Abstract 1406
Background
Approximately 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 design
Liver 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 identification
NCT03398291.
Editorial acknowledgement
Legal entity responsible for the study
The Chinese Study Group for Pancreatic Cancer (CSPAC), Shanghai Shenkang Hospital Development Center, BeiGene Pharmaceutical Co., Ltd.
Funding
The Chinese Study Group for Pancreatic Cancer (CSPAC), Shanghai Shenkang Hospital Development Center, BeiGene Pharmaceutical Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5185 - Systemic administration of the hyaluronidase-expressing oncolytic adenovirus VCN-01 in patients with advanced or metastatic pancreatic cancer: first-in-human clinical trial
Presenter: Rocio Garcia-Carbonero
Session: Poster Display session 2
Resources:
Abstract
4842 - The analysis of genomic signatures of head and body/tail of pancreatic cancer in Chinese patients
Presenter: Qi Ling
Session: Poster Display session 2
Resources:
Abstract
4988 - MGMT methylation in metastatic pancreatic cancer (mPAC): a single center experience
Presenter: Monica Niger
Session: Poster Display session 2
Resources:
Abstract
5035 - Advantage of three-dimensional image analysis of pancreatic cancer using computed tomography
Presenter: Seung Bae Yoon
Session: Poster Display session 2
Resources:
Abstract
1465 - Phase I study of the oncolytic viral immunotherapy agent Canerpaturev (C-REV) with S-1 in patients with stage IV pancreatic cancer.
Presenter: Susumu Hijioka
Session: Poster Display session 2
Resources:
Abstract
1982 - Impact of anatomic site of biliary tract tumour origin and conditional probability of survival (CS): results from 15 prospective advanced first-line clinical trial
Presenter: Mairead McNamara
Session: Poster Display session 2
Resources:
Abstract
2244 - FOLFOXIRI versus FOLFIRINOX in first-line chemotherapy in patients with advanced pancreatic cancer: a propensity score analysis
Presenter: Angélique Vienot
Session: Poster Display session 2
Resources:
Abstract
4557 - Cellfree tumor-DNA (cfDNA) as a very early predictor of therapeutic outcome in pancreatic ductal adenocarcinoma (PDAC)
Presenter: Sabine Payr
Session: Poster Display session 2
Resources:
Abstract
4406 - Comprehensive genomic profiling (CGP) of gall bladder adenocarcinoma (GBAC) in patients from distinct ancestral populations
Presenter: Milind Javle
Session: Poster Display session 2
Resources:
Abstract
4283 - Phase II Monotherapy Efficacy of Cancer Metabolism Targeting SM-88 in Heavily Pre-Treated PDAC Patients.
Presenter: Allyson Ocean
Session: Poster Display session 2
Resources:
Abstract