A Phase 3 clinical trial investigating liquid biopsy (ctDNA) guided treatment in localized Pancreatic Cancer reached its primary completion on December 31, 2025. The study, which enrolled 100 participants, aims to evaluate the prognostic impact of this approach compared to standard care.
Background
Pancreatic cancer remains one of the most challenging malignancies to treat, often diagnosed at advanced stages with limited therapeutic options. Current standard of care for localized pancreatic cancer typically involves upfront surgery, followed by adjuvant chemotherapy, or neoadjuvant chemotherapy before surgery, depending on various factors including tumor resectability and patient health. However, even after successful surgery, recurrence rates are high due to the aggressive nature of the disease and the presence of micrometastases. Circulating tumor DNA (ctDNA), a form of liquid biopsy, offers a non-invasive method to detect minimal residual disease and assess biological risk, potentially guiding more personalized treatment strategies. Identifying patients at high biological risk for early recurrence through ctDNA could inform decisions to administer neoadjuvant chemotherapy instead of immediate surgery, aiming to improve long-term outcomes like disease-free survival (DFS) and overall survival (OS).
Trial design
This Phase 3 study (NCT06391892), titled "Liquid Biopsy (ctDNA) Guided Treatment in Localized Pancreatic Cancer: Neoadjuvant CTX vs. Upfront Surgery," has an estimated enrollment of 100 participants. The trial focuses on patients with Pancreatic Cancer, also considering Circulating Tumor Cell and Predictive Cancer Model aspects. The study evaluates the clinical prognostic impact of liquid biopsy-guided treatment versus standard of care (physician's choice). Specifically, ctDNA-positive patients are assigned to receive neoadjuvant chemotherapy at the current gold standard physician's choice instead of upfront surgery, based on an assumed high biological risk for early recurrence. The trial is currently listed as RECRUITING, despite reaching primary completion for its initial data collection phase.
What this means
The primary completion of this Phase 3 trial signifies that data collection for its primary endpoints in 100 participants with localized Pancreatic Cancer has concluded. This is a crucial step towards understanding the potential role of liquid biopsy (ctDNA) in guiding treatment decisions for this aggressive cancer. While specific results are not yet available, the completion of this phase indicates that researchers are moving closer to analyzing whether a ctDNA-guided approach, particularly in directing neoadjuvant chemotherapy for high-risk patients, can improve prognostic outcomes like disease-free survival and overall survival compared to traditional upfront surgery. The findings from this study could potentially refine treatment algorithms for localized pancreatic cancer, offering a more personalized approach based on individual biological risk profiles.
Source
Information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06391892, "Liquid Biopsy (ctDNA) Guided Treatment in Localized Pancreatic Cancer: Neoadjuvant CTX vs. Upfront Surgery," was recorded with a primary completion date of December 31, 2025 on clinicaltrials.gov.