View clinical trials related to Neoplasms.
Filter by:This is a phase Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors.
Background: Family caregivers are of great importance to patients undergoing treatment for cancer, but at the same time, caregivers themselves are in great risk of distress and high symptom burden which affects their quality of life and ability to support the patients. Within hematology the context of treatment from hospital to home has changed in the past years placing more responsibilities on caregivers. Finding new ways to support caregivers within the health care context is important. Psychosocial interventions can enhance emotional well-being, and peer to peer support model has been found to be effective for patients coping with cancer. There is a lack of knowledge and evidence of the feasibility and effects of a peer-to-peer support in caregivers within hematology. Aims: The study aim to examine the feasibility and safety of Family Caregiver Ambassador Support in caregivers of newly diagnosed patients with hematological disease, and to examine if it has an effects on symptoms and psychological wellbeing in both family caregivers and ambassadors. It is hypothesized that the family caregiver peer to peer support model will reduce symptoms of burden, reduce concerns and improve emotional and social well-being in family caregivers. Design and methods: The study is a one arm feasibility intervention trial with family caregivers (n=30) and family caregiver ambassadors (N=20). Family Caregivers will be recruited at the Department of Hematology, Rigshospitalet. Family Caregivers will be partnered with a family caregiver ambassador. The intervention will be carried out in a 12-week period and consist of telephone and/or e-mail contact and face to face meetings with one follow-up at three months. Both caregiver and ambassador data will be collected at baseline, post intervention and follow-up 3 months. Implication: The study has the potential to be a new model of care incorporated in the clinical setting to strengthen the support system for caregivers and may likely be tailored to other cancer groups and caregivers.
This study is a randomized open-label phase 2b study of the efficacy and safety of regional infusion therapy with Anti-CEA CAR-T cells using the hepatic immunotherapy for metastases (HITM) method and the Trisalus pressure enabling drug delivery (PEDD) device alternating with systemic chemotherapy versus chemotherapy alone in patients with CEA-expressing pancreatic adenocarcinoma with liver metastases.
This is a prospective interventional open-label randomized trial. The patients treated with anti- PD-1 (programmed-death receptor type 1) or anti-PD-L1 (programmed-death ligand) antibodies in case of new acute onset interstitial changes or new seriuos respiratory system related symptoms will be recruited for this study to perform diagnostics. At the recruitment the patient will be randomized 1:1 to investigatory or control arm, the randomization will be stratified upon three criteria: 1. severity of suspected pneumonitis at baseline (grade 2 vs. grade 3-4) 2. response for oncological treatment (partial response (PR) and complete response (CR) vs. stable disease (SD) and progression disease (PD)) 3. chronic respiratory system disorders Both groups will be treated in the same way in terms of diagnostic procedures. In case of interstitial lung diseases related to immune checkpoint inhibitor is confirmed with the severity of grade 2-4 in the modified CTCAE criteria the patient will get the treatment, accordingly to the randomization: ARM A - INVESTIGATORY GROUP the start dose will be 1-4 mg/kg of body weight of prednisone, depending on clinical condition and pneumonitis severity, the induction treatment will last for 5-7 days, in case of severe condition - no improvement after 48-72 h of initial treatment - introduction of immunosuppressive agent is recommended - cyclophosphamide, mofetil mycophenolate or infliximab. A continuation treatment with dose tapering is than recommended, starting from 60mg q 24h of prednisone for 2-4 weeks, and dropping the dose 10mg q 24 h not faster than over 14 days; the maintenance dose of prednisone 10mg q 24 h should be hold for 8 weeks and withdraw should last for 4 weeks. This arm will be treated with corticosteroid for at least 12-24 weeks. ARM B - CONTROL GROUP the starting dose will be 1-4mg/kg of body weight of prednisone , depending on clinical condition and pneumonitis severity, the induction treatment will last 5-7 days; in case of severe condition - no improvement after 48-72 h of initial treatment - introduction of immunosuppressive agent is recommended: cyclophosphamide, mofetil mycophenolate or infliximab. A continuation treatment with dose tapering is than planned, starting from oral dose of 30-60mg q 24h of prednisone, and dose reduction of 10mg q 24 h each 1 week. This arm will be treated for 6-12 weeks. During the treatment and after its termination the function of respiratory system, interstitial changes in radiologic examinations, anticancer response, survival time, pneumonitis relapse and glucocorticosteroid side effects will be monitored and evaluated. The observation will last up to 52 weeks.
This is a pilot study to evaluate the feasibility of a mobile health exercise intervention (GO-EXCAP Mobile App) over 7 weeks in 25 patients with myeloid neoplasms receiving hypomethylating agents.
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.
This trial studies how well Yoga works in supporting children with cancer and their parents during chemotherapy infusion. Pediatric cancer and its treatment is one of life's most stressful events for children and their parents. Yoga is an ancient holistic healing science that incorporates postures, breathing, relaxation, and meditation to facilitate harmony between body, mind, and spirit. Participating in Yoga exercise may improve the negative psychosocial effects in children with cancer and their parents during chemotherapy treatment.
The spine is a common metastatic site for malignancy and it can lead to serious and devastating events, including pain, neurological dysfunction, and reduction in quality of life. The radiotherapy (RT) has been the mainstay for palliating painful spinal metastases for the past decades. It is utilized to arrest the tumor growth, control pain, and stabilize or improve skeletal and/or neurological function. One of the limitations of the conventional radiotherapy is that radiation dose intensification is not achievable with conventional RT techniques due to the dose-limiting spinal cord, which is close to the vertebral body and sometimes encased by epidural lesion. The management of patients with spine metastasis has undergone a great deal of change in the past 10 years. The concept of radiosurgery, a high dose of radiation targeted to a pathological entity and delivered in 1-5-fractions, has proven so successful at treating both benign and malignant lesions that it changed the paradigm for radiation therapy. Clinical experiences with high dose spine stereotactic radiosurgery (SSRS) for spinal metastases demonstrated both safety and efficacy. Nontheless, the patterns of clinical practice of SSRS varies considerably regarding the dose fractionation, target delineation, and dosimetry. There is lack of evidence-based recommedations for SSRS. In our prior clinical trial comparing single fraction and multiple fractions SSRS (NCT02608866), single-fraction with 16 Gy is the preferred regimen for further evaluation since it met the predefined primary endpoint and has lower risk of treatment failure compared to the multiple-fraction arm. Regarding the target volume definition, the International Spine Radiosurgery Consortium published concensus guidelines based on expert opinions and limited case series. We proposed this randomized study to determine the preferred or acceptable definition of target volume delineation in SSRS and to evaluate their toxicity, efficacy, and patterns of failure. Our analysis will provide evidence-based recommendations as well as predictive factors regarding the clinical practice of SSRS.
This is an open, prospective, single-arm, multi-cohort clinical study to evaluate the efficacy and safety of high-dose vitamin C combined with metformin in the treatment of malignant tumors.
This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).