The purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticulate paclitaxel in patients with refractory malignancies principally confined to the peritoneal cavity.
This study will develop a whole-of-body markerless tracking method for measuring the motion of the tumour and surrounding organs during radiation therapy to enable real-time image guidance.
Routinely acquired patient data will be used to improve the training, testing and accuracy of a whole-of-body markerless tracking method. When the markerless tracking method is sufficiently advanced, according to the PI of each of the data collection sites, the markerless tracking method will be run in parallel to, but not intervening with, patient treatments during data acquisition.
This phase I trial is studying the side effects and best dose of dovitinib lactate when given together with gemcitabine hydrochloride and capecitabine in treating patients with advanced or metastatic solid tumors or advanced pancreatic cancer. Dovitinib lactate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving dovitinib lactate together with combination chemotherapy may kill more tumor cells
Pancreatic cancer is a group of malignant tumors mainly originated from pancreatic ductal epithelium and follicular cells, with high degree of malignancy, insidious onset, difficult early diagnosis, rapid progression, short survival time, and one of the malignant tumors with the worst prognosis, which is known as the "king of cancers". In recent years, the incidence rate of pancreatic cancer has been increasing both at home and abroad. At present, the palliative treatment of advanced pancreatic cancer is still mainly based on chemotherapy, such as FOLFIRINOX regimen. And after standard first-line treatment, most of the patients have problems such as poor physical status, no standard treatment options and limited options available.
Capecitabine is a selective fluorouracil methionine salt antitumor drug, belongs to the pyrimidine class of antimetabolites, and is the precursor drug of 5-fluorouracil. Its first-line monotherapy for pancreatic cancer is 24% effective, and it is directly recommended by NCCN 2024 V2.0 as a second-line treatment for patients with pancreatic cancer who have failed gemcitabine therapy.The 2024 CSCO Guidelines for Pancreatic Cancer recommend the use of 5-fluorouracil (5-FU)-like regimens as a second-line treatment for patients who have been treated with a gemcitabine-based regimen as first-line treatment. In a clinical study exploring capecitabine in gemcitabine-treated patients with metastatic or unresectable locally advanced pancreatic cancer, 42 patients received oral capecitabine 1,250 mg/m2 twice daily (2,500 mg/m2/d) as intermittent therapy in 3-week cycles consisting of 2 weeks of dosing followed by 1 week of withdrawal. A total of 4 remissions were achieved in 42 evaluable patients, for an overall remission rate of 9.5%.
Irinotecan Hydrochloride Liposome Injection, the first domestic generic product developed by Shiyao Group, was launched in China in September 2023 with an approved indication for use in combination with 5-FU and calcium folinate (LV) in patients with metastatic pancreatic cancer that has progressed after treatment with gemcitabine. Liposomal irinotecan hydrochloride has been studied in a number of indications including biliary tract cancer, colorectal cancer, glioma, gastric cancer, small cell lung cancer, cervical cancer, breast cancer, head and neck cancer, esophageal cancer, and neuroendocrine cancer. In the bioequivalence trial of Shiyi Group's irinotecan hydrochloride liposome injection, the ORR rate reached 12.9%, the median PFS was 6.24 months, and the median OS was 10.38 months; indicating similar efficacy and a similar safety profile. A randomized, open-label, phase 3 NAPOLI 3 study and the first phase 3 trial comparing two combination chemotherapy regimens in the first-line treatment of patients with pancreatic ductal carcinoma head-to-head was designed to compare the efficacy and safety differences between the NALIRIFOX regimen (irinotecan liposomal, fluorouracil, and calcium folinic acid in combination with oxaliplatin) versus the doublet regimen (gemcitabine + albumin-conjugated paclitaxel) in the first-line treatment of metastatic pancreatic ductal carcinoma efficacy and safety differences in the treatment of metastatic pancreatic ductal cancer. The results showed that the median OS in the NALIRIFOX treatment group was 11.1 months, while the median OS in the dual combination treatment group was 9.2 months (HR=0.83; 95% CI 0.70-0.99; p=0.036).
Based on the above literature research, combined with the efficacy and safety advantages of irinotecan liposome chemotherapy combination regimen in patients with metastatic pancreatic cancer, we propose to carry out a phase II clinical study of irinotecan liposome combined with capecitabine in the second-line treatment of advanced pancreatic cancer. The aim is to explore the efficacy and safety of irinotecan liposomal chemotherapy combined with capecitabine in second-line unresectable or metastatic pancreatic cancer patients, and to explore more effective clinical options for patients with pancreatic cancer that has progressed after previous treatment.
In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of upper GI, lower GI and hepatobiliary surgery with anastomosis formation in open or laparoscopic surgery. Postoperatively, a detailed software-based assessment of each recording is performed to determine the objective ICG-NIRF perfusion rate before and after anastomosis formation, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak.
The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.
The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.
The main purpose of this study is to learn whether or not the combination of gemcitabine, bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved by the FDA for the treatment of colorectal cancer but is still considered investigational for treating pancreatic cancer.
PACAP-1 will evaluate to what extent an enhanced implementation of best practices in pancreatic cancer care leads to a prolonged survival and improvement of quality of life as compared to current practice.
Multicenter, open-label, phase 1, cohort dose escalation study to determine the Maximum Tolerated Dose (MTD) of OSI-906 in combination with erlotinib
Gemcitabine is considered one of the standard drugs for advanced pancreatic cancer and is approved by the FDA to treat it. Cabozantinib is a new drug that has demonstrated effectiveness against pancreatic cancer in laboratory experiments, especially when given with gemcitabine. Initial studies with cabozantinib in pancreatic cancer have shown some activity against the disease. The purpose of this study is to determine the safest and highest dose of cabozantinib that can be given together with standard doses of gemcitabine in patients with pancreatic cancer. This study will determine the safety and tolerability of this two drug combination.
