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Holmium-166-radioembolization in patients with unresectable hepatocellular carcinoma; a multi-center, interventional, non-randomized, non-comparative, open label, early phase II study: HEPAR Primary

Primary objective:To establish the safety and toxicity profile of 166Ho-RE in patients with hepatocellular carcinoma. Secondary objectives:* To evaluate efficacy of 166Ho-RE in hepatocellular carcinoma without curative treatment options in a non-…

COLDFIRE-2 study: Colorectal metastatic liver disease: efficacy of irreversible electroporation (IRE) - a phase II clinical trial

The primary objective of this project is to evaluate the primary and secondary technique effectiveness of IRE for centrally located colorectal liver metastases that are neither amenable for resection nor for other local ablation methods due to the…

Phase II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating unresectable liver metastases of uveal melanoma

Primary objective • To determine the overall response rate of two PHP with an at least 6 week interval and 3 mg/kg melphalan in irresectable liver metastases patients. • To determine the percentage of patients qualifying for resection. Secondary…

Adjuvant hepatic Holmium-166-radioembolization in patients with unresectable liver metastases of neuroendocrine origin, who have been treated with Lutetium-177-dotatate; a single center, interventional, non-randomized, non-comparative, open label, phase II study

Primary objectives:* To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study Secondary objectives:* To establish the safety and toxicity profile of adjuvant 166Ho-RE after…

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.

Cone-beam CT guided Stereotactic Radiation Therapy for Locally Advanced and Locally Recurrent Pancreatic Cancer

To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced and locally recurrent pancreatic carcinoma.

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.…

Irreversible Electroporation for treatment of unresectable, locally advanced pancreatic cancer in the Leiden University Medical Centre: a phase I/II study.

Main objectiveTo investigate feasibility and safety of tumor ablation using IRE in patients with irresectable locally advanced pancreatic head carcinomas.Secondary objective(s)To investigate tumor downstaging efficacy, pain perception and hospital…

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.

Radioactive holmium microspheres for the treatment of patients with unresectable liver metastases; a single center, interventional, non-randomized, phase II efficacy (HEPAR II) trial.

Primary objective:To determine target lesions tumour response.Secondary objectives:* To determine overall tumour response.* To determine the liver specific progression-free survival.* To determine non-liver specific progression-free survival.* To…

Neo-adjuvant dovitinib in patients with hepatocellular carcinoma prior to local treatment: a phase II study

Introduction of dovitinib in the neo-adjuvant setting, can provide both clinical informationabout it*s activity in patients with HCC (reduction of tumor size, influence on the tumor bloodflow as assessed by CT perfusion imaging) and (histo-)…

Photodynamic laser therapy using Foscan for non-curatively-resectable bile duct carcinoma

To assess efficacy and safety of temoporfin (Foscan*) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.

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…

Hepatocellular carcinoma: vascular abnormalities prior to, during and following systemic anti-cancer treatment

To determine the efficacy of the combination of everolimus and capecitabine in a group of patients with metastatic or locally advanced HCC with Child-Pugh class B liver cirrhosis. In addition, to investigate biomarkers of HCC before and during the…

Radioembolization for Colorectal Liver Metastases after Ablation: a Prospective study

Primary objective is to assess the efficacy of ablation therapy in combination with Y-90 radioembolization in patients with CRLM. Secondary objectives are: 1) Assessment of occurrence of any treatment related adverse events following ablation in…

Second-line chemotherapy FOLFIRINOX in unresectable cholangiocarcinoma

Pilot study:Primary objective: feasibilitySecondary objectives: response rate, time to progression, overall survival and quality of life.Phase II study:Primary objective: efficacy.Secondary objectives: toxicity, especially grade 3 and 4 toxicities,…

Fase I/II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating irresectable liver metastases

Primary objective * To determine the overall response rate of two PHP with an interval of at least 6 weeks and 3 mg/kg melphalan in irresectable liver metastases patients.* To determine the percentage of patients qualifying for resection. Secondary…

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)

Hepatic arterial infusion pump chemotherapy in patients with unresectable intrahepatic cholangiocarcinoma

The aim of the study is to demonstrate that HAIP chemotherapy is an effective treatment for unresectable intrahepatic cholangiocarcinomas.

Selective Indocyanine Green Injection of a Segmental Hepatic Artery Followed by Near-Infrared Fluorescence
Guided Anatomical Liver Resection: A Feasibility Study

Primary objective: To investigate the feasibility of using intraarterial ICG preoperatively to allow for liver segment visualization during anatomical liver resection.Secondary Objective(s): 1. To investigate the dosage which provides sufficient…