Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic...
Pancreatic NeoplasmPancreatic Adenocarcinoma1 moreSurgical resection is the only potentially curative treatment for patients with pancreatic cancer with the aim of curative R0 resection and related improvement of survival. As a standard, surgery is usually followed by adjuvant therapy that improves survival but neoadjuvant therapy (NAT) is a rapidly emerging concept that needs to be explored and validated in terms of therapeutic options in borderline resectable pancreatic tumors. In this setting, preoperative FFX seems to be feasible and can be prolonged by radiation therapy. However, the exact and best therapeutic sequence is not yet known and the additional role of adding isotoxic high-dose stereotactic body radiotherapy (iHD-SBRT) to chemotherapy requires validation in randomised trials. We propose to evaluate the impact and efficacy of adding iHD-SBRT to preoperative neoadjuvant mFFX or Gem-NabP in patients with borderline resectable pancreatic adenocarcinoma.
Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery
Pancreas CancerPancreatic Cancer1 moreThis is a randomized phase 1 clinical trial to evaluate the safety of an optimized neoantigen synthetic long peptide (SLP) vaccines in pancreatic cancer patients following neoadjuvant chemotherapy. The neoantigen SLP vaccines will incorporate prioritized neoantigens and will be co-administered with poly-ICLC. Patients will be randomized to one of two arms: Arm 1 (neoantigen vaccine following neoadjuvant chemotherapy and surgery) or Arm 2 (neoantigen vaccine following neoadjuvant chemotherapy in the window prior to surgery). Those who are ineligible for vaccine administration including those whose disease progresses or recurs during neoadjuvant chemo or who are otherwise unable to complete surgical resection but who had a personalized neoantigen vaccine manufactured, or significant progress has been made as determined by treating physician, are permitted to receive vaccine injections on study.
Stereotactic PAncreatic RadioTherapy Adjuvant Therapy
Pancreas CancerWhile surgery is considered the only potentially curative therapy for pancreatic cancer, 5-year overall survival (OS) is typically <25%. Following surgical resection of pancreatic cancer, adjuvant conventionally fractionated RT (CRT, delivering 45-54 Gy in 1.8-2.0 Gy per fraction) with 5-FU chemotherapy is recommended in high-risk patients (positive lymph nodes and/or R1-R2 resection margin status). However, the benefit of CRT in this setting is controversial due to lack of prospective positive data. Moreover, duration of treatment course (delaying initiation of more effective chemotherapy schedules), insufficient dose delivery due potential radiation-related severe toxicity to proximity organs represents a serious limitation to treatment efficacy. Stereotactic Body Radiotherapy (SBRT) is a novel radiotherapy technique consisting of highly focused irradiation with a steep dose gradient, thus allowing the delivery of ablative radiation doses and significant sparing of proximity critical structures. Higher doses per fraction allows for more intensive treatments and shorter duration of the radiation course.
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
Pancreatic CancerPancreatic Ductal Adenocarcinoma1 moreThe PREOPANC-3 study is a randomized, multicenter, phase 3 trial. Patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX (arm 2). The primary objective of the trial is to determine whether perioperative mFOLFIRINOX improves overall survival compared with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer.
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations...
Advanced Pancreatic CarcinomaAnatomic Stage III Breast Cancer AJCC v826 moreThis phase II trial studies if talazoparib works in patients with cancer that has spread to other places in the body (advanced) and has mutation(s) in deoxyribonucleic acid (DNA) damage response genes who have or have not already been treated with another PARP inhibitor. Talazoparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. All patients who take part on this study must have a gene aberration that changes how their tumors are able to repair DNA. This trial may help scientists learn whether some patients might benefit from taking different PARP inhibitors "one after the other" and learn how talazoparib works in treating patients with advanced cancer who have aberration in DNA repair genes.
Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized...
Pancreas AdenocarcinomaResectable Pancreatic CancerThe purpose of this phase 2 research study is to determine whether a combination of chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic cancer, can help to increase the chances of surgeons achieving and R0 resection. The chemotherapy drugs used are gemcitabine and nab-paclitaxel. These drugs are both approved by the FDA for use in treating adults with pancreatic adenocarcinoma. The investigational portion of this study is providing the chemotherapy drugs and radiation therapy before surgery. Primary Endpoint, R) resection rate ≥70%. Secondary Endpoints, Disease free survival, Overall survival , Perioperative mortality and morbidity.
Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer...
Pancreatic Adenosquamous CarcinomaResectable Pancreatic Adenocarcinoma1 moreThis phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, 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. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).
Safety and Efficacy of CEA-Targeted CAR-T Therapy for Relapsed/Refractory CEA+ Cancer
Solid TumorLung Cancer5 moreThis is a single arm study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy for patients with relapsed/refractory CEA+ Cancer,and obtain the recommended dose and infusion plan.
Personalized Precision Diagnosis and Treatment of Pancreatic Cancer
Pancreatic CancerPancreatic cancer (PC) is the 4th common cancer in the world and occupied the second place for digestive tumors, of which the incidence has also increased sharply in China. It harbors a particularly poor prognosis due to the late onset of symptoms and the advanced stage that the disease usually reaches before diagnosis. Therefore, searching more sensitive and accurate tumor markers has great value for application. Circulating tumor cell (CTC) is a noninvasive index that could help diagnosis and monitor the load of tumor, having excellent prospect for clinical application. Early in the formation and growth of a primary tumor (breast, colon, lung, or prostate cancer, et al.), CTC are released into blood. The published studies on CTCs have focused on their prognostic significance, utility in real-time monitoring of therapies, resistance targets and understanding the process of metastasis. Our main purpose is to use the platform to identify correlations between CTC counts and PC progression. Chemotherapy plays an important role in the postoperative treatment for PC. However, the efficiency of chemotherapeutic drugs for PC remains relatively limited. Patient-derived xenograft (PDX) preferably reproduce the clinical biological characteristics of PC, leading that we could deeply study the pathogenesis and metastasis of PC. Moreover, using PDX platform defines drug-resistant PC. From the present study, PDX and Mini-PDX platforms maintained architectural characteristics of the original PC specimen after continuous passaging, which could reflect the preclinical medicine study, better serving the clinical chemotherapy and improving the treatment efficiency. Conditional reprogramming (CR) technique adds no virus or cell oncogene to the non-genetic operation, which will not change any gene phenotype during normal growth and continuous passage of the cells in vitro. After a small sample of PC patient is obtained by CR, the project could enlarge the tumor samples from micro-biopsy tissue samples, and provide a basis for the follow-up of tumor drug susceptibility testing. This experiment also uses ctDNA (circulation tomor DNA)technology to detect the genetic information of PC, through which it is expected to improve personalized precision diagnosis and treatment of PC and help to establish a complete database of individual PC PDX. It provides ideal research materials and platform for basic development and translational medicine research of oncology.
Pancreatic Adenocarcinoma Signature Stratification for Treatment
Pancreatic Cancer MetastaticPancreatic Ductal Adenocarcinoma1 moreThis is a randomized multicentre phase II trial with a large translational component. The trial will evaluate the two standard chemotherapy regimens: modified folfirinox (mFFX) and gemcitabine/nab-paclitaxel (GA), in patients with untreated metastatic pancreatic ductal adenocarcinoma. Integrated into this phase II trial are a number of laboratory components including molecular profiling, patient derived organoid establishment, and drug testing sensitivity and other biomarkers.