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Transarterial Chemoembolization with Drug-Eluting Beads (standard arm) versus Stereotactic Body Radiation Therapy (experimental arm) for hepatocellular carcinoma:
A multicenter randomized phase II trial *The TRENDY trial*

To assess the time to progression after TACE-DEB and after SBRT in a comparable population of patients diagnosed with HCC.

A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Proof of Concept, and Dose-Finding Adaptive Phase 2a/2b Study to Investigate the Safety, Tolerability and Efficacy and Effect on Quality of Life of Human Recombinant Alkaline Phosphatase in the Treatment of Patients With Sepsis-Associated Acute Kidney Injury.

The primary objectives of the study are as follows:• To investigate the effect of recAP on renal function and related clinical parameters in patients with SA-AKI.• To determine the therapeutic dose(s) of recAP to support the pivotal Phase 3 program.…

A multicenter, open label, phase I / II study to evaluate safety, pharmacokinetics and efficacy of BIBF 1120 in comparison with oral sorafenib for advanced hepatocellular carcinoma patients.

To evaluate the efficacy and safety of BIBF 1120 in HCC patients without prior systemic treatment as compared to Sorafenib.

Evaluation of Sorafenib in combination with local micro-therapy guided by Gd-EOB-DTPA enhanced MRI in patients with inoperable hepatocellular carcinoma

Treatment strategy in early HCC aims at the local removal of the tumor and represents a potentially curative treatment option (resection, liver transplantation, PEI, RFA, BT). Patients in intermediate and advanced stage of HCC receive treatment with…

OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients with Severe Sepsis

The primary objective is to determine the effect of oral talactoferrin alfa on 28-day (672-hour post first dose of study drug) all-cause mortality in patients with severe sepsis.The secondary efficacy objectives are to determine the effect of oral…

A randomized, placebo-controlled, double-blind, multi-center Phase 2/3 trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with symptomatic polycystic liver disease

This study has been transitioned to CTIS with ID 2023-505313-24-00 check the CTIS register for the current data. To evaluate the treatment effect of CAM2029 compared to placebo on liver volume in patients with polycystic liver disease (PLD)

Radioembolization with 166Ho-microspheres in elderly and/or fragile patients with previously untreated unresectable liver-only metastases of colorectal cancer, CAIRO7 study endorsed by the Dutch Colorectal Cancer Group (DCCG)

Primary objective:The objective of this randomized phase 2 study is to demonstrate efficacy of RE in terms of PFS in colorectal cancer patients with liver-only metastases who are candidates for palliative systemic treatment with capecitabine plus…

A Randomized Phase II Study of Systemic Chemotherapy with or without HAI FUDR/Dexamethasone in Patients with Unresectable Intrahepatic Cholangiocarcinoma

This study has been transitioned to CTIS with ID 2024-518065-10-00 check the CTIS register for the current data. The aim of the study is to demonstrate that HAI P chemotherapy is an effective treatment for unresectable intrahepatic…

an open label, randomised, phase 2 study to evaluate the safety and efficacy of mtl-cebpa administered in combination with sorafenib or sorafenib alone, in TKI naïve participants with previously treated advanced hepatocellular carcinoma (HCC) and hepatitis B or hepatitis C virus (outreach2)

We compare the efficacy and safety of the new medication MTL-CEBPA in combination with sorafenib with the efficacy and safety of sorafenib alone. Sorafenib is already being used for the treatment of HCC.

A prospective, multicentre, randomised, controlled study evaluating SIR-Spheres® Y-90 resin microspheres preceding standard cisplatin-gemcitabine (CIS-GEM) chemotherapy versus CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic CholangioCArcinoma.

This study will assess the benefit of adding SIRT to a standard regimen of cisplatin and gemcitabine (CIS-GEM) systemic chemotherapy in unresectable liver-only or liver predominant intrahepatic cholangiocarcinoma.Patients will be offered the…

A Double-Blind, Placebo-Controlled, Randomized, Multicenter, Proof of Concept and Dose-Finding Phase II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of ADRECIZUMAB in Patients with Septic Shock and Elevated Adrenomedullin

Patients will be evaluated for safety and tolerability of the therapy, but also for signs of clinical efficacy. As long as the patients are on the ICU, measurements of clinical signs and laboratory data will be collected for safety reasons and for…