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
5629 - Outcome of triple negative inflammatory breast cancers (TNIBC) treated with dose dense neoadjuvant epirubicin cyclophosphmide, prognostic impact of pre and post neoadjuvant chemotherapy (NAC) tumor infiltrating lymphocytes (TIL) and post NAC lymphovascular invasion
Presenter: Luca Campedel
Session: Poster Display session 2
Resources:
Abstract
5792 - A novel PET parameter for cancer stem cell metabolism: early prediction of chemosensitivity to neoadjuvant chemotherapy in locally advanced breast cancer
Presenter: Chanwoo Kim
Session: Poster Display session 2
Resources:
Abstract
3728 - Using nodal ratio to predict recurrence in patients with 4 or more positive lymph nodes early stage breast cancer
Presenter: Besma Graja
Session: Poster Display session 2
Resources:
Abstract
3395 - Re-sentinel node biopsy for local recurrence after breast-conserving surgery
Presenter: Yuka Matsubara
Session: Poster Display session 2
Resources:
Abstract
4302 - Assessment of prognostic and therapeutic factors in men with breast cancer
Presenter: Daniel Herrero Rivera
Session: Poster Display session 2
Resources:
Abstract
4263 - Genomic Profiling of Chinese Breast Cancer Patients
Presenter: Zhonghua Tao
Session: Poster Display session 2
Resources:
Abstract
2406 - Genome copy number alteration burden represents predictor of response in long-term, never relapse exceptional responders of trastuzumab-treated HER2+ metastatic breast cancer
Presenter: Naomi Walsh
Session: Poster Display session 2
Resources:
Abstract
2575 - Next-generation DNA Sequencing (NGS) Results for Tumors From Phase 2 ABRAZO Study of Talazoparib After Platinum or Cytotoxic Non-Platinum Regimens in Patients (pts) With Advanced Breast Cancer (ABC) and Germline BRCA1/2 (gBRCA) Mutations
Presenter: Nicholas C. Turner
Session: Poster Display session 2
Resources:
Abstract
4499 - FGFR1 and CCND1 gene amplifications are associated with breast cancer resistance to aromatase inhibitors
Presenter: Evgeny Imyanitov
Session: Poster Display session 2
Resources:
Abstract
4110 - Clinicopathologic features of BRCA mutated breast cancer patients: Hacettepe Experience
Presenter: Sercan Aksoy
Session: Poster Display session 2
Resources:
Abstract