Neoadjuvant Triple Treatment with FOLFIRINOX Plus Pembrolizumab and SABR in Patients with Borderline Resectable Pancreatic Cancer (PREOPANC-5): a Multicenter Single Arm Phase I/II Trial of the Dutch Pancreatic Cancer Group

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Since patients with borderline resectable pancreatic cancer (BRPC) have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment chemotherapy, immunotherapy and radiotherapy, followed by surgery and chemotherapy and immunotherapy survival in patients with BRPC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed pancreatic cancer

• Male or female participants who are at least 18 years of age on the day of signing in-formed consent

• Borderline resectable tumor (see table 1 for definitions of resectability)

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Ability to undergo surgery, radiotherapy and chemotherapy

• Leucocytes (WBC) ≥ 3.0 X 109/l

• Platelets ≥ 100X 109 /l

• Hemoglobin ≥ 6 mmol/l

• Renal function: E-GFR \> 50 ml/min

• Bilirubin \< 50 µmol/l or planned for biliary drainage

• A male participant must agree to use a contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 18 weeks after the last dose of study treatment and refrain from donating sperm during this period.

• A female participant is eligible to participate if she is not pregnant (see Appendix 5), not breastfeeding, or a woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the treatment period and for at least 18 weeks after the last dose of study treatment.

• Written informed consent

Locations
Other Locations
Netherlands
Amsterdam University Medical Center
RECRUITING
Amsterdam
Maastricht University Medical Center
NOT_YET_RECRUITING
Maastricht
St. Antonius Ziekenhuis
RECRUITING
Nieuwegein
Erasmus University Medical Center
RECRUITING
Rotterdam
Contact Information
Primary
J. W. Wilmink, MD, PhD
j.w.wilmink@amsterdamumc.nl
+31 204444321
Backup
A. M. Gehrels, MD, MA
a.gehrels@amsterdamumc.nl
Time Frame
Start Date: 2024-09-23
Estimated Completion Date: 2028-03
Participants
Target number of participants: 66
Treatments
Experimental: Neoadjuvant FOLFIRINOX, SABR and pembrolizumab
Treatment starts with four cycles of neoadjuvant FOLFIRINOX chemotherapy every two weeks, combined with pembrolizumab every six weeks, starting at the same day as the second cycle of FOLFIRINOX. Restaging is performed after cycle 4 of FOLFIRINOX with a CT-scan. Patients with a response or stable disease will undergo SABR 5 X 8 Gy followed by an additional four cycles FOLFIRNOX chemotherapy, combined with pembrolizumab. Restaging is repeated after 8 cycles FOLFRINOX in total. Patients undergo a surgical exploration if they have non-metastatic borderline resectable disease on CT-scan of the chest and abdomen, 3-6 weeks after completion of chemotherapy. Patients also proceed to surgical exploration if they discontinue neoadjuvant FOLFIRINOX and/or pembrolizumab because of toxicity or have local progression at restaging within criteria for borderline resectable disease.
Related Therapeutic Areas
Sponsors
Collaborators: St. Antonius Hospital, Maastricht University Medical Center, Erasmus Medical Center
Leads: Amsterdam UMC, location VUmc

This content was sourced from clinicaltrials.gov