scholarly journals Targeting Pancreatic Ductal Adenocarcinoma (PDAC)

2020 ◽  
Vol 55 (1) ◽  
pp. 61-90
Keyword(s):  
Overall Survival ◽  
Standard Of Care ◽  
Ductal Adenocarcinoma ◽  
Current Standard ◽  
Pancreatic Cancers ◽  
Experimental Drugs ◽  
Chemotherapeutic Approach ◽  
Physiology And Biochemistry ◽  
Recent Developments ◽  
The Mean

Pancreatic cancers are among the most ominous, and among the most studied. Their complexities have provided ample material for a huge investigative effort, which is briefly surveyed in this review. Eradication by surgery has proven extremely difficult, and a successful chemotherapeutic approach is desperately needed. Treatment with "traditional" anticancer drugs, such as benchmark gemcitabine or the current standard-of-care FOLFIRINOX quaternary combination increase the mean overall survival by only a few months and often leads to chemoresistance. Much work is therefore currently devoted to potentiating our pharmacological weapons by accurate targeting and, in particular, by acting on the dense tumoral stroma, a distinctive feature of PDAC accounting for much of the therapeutic difficulty. We give an overview of recent developments, touching on the major aspects of PDAC physiology and biochemistry, currently-used and experimental drugs, and targeting technologies under development. A few papers are discussed in some detail to help provide a sense of how the field is moving.

A Direct Comparison of High Dose Cytarabine to Combination of Gemtuzumab and High Dose Cytarabine for Acute Myeloid Leukemia Patients in First Relapse Confirmed the Benefit of Gemtuzumab Based Regimens.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2051-2051
Author(s):  
Thomas Prébet ◽  
Aude Charbonnier ◽  
Anne Etienne ◽  
Evelyne D'Incan ◽  
Sabine Fürst ◽  
...  
Keyword(s):  
Overall Survival ◽  
Response Rate ◽  
Standard Of Care ◽  
Allogeneic Transplantation ◽  
Control Group ◽  
High Dose ◽  
Current Standard ◽  
Advanced Phase ◽  
High Dose Cytarabine ◽  
First Relapse

Abstract Abstract 2051 Poster Board II-28 Acute meyloid leukemia (AML) in first relapse is associated with a poor outcome when treated with standard dose cytarabine regimens and intermediate to high dose cytarabine (IHDAraC) is the current standard of care. During the last years, Gemtuzumab Ozogamycin (GO) has demonstrated a relevant clinical activity in relapsed and refractory AML. This antibody directed against CD33 is conjugated to calicheamycin that triggers apoptosis when hydrolyzed in the leukemic blasts. Combination regimen of GO are currently extensively studied in both frontline and advanced phase disease. Nevertheless, analysis of the litterature showed that only few data are available regarding a direct comparison of IHDAraC and IHDAraC+GO regimen. To this respect, we conduced a retrospective analysis of response (CR and CRi) and survival for patients with first relapse AML treated in our centre with either IHDAraC or IHDAraC+GO regimen. A total of 84 patients were included in the analysis: 28 were induced in the IHDAraC+GO group (mean GO dose: 6mg/m2, range:[3-9], including 82% of combination with anthracyclines or etoposide) and 56 in the IHDAraC group (including 57% of combination with other agents, mostly etoposide and anthracyclines). Patients characteristics were comparable between the IHDAraC+GO group and the control group in terms of median age (51y vs 49y), Performance Status at relapse (1 vs 1), median time to relapse (221 days vs 280 days), cytogenetic risk group clustering and previous allogeneic transplantation in first CR (21% vs 16%). Median Follow-up was 24 months. Univariate analysis showed that IHDAraC+GO induction, as compared with IHDAraC, was associated with a better response rate (68% vs 48%, p=0.08), a lower relapse rate (31% vs 66%, p=0.02), a better Overall Survival (median 35 months vs 19 months, p=0.02) and a better Event Free Survival (median Not Reached vs 10 months, p=0.02). Of note, the better response rate in the IHDAraC+GO group allowed to bring more patients to allogeneic transplantation in second CR (33% vs 16% respectively, p=0.08).Multivariate analysis using logistic regression method for response evaluation and Cox model for survival showed that treatment in the IHDAraC+GO group was an independent prognosis factor with a favorable impact on both response (HR:2.8, 95%CI:[1.1-7.7], p=0.048) and Overall Survival (HR:1.9, 95%CI:[1.1-3.4], p=0.047). It is already known that combination of IHDAraC and GO could give good results for advanced phase AML patients but, to our knowledge, this report is the first that directly compared the results of IHDAraC+GO with the current standard of care regimen on an homogeneous sample of patients in first relapse. This report also underline the importance of a prospective comparison in order to define the best combination therapy. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Rationale and Clinical Implications of Fluorescein-Guided Supramarginal Resection in Newly Diagnosed High-Grade Glioma

2021 ◽  
Vol 11 ◽  
Author(s):  
Linda M. Wang ◽  
Matei A. Banu ◽  
Peter Canoll ◽  
Jeffrey N. Bruce
Keyword(s):  
Overall Survival ◽  
Surgical Resection ◽  
Local Treatment ◽  
Standard Of Care ◽  
High Grade Glioma ◽  
Extent Of Resection ◽  
Brain Parenchyma ◽  
Clinical Implications ◽  
Current Standard ◽  
Supramarginal Resection

Current standard of care for glioblastoma is surgical resection followed by temozolomide chemotherapy and radiation. Recent studies have demonstrated that >95% extent of resection is associated with better outcomes, including prolonged progression-free and overall survival. The diffusely infiltrative pattern of growth in gliomas results in microscopic extension of tumor cells into surrounding brain parenchyma that makes complete resection unattainable. The historical goal of surgical management has therefore been maximal safe resection, traditionally guided by MRI and defined as removal of all contrast-enhancing tumor. Optimization of surgical resection has led to the concept of supramarginal resection, or removal beyond the contrast-enhancing region on MRI. This strategy of extending the cytoreductive goal targets a tumor region thought to be important in the recurrence or progression of disease as well as resistance to systemic and local treatment. This approach must be balanced against the risk of impacting eloquent regions of brain and causing permanent neurologic deficit, an important factor affecting overall survival. Over the years, fluorescent agents such as fluorescein sodium have been explored as a means of more reliably delineating the boundary between tumor core, tumor-infiltrated brain, and surrounding cortex. Here we examine the rationale behind extending resection into the infiltrative tumor margins, review the current literature surrounding the use of fluorescein in supramarginal resection of gliomas, discuss the experience of our own institution in utilizing fluorescein to maximize glioma extent of resection, and assess the clinical implications of this treatment strategy.

scholarly journals RARE-09. CYSTIC GLIOBLASTOMA PRESENTATION AS A BENEFICIAL PROGNOSTIC INDICATOR FOR OVERALL SURVIVAL

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi223-vi223
Author(s):  
Lee Curtin ◽  
Paula Whitmire ◽  
Cassandra Rickertsen ◽  
Peter D Canoll ◽  
Maciej Mrugala ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Benefit ◽  
Standard Of Care ◽  
Prognostic Impact ◽  
Current Standard ◽  
Significant Survival Benefit ◽  
Care Treatment ◽  
Significant Survival ◽  
Cystic Component ◽  
Standard Of Care Treatment

Abstract Glioblastoma (GBM) is the most aggressive primary brain tumor with a median overall survival of 15 months with standard-of-care treatment. GBM patients sometimes present with a cystic component, which can be identified through magnetic resonance imaging (MRI). Previous studies suggest that cysts occur in 7–22% of GBM patients and have reported mixed results regarding whether cystic GBM have a survival benefit compared to noncystic GBM. Using our large retrospective cohort of 493 first-diagnosis GBM patients, we aim to elucidate this link between cystic GBM and survival. Within this cohort, 88 patients had a significant cystic component at presentation as identified on MRI. Compared to noncystic GBM (n=405), cystic GBM patients had significantly better overall survival (15 vs 22 months median, log-rank, p=0.001) and were significantly younger at the time of presentation (t-test, p=0.002). However, within patients that received current standard-of-care treatment (n=184), cystic GBM (n=40) was not as beneficial for outcome (22 vs 25 months, log-rank, p=0.3). We also did not observe a significant survival benefit when comparing this standard-of-care cystic cohort to cystic GBM patients diagnosed before the standard was established (n=19, 25 vs 23 months, log-rank, p=0.3), but the analogous result for noncystic GBM patients gives a sizeable benefit, as expected (n=144, n=111, respectively, 22 vs 12 months, log-rank p < 0.0001). Together, these results on current standard-of-care may explain later studies that note no significant survival benefit for cystic GBM patients receiving current standard-of-care. We also report differences in the absolute and relative sizes of imaging abnormalities on MRI and in prognostic impact of cysts based on sex. We discuss current hypotheses for these observed differences, including the possibility that the presence of a cyst could be indicative of a less aggressive tumor.

scholarly journals Therapies for Type 1 Diabetes: Current Scenario and Future Perspectives

2019 ◽  
Vol 12 ◽  
pp. 117955141984452 ◽  
Author(s):  
Varun Pathak ◽  
Nupur Madhur Pathak ◽  
Christina L O’Neill ◽  
Jasenka Guduric-Fuchs ◽  
Reinhold J Medina
Keyword(s):  
Type 1 Diabetes ◽  
Islet Cells ◽  
Standard Of Care ◽  
Current Standard ◽  
Post Transplantation ◽  
Prediction And Prevention ◽  
Recent Developments ◽  
Current Scenario ◽  
Long Acting

Type 1 diabetes (T1D) is caused by autoimmune destruction of insulin-producing β cells located in the endocrine pancreas in areas known as islets of Langerhans. The current standard-of-care for T1D is exogenous insulin replacement therapy. Recent developments in this field include the hybrid closed-loop system for regulated insulin delivery and long-acting insulins. Clinical studies on prediction and prevention of diabetes-associated complications have demonstrated the importance of early treatment and glucose control for reducing the risk of developing diabetic complications. Transplantation of primary islets offers an effective approach for treating patients with T1D. However, this strategy is hampered by challenges such as the limited availability of islets, extensive death of islet cells, and poor vascular engraftment of islets post-transplantation. Accordingly, there are considerable efforts currently underway for enhancing islet transplantation efficiency by harnessing the beneficial actions of stem cells. This review will provide an overview of currently available therapeutic options for T1D, and discuss the growing evidence that supports the use of stem cell approaches to enhance therapeutic outcomes.

scholarly journals OP0154-HPR EFFECT OF NURSE-LED-CARE ON PATIENT OUTCOMES IN RHEUMATOID ARTHRITIS IN GERMANY: A MULTICENTRE RANDOMISED CONTROLLED TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 97-98
Author(s):  
J. R. Hoeper ◽  
G. Gauler ◽  
D. Meyer-Olson ◽  
K. Rockwitz ◽  
P. Steffens-Korbanka ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Standard Of Care ◽  
Research Support ◽  
Current Standard ◽  
Clinical Nurse ◽  
Clinical Nurse Specialists ◽  
The Mean ◽  
Secondary Outcomes ◽  
Over Time

Background:Inflammatory rheumatic disorders are very complex and require high medical resources. However, there is a shortage of care for these patients, which results in suboptimal reach of therapy objectives. Nevertheless, these very objectives need to be pursued quickly to prevent permanent joint damage. In order to ensure adequate care, multidisciplinary teams which include clinical nurse specialists are required. These clinical nurse specialists play an important role in improving standard-of-care in addition to the rheumatologist. The current standard of care ensures that essential medical provision remains intact, however, psychological, social, rehabilitative and educational needs are often skipped due to time constraints. While studies from e.g. the UK and Denmark have already supported the non-inferiority of nurse-led care (NLC)1, no such studies have yet been published in Germany.Objectives:To demonstrate the non-inferiority of NLC to the current standard-of-care, rheumatologist-led care (RLC), for patients with seropositive rheumatoid arthritis (RA) with induction, escalation or change of therapy regarding disease activity as well as different patient reported outcomes (PROs).Methods:This trial was conducted as a prospective multi-centered RCT with a non-inferiority design over the course of 12 months. Based on power calculations, 236 adults with RA were included in the study and randomized to either NLC or RLC. The primary outcome measure is disease activity (DAS28), assessed at baseline (T0), 6 weeks (T1), 3,6, 9, and 12 months (T3, T6, T9, T12). Secondary measures are health related quality of life (RAID), functionality (FFbH) and depression (PHQ9).Results:There are no significant differences between intervention group (IG) (n=117) and control group (CG) (n=119) at baseline. The mean age of the IG is 58.80 years (SD=12.09) and of the CG 58.34 years (SD=11.72). 72.4% of the IG and 78.1% of the CG are female. The mean duration of symptoms was 147 months (SD=144.63) for the IG and 116 months (108.89) for the CG. The mean DAS28 for the IG is 4.36 (SD=1.24) and 4.51 (SD=1.24) for the CG.A mixed one-way repeated measures ANOVA showed that the DAS28 improves significantly over time, Huyn-FeldtF(4.42, 751.72) = 105.701,p< .001, partialη2= 0.383, but the interaction of the DAS28 and the randomization is not significant, Huyn-FeldtF(4.42, 751.72) = 1.464,p= 0.260, partialη2= 0.009. No main effect for randomization was found, meaning that the IG and CG did not differ significantly,F(1, 170) = 1.005,p= 0.317, partialη2= 0.006.The Mann-Whitney-Test showed that the change of the secondary outcomes does not depend on the randomization FFbHU= 4978.50,Z= -.755,p=.450. RAIDU= 5121.00,Z= -.539,p=.590. PHQ9U= 4800.50,Z= -1.281,p=.200. The secondary outcomes improve significantly over time, as shown by a Wilcoxon Signed Rank test for the FFbHZ= -5.589,p< .001, the RAIdZ= -9.884,p< .001 and the PHQ9Z= -7.960,p< .001.Conclusion:The results support the non-inferiority of NLC in the management of RA regarding the primary and secondary outcome measures and provide first evidence that NLC could improve care and help carry the doctors’ workflow.Figure 1.Figure 2.References:[1]de Thurah A, Esbensen BA, Roelsgaard IK, et al. Efficacy of embedded nurse-led versus conventional physician-led follow-up in rheumatoid arthritis: a systematic review and meta-analysis. RMD Open 2017;3:e000481.Disclosure of Interests:Juliana R Hoeper: None declared, Georg Gauler Consultant of: Abbvie, Lilly, MSD, Speakers bureau: Abbvie, Celgene, Novartis, Sanofi,, Dirk Meyer-Olson Grant/research support from: Novartis, Sandoz Hexal, Consultant of: Abbvie, Amgen, Bristol Myers Squibb, Chugai, Lilly, Mylan, Novartis, Sandoz Hexal, Sanofi, Speakers bureau: Abbvie, Bristol Myers Squibb, Chugai, Lilly, Novartis, Pfizer, Sandoz Hexal, Sanofi, Karin Rockwitz Consultant of: Janssen Cilag, Speakers bureau: Janssen Cilag, Patricia Steffens-Korbanka Consultant of: Abbvie, Chugai, Novartis, Sanofi, Mylan, Lilly, Speakers bureau: Abbvie, Chugai, Novartis, Sanofi, Lilly, Carsten Stille: None declared, Jochen Walter Consultant of: Pfizer, Speakers bureau: AbbVie, Frauenhofer Institut, Gilead, Janssen-Cilag, Medac, Novartis, Pfizer, Martin Welcker Grant/research support from: Abbvie, Novartis, UCB, Hexal, BMS, Lilly, Roche, Celgene, Sanofi, Consultant of: Abbvie, Actelion, Aescu, Amgen, Celgene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Speakers bureau: Abbvie, Aescu, Amgen, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB, Joerg Wendler Consultant of: Janssen, AbbVie, Sanofi, Speakers bureau: Roche, Chugai, Janssen, AbbVie, Novartis, Jan Zeidler: None declared, Kirsten Hoeper Consultant of: AbbVie, Celgene,, Speakers bureau: Abbvie, Chugai, Novartis, Lilly, Celgene, Sandoz Hexal

Präzisionsonkologie und molekulare Tumorboards – Konzepte, Chancen und Herausforderungen

2017 ◽  
Vol 142 (22) ◽  
pp. 1676-1684 ◽  
Author(s):  
Julian Holch ◽  
Christoph Westphalen ◽  
Wolfgang Hiddemann ◽  
Volker Heinemann ◽  
Andreas Jung ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Genetic Analysis ◽  
Treatment Strategies ◽  
Standard Of Care ◽  
Tumor Board ◽  
Precision Oncology ◽  
Current Standard ◽  
Recent Developments ◽  
Tumor Types ◽  
New Strategies

AbstractRecent developments in genomics allow a more and more comprehensive genetic analysis of human malignancies, and have sparked hopes that this will contribute to the development of novel targeted, effective and well-tolerated therapies.While targeted therapies have improved the prognosis of many cancer patients with certain tumor types, “precision oncology” also brings along new challenges. Highly personalized treatment strategies require new strategies for clinical trials and translation into routine clinical practice. We review the current technical approaches for “universal genetic testing” in cancer, and potential pitfalls in the interpretation of such data. We then provide an overview of the available evidence supporting treatment strategies based on extended genetic analysis. Based on the available data, we conclude that “precision oncology” approaches that go beyond the current standard of care should be pursued within the framework of an interdisciplinary “molecular tumor board”, and preferably within clinical trials.

scholarly journals EPID-18. NATIONAL TRENDS IN THE USE OF TARGETED AND IMMUNOTHERAPY IN THE UP FRONT MANAGEMENT OF GLIOBLASTOMA

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi78-vi78
Author(s):  
Rodney Wegner ◽  
Richard White ◽  
Stephen Abel ◽  
Alexander Yu ◽  
Linda Xu ◽  
...  
Keyword(s):  
Overall Survival ◽  
Standard Of Care ◽  
Current Standard ◽  
Caucasian Race ◽  
Analysis Survival ◽  
Overall Survival Benefit ◽  
Multimodality Approach ◽  
National Trends ◽  
Treatment Trends ◽  
Lost To Follow Up

Abstract BACKGROUND Current standard of care for GBM involves an aggressive multimodality approach including surgical resection followed by adjuvant chemoradiation. Despite this approach, overall survival remains poor and treatment approaches continue to evolve. Given the successes of immunotherapy in other disease sites, implementation in GBM management may improve outcomes. METHODS We conducted this retrospective NCDB study to analyze treatment trends and outcomes from 2004–2015 regarding immunotherapy for GBM. We excluded patients treated without surgery, extracranial radiation, or chemotherapy as well as those lost to follow up. RESULTS Of the 39,317 eligible patients in this study, 511 were treated with immunotherapy and 38,806 lack thereof. Median overall survival for all patients was 15 months with a 2 and 5 year survival rate of 29% and 8%, respectively. Factors influencing delivery of immunotherapy included younger age, higher income, facility location in a metropolitan location, greater distance to the treatment facility, treatment at an academic facility, treatment outside of the years 2007 to 2009, and Caucasian race. On propensity matched analysis, survival was 18 months and 17 months with and without immunotherapy, respectively (p=0.15). Higher comorbidity, lower income, and male gender predicted for worse survival. CONCLUSIONS The results of this analysis show an initial decrease and then increase in the use of immunotherapy in the management of GBM. Propensity-matched analyses did not show an overall survival benefit.

scholarly journals What is a clinically meaningful survival benefit in refractory metastatic colorectal cancer?

2019 ◽  
Vol 26 (2) ◽  
Author(s):  
Y. J. Ko ◽  
M. Abdelsalam ◽  
P. Kavan ◽  
H. Lim ◽  
P. A. Tang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Metastatic Colorectal Cancer ◽  
Clinical Benefit ◽  
Policy Decision ◽  
Standard Of Care ◽  
Current Standard ◽  
Cancer Treatments ◽  
Medical Oncologists ◽  
Definition Of

Assessment of the clinical benefit of cancer treatments can be highly subjective, influenced by both perspective and context. Such assessments are required in regulatory and policy decision-making, but consistency between jurisdictions is often lacking. Clear and consistent standards for determining when a treatment offers a meaningful benefit, relative to the current standard of care, can help to address issues of equity and transparency in health technology assessment.    For metastatic colorectal cancer (mcrc), no standardized Canadian definition of clinically meaningful benefit has yet been proposed. Colorectal Cancer Canada therefore convened a group of medical oncologists expert in colorectal cancer to review the literature about clinical significance. The resulting consensus is intended to apply to any therapeutic agent being considered in the setting of chemotherapy-refractory mcrc.    It was agreed that overall survival is the appropriate measure of clinical efficacy in chemorefractory mcrc. As quantitative targets for efficacy, an improvement of 2 months or more in median overall survival or a hazard ratio for survival of 0.75 or lower (or both) are proposed as the threshold for clinically meaningful benefit. That threshold could be influenced by a treatment’s effect on quality of life. Treatment toxicity is also relevant to the assessment of clinical benefit in this setting, specifically when significant differences in treatment tolerability are evident.

scholarly journals Overall Survival As the Outcome for Randomized Clinical Trials With Effective Subsequent Therapies

2011 ◽  
Vol 29 (17) ◽  
pp. 2439-2442 ◽  
Author(s):  
Edward L. Korn ◽  
Boris Freidlin ◽  
Jeffrey S. Abrams
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Randomized Clinical Trial ◽  
Clinical Benefit ◽  
Randomized Clinical Trials ◽  
Experimental Treatment ◽  
Standard Of Care ◽  
Current Standard ◽  
End Point

We review how overall survival (OS) comparisons should be interpreted with increasing availability of effective therapies that can be given subsequently to the treatment assigned in a randomized clinical trial (RCT). We examine in detail how effective subsequent therapies influence OS comparisons under varying conditions in RCTs. A subsequent therapy given after tumor progression (or relapse) in an RCT that works better in the standard arm than the experimental arm will lead to a smaller OS difference (possibly no difference) than one would see if the subsequent therapy was not available. Subsequent treatments that are equally effective in the treatment arms would not be expected to affect the absolute OS benefit of the experimental treatment but will make the relative improvement in OS smaller. In trials in which control arm patients cross over to the experimental treatment after their condition worsens, a smaller OS difference could be observed than one would see without cross-overs. In particular, use of cross-over designs in the first definitive evaluation of a new agent in a given disease compromises the ability to assess clinical benefit. In disease settings in which there is not an intermediate end point that directly measures clinical benefit, OS should be the primary end point of an RCT. The observed difference in OS should be considered the measure of clinical benefit to the patients, regardless of subsequent therapies, provided that the subsequent therapies used in both treatment arms follow the current standard of care.

scholarly journals Randomized Phase III Trial of Intravenous And Intraperitoneal Paclitaxel With S-1 Versus Gemcitabine Plus Nab-Paclitaxel For Pancreatic Ductal Adenocarcinoma With Peritoneal Metastasis (SP Study)

2021 ◽  
Author(s):  
Tomohisa Yamamoto ◽  
Tsutomu Fujii ◽  
Satoshi Hirano ◽  
Fuyuhiko Motoi ◽  
Goro Honda ◽  
...  
Keyword(s):  
Overall Survival ◽  
Peritoneal Metastasis ◽  
Systemic Chemotherapy ◽  
Ductal Carcinoma ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Pancreatic Ductal Carcinoma ◽  
Current Standard ◽  
Phase Iii Trial ◽  
Peritoneal Washing Cytology

Abstract The prognosis of pancreatic ductal carcinoma (PDAC) with peritoneal metastasis remains dismal. Systemic chemotherapy alone may not be effective, and the combination of intraperitoneal chemotherapy with systemic chemotherapy is expected to prolong overall survival in patients with peritoneal metastasis. We have designed a randomized phase III trial to confirm the superiority of intravenous (i.v.) and intraperitoneal (i.p.) paclitaxel (PTX) with S-1 relative to gemcitabine plus nab-PTX (GnP), which is the current standard therapy for patients with metastatic PDAC. A total of 180 patients will be accrued from 30 institutions within 3 years. Patients will be randomly assigned in a 1:1 ratio to receive either i.v. and i.p. PTX with S-1 or GnP (target of 90 patients per group). The primary endpoint is overall survival; secondary endpoints are progression-free survival, response rate, proportion with negative peritoneal washing cytology during chemotherapy, proportion requiring conversion surgery, and adverse event profiles. This study has been registered with the Japan Registry of Clinical Trials, registration number jRCTs051180199 (https://jrct.niph.go.jp/).

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