ANZCTR search results

The purpose of the study is to assess the safety and efficacy of OncoSil™ when given in addition to standard FOLFIRINOX chemotherapy for treatment of Locally Advanced Pancreatic Cancer

The current study assesses the tolerability and efficacy of monotherapy with pan-RAF-kinase (Tovorafenib) inhibition for the treatment of children and young adults with craniopharyngioma.

The purpose of the study was to find out if the investigational treatment named QUC398 had beneficial effects on osteoarthritis (OA) knee pain and knee cartilage, and if it was safe and tolerated.

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.

The study is a 2-part study of Tinodasertib alone or in combination with Pembrolizumab/Irinotecan in patients with CRC.

Feasibility of the Vessel Restoration System for AVF

Prospective, multi-center, non-interventional, randomized, comparative clinical study to identify an optimal refractive technique that provides maximum plus refractive endpoint for best corrected distance visual acuity (BCDVA).

Tibia shaft fractures are common long bone fractures in the field of Orthopaedic Trauma. In the USA, a total of 492.000 tibial fractures were reported per year by the National Center of Health Statistics (NCHS). Intramedullary nailing (IMN) is the treatment of choice for shaft fractures. However, rotational malalignment (RM) remains an iatrogenic pitfall with a prevalence up to 30%. From a clinical point of view, there is limited knowledge on how to avoid RM during IMN. Clinical estimation of tibial alignment is difficult, resulting frequently in RM following IMN. Low-dose CT-assessment is considered the gold standard to objectify RM, but is performed after surgery when the opportunity for direct revision has passed. Both difficulties in intraoperative clinical judgement of tibial alignment as well as postoperative detection of RM when the possibility for direct revision has passed, do support the need for an easy-to-use intraoperative fluoroscopy protocol to minimize the risk for RM during IMN of tibial shaft fractures. Recently, a standardized intraoperative fluoroscopy protocol named the 'C-Arm Rotational View (CARV)' was determined in order to improve the accuracy of alignment control during IMN of tibial shaft fractures. CARV includes predefined fluoroscopy landmarks of the uninjured side to correct for rotational malalignment of the injured side in which the rotation of the C-Arm Image Intensifier is used. Promising preliminary results were found to reduce the risk on RM following IMN of tibia fractures. However, a prospective trial is needed to determine the performance of CARV in clinical practice. Therefore, a prospective multi-center randomized controlled trial is designed to assess the clinical feasibility and potential benefits of the CARV-protocol. The following primary research question was defined: can the risk for RM following IMN of tibial shaft fractures be minimized by use of the CARV-protocol?

This is a Phase Ia/Ib, multicenter, open-label, first-in-human study to evaluate the safety, tolerability, PK, and efficacy of IBI343 in participants with locally advanced unresectable or metastatic solid tumors. It is planned to be carried out in different countries or regions such as China, Australia and US. There are three parts in phase Ia. Part 1 includes dose escalation and expansion phase and part 2 is designed for dose optimization for IBI343 monotherapy. Part 3 1L G/GEJ AC and 1L PDAC cohorts will include an initial safety lead-in stage to confirm the tolerability of IBI343 in combination with chemotherapy in 1L PDAC and G/GEJ AC, followed by a randomized dose-optimization stage designed to further characterize safety, pharmacokinetics, and preliminary efficacy to inform selection of the recommended Phase 3 dose.

This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical \[haplo\]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy and/or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all.