Fraile, Spain
Study of AK105 With Anlotinib and Radiotherapy Adjuvant Therapy in MGMT Unmethylated Newly Diagnosed Glioblastoma.
Glioblastoma is the most common and aggressive primary brain tumor in adults. Treatment usually involves surgery, after which chemotherapy and radiation therapy are used. The Central Brain Tumor Registry of the United States (CBTRUS) Statistical Report primary brain and other central nervous system tumors diagnosed in the United States in 2012-2016, glioblastoma accounted for 48.3% of primary malignant brain tumors. The Stupp protocol has become standard of care for the treatment of newly diagnosed GBM, however, some MGMT unmethylated glioblastomas are still resistant to temozolomide. Immunotherapy is being studied as treatment for the cancer, AK105 is a humanized monoclonal antibody that specially binds to PD-1. Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor. Based on the mechanism study, tumor vascular abnormalities promote tissue hypoxia and increase lactic acid, thereby activating immunosuppression and inhibiting T cell function. Anti-angiogenic drugs enhance the infiltration of effector immune cells by inducing normalization of blood vessels and reducing immunosuppression.
Phase
2Span
113 weeksSponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolNanjing, Jiangsu
Recruiting
CaRe-ECMO Program on ECMO Weaning
Studies have documented that rate of mechanical ventilation weaning was improved in patients received early rehabilitation intervention while its effectiveness in ECMO weaning remains unclear. This inspires us to hypothesize that if the medical rationale is based on its assumed benefits on cardiac function and oxygenation, then cardiopulmonary rehabilitation may subsequently contribute to earlier weaning of ECMO. The "CaRe-ECMO" trial is a prospective, multidisciplinary, randomized controlled, parallel group, clinical trial. Cardiopulmonary rehabilitation program which encompasses six evidence-based components:1) positioning; 2) passive range of motion (PROM) training; 3) neuromuscular electronic stimulation (NMES); 4) surface electrical phrenic nerve stimulation (SEPNS); 5) respiratory PNF techniques 6) airway clearance techniques; 366 ECMO-supported patients in department of emergency medicine will be randomized to control and CaRe-ECMO group. CaRe-ECMO group will be treated with usual care, ECMO therapy, and cardiopulmonary rehabilitation program. Usual care normally comprises pharmacotherapy, mechanical ventilation, continuous renal replacement therapy (CRRT), intra-aortic balloon pump (IABP), and specific nursing for ECMO therapy and their original injuries, as appropriate. Control group will be treated with usual care, ECMO therapy. The primary objective of the CaRe-ECMO trial is to investigate the impact of cardiopulmonary rehabilitation combined with usual care on rate of ready for ECMO weaning at CaRe-ECMO Day 7, when compared to usual care alone. Secondary objectives are to evaluate the effects of cardiopulmonary rehabilitation on rate of ECMO weaning, total length of ready for ECMO weaning, total length of ECMO weaning, rate of mechanical ventilation weaning, total length of mechanical ventilation, all-cause mortality, rate of major post-ECMO complications, diaphragmatic thickness and mobility, ECMO Unit length of stay (LOS), total hospital LOS, total cost for hospitalization, cerebral performance category (CPC) index, activity of daily living (ADL), and health related quality of life (HRQoL). The CaRe-ECMO trial is designed to test the hypothesis that early cardiopulmonary rehabilitation can accelerate weaning of ECMO-supported patients. If CaRe-ECMO trial results in superior improvement in primary and secondary outcomes, it will offer an innovative treatment option for ECMO-supported patients.
Phase
N/ASpan
220 weeksSponsor
The First Affiliated Hospital with Nanjing Medical UniversityNanjing, Jiangsu
Recruiting
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
Phase
3Span
173 weeksSponsor
Jiangsu HengRui Medicine Co., Ltd.Nanjing, Jiangsu
Recruiting
A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia.
The study plan includes approximately 140 participants who will be randomly assigned to the WS016 and placebo treatment groups. Participants will begin a 48-hour acute treatment phase with three times-daily oral administrations. After the 48-hour acute treatment, participants have returned to normokalemia will be randomly assigned again to enter a 12-day maintenance treatment phase with once-daily oral administration.
Phase
2Span
47 weeksSponsor
Waterstone Pharmaceutical (Wuhan) Co., LTD.Nanjing, Jiangsu
Recruiting
A Prospective Study on the Treatment of CLM Based on ICG Imaging
Phase
N/ASpan
183 weeksSponsor
Nanjing Children's HospitalNanjing, Jiangsu
Recruiting
Clinical Observation of Exosomes in Patients After Q-switched Laser Surgery
The main objective was to collect patients with fleae or seborrheic keratosis after Q-switched laser treatment, and then to use exosomes or matrix on both sides of the face, and finally to evaluate the effect of exosomes on wound healing and prevention of post-inflammatory hyperpigmentation after Nd:YAG laser 532 treatment
Phase
N/ASpan
122 weeksSponsor
Nanjing First Hospital, Nanjing Medical UniversityNanjing, Jiangsu
Recruiting
Healthy Volunteers
Nanjing
Recruiting
A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer
This is a randomized controlled, 2-arm, open-label, multicenter phase III study to assess the efficacy and safety of DB-1303/BNT323 versus Trastuzumab Emtansine (T-DM1) in patients with human epidermal growth factor receptor 2 (HER2) -positive unresectable/metastatic breast cancer who have been treated with trastuzumab and taxanes. Approximately 224 patients with unresectable or metastatic HER2-positive breast cancer will be randomized 1:1 to receive DB-1303/BNT323 or T-DM1, respectively.
Phase
3Span
109 weeksSponsor
DualityBio Inc.Nanjing, Jiangsu
Recruiting
A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC
Phase
2Span
262 weeksSponsor
MediLink Therapeutics (Suzhou) Co., Ltd.Nanjing, Jiangsu
Recruiting
Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients with Recurrent or Metastatic Cervical Cancer
Phase
2Span
148 weeksSponsor
Grit BiotechnologyNanjing, Jiangsu
Recruiting