
CI Following VS Removal or Labyrinthectomy
Vestibular SchwannomaMeniere DiseaseThis study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance nerve or undergoing a labyrinthectomy for treatment of Meniere's disease. Individuals undergoing these surgeries will be deaf on the surgical side after the procedure. Currently, cochlear implants are approved for use and not considered investigational in individuals with hearing loss on both sides. However, use of a cochlear implant for these patient populations (single-sided hearing loss) will be considered a new use of an approved device. Participants undergoing surgery to remove a VS or having a labyrinthectomy will have a cochlear implant inserted after the surgical procedure for clinical care. Approximately 4 weeks after surgery, participants will be fitted with an external speech processor on the surgical side that will stimulate the internal cochlear implant. Participants will return at the following intervals after the initial processor fitting: 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months. At each interval, participants will complete questionnaires on how they are hearing with the implant and their quality of life with the implant and be tested on their ability to hear sounds and understand speech. Potential risks are those associated with all cochlear implant surgeries, and include device failure resulting in removal of device, irritation or redness in surgical area and/or area where processor is attached, increased ringing in the ear, facial nerve stimulation and a change in the way speech and other sounds sound through the implant. Potential benefits to individual participants in this study include improvement in detection and speech understanding of the surgical ear. Participants may also experience improved abilities to locate sound and understand speech in noise as the result of having hearing on both sides.

A Study of the Efficacy and Safety of Chemotherapy Combined With Toripalimab in Advanced Biliary...
Biliary Tract CancerTarget population: patients with advanced biliary tract cancer (including gallbladder carcinoma, intrahepatic and extrahepatic cholangiocarcinoma) . Primary objective: progression free survival (PFS)/ overall survival (OS) of first-line chemotherapy plus PD-1 antibody (Toripalimab) in patients with advanced biliary tract cancer. Secondary objectives: objective response rate (ORR) of first-line chemotherapy plus PD-1 antibody (Toripalimab) safety of first-line chemotherapy plus PD-1 antibody (Toripalimab) 3.Trial design: This is a monocenter, single arm, phase II study to evaluate the efficacy and safety of first-line chemotherapy plus PD-1 antibody (Toripalimab) in patients with advanced advanced biliary tract cancer. 4.Treatment plan: Patients will be given treatment as below once recruited: PD-1 antibody Toripalimab(240mg, iv, q3w),combined with GS regimen(gemcitabine 1000mg/m2 ,d1,d8 + S1 40-60mg bid*14d,Q21d). The treatment will be continued until emerging of disease progression or intolerable adverse effects (The upper time limit for treatment is 2 years). 5.Number of subjects: 40 patients. Number of centers: 1 sites ( Fudan University Affiliated Zhongshan Hospital).

Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating...
High Risk NeuroblastomaRecurrent Neuroblastoma1 moreThis phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, 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. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.

Newton Study (NEW Dosing mainTenance Therapy Ovarian caNcer)
Ovarian CancerFallopian Tube Cancer1 moreThis study evaluates whether the adoption of the RADAR dosing strategy could further reduce treatment related toxicities improving the safety profile of niraparib.

Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer
Lung CancerThis research study is studying a combination of drugs as a possible treatment for EGFR-Mutated Advanced Lung Cancer. The names of the study drugs involved in this study are Niraparib and Osimertinib.

Laparoscopic Ischemic Conditioning Prior to Esophagectomy
Esophageal CancerThis is a two center phase II prospective single-arm safety and feasibility trial for 20 patients with resectable esophageal carcinoma with an increased risk for anastomotic leakage, as based upon UCS and NASCET calcification scores on pre-op CT-scan. In these patients, laparoscopic ischemic conditioning is performed 12-18 days before an Ivor-Lewis esophagectomy. The primary outcome is all complications grade 2 and higher (Clavien-Dindo classification) occurring during or after the laparoscopic ischemic conditioning. Secondary outcomes are complications after the esophagectomy, and the induction of angiogenesis by biomarkers of microcirculation and redistribution of blood flow by measurement of indocyanine green (ICG) fluorescence angiography.

CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Acute Myeloid LeukemiaThis is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19 positive relapsed or refractory acute myeloid leukemia.

Focused Ultrasound (FUS) Mesencephalotomy for Head & Neck Cancer Pain
Cancer of Head and NeckPain3 moreThis proposed pilot study will investigate the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head and neck cancer

Transarterial Chemoembolization (TACE) Versus TACE Plus Stereotactic Body Radiation Therapy (SBRT)...
Hepatocellular CarcinomaTrans-arterial chemoembolization (TACE) is a standard treatment for patients with hepatocellular carcinoma (also called liver cancer). This is where chemotherapy is injected into the arteries of the liver and liver cancer. Unfortunately, the tumour grows after TACE in many patients. A new treatment using a specialized radiation procedure called Stereotactic ablative body radiotherapy (SBRT) may increase the chance to control liver cancer. SBRT allows radiation treatments to be focused more precisely, and be delivered more accurately than with older treatments. The purpose of this study is to find out if TACE alone versus TACE plus SBRT is better for you and your liver cancer.

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin...
B-cell Non-Hodgkin Lymphoma (NHL)Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups: In patients with follicular lymphoma (FL) grade 1-3a *1,2 In patients with diffuse large B-cell lymphoma (DLBCL) *1,2 In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy. In patients with marginal zone lymphoma (MZL) *1 In patients with other B-NHL subtypes *1 Secondary objectives are: To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by: ORR according to the Lugano Classification and as assessed by local investigator evaluation Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review Progression-free survival (PFS)*3 Overall survival (OS) Duration of response (DOR)*3 Disease control rate (DCR)*3 To evaluate the safety and tolerability of odronextamab To assess the pharmacokinetics (PK) of odronextamab To assess the immunogenicity of odronextamab To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) 1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy 2 including an anti-CD20 antibody and an alkylating agent 3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation