Clinical trials: De-escalation Therapy
Acute Coronary Syndrome (ACS), High Bleeding Risk(HBR)
Safety and Efficacy of De-escalation Dual Antiplatelet Therapy After BioFreedom™ Stenting in ACS Patients With Moderate-to-high Ischemic and High Bleeding Risk
Patients with acute coronary syndrome (ACS) who have both high ischemic risk and high bleeding risk represent a challenging population following percutaneous coronary intervention (PCI), as prolonged dual antiplatelet therapy…
- Conditions
- Acute Coronary Syndrome (ACS), High Bleeding Risk(HBR), Coronary Artery Disease (CAD)
- Trial name
- NCT07374718
- Testing
- IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy, Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)
- Where
- China
- Volunteers
- 468 people
- Sponsor
- Shenyang Northern Hospital
Inflammatory Bowel Diseases, Crohn Disease
De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease
BACKGROUND/RATIONALE: Treatment outcomes of patients with inflammatory bowel disease (IBD) have improved enormously during the past decade due to the use of anti-tumour necrosis factor (anti-TNF) therapy.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
- Trial name
- FREE (NCT04646187)
- Testing
- Infliximab, Adalimumab
- Where
- 7 sites in Belgium, Netherlands and 1 more
- Volunteers
- 148 people
- Sponsor
- University Medical Center Groningen
Multidrug Resistant Tuberculosis, Pediatric
Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis
The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.
- Trial name
- NCT01856634
- Testing
- 100 mg Delamanid, 50 mg Delamanid, 25 mg Pediatric Formulation Delamanid
- Where
- 2 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Solid Tumor
Evaluationn of Tolerability and Safety of CBT101, an Autologous Natural Killer Cell, in Patients With Solid Cancer
The objective of the study is to evaluate tolerability and safety of CBT101 in patients who underwent curative surgery and adjuvant therapy for solid cancer
- Trial name
- NCT04557306
- Testing
- CBT101 cells, every 2 weeks, CBT101 cells, every 4 weeks
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- CHABiotech CO., Ltd
Locally Advanced Nasopharyngeal Carcinoma
Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma
This phase III trial aims to evaluate the efficacy and safety of induction chemotherapy combined with serplulimab (induction/maintenance therapy) with omission of concurrent chemotherapy in patients with locally advanced…
- Trial name
- NCT07177443
- Testing
- Radiotherapy, Serplulimab, Cisplatin
- Where
- China
- Volunteers
- 710 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Natural Killer/T-cell Lymphoma
GELAD-Based Response-Adapted Treatment for Early-Stage Extranodal NK/T-Cell Lymphoma
This prospective, multicenter study evaluates a response-adapted treatment strategy for previously untreated patients with early-stage extranodal NK/T-cell lymphoma of the upper aerodigestive tract.
- Trial name
- NCT07768943
- Testing
- Gemcitabine (GEM), Etoposide Injection, Dexamethasone
- Where
- China
- Volunteers
- 620 people
- Sponsor
- Fudan University
Rheumatoid Arthritis
Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction
This is an international (Sweden, Finland, Norway, Denmark, Iceland and the Netherlands) trial designed to compare the safety and efficacy of active conventional therapy (ACT) and three biologic treatments in subjects with early…
- Trial name
- NCT01491815
- Testing
- Non-biological DMARD's, Cimzia, Orencia
- Where
- 30 sites in Denmark, Finland and 4 more
- Volunteers
- 812 people
- Sponsor
- Karolinska Institutet
Pneumonia, Bacterial
Rapid De-escalation of Anti-MRSA Therapy Guided by S. Aureus Nares Screening in Case of Pneumonia
The current IDSA/ATS guidelines recommend Linezolid and Vancomycin for MRSA coverage in hospitalized patients with pneumonia, which is common clinical practice in Italy.
- Trial name
- SNAP (NCT06238297)
- Testing
- MRSA nasal swab based de-escalation
- Where
- Italy
- Volunteers
- 76 people
- Sponsor
- University of Bari Aldo Moro
Breast Cancer
Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk
Hormone therapy is recommended for five years in all patients with hormone receptor-positive breast cancer, but there is no consensus on its duration in low-risk tumours and especially in postmenopausal women.
- Trial name
- LESS (NCT05297617)
- Testing
- Anti-aromatase inhibitor
- Where
- 2 sites in France
- Volunteers
- 696 people
- Sponsor
- UNICANCER
Oropharyngeal Carcinoma
A Study of Reduced Radiation Therapy With Chemotherapy in People With HPV-Positive Throat Cancer
The researchers are doing this study is to find out if lower doses (given in fewer treatments over a shorter period of time) of radiation therapy in combination with standard-of-care chemotherapy is an effective treatment for…
- Trial name
- NCT06984861
- Testing
- 18F-FMISO PET/CT Scan, Chemoradiation, Questionnaires
- Where
- 7 sites in United States
- Volunteers
- 74 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Oropharyngeal Cancer, Squamous Cell Carcinoma of the Oropharynx
A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)
Single center, non-randomized Phase II study enrolling Stage I-II p16+ oropharyngeal cancer patients to one of two de-escalation treatment paradigms: (1) receive surgery followed by observation or risk-adjusted adjuvant radiation…
- Trial name
- NCT05894083
- Testing
- Surgery, Chemoradiation, Observation
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Michigan Rogel Cancer Center
Locally Advanced Rectal Carcinoma
Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer
The aim of this clinical trial is to compare triplet induction therapy (FOLFOXIRI) with doublet induction therapy (CAPOX/FOLFOX), followed by chemoradiotherapy and either surgery or a watch-and-wait approach, in patients with…
- Trial name
- MEND-IT II (NCT07472868)
- Testing
- FOLFOXIRI, CAPOX, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
- Where
- 20 sites in Netherlands
- Volunteers
- 394 people
- Sponsor
- J. W. A. Burger
Cutaneous Squamous Cell Carcinoma of the Head and Neck, Head and Neck Cancer
Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma
Cutaneous Squamous Cell Carcinoma (cSCC) is typically associated with a high tumour mutation burden, with the majority caused by Ultraviolet (UV) exposure (Pickering et al., 2014).
- Trial name
- DESQUAMATE (NCT05025813)
- Testing
- Pembrolizumab
- Where
- 3 sites in Australia
- Volunteers
- 27 people
- Sponsor
- Queensland Health
Metastatic Invasive Breast Cancer
Rising ctDNA to Tailor Endocrine Therapy Switch in Patients With ER+/HER2- Metastatic Breast Cancer.
Rationale: In patients with metastatic breast cancer, fragments of tumor DNA called "circulating tumor DNA" or "ctDNA" can be detected in the blood.
- Trial name
- TAILORswitch (NCT07717450)
- Testing
- Tumor assessment, Completion of Quality-of-life questionnaires, ECG
- Volunteers
- 370 people
- Sponsor
- UNICANCER
Invasive Fungal Disease, Critical Illness
De-escalation - Antifungal Treatment Immunocompromised Patients
A small proportion of intensive care unit patients receiving antifungals have a proven invasive fungal infection. However, antifungal treatment has side effects such as toxicity, emergence of resistance, and high cost.
- Trial name
- D-ATFIM (NCT03774316)
- Where
- France
- Volunteers
- 275 people
- Sponsor
- University Hospital, Lille
Anatomic Stage II Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
This phase III trial compares the effect of continuation of treatment with pembrolizumab (usual approach) to observation only at preventing cancer from coming back in patients with early-stage triple-negative breast cancer (TNBC)…
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Trial name
- NCT05812807
- Testing
- Pembrolizumab, Patient Observation, Biopsy
- Where
- 846 sites in United States, Canada and 1 more
- Volunteers
- 1,295 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Sepsis
Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults
Trial design: Randomised controlled, two-arm, parallel, clinical trial to assess the efficacy and safety of sequential daily procalcitonin assessments to guide de-escalation of empirical antibiotic therapy in adult patients with…
- Trial name
- PROCALBAN (NCT05955612)
- Testing
- Procalcitonin measurement
- Where
- Bangladesh
- Volunteers
- 532 people
- Sponsor
- University of Oxford
Oropharyngeal Cancer
Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer
The goal of this randomized treatment de-escalation study is to formally compare outcomes in HPV related oropharyngeal cancer tumors treated with a primary radiotherapy versus a primary surgical approach, to provide a high level…
- Trial name
- ORATOR2 (NCT03210103)
- Testing
- Radiation, Transoral Surgery (TOS) + Neck Dissection
- Where
- 9 sites in Australia, Canada
- Volunteers
- 61 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Triple Negative Breast Cancer (TNBC), Elevated Tumor-Infiltrating Lymphocytes
A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs)
This study tests a new treatment approach for people with early-stage triple negative breast cancer whose tumors have a high number of immune cells, called tumor-infiltrating lymphocytes or TILs, as seen by a pathologist on…
- Trial name
- NeoTILs (NCT07743190)
- Testing
- Carboplatin, Paclitaxcel, Pembrolizumab
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- Medical University of South Carolina
Seminoma
THERApy De-escalation for TESTicular Cancer
THERATEST is looking to collect data from 30 patients actively receiving de-escalation treatments or other standard of care treatments in two UK hospitals.
- Trial name
- THERATEST (NCT06309745)
- Testing
- retroperitoneal lymph node dissection, Carboplatin AUC10
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Queen Mary University of London