Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Fudan University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Real overall survival
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Standard treatment
Patients continue to receive standard chemotherapy.
Intervention: Standard chemotherapy (Drug)
Surgical exploration
Patients receive surgical exploration and synchronous resection of primary pancreatic cancer and liver oligometastasis will be performed.
Intervention: Synchronous resection of primary pancreatic cancer and liver oligometastasis (Procedure)
Outcomes
Primary Outcomes
Real overall survival
Time Frame: Up to 2 years
Including the time of induction chemotherapy
Secondary Outcomes
- Overall survival(Up to 2 years)
- Life quality score(Up to 2 years, every 2 months)
- Postoperative morbidity(Up to 90 days after operation)
- Postoperative mortality(Up to 90 days after operation)
Investigators
Xian-Jun Yu
Chair of Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
Fudan University