Search for a trial

Endobiliary radiofrequency ablation for malignant biliary obstruction due to perihilar cholangiocarcinoma: a randomized controlled trial

The aim is to evaluate whether the use of eRFA prior to stenting prolongs stent patency in patients with biliary obstruction due to inoperable perihilar cholangocarcinoma.

Peri-operative (Continuous) Remote Patient Monitoring of Patients Undergoing Major Gastrointestinal Surgery: a Feasibility Study

The aim of this study is to determine the feasibility of perioperative (continuous) remote patient monitoring using Ehealth devices and a daily questionnaire in patients undergoing major gastrointestinal surgery. Additionally, to determine (early)…

Ultrasound-based navigation during liver resection

The primary objective of this study is to assess the feasibility of ultrasound-based navigation for assistance during hepatic resection. Secondary objectives are 1) to evaluate the ease of use and support for decisiveness during surgery, 2) to…

DRAGON 2 - An international multicenter randomized controlled trial to compare combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE alone in patients with Colorectal Liver Cancer Metastases (CRLM) and a small Future Liver Remnant (FLR).

The primary objective of DRAGON 2 is to demonstrate the superiority of combined PVE/HVE over PVE alone in either the resectability of the patients within 3 weeks after intervention defined as FLR sufficient for resection on week 3 and the 5-year…

Study of EMF Neutrophil Activation effects phase 1

To show that this EMF exposure activates neutrophils in a group of subjects with diversity in age and gender.

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

This study has been transitioned to CTIS with ID 2024-513513-12-00 check the CTIS register for the current data. Primary ObjectivesEvaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants…

External validation of the beta-lactam target non-attainment (BATMAN) risk score in adult ICU patients: a diagnostic multivariate predictive risk model

The primary objective is an external validation of the beta-lactam target non-attainment (BATMAN) risk score, a four-routinely available prediction model in adult critically ill patients with a convenient scoring system in Dutch hospitals.

A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy

The primary objective of this study is to evaluate the efficacy of cabozantinib in combination with atezolizumab versus sorafenib in subjects with advanced HCC who have not received previous systemic anticancer therapy. An secondary objective is to…

Dose individualization of Antibiotics in ICU patients: to TDM or not to TDM and the effects on outcome (DOLPHIN-trial)

The aim of this trial is to evaluate a new early dosage adjustment strategy (TDM) of beta-lactam and fluoroquinolones in adult ICU patients to achieve the adequate pharmacodynamic targets (PDT), compared to the usual treatment strategy.

Single-arm, phase II trial of trifluridine/tipiracil (FTD-TPI), bevacizumab, and individualized radioembolization with 166Ho-microspheres in refractory metastatic colorectal cancer.

To determine safety, tolerability, and activity of individualized radioembolization with 166Ho-microspheres combined with FTD-TPI and bevacizumab.

Hepatic arterial infusion PUMP chemotherapy combined with systemic therapy versus systemic therapy alone as Induction Therapy for initially unresectable colorectal liver metastases: a randomised controlled trial

The main objective of this trial is to investigate whether HAIP with concomitant systemic therapy prolongs overall survival in chemo-naive patients with initially unresectable synchronous colorectal liver metastases as compared with systemic therapy…

aCcelerated erAS carE for minor and major liver surgery: the CHASE liver study

The aim of this study is to investigate the feasibility and safety of an accelerated protocol for patients undergoing liver surgery compared to a retrospective cohort of patients who followed the standard ERAS care for liver surgery. In this…

Perivascular and peribiliary colorectal liver metastases (0-5 cm): irreversible electroporation versus stereotactic body radiotherapy.

The primary objective of this study is to compare efficacy of IRE to the efficacy of SBRT regarding the primary endpoint (local control at 2 years) in patients with perivascular and peribiliary CRLM (0-5 cm). The CRLM are unsuitable for surgery and…

Stereotactic body radiation therapy after chemotherapy for unresectable perihilar cholangiocarcinoma: a multicenter phase II trial (The STRONG 2 trial)

To evaluate the efficacy of SBRT as additional treatment after standard care chemotherapy regarding tumor local control, toxicity, progression-free survival, overall survival and quality of life. In addition, to explore the value of immunodynamics…

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…

A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for
Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative
Hepatic Resection or Ablation

This study has been transitioned to CTIS with ID 2023-508726-10-00 check the CTIS register for the current data. Objectives of the studyPrimary ObjectiveTo compare recurrence-free survival (RFS)(based on BICR assessment) of nivolumab versus placebo…

Individualized dosimetry for holmium-166-radioembolization in patients with unresectable hepatocellular carcinoma; a multi-center, interventional, non-randomized, non-comparative, open label, early phase II study: iHEPAR

Primary objective:To establish the safety and toxicity profile of individualized 166Ho-RE in patients with hepatocellular carcinoma. Secondary objectives:• To evaluate efficacy of individualized 166Ho-RE.• To evaluate biodistribution / dosimetry.•…

Endobiliary radiofrequency ablation for malignant biliary obstruction due to perihilar cholangiocarcinoma: a pilot study (RACCOON-pilot)

It is hypothesized that eRFA leads to increased stent patency, fewer re-interventions, fewer (permanent) external drains, and consequently increased quality of life. The primary aim of the proposed pilot study is to evaluate whether eRFA is feasible…

A phase II study to determine the efficacy and safety of Vvax001, a therapeutic Semliki Forest Virus based cancer vaccine, in patients with HPV-16 induced grade 3 cervical intraepithelial neoplasia.

The primary objective of this trial is to determine clinical efficacy of Vvax001 in CIN3 patients.

DRAGON 1 - training, accreditation, implementation and safety evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to accelerate Future Liver Rem-nant (FLR) hypertrophy

DRAGON I is a pre-trial that aims to introduce PVE/HVE in liver surgery centers worldwide in a controlled fashion to ensuring patient safety, proper data monitoring and a critical assessment of efficacy. The goal of DRAGON 1 is to assemble the…