve knowledge of this aggressive cancer subtype and support development of new treatments.

Researchers are conducting a French multicenter retrospective study to describe the clinical, histological, and radiological features of rare primary liver cancers. The study aims to collect biological tumor and blood samples and evaluate the effectiveness of treatments used in clinical practice to determine the best therapeutic sequences. This research will serve as the foundation for future translational studies to identify new molecular, histological, circulating, and radiological tumor biomarkers useful for diagnosis, prognosis, and treatment guidance. This study involves collecting data from patients diagnosed with rare liver cancers such as hepatocholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma, and hepatic angiosarcoma since January 1, 2018. Both living patients who agree to participate and deceased patients are included. Biological samples and tumor blocks are collected for analysis. Treatments received by patients in routine practice are reviewed to assess their efficacy and help define optimal treatment sequences. Participants provide consent for biological studies if living, and their medical records and tumor characteristics are reviewed. Researchers will describe the clinical, histological, and radiological tumor features and monitor outcomes up to five years from diagnosis. This detailed data collection supports long-term evaluation of rare liver cancers and aids in developing future biomarkers and therapeutic strategies.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

This research aims to evaluate the real-life effectiveness, safety, usage, tolerance, and satisfaction of four CE-marked isotonic and hypertonic seawater-based nasal sprays. It focuses on infants, children, adults, and pregnant or breastfeeding women who suffer from acute and chronic sinonasal conditions such as upper respiratory tract infections, COVID-19, bronchiolitis, allergic rhinitis, chronic rhinosinusitis, and post-surgery recovery. The study seeks to answer key questions on how well these nasal sprays work and how safe and satisfactory they are in everyday use. Participants will use one of four nasal sprays designed for different age groups and indications. The sprays are applied by spraying 1 to 3 seconds into each nostril multiple times daily, depending on the product and condition. Treatment for nasal symptoms ranges from 2 to 6 times a day, while hygiene and prevention uses are less frequent. The nasal sprays are used according to their intended purpose and population, including special instructions for babies, children, and adults. During the study, participants or their parents/caregivers will perform nasal washes following healthcare provider advice and complete online questionnaires about their symptoms and experience. Researchers will monitor nasal symptom improvement over 5 days for acute conditions and up to 14 days for chronic conditions. The study includes assessments of nasal symptom intensity, nasal breathing impairment, safety, and user satisfaction. Participants are expected to comply with study requirements for up to 3 months and have daily internet access for questionnaire completion.

Anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) is a rare disease that affects only women who have breast implants. Due to the rarity and unique type of this disease, French authorities have recommended creating a registry to track BIA-ALCL cases. This registry operates in France and Belgium in connection with a national multidisciplinary meeting for case review. This study involves an observational registry that does not include any treatment or intervention. It collects and records data from adult women diagnosed with BIA-ALCL to better understand the disease and its characteristics. Participants in this registry provide information about their diagnosis and disease course. Researchers monitor overall response to the disease over a period of 13 years. The registry helps experts gather important data to support future research and improve understanding of BIA-ALCL in affected women.

Researchers are exploring a treatment approach for women with early-stage hormone receptor-positive, HER2-negative breast cancer who face an intermediate risk of cancer recurrence. This phase III trial builds on previous findings that adding the drug ribociclib, a CDK4/6 inhibitor, to standard hormone therapy after surgery can extend the time patients remain free from invasive disease. The study aims to see if using ribociclib allows some patients to avoid chemotherapy and its side effects without compromising treatment effectiveness. Participants will either receive chemotherapy followed by hormone therapy combined with ribociclib or a de-escalated treatment plan that reduces or omits chemotherapy while still using ribociclib and hormone therapy. Ribociclib will be administered for three years as part of the adjuvant treatment after surgery. The study is designed to reflect routine clinical practices for deciding chemotherapy eligibility, using standard pathological assessments and genomic tests. Throughout the trial, women will undergo regular monitoring, including clinical visits, laboratory tests, and heart function assessments, to ensure safety and treatment adherence. Researchers will measure invasive breast cancer-free survival over a period of up to 12 years from randomization. The study also tracks patients' ability to comply with treatment schedules and evaluates long-term outcomes to confirm if chemotherapy can be safely reduced or avoided in this group.

Researchers are investigating treatments for metastatic Grade 3 poorly differentiated neuroendocrine carcinomas (G3 NEC) of gastro-entero-pancreatic (GEP) origin or unknown primary. These rare cancers often have a poor prognosis and are usually diagnosed at an advanced stage. The current standard first-line chemotherapy is the platinum-etoposide regimen, which shows a response rate of 40 to 70% but limited progression-free survival and overall survival. This trial aims to evaluate whether a more personalized chemotherapy approach using the mFOLFIRINOX regimen could improve outcomes compared to the standard treatment, while also exploring molecular characteristics of tumors to identify predictive biomarkers for treatment efficacy. Participants will receive either the mFOLFIRINOX regimen, which includes 5-fluorouracil, oxaliplatin, and irinotecan, or the platinum-etoposide regimen. The platinum-etoposide treatment is given every 21 days for 6 to 8 cycles or up to 24 weeks, with specific dosing schedules for cisplatin or carboplatin and etoposide. The study investigates the potential benefits of the intensive mFOLFIRINOX regimen as a first-line therapy, considering its previous efficacy in other digestive cancers and manageable side effects administered on an outpatient basis. During the study, participants will be closely monitored with imaging scans such as CT or MRI to assess tumor response following RECIST 1.1 criteria. Blood tests will evaluate blood counts and liver function to ensure safety. Researchers will track progression-free survival as the primary outcome, with a median target of 7.5 months. Safety assessments and adherence to treatment protocols will be maintained throughout the trial. Participants must meet specific health and performance criteria and provide informed consent, with follow-up planned to evaluate treatment effects and identify molecular biomarkers related to therapy response.

Multicenter phase II trial evaluating different strategies of pre-specified fluoropyrimidine-dose adjustment according to \[U\] in DPD-deficient patients with gastrointestinal cancer.

Pseudoexfoliative glaucoma is a form of glaucoma caused by pseudoexfoliative syndrome, often making cataract surgery more challenging and prone to complications. This research aims to compare the effectiveness of the Tran cannula, a single-use irrigation device designed to clean pseudoexfoliative material from the eye's drainage system, with increased standard irrigation in lowering eye pressure in patients with pseudoexfoliative glaucoma undergoing cataract surgery. Participants will undergo isolated cataract surgery followed by treatment of the trabecular meshwork using either the Tran cannula connected to the irrigation system or the classical aspiration cannula for augmented irrigation. The Tran cannula treatment occurs after phacoemulsification, intraocular implant insertion, and viscoelastic aspiration. The study evaluates these two procedures to assess their impact on intraocular pressure control. During the study, intraocular pressure will be measured at several time points: day 1, day 30, and months 3, 6, and 12 after surgery. The study focuses on patients with pseudoexfoliative glaucoma and cataracts, monitoring safety and efficacy throughout a year. Various examinations will be conducted to confirm eligibility and assess outcomes, including visual field tests, optical coherence tomography, and slit-lamp examinations.

This trial investigates advanced gastric cancer patients with a PD-L1 combined positive score (CPS) of 5 or higher. It aims to evaluate the effectiveness and safety of adding EXL01 to a first-line treatment regimen of nivolumab and FOLFOX chemotherapy. This is a randomized, phase II, multicenter study enrolling patients with inoperable, advanced, or metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior systemic therapy for advanced disease. Participants are randomly assigned in a 2:1 ratio to receive either the experimental treatment of nivolumab plus FOLFOX combined with EXL01 or the control treatment of nivolumab plus FOLFOX alone. Nivolumab is administered intravenously every two weeks, FOLFOX chemotherapy is given every two weeks with specified dosing of oxaliplatin, leucovorin, and 5-FU, and EXL01 is taken orally as one capsule daily starting on the first day of each treatment cycle. Treatment continues until disease progression, unacceptable side effects, or for a maximum of 24 months (52 cycles). Throughout the study, patients undergo regular radiological assessments to measure tumor response based on RECIST criteria. Researchers evaluate the primary outcome of objective response rate at 4 months. Safety is closely monitored, and laboratory tests ensure adequate organ function. Tissue samples are collected for additional research, and patients must be able to comply with study visits and treatment schedules. The total planned enrollment is 120 patients, with follow-up and outcome analyses conducted on defined patient groups.