A Study to Evaluate Tislelizumab Combined With Sitravatinib as Adjuvant Therapy in Participants...
Hepatocellular CarcinomaThis is an open label, multi-center, single arm study to evaluate the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.
It's Time to Address Fear of Cancer Recurrence in Family Caregivers: Online Version of the Fear...
CancerCaregiver2 moreFear of cancer recurrence (FCR) is common, persistent, and is associated with negative outcomes. Studies show that family caregivers (FC) of cancer patients experience equal or greater levels of FCR than patients themselves. In the past 5 years, several interventions have demonstrated their ability to reduce FCR among cancer patients, including a group intervention called Fear of Recurrence Therapy (FORT). However, none have ever been adapted and offered to caregivers. The goals of the proposed study are to demonstrate 1) that a newly adapted intervention of FORT (FC-FORT) is feasible (i.e., participant recruitment, attendance and participation) and acceptable (i.e., FC satisfaction of the intervention) for a larger study, and 2) the clinical implications of FC- FORT on FCR and quality of life. An advisory board composed of researchers, therapists, and FC was created to adapt FORT for FC and to an online format. FC and therapists are currently being recruited to conduct a usability study of the newly adapted FC-FORT. They will be asked to complete a session feedback questionnaire after each session and to take part in an exit interview. The content of these will be summarized back to the advisory board in order to further refine FC-FORT. Following a successful usability study, FC-FORT will be given to four groups of nine new FC (pilot study). Participants will be recruited directly by clinicians and by outreach mailout efforts. They will complete a questionnaire package before and after the intervention, as well as at a three month follow up. The proposed study is needed to determine if an already developed FCR intervention can be adapted to family caregivers and if it can be successfully pilot tested. This will help bridge an important gap in bringing evidence-based care to caregivers who have never been offered help before for their FCR. The proposed project will also allow to further feasibility and acceptability of E-Health interventions.
Salvage Systemic Therapy With or Without Stereotactic Ablative Radiotherapy for Recurrent Ovarian...
Recurrent Epithelial Ovarian CancerRationale Ovarian cancer is the 3rd most common gynecologic malignancy in Korea. The standard treatment is tumor debulking surgery with or without adjuvant chemotherapy. However, with a recurrence rate of 80%, the treatment results are the worst among gynecological cancers. The use of target and immune agents have demonstrated to improve survival. However, long-term maintenance of systemic therapy is often difficult because recurrent tumors do not respond uniformly to systemic therapy. In the 1980~1990s, whole abdomen irradiation had been tried and faded out owing to many side effects with the introduction of taxane. Efforts have been made to find the role of salvage radiation therapy (RT) in recurrent ovarian cancer. Involved field radiotherapy (IFRT) emerged to cover the gross tumor plus regional microscopic disease in addition to salvage chemotherapy. It showed high local control, provided chemotherapy holiday in selected cases, but did not prevent out-field progression. Stereotactic ABlative Radiotherapy (SABR) is the latest treatment using an intensity modulated technique to increase the fractional dose, reduces the number of treatments, and destroys the tumor with high accuracy. SABR-COMET study, a representative clinical study, showed a significant increase in overall survival in solid cancers. Objectives The primary objective; to evaluate whether the addition of SABR to standard salvage treatment significantly improves 3-year overall survival (OS) in patients with recurrent ovarian cancer. The secondary objectives; to check whether it significantly affects quality of life (Health-related QoL), patient-reported outcome (PRO) to develop an deep learning-based predictive model for the treatment response of ovarian cancer subjects using radiomic and genomic analysis. Study design Arm 1; Standard salvage therapy Subjects will continue to receive current salvage treatment suitable for subjects at the discretion of their doctor, considering the location and size of recurrence, and the patient's comorbidities. Arm 2; Standard salvage therapy+ SABR Subjects receive SABR for lesions found in imaging studies. Before or After SABR, standard salvage treatment continues as planned at the discretion of the doctor. Stratification factors The number of No ascites, Platinum-sensitive, Normal CA125 and ECOG0-1; 0~3 vs. 4 Location of the lesion; Lymph node lesion vs. Non-lymph node lesion PARP inhibitor; Used vs. Not used Randomization Arm 1 : Arm 2 = 1 : 2 Estimated Accrual : The sample size 270 was calculated by setting the sample size to a Type I error rate (α) of 0.05 and Statistical Power of 80% using 2-Sided Equity and log-rank test. Accurate time: 2 years, Follow-up: 3 years (total 5 years) Alpha = 0.05, Power = 80% 1 year drop-out: 5% per group 3 year survival proportion: RT group 74.42%, No RT group 58% Arm 1: Arm 2 = 1 : 2 ratio
Pilot Trial for Treatment of Recurrent Glioblastoma
GlioblastomaRecurrent Disease1 moreThis will be a single-arm open-label prospective pilot feasibility trial recruiting 10 adult patients with recurrent glioblastoma who are assigned to receive the personalized study treatment based on the genetic profile of their recurrent GBM tumor resected at the time of surgery. It will be aimed to gather preliminary information on the study intervention and the feasibility of conducting a full-scale trial.
Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab...
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v830 moreThis phase I trial evaluates the best dose, possible benefits and/or side effects of combination therapy with elimusertib (BAY 1895344), stereotactic body radiation, and pembrolizumab in treating patients with head and neck squamous cell cancer that has come back (recurrent) and cannot be removed by surgery (unresectable). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. 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. Giving BAY 1895344, stereotactic body radiation therapy in combination with pembrolizumab may shrink or stabilize head and neck squamous cell cancer for longer than treatment with radiation and immunotherapy without BAY 1895344.
Total Intravenous Anesthesia and Recurrence Free Survival
Esophageal CancerThe investigators propose to compare recurrence-free survival in patients having potentially curative (Stages 1-3) surgery for esophageal cancer who will be randomly assigned to propofol-based total intravenous anesthesia or sevoflurane-based balanced general anesthesia.
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients...
Advanced Differentiated Thyroid Gland CarcinomaAdvanced Head and Neck Carcinoma61 moreThis phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may shrink or stabilize cancer in patients undergoing treatment for HIV.
Apatinib Combined With Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma...
Recurrent MedulloblastomaThis study is a prospective single-center clinical study, which aims to observe and evaluate the efficacy and safety of apatinib combined with temozolomide and oral etoposide in the treatment of recurrent medulloblastoma in children.
Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent...
GlioblastomaGliosarcoma5 morePaclitaxel is among the most active agents against glioblastoma in preclinical models. However, its clinical use has been hampered by the blood-brain barrier (BBB). In this trial we will implant a novel device with 9 ultrasound emitters allowing to temporarily and reversibly open the BBB immediately prior to chemotherapy infusion with albumin-bound paclitaxel. In the phase 1 component, increasing doses of chemotherapy will be delivered as long deemed safe based on the prior patient not experiencing severe toxicity. Once the the recommended dosing has been established, carboplatin will be added to the regimen and additional patients will be treated in order to better evaluate the antitumor efficacy of this novel treatment. The device will be implanted at the time of surgical resection of the recurrent tumor. During that procedure and when feasible, a first test dose of the chemotherapy will be administered in the operating room after sonication (procedure of activating ultrasound and opening the BBB) and tissue concentrations in different parts of the resected tumor will be measured. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The objectives of this trial are to establish a safe and effective dose of albumin-bound paclitaxel, to demonstrate that the opening of the BBB increases chemotherapy concentration in the tumor, and to estimate how effective this treatment is in reducing the tumor burden and prolonging life.
Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas...
Recurrent World Health Organization (WHO) Grade II GliomaLow-grade Glioma1 moreThis phase I trial studies the side effects and best dose of trametinib and everolimus in treating pediatric and young adult patients with gliomas that have come back (recurrent). Trametinib acts by targeting a protein in cells called MEK and disrupting tumor growth. Everolimus is a drug that may block another pathway in tumor cells that can help tumors grow. Giving trametinib and everolimus may work better to treat low and high grade gliomas compared to trametinib or everolimus alone.