Liver Metastases, Pancreatic Cancer, Surgery
Conditions
Brief summary
This study is a multi-center phase 3 trial to evaluate a treatment strategy for selecting patients who can benefit from the synchronous resection of primary pancreatic cancer and liver oligometastasis after induction chemotherapy. Half of participants who meet the entry criterion will receive surgical intervention, while the other half will continue to receive standard chemotherapy.
Interventions
PROCEDURESynchronous resection of primary pancreatic cancer and liver oligometastasis
Patients undergo surgical exploration. If no extensive metastatic sites are found, the synchronous resection of primary pancreatic cancer and liver metastatic sites will be performed. Adjuvant chemotherapy was recommended, and the regimen selection is recommended to be based on the preoperative chemotherapy.
DRUGStandard chemotherapy
Patients continue to receive standard chemotherapy including folinic acid, fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX), gemcitabine plus nab-paclitaxel, or gemcitabine plus S-1
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Note: This study has two steps. In the first step, patients who meet the criteria for candidates will receive standard first-line chemotherapy for pancreatic cancer. Response Evaluation Criteria in Solid Tumors (RECIST) criteria was employed to measure tumor's response to chemotherapy every two cycles. Until some of them meet the criteria for intervention, they will be randomized and receive relevant interventions. Inclusion Criteria for candidates: 1. Voluntary participation 2. 18-75 years old 3. Eastern Cooperative Oncology Group (ECOG) 0-1 4. Stage IV pancreatic cancer with no more than 3 liver metastases 5. Histologically confirmed diagnosis of pancreatic cancer 6. No contraindication of chemotherapy
Exclusion criteria
for candidates: 1. Not want to receive chemotherapy or potential operation. 2. Metastases at other sites except for liver 3. With other malignancies 4. Receive chemotherapy, radiotherapy, and interventional therapy before 5. Contraindication of potential operation Inclusion Criteria for intervention: 1. Primary tumor and liver metastatic sites are both resectable. 2. No new metastatic sites were observed 3. Abnormal serum tumor maker levels decreased by more than 50% after chemotherapy. In the serum tumor makers, carbohydrate antigen 19-9 (CA19-9) was always the first choice for evaluation and it should be below 500U/L after treatment. However, when the baseline CA19-9 was within the normal range, carbohydrate antigen 125 (CA125) and carcinoembryonic antigen (CEA) were the alternative candidate indicators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real overall survival | Up to 2 years | Including the time of induction chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative mortality | Up to 90 days after operation | Patients die from any cause during 90 days after operation |
| Overall survival | Up to 2 years | Not including the time of induction chemotherapy |
| Life quality score | Up to 2 years, every 2 months | Quality of life will be measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 |
| Postoperative morbidity | Up to 90 days after operation | Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation |
Countries
China
Contacts
Primary ContactXianjun Yu, M.D., Ph.D.
Backup ContactSi Shi, M.D.
Outcome results
None listed