Pancreatic Cancer Clinical Trial
Official title:
Artery Divestment Technique in Artery-Involved Pancreatic Cancer: A Single-Institution, Open-Labeled Randomized Controlled Trial
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.
n/a
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