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An open-label, randomised, non-comparative phase 2 study evaluating S 95005 (TAS-102) plus bevacizumab and capecitabine plus bevacizumab in patients with previously untreated metastatic COlorectal cancer who are non-eligible for intensive therapy (TASCO1 study)

This study will evaluate 2 different treatment strategies : a combination of S 95005 and bevacizumab (experimental combination) and a combination of capecitabine and bevacizumab (control arm) as first-line treatment for metastatic colorectal cancer…

Pathogenic microbes: an exploration for their driving role in colitis associated cancer

To identify pathogenic bacterial biofilms in UC-patients with and without neoplasia in tandem with host factors such as barrier defects and carcinogenic pathway activation in a prospective cohort study.

89Zr-AMG211 PET imaging in patients with relapsed/refractory gastrointestinal adenocarcinoma before and during treatment with AMG 211.

Primary objective: To evaluate the in vivo biodistribution (measured in SUV) and quantitative radioactivity in organs of 89Zr-AMG211 in patients with relapse/refractory gastrointestinal adenocarcinoma as assessed by PET/CT. Secondary objectives: I)…

Free circulating tumour DNA in patients with peritoneal metastases of colorectal origin and HIPEC therapy; LIBEC trial - a feasibility study

To evaluate the detection ctDNA in patients with PC of colorectal origin undergoing cytoreductive surgery and HIPEC at time of diagnosis in a feasibility trial This study is considered feasible:1. If in at least 70% of the patients ctDNA status…

Intraoperative detection of tumor tissue in pancreatic cancer using a VEGF-targeted optical fluorescent imaging tracer

Part 1 1. Determine if accumulation of the fluorescent tracer bevacizumab-800CW can be detected for identification of pancreatic cancer tissue during surgery.2. Identify two doses of conjugate that provide the best visualization of tumor tissue…

Improved screening of esophageal cancer by optical detection of field cancerization.

1. Evaluate the feasibility of ESS for detection of field cancerization in BE patients. 2. Investigate the biological background of field cancerization by studying: a) (ultra)structural changes in the tissue and b) genetic abnormalities and clonal…

The effects of the proton pump inhibitor esomeprazole on the bioavailability of regorafenib in patients with a metastatic colorectal cancer (mCRC) or gastrointestinal stromal tumour (GIST).

To determine the influence of esomeprazole on the AUC of regorafenib in patients with mCRC or GIST.

Accuracy of MRI versus CT iMAGing to assess resectability following FOLFIRINOX for locally advancEd pancreatic cancer (IMAGE)

The primary objective of this study is to investigate the capability of diffusion weighted magnetic resonance imaging (DWI) to assess tumor resectability after FOLFIRINOX, compared to standard CT scan.

Molecular fluorescence endoscopy for the detection of (pre)malignant lesions in Barrett*s esophagus using a fluorescent tracer EMI-137 targeting c-Met: a single-center feasibility and safety study.

Primary objective: - To determine the feasibility of molecular fluorescence endoscopy using the fluorescent tracer EMI-137 in order to identify dysplasia and/or malignant lesions in patients with Barrett*s esophagus. - To evaluate the safety of EMI-…

Postoperative telerehabilitation to improve functional recovery in patients after esophagectomy: a feasibility-study

Primary Objective: To investigate the feasibility of a 12 -week postoperative Telerehabilitation program for patients with esophageal cancer treated with esophagectomy and suffering from postoperative complicationsSecondary Objective: To investigate…

Cancer Cachexia: Organ-specific Protein Synthesis 2

Primary Objectives:1. To compare protein synthesis rate of the tumour and normal pancreas between cachectic and non-cachectic patients with pancreatic cancer.Secondary Objective(s):1. To compare protein synthesis rate of liver, intestinal, adipose…

Comparison of laparoscopic procedures with and without the aid the AutoLap system - a Robotic Camera Holder

The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections (right hemicolectomy, left hemicolectomy/sigmoid resection), anti-reflux/hiatal hernia…

A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab with a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients with BRAF V600E mutant Metastatic Colorectal Cancer

Safety Lead-inIn patients with BRAF V600E mutant (BRAFV600E) metastatic colorectal cancer (mCRC):Primary: • Assess the safety/tolerability of the combination of encorafenib + binimetinib + cetuximabSecondary:• Assess the activity of encorafenib +…

Endoscopic sphincterotomy before fully covered self-expandable metal stent placement for malignant extrahepatic biliary obstruction to prevent pancreatitis: a randomised controlled trial

To investigate the role of endoscopic sphincterotomy prior to biliary fully covered SEMS (FCSEMS) placement in the prevention of post-ERCP pancreatitis.

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…

Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone: a multicentre, open-label, parallel-group, phase II-III, randomised superiority study (CAIRO6).

This study has been transitioned to CTIS with ID 2024-518570-13-00 check the CTIS register for the current data. Objectives of the phase II study (80 patients) are to explore the feasibility of accrual, the feasibility, safety, and tolerance of…

A Phase III Study of BBI-608 in combination with 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients with Previously Treated Metastatic Colorectal Cancer (CRC)

Primary objective of the study:* To compare overall survival (OS) in the General Population patients treated with BBI-608 plus biweekly FOLFIRI (Arm 1) versus biweekly FOLFIRI (Arm 2)* To compare OS in the pSTAT3-positive (pSTAT3(+)) Subpopulation…

Treatment of PERitoneal dissemination in Stomach Cancer patients with
cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: the
PERISCOPE II study

This study has been transitioned to CTIS with ID 2023-510159-53-01 check the CTIS register for the current data. The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis…

Neoadjuvant immune checkpoint inhibition and novel IO combinations in early-stage colon cancer. The NICHE trial.

This study has been transitioned to CTIS with ID 2024-513314-35-00 check the CTIS register for the current data. Primary Objective: To determine the safety and feasibility of pre-operative immunotherapy in CRC. Additional Primary Objective for the…

A multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery vs. neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery vs. neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer

This study has been transitioned to CTIS with ID 2023-503248-15-00 check the CTIS register for the current data. • To assess which preoperative regimen provides superior event free survival 1 year after randomisation in patients with resectable…