The purpose of this study is to compare the diagnosis accuracy of modified wet suction technique and 5ml dry suction technique on solid occupying lesions.
This study aims to investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors.
Systemic treatment for advanced, non-resectable pancreatic cancer still having minimal impact on the survival of patients. Even with the application of more potent gemcitabine-based regimens, survival of more than 1 year is uncommon for advanced disease. Accordingly, there is substantial unmet needs for the improvement of treatment options. The combination and simultaneous application of tumor-targeted L19IL2 with gemcitabine could result in improved anti-cancer efficacy, based on preliminary clinical and strong preclinical data.
The primary purpose of this Phase I study is to define a safe and potentially more active treatment regimen of L19IL2 (escalating doses) combined with gemcitabine for advanced pancreatic cancer patients. Also, early signs of anticancer responses of the L19IL2/gemcitabine regimen will be assessed and compared to historical controls (gemcitabine monotherapy).
Title: Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer.
Protocol code: IRST157.01
Phase: II
Study Design: monocentric, prospective, open-label not randomized trial.
Description of Study Treatment: radio-chemotherapy schedule
* GEMOX: Gemcitabine (GEM) 1000 mg/m2, day 1, and Oxaliplatin (OX) 100 mg/m2, day 2, every 2 weeks for 4 cycles.
* Hypofractionated radiotherapy (35 Gy in 7 fractions in 9 consecutive days, one session per day excluding Saturday and Sunday) administered 15 days after the 4th chemotherapy cycle.
* Further 4 cycles of GEMOX, starting 7-15 days after the end of the radiotherapy.
Objectives:
Step A: primary objective = to evaluate the safety of radiotherapy treatment. Secondary objective = the control of IM (internal margin) intra-fraction.
Step B: primary objective = to evaluate the proportion of the resectable patients after radio-chemotherapy. Secondary objectives = overall Response Rate (ORR); safety profile of combinated treatment;overall survival (OS); local progression free survival (LPFS) and progression free survival (PFS).
Statistical Considerations:
Step A:
Assuming that the probability to observe a toxicity involving the radiotherapy treatment discontinuation with the new treatment is less than 20%, 11 patients are to be evaluated for toxicity. If no toxicity involving the radiotherapy treatment discontinuation will be observed in 11 patients, the treatment can be considered safe with a probability > 90%. If 1 toxicity involving the radiotherapy treatment discontinuation will be observed, 7 more patients needs to be recruited. If no further toxicity involving the radiotherapy treatment discontinuation occurs, the treatment could be considered safe with a probability ≥ 90%.
If 2 or more toxicity involving the radiotherapy treatment discontinuation on 11 patients or 2 or more toxicity involving the radiotherapy treatment discontinuation on 18 patients will be observed, the study will be stopped because not safe and another kind of radiotherapy schedule must be designed.
Step B:
If the radiotherapy treatment will be considered no toxic, the study will continue in Step B : the goal of this phase II study is to increase the proportion of resectable patients of at least 15% with the new radio-chemotherapeutic treatment. By using the single-stage design (Gehan EA, J Chron Dis 1961) a total of 40 patients is required to be recruited in 2 years, and a further one-year period of follow-up is requested. If at least 7 patients out of 40 enrolled will be resectable, the hypothesis that the proportion of resectable patients will be less or equal to P1 (P1=the proportion of resectable patients with the new radio-chemotherapeutic treatment) will be refused and the treatment could be considered active.
This study is a single-center, Phase II Study to assess the efficacy and safety of the regimen of Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in combination with Cadonilimab in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.
This randomized study examines how well zinc works in improving quality of life in patients with gastrointestinal cancer that cannot be removed by surgery who are receiving chemotherapy. Zinc may help to improve patient's quality of life by preventing zinc deficiency.
This trial is a prospective, exploratory and descriptive study. The primary objective is to identify early diagnostic biomarkers in patients with TIPMP based on the analysis of Treg lymphocyte subpopulations and epigenetic signatures, and the secondary objective is to characterize the biological processes underlying the transformation of a pre-neoplastic lesion into established ADPC.
Study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated subcutaneous (SC-injected under the skin) doses.
The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
NRG1 gene fusions are extremely rare across solid tumours (estimate 0.3-0.5%). However, it is felt to be an actionable and potentially major growth pathway for those tumours that harbour this gene rearrangement. Tumours that harbour NRG1 fusions are driven by HER3 overactivation. Seribantumab is a mono-clonal antibody against HER3, it binds HER3 and inhibits NRG1-dependent activation and HER2 dimerization.
