Divestment for Artery-involved Pancreatic Cancer

Pancreatic cancer is the most lethal malignancy of human being. Surgery is the only potential cure of pancreatic cancer. The invasion of major abdominal arteries is one of the most important factor restricting surgical intervention. For artery-involved pancreatic cancer (ai-PC) patients, pre-operative adjuvant therapies, especially the neoadjuvant chemotherapy, has brought exciting postoperative survival. Yet due to the potential screening effect of this treatment strategy, nearly half of ai-PC patients failed to benefit from surgery because of disease progression, adverse reactions of adjuvant treatment and other reasons. Artery divestment for the treatment of ai-PC firstly reported by our center, can significantly increase resection rate and produce overall survival benefit in some patients. This study is to explore whether up-front surgery with artery divestment combined curative pancreatectomy or the chemotherapy-first strategy would be more beneficial for ai-PC patients' survival. Subjects will be randomized to treatment group either receiving up-front artery divestment combined pancreatectomy (Surgery Group) or adjuvant chemotherapies (Chemo Group). In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status. In Chemo Group, adjuvant chemotherapy of gemcitabine or gemcitabine + cisplatin will be utilized according to performance status. After 2 circles of adjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression. Overall mortality at one year after randomization will be the primary endpoint. Other parameters as overall survival after 2 and 3 years, median survival, disease-free survival, margin status of subjects receiving curative surgery, etc. will also be observed.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

1. Diagnosed with pancreatic cancer staged at cT4NxM0(AJCC Cancer Staging Manual, 8th Edition) based on contrast enhanced CT\&MRI scan and tumor markers;
2. Age \> 18 year and \<80 year;
3. Agree to participate in the study with signed informed consent.

Exclusion Criteria:

1. Evidence of metastasis based on physical examination, enhanced CT or enhanced MRI;
2. Poor performance status and/or co-morbidity precluding pancreatectomy and chemotherapy;
3. Focal vessel narrowing or contour irregularity revealed by radiology examinations;
4. Economic situations cannot afford designed treatment.

• BACKGROUNDRyan DP, Hong TS, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014 Nov 27;371(22):2140-1. doi: 10.1056/NEJMc1412266. No abstract available. PMID 25427123
• BACKGROUNDZhang H, Wroblewski K, Jiang Y, Penney BC, Appelbaum D, Simon CA, Salgia R, Pu Y. A new PET/CT volumetric prognostic index for non-small cell lung cancer. Lung Cancer. 2015 Jul;89(1):43-9. doi: 10.1016/j.lungcan.2015.03.023. Epub 2015 Apr 9. PMID 25936471
• BACKGROUNDTang K, Lu W, Qin W, Wu Y. Neoadjuvant therapy for patients with borderline resectable pancreatic cancer: A systematic review and meta-analysis of response and resection percentages. Pancreatology. 2016 Jan-Feb;16(1):28-37. doi: 10.1016/j.pan.2015.11.007. Epub 2015 Dec 2. PMID 26687001
• BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. PMID 28055103
• BACKGROUNDSeufferlein T, Bachet JB, Van Cutsem E, Rougier P; ESMO Guidelines Working Group. Pancreatic adenocarcinoma: ESMO-ESDO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012 Oct;23 Suppl 7:vii33-40. doi: 10.1093/annonc/mds224. No abstract available. PMID 22997452
• BACKGROUNDFortner JG, Kim DK, Cubilla A, Turnbull A, Pahnke LD, Shils ME. Regional pancreatectomy: en bloc pancreatic, portal vein and lymph node resection. Ann Surg. 1977 Jul;186(1):42-50. doi: 10.1097/00000658-197707000-00007. PMID 195543
• BACKGROUNDChua TC, Saxena A. Extended pancreaticoduodenectomy with vascular resection for pancreatic cancer: a systematic review. J Gastrointest Surg. 2010 Sep;14(9):1442-52. doi: 10.1007/s11605-009-1129-7. Epub 2010 Apr 9. PMID 20379794