25 results
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,…
Primary Safety Objective * Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602*2403 mg/d and nintedanib at a dose of 200*300 mg/d Secondary Safety Objective * Proportion of patients who discontinue…
This study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone treatment (study treatments) in patients with advanced idiopathic pulmonary fibrosis (IPF) and intermediate or high probability of Group 3…
* The primary objective of this study is:- the study of the response rate and the macroscopic and microscopic response charactheristics of neo-adjuvant chemotherapy of patients with peritoneal carcinomatosis (PC) of colorectal origin. * Secundary…
The primary objective of this study is to determine whether the addition of induction chemotherapy to the neoadjuvant treatment of patients with locally recurrent rectal cancer results in more R0 resections compared to treatment with neoadjuvant…
Investigate whether perioperative mFOLFIRINOX improves overall survival compared to adjuvant mFOLFIRINOX in resectable pancreatic cancer.
The purpose of this Safety Lead In study is to explore if encorafenib and cetuximab in combination with a chemotherapy regimen (either mFOLFOX6 or FOLFIRI) are safe and have beneficial effects on you and your colorectal cancer. This is a small…
• To assess which preoperative regimen provides superior event free survival 1 year after randomisation in patients with resectable gastric cancer
The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and hyperthermic…
Primary objective:- to study the safety, tolerability and feasibility of gastrectomy combined with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) after neoadjuvant systemic chemotherapy as primary treatment option for…
The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of BMS-986178 administered alone or in combination with nivolumab and/or ipilimumab in…
Primary objectiveThe primary objective is to evaluate the effect of Pirfenidone on the change in FEV1 over 6 months in lung transplant recipients with BOS, who are treated with Azithromycin.Secondary objectives The secondary objectives involve the…
The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…
Primary ObjectivesThe main purpose of this study is to compare how long subjects with oesophageal cancer live overall (called overall survival, OS) or live without disease progression (called progression free survival, PFS) after receiving BMS-…
to investigate the safety and tolerability of pirfenidone in asbestosis patients
The primary study objective is to compare the efficacy, as assessed by overall survival, of surgery and neo-adjuvant chemotherapy to surgery alone in patients with resectable liver metastases of colorectal cancer and a high clinical risk score.…
Primary objective:To assess the effect of immediate versus delayed start of chemotherapy on quality adjusted survival in patients with metastatic pancreatic cancer. Secondary Objectives:To determine time to disease progression after randomizationTo…
Primary Objective: - To establish the population range (24-h AUC) of high-dose infusional 5-FU in patients with locally advanced, resectable gastric or gastro-esophageal junction cancer treated with perioperative FLOT.Secondary objectives: - To…
Primary objective: To explore the safety and feasibility of neoadjuvant capecitabine, oxaliplatin, docetaxel, and atezolizumab in GE-junction and gastric adenocarcinoma Secondary objectives: • To assess pathological tumor regression and rates of…
To prospectively explore the feasibility safety, tolerability, preliminary efficacy, costs, and pharmacokinetic profile of repetitive ePIPAC-OX as a palliative monotherapy for isolated unresectable colorectal PM under controlled circumstances.