Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial...
Crohn DiseaseStudy type : A 30 months, multicentre, open-label strategic randomized controlled trial Population : Chron's Disease (CD) patients with an i2 endoscopic postoperative recurrence in the year following ileocolonic resection (6-12months after ileocolonic resection). Treatments : Stratification at inclusion according to prophylactic therapy. Patients randomized in 2 arms: Status quo arm: if the patient received no prophylactic therapy, no treatment will be started; if the patient received a prophylactic therapy, the same will be continued at the same dose. Therapy escalation arm: infliximab-CT-P13 will be started with two intravenous infusions of 5 mg per kg bodyweight at week 0 and week 2 and subcutaneous injections of 120 mg every 2 weeks from week 6 onwards. Main objective : To evaluate the proportion of CD patients without endoscopic postoperative recurrence (i0-i1) at 12 months in the arm receiving therapy escalation compared to status quo arm in patients having an i2 endoscopic postoperative recurrence 6-12months after ileocolonic anastomosis with restoration of faecal stream.
Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative...
Gastric CarcinomaThe purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.
Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal...
Recurrent Clostridium Difficile InfectionPrimary Clostridium Difficile InfectionPatients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI). The incidence and severity of CDI has increased in recent years and CDI recurrences (r-CDI) due to the appearance of new episodes in patients with a previous cured CDI, represent a serious and complex clinical issue. Although antibiotics are the recommended therapy for the first episode of CDI, treatment with oral vancomycin and/or metronidazole often results in significant treatment failure. In addition, the treatment of r-CDI is not adequately standardized, and although the most widely used treatment is the administration of fidaxomicin and bezlotoxumab, its efficacy in patients who already have r-CDI is not proven. In the late years, Fecal Microbiota Transfer (FMT) has emerged as the preferred non-pharmacological treatment to manage CDI with multiple recurrences and recent clinical trials have evaluated its potential efficacy and safety in the treatment of patients with primary CD infection. The objective of this study is to assess the efficacy and safety of the MBK-01 medication, consisting of heterologous lyophilized fecal microbiota capsules coming from healthy donors in comparison to the treatment with Fidaxomicin, in 66 patients with primary or r-CDI.
Ex Vivo Expanded NK Cells Infusion Decrease Relapse Post Hematopoietic Stem Cell Transplantation...
Hematologic MalignancyThis phase I/II study the side effects and efficacy of natural killer cells after donor stem cell transplant and how they treat patients with myeloid malignancies or lymphoproliferative disorders. Investigators expanded NK cells ex vivo with a non-feeder cell regimen to avoid the risk of infusion of feeder cells with expanded NK cells. Investigators infuse NK cells after myeloablative conditioning therapy. These cells may help decrease relapse of malignant disease, severe graft versus host disease, reactivation of certain viruses, and, therefore, prolong the survival of participants.
Feasibility Study of Lidocaine Infusion During Bowel Cancer Surgery for Cancer Outcome
Colorectal CancerQuality of Life1 moreThis feasibility (small) study aims to see if it is possible to run a large study looking at the effect of lidocaine on large bowel cancer recurrence after surgery in the NHS hospitals.
Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence...
Clostridioides Difficile InfectionThe clinical trial aims to evaluate the efficacy of fecal microbiota transplantation (FMT) after standard of care treatment (either vancomycin or fidaxomicin) vs the pragmatic use of standard of care treatment (either vancomycin or fidaxomicin) in severe and non-severe first episode and first recurrence of Clostridioides difficile infection (CDI). Experimental arm: antibiotic treatment (vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days) followed by FMT by oral capsules (one FMT, i.e. 20 FMT capsules given on 2 consecutive days, and followed by a 2nd FMT in severe CDI). Control Arm: vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days.
A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma...
Head and Neck CancerSquamous Cell Carcinoma of Head and Neck3 moreThis is a multi-center, open-label Phase 2 study designed to evaluate the efficacy and safety of BA3021 in PD-1/L1 failure patients with ROR-2 expression in recurrent or metastatic squamous cell carcinoma of the head and neck.
Expanded Activated Lymphocytes (EAL) as Adjuvant Therapy in Patients With HCC at High Risk of Recurrence...
Hepatocellular Carcinoma (HCC)This is a multi-center, randomized, open-label pivotal phase II study to evaluate the efficacy and safety of EAL as adjuvant therapy in preventing recurrence in patients with primary HCC at high recurrence risk after radical resection.
Pembrolizumab and Carboplatin for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary...
Recurrent Fallopian Tube CarcinomaRecurrent Ovarian Carcinoma1 moreThis phase II trial investigates how well pembrolizumab and carboplatin work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together with carboplatin may work better in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Camrelizumab Combined With CRT for Treatment of Patients With Local Recurrence of Esophageal Cancer...
Esophageal CancerChina is a country with a large incidence of esophageal cancer. The prevalence and mortality rate of esophageal cancer in China ranks fifth in the world. However, due to China's huge population base, new patients with esophageal cancer and deaths account for about 55% of the world. This study aimed to explore the efficacy and safety of Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Treatment of Patients With Local Recurrence of Esophageal Cancer.