Surgery for pancreatic cancer and liver metastases after chemotherapy
Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy
This study tests if surgery to remove both the pancreatic tumor and liver spots after chemotherapy helps people with stage IV pancreatic cancer live longer compared to just continuing chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT03398291 on ClinicalTrials.gov |
What this trial studies
This multi-center phase 3 trial evaluates a treatment strategy for patients with stage IV pancreatic cancer and liver oligometastasis. Participants will first receive standard chemotherapy, and those who respond will be randomized to either undergo synchronous surgical resection of both the primary pancreatic tumor and liver metastases or continue with chemotherapy. The study aims to determine the effectiveness of this surgical approach compared to standard treatment alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with stage IV pancreatic cancer and no more than 3 liver metastases who are fit for chemotherapy and surgery.
Not a fit: Patients with metastases in sites other than the liver or those with other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and quality of life for patients with advanced pancreatic cancer and limited liver metastases.
How similar studies have performed: While there have been studies on surgical interventions for metastatic cancers, this specific approach of simultaneous resection after chemotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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. Exclusion Criteria for intervention: 1. Contraindication of operation
Where this trial is running
Shanghai, Shanghai
- Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Xianjun Yu, M.D., Ph.D.
- Email: yuxianjun@fudanpci.org
- Phone: +86-21-64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.