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Safety and feasibility of CT-guided percutaneous radionuclide therapy with the OncoSil* device in patients with non-progressive locally advanced pancreatic cancer (PANCOSIL): an open-label, single-arm phase 1-2 feasibility study

To assess the safety and feasibility of percutaneous CT-or ultrasound-guided RNT using the Oncosil* device in patients with non-progressive LAPC after induction chemotherapy treatment.

A Randomized, Phase 3 Study of Eryaspase in Combination with Chemotherapy versus Chemotherapy Alone as Second-Line Treatment in Patients with Pancreatic Adenocarcinoma

Primary Objective:To determine whether the addition of eryaspase to chemotherapy improves overall survival (OS) in second-line treatment of pancreatic adenocarcinoma compared to chemotherapy alone.Secondary Objectives:• To compare progression-free…

RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE, EFFICACY, SAFETY AND TOLERABILITY OF EPA-FFA GASTRO-RESISTANT CAPSULES, IN PATIENTS WITH FAMILIAL ADENOMATOUS POLYPOSIS (FAP)

Primary Objective* To determine the efficacy of EPA-FFA gastro-resistant capsules in patients with FAP in reducing polypectomy.Secondary Objectives* To evaluate the clinical disease progression.* To evaluate the long-term safety and tolerability of…

A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma;

Primary objectives:(1) Evaluate Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded central radiologists' review in subjects with PD-L1 Combined Positive Score (CPS) *1. (2) Evaluate overall survival (OS).Secondary Objectives(…

LIMited wEdge ResectIon for Colonic T1 cancer - a prospective multicenter cohort study

The aim of this study is to investigate the safety and efficacy of CAL-WR as primary and curative colon-preserving treatment for T1 colon cancer. Our primary endpoint is reduction of oncologic resections for low-risk T1 colon cancer. As secondary…

HERBERT II: external beam radiation therapy followed by high-dose rate endorectal brachytherapy (HDRBT) in elderly early rectal cancer patients not undergoing surgery: A randomized multicenter phase III study

To assess the added value of a brachytherapy boost after external beam radiotherapy in elderly, frail patients with rectal cancer.

Esophageal self-expandable metal stent for malignant strictures: an observational study

The aim of this study is to evaluate the safety and efficacy of the esophageal partially covered SEMS. We will pay specific attention to recurrent dysphagia rates, migration rates and pain.

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…

Systemic and local intestinal pharmacokinetics of irinotecan

The primary objective of this study is to describe the pharmacokinetics (PK) of irinotecan, SN-38 and SN-38G in human by using apharmacokinetic compartment model .

Sentinel node and organ sparing surgery in stage I colon carcinoma (SENTRY trial)

The aim of this study is to reduce the need for colectomy and its* associated morbidity and mortality in patients with high-risk pT1 or low-risk pT2 colon carcinoma after endoscopic polypectomy by performing a (robot-assisted) laparoscopic wedge…

Oral Fecal Microbiota Transplantation Capsules from Healthy Donors in Patients with Locally Advanced, Resectable Gastric or Gastro-esophageal Junction Adenocarcinoma

The primary goal is to demonstrate that in gastric esophageal cancer the addition of a microbiome intervention with fecal capsules from healthy donors can improve the effectiveness of perioperative chemotherapy as measured by the tumor regression…

Focal cryoballonablation for dysphagia in patients with advanced esophageal cancer

1. To evaluate the feasibility of cryoballoon therapy in patients with incurable esophageal carcinoma and symptoms of dysphagia, defined as technical success rate. In addition, the efficacy and safety will be assessed by looking at the clinical…

Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases - a phase II study

This study has been transitioned to CTIS with ID 2024-517152-34-00 check the CTIS register for the current data. The primary objectives are to explore the overall survival for the addition of intraperitoneal irinotecan (75 mg) to palliative systemic…

PDL-1 targeting in resectable oesophageal cancer: a phase II feasibility study of Atezolizumab and chemoradiation (PERFECT)

Possibly, outcomes of treatment can be further improved by adding atezolizumab to neoadjuvant chemoradiation. As a first step we aim to know whether the addition of atezolizumab feasible. That is, we want to know how the treatment is tolerated and…

A randomized multicenter clinical trial for patients with multi-organ colorectal cancer metastases comparing the combination of chemotherapy and maximal tumor debulking versus chemotherapy alone.

The primary objective of this study is to compare overall survival rates of CRC patients with multi-organ metastases with indication for first line palliative systemic treatment for mCRC, randomized for treatment with combination chemotherapy or…

A Global Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 910 in Subjects With Claudin 18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma

Primary• To evaluate the safety and tolerability of AMG 910 in adult subjects. • To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)Secondary• To characterize the PK of AMG 910• To evaluate preliminary anti-tumor…

Hepatic arterial infusion PUMP chemotherapy combined with systemIc chemoTherapy for potentially resectable colorectal liver metastases

This study has been transitioned to CTIS with ID 2024-515525-28-00 check the CTIS register for the current data. The aim of this study is to prove feasibility of HAIP chemotherapy (floxuridine) in combination with standard systemic chemotherapy…

A randomised Phase III feasibility study to compare radical TME surgery versus preoperative (chemo)radiotherapy and watchful waiting or local excision for treatment of early stage rectal cancer.

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A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)

Primary Objective & HypothesisIn subjects with first line (1L) stage IV MSI-H or dMMR CRC treated with first line (1L) pembrolizumab (MK-3475) versus SOC chemotherapies,Objective: To compare Progression Free Survival (PFS) per RECIST 1.1 by…

Liposomal iRInotecan, Carboplatin or oXaliplatin in the first line treatment of esophagogastric cancer: a randomized phase 2 study (LyRICX)

This study has been transitioned to CTIS with ID 2023-509287-26-00 check the CTIS register for the current data. To compare the progression free survival and neurotoxity of first line treatment with F-Nal-IRI, CapCar and CapOx.