Surgical Resection for Pancreatic Cancer
(PHOLIPANC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a surgical treatment for pancreatic cancer that has spread to a few spots in the liver or lungs. All participants receive the same treatment, beginning with a chemotherapy regimen called NALIRIFOX. If the cancer shrinks or remains stable after chemotherapy, doctors will assess the possibility of surgical resection to remove the tumors. Patients with pancreatic cancer that has limited spread to the liver or lungs and who are currently receiving NALIRIFOX chemotherapy might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity for patients to explore innovative treatment options that may not yet be widely available.
What prior data suggests that this surgical treatment is safe for pancreatic cancer patients?
Research has shown that removing tumors through surgery is generally safe for people with pancreatic cancer. One study found that surgery is both feasible and safe, potentially extending patients' lives. Another study revealed that patients who underwent surgery lived longer than those who did not, with an average survival time of 17.7 months post-surgery.
Surgery is considered safe when performed on suitable patients, including a less invasive method that is as effective as the traditional approach. Most patients recover well, and any complications are usually manageable. However, as with any surgery, risks exist, particularly given the seriousness of pancreatic cancer. Some patients experienced complications, but these were generally expected for this type of procedure.
In summary, surgery for pancreatic cancer is generally safe and can extend patients' lives. Patients should discuss all potential risks and benefits with their doctors to determine if this treatment is appropriate for them.12345Why are researchers excited about this trial?
Unlike the standard treatments for pancreatic cancer, which often involve chemotherapy, radiation, or palliative care to manage symptoms, surgical resection offers a direct approach by removing the cancerous tissue. Researchers are excited about this technique as it specifically targets oligometastatic tumors, which are limited in number and location, potentially leading to better outcomes in patients with metastases in the liver or lungs. This method could provide a more effective way to control or even eliminate certain cancerous growths, offering hope for improved survival rates and quality of life.
What evidence suggests that surgical resection is effective for pancreatic cancer?
Research has shown that removing the tumor through surgery can significantly extend the lifespan of people with pancreatic cancer. This trial will evaluate surgical resection in different cohorts. Participants in the Liver Oligometastatic Cohort and the Lung Oligometastatic Cohort will undergo surgical resection. Typically, those who have the surgery live about 18 months, while those who do not live around 7 months. Long-term studies reveal that individuals who undergo surgery followed by chemotherapy have a 25–30% chance of surviving five years. For patients whose tumors can be completely removed, the average lifespan extends to about two and a half years, with a 50% chance of surviving five years. These findings suggest that surgery can be a crucial option for improving survival in pancreatic cancer patients.26789
Who Is on the Research Team?
Lei Zheng, MD, PhD
Principal Investigator
The University of Texas Health Science Center at San Antonio
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Participants receive NALIRIFOX chemotherapy for 4 cycles to assess tumor response or stability
Surgical Evaluation and Resection
Evaluation of tumor resectability followed by surgical resection if feasible
Adjuvant Chemotherapy
Participants may receive additional chemotherapy if the tumor is unresectable during surgery
Follow-up
Participants are monitored for recurrence-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Surgical resection
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants who have hepatic oligometastatic pancreatic tumor
Participants who have pulmonary oligometastatic pancreatic tumor
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor
Ipsen
Industry Sponsor
David Loew
Ipsen
Chief Executive Officer since 2020
BA in Business Administration and MBA from the University of St. Gallen, Switzerland
Sandra Silvestri
Ipsen
Chief Medical Officer since 2023
MD, PhD
Citations
Surgical resection improves survival in pancreatic cancer ...
Patients who underwent surgery had a significantly longer median survival (18 months) compared to those who did not undergo surgery (7 months) and this was ...
Relationship between pancreatic cancer resection rate and ...
A higher resection rate at a population level was associated with improved survival of the pancreatic cancer population.
Optimal strategies for surgical resection of pancreatic body ...
A total of 311 patients were enrolled; 71 (23%) underwent pancreaticoduodenectomy, and 240 (77%) underwent distal pancreatectomy. In the total cohort, the rates ...
Radical resection and outcome for malignant tumors of ... - PMC
RESULTS: One hundred and twenty/214 pancreatic body and tail cancer patients underwent surgical treatment; the overall resection rate was 59.2% (71/120), and ...
Surgical resection of metastatic pancreatic cancer: is it worth it?
This study aimed to summarize and clarify the experience of surgical treatment of M1 PDAC in our center and evaluate whether it may offer benefits to some ...
Safety and Efficacy of Surgery for Metastatic Tumor to ... - PMC
In conclusion, radical resection of metastases to the pancreas is feasible and safe, and may confer a survival benefit for selected patients.
Surgical resection is associated with improved long-term ...
In a sub-analysis for resectable patients, Versteijne et al. reported a median overall survival of 17.7 months in patients that underwent upfront resection for ...
The Landmark Series: Minimally Invasive Pancreatic ... - PMC
The authors concluded that MIDP is a safe and effective alternative to ODP in appropriately selected patients with PDAC, offering equivalent oncologic outcomes ...
Does Surgical Resection Significantly Prolong the Long ...
The 1 year, 3 year, and 5 year overall survival (OS) of patients undergoing surgery was 34.3%, 15.2%, and 11.0%, respectively. The 1 year, 3 year, and 5 year ...
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