828TiP - Simultaneous resection of pancreatic cancer and liver oligometastases after induction chemotherapy in stage IV patients: An open-label prospective randomized multicenter phase III trial (CSPAC-1)

Abstract

BackgroundApproximately 40% pancreatic ductal adenocarcinoma (PDAC) patients (pts) are diagnosed with distant metastasis, especially liver metastasis. The current standard treatment for these Stage IV pts is palliative chemotherapy. However, the improved safety of pancreatic surgery has led to the consideration of more aggressive approaches. There is increasing agreement that the synchronous resection of PDAC and liver metastases may benefit highly selected pts. Thus, CSPAC-1 trial to evaluate a treatment strategy for selecting pts who can benefit from the synchronous resection after induction chemotherapy is launched by Chinese Study Group for Pancreatic Cancer (CSPAC). Trial designLiver oligometastases is defined as no more than 3 metastatic lesions irrespective of distribution within liver lobes. The study contains two steps. In the first step, 1000∼1200 cases of stage IV PDAC pts 18∼75 yo who had pathologically confirmed via needle biopsy from hepatic oligometastases or pancreatic lesions, ECOG 0∼1 are eligible for inclusion. Candidates will receive standard first-line chemotherapy including standard or modified FOLFIRINOX (5-FU, leucovorin, irinotecan, oxaliplatin), NG (nab-paclitaxel plus gemcitabine) or GS (gemcitabine plus S-1). RECIST v1.1 criteria combining with tumor markers would be applied to evaluate tumor response to chemotherapy every two cycles. Approximately 30% surgical conversion rate after induction chemotherapy can be achieved according to our prior small sample study. 300 pts who meet the criteria for intervention will get access to the second step and be randomly assigned in a 1:1 ratio to simultaneous resection of primary PDAC and liver oligometastases or standard chemotherapy. The primary outcome of this clinical trial is real overall survival (from enrollment to death). Main secondary outcome measures including overall survival (from randomization to death), life quality score, postoperative morbidity, and mortality. This study was activated in July 2018 and is expected to complete accrual within 5 years. Clinical trial identificationNCT03398291. Legal entity responsible for the studyThe Chinese Study Group for Pancreatic Cancer (CSPAC), Shanghai Shenkang Hospital Development Center, BeiGene Pharmaceutical Co., Ltd. FundingThe Chinese Study Group for Pancreatic Cancer (CSPAC), Shanghai Shenkang Hospital Development Center, BeiGene Pharmaceutical Co., Ltd. DisclosureAll authors have declared no conflicts of interest.