Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy

Conditions
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Pancreatic Cancer, Liver Metastases, Surgery

Intervention / Treatment
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* Procedure: Synchronous resection of primary pancreatic cancer and liver oligometastasis
* Drug: Standard chemotherapy


Participation Criteria
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Eligibility Criteria
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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: Voluntary participation 18-75 years old Eastern Cooperative Oncology Group (ECOG) 0-1 Stage IV pancreatic cancer with no more than 3 liver metastases Histologically confirmed diagnosis of pancreatic cancer No contraindication of chemotherapy Exclusion Criteria for candidates: Not want to receive chemotherapy or potential operation. Metastases at other sites except for liver With other malignancies Receive chemotherapy, radiotherapy, and interventional therapy before Contraindication of potential operation Inclusion Criteria for intervention: Primary tumor and liver metastatic sites are both resectable. No new metastatic sites were observed 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. Exclusion Criteria for intervention: 1. Contraindication of operation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>Patients continue to receive standard chemotherapy. | Drug: Standard chemotherapy<br>* Patients continue to receive standard chemotherapy including folinic acid, fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX), gemcitabine plus nab-paclitaxel, or gemcitabine plus S-1<br>|
| Experimental: Surgical exploration<br>Patients receive surgical exploration and synchronous resection of primary pancreatic cancer and liver oligometastasis will be performed. | Procedure: Synchronous resection of primary pancreatic cancer and liver oligometastasis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real overall survival | Including the time of induction chemotherapy | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Not including the time of induction chemotherapy | Up to 2 years | 
| Life quality score | Quality of life will be measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | Up to 2 years, every 2 months | 
| Postoperative morbidity | Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation | Up to 90 days after operation | 
| Postoperative mortality | Patients die from any cause during 90 days after operation | Up to 90 days after operation |