A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients With Advanced Stage or Metastatic...
CYP3A InhibitorAdvanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma3 moreTo explore the possibility to overcome CYP3A-mediated resistance to anticancer drugs in pancreatic cancer, we will investigate the pharmacokinetics, safety, tolerability, and efficacy of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in combination with gemcitabine and the CYP3A inhibitor cobicistat in a phase I proof-of-concept trial to determine the safety profile, the recommended dose of nab-paclitaxel in combination with gemcitabine and cobicistat, and to determine whether there is an early efficacy signal warranting a larger scale trial. The present trial is an open-label trial consisting of a dose-escalation part and an expansion part. The dose escalation part is designed to determine the safety, tolerability, and pharmacokinetics of nab-paclitaxel in combination with gemcitabine and cobicistat and will guide the dosing in the expansion part of the trial. The trial enrolls patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma and adequate performance score (ECOG PS 0-2) who would usually receive gemcitabine and nab-paclitaxel according to standard of care. Primary endpoint for the phase I trial is the safety of the combination. Overall survival (OS), disease control rate (DCR), overall response rate (ORR), duration of response (DoR) and progression free survival (PFS) are secondary efficacy endpoints. Further secondary endpoints are tolerability, pharmacokinetics, pharmacodynamics, and pharmacogenomics.
A Single-arm Exploratory Study of Neoadjuvant Therapy
Lung AdenocarcinomaNeoadjuvant EGFR TKI therapy targeting EGFR mutation has some problems failure to fulfill clinical requirements such as low MPR rate, tissue fibrosis and other major surgical impacts and unmet clinical needs.This study hypothesized that Tisleizumab combined with chemotherapy in the neoadjuvant treatment of stage II-IIIA non-squamous NSCLC with EGFR-mutant PD-L1 expression ≥1% could significantly improve the pathological response rate after neoadjuvant therapy, improve the surgical complete resection rate, reduce perioperative complications and do not increase the surgical difficulty.In this study, biomarker analysis is going to explore the possible direction of neoadjuvant therapy population screening, and to explore a possible method for the efficacy and safety of neoadjuvant immunotherapy in clinical stage II-IIIA non-squamous non-small cell lung cancer with EGFR mutation and expression of PD-L1.
PT886 For Treatment of Patients With Advanced Gastric, Gastroesophageal Junction and Pancreatic...
Gastric AdenocarcinomaPancreas Adenocarcinoma1 morePT886 is a novel bispecific antibody that targets Claudin 18.2 and CD47. Claudin 18.2 is overexpressed in a significant proportion of gastric, esophageal, and pancreatic adenocarcinomas and its restricted expression makes it a promising therapeutic target for the treatment of these carcinomas. Moreover, studies have found that immunoglobulin superfamily CD47 is overexpressed widely across tumor types, and CD47 plays an important role in suppressing phagocytes activity through binding to the transmembrane protein SIRPα in phagocytic cells. Hence by targeting both pathways, one can direct macrophage-mediated phagocytotic activity to tumor cells by blocking the "don't eat me signal" mediated by CD47/ SIRPα interaction, potentially offering a better safety profile than anti-CD47 monoclonal antibodies. This is an open label, Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of PT886 in subjects with advanced or refractory cancers. Patients with the following tumor types will be eligible for screening: unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and pancreatic ductal adenocarcinoma (PDAC) for which there is no available standard therapy.
Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction...
Siewert Type II Adenocarcinoma of Esophagogastric JunctionThe incidence of esophagogastric junction has been increasing in recent years, and surgery is an important method for the treatment of adenoma at the esophagogastric junction. Currently, there is a great controversy about the surgical method of Siewert II, mainly choosing the right chest or the left chest for thoracic surgery. Therefore, it is of great significance to further study the surgical methods of Siewert II esophagogastric junction adenoma. Objective: To compare the safety, feasibility, and clinical efficacy of endoscopic Ivor-Lewis versus laparoscopic extended abdominal gastrectomy for Siewert type Ⅱadenocarcinoma at the resectable esophagogastric junction.
Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
Pancreatic Ductal AdenocarcinomaResectable Pancreatic CancerThis study is a single-arm, phase I trial, up to 16 participants with resectable PDA. The study will examine the efficacy of the mutant IDH1 inhibitor ivosidenib, in conjunction with standard-of-care mFOLFIRINOX in the neoadjuvant setting.
Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion
MesotheliomaNon Small Cell Lung Cancer4 moreThis is a Phase 1/2, open-label, multicenter, study of the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene.
An Evaluation Trial About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells...
CAR T-Cell TherapyAn Evaluation Trial About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells in the Advanced Gastric / Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer Subjects. To evaluate the tolerability and safety of different doses of HEC-016 CAR-T cell injections in patients with advanced gastric / esophagogastric junction adenocarcinoma and pancreatic cancer, to observe dose limiting toxicity (DLT), to determine the maximum tolerated dose (MTD) and to recommend the regimen for subsequent clinical trials.
Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian,...
Low Grade Fallopian Tube Serous AdenocarcinomaOvarian Low Grade Serous Adenocarcinoma10 moreThis phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.
Beyond TME Origins
NeoplasmsAdenocarcinoma1 moreAll patients with recurrent colorectal cancer in the pelvis are eligible. The original primary tumour staging scans and resected surgical specimen needs to be available. Patients' recurrence will be staged using our proposed MRI classification. We will be assessing the original primary staging scans and histopathology to learn about risk factors for recurrence. We will record treatment for the recurrence, and patients will be followed up for three years.
Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma...
Pancreatic CancerThis platform trial will evaluate various immunotherapy combinations given in the neo-adjuvant and adjuvant setting in patients with surgically resectable pancreatic ductal adenocarcinoma.