RecruitingPhase 3NCT06391892

Liquid Biopsy (ctDNA) Guided Treatment in Localized Pancreatic Cancer: Neoadjuvant CTX vs. Upfront Surgery

Liquid Biopsy Guided Treatment in Localized Pancreatic Cancer (LIQUIPANC): Circulating Tumor DNA (ctDNA) as Precision Medicine Tool for Stratification of Neoadjuvant Chemotherapy vs. Upfront Surgery

Sponsor

Elisabethinen Hospital

Enrollment

100 participants

Start Date

Jan 11, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Circulating Tumor Cell Predictive Cancer Model

Summary

This study evaluates the clinical prognostic impact (on DFS and OS) of liquid biopsy guided treatment vs. standard of care (physicians choice) in localized pancreatic cancer (despite because of CA 19-9 levels and computed tomography, upfront surgery is recommended by tumor board). ctDNA positive patients will receive neoadjvuant chemotherapy at current gold standard physicians choice instead of upfront surgery, because of assumed high biological risk for early recurrence.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a liquid biopsy — a blood test that detects fragments of tumor DNA (called ctDNA) — can help guide treatment decisions for people with localized pancreatic cancer. Specifically, it looks at whether ctDNA results can help decide if someone should have chemotherapy before surgery or go straight to surgery. **You may be eligible if...** - You are over 18 years old - You have localized pancreatic cancer (meaning it has not spread beyond the pancreas and is potentially removable with surgery) - You are willing and able to provide informed consent **You may NOT be eligible if...** - You have another cancer at the same time - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENeoadjuvant chemotherapy instead of upfront surgery

All patients included into the study are recommended to go for upfront surgery (CT and CA19-9) by tumor board. If preoperative ctDNA is positive, the investigators assume high risk for early recurrence (because of systemic tumor burden) and apply neoadjuvant chemotherapy at physicians choice instead. * Apart from blood collection (within the scope of clinical routine), there is no additional diagnostic intervention performed on the patient. * The respective neoadjuvant chemotherapeutical drug will be selected and applied by the treating medical oncologist at physicians choice (unaffected by study participation), usually mFOLFIRINOX or Gemcitabine/nabPaclitaxel at standardized dosage recommended by NCCN and local guidelines. FOLFIRONOX: Folinic acid (also known as leucovorin), F - Fluorouracil (5-FU), IRIN - Irinotecan, OX - Oxaliplatin.

PROCEDUREUpfront surgery

Standard of care as recommended by tumor board (not affected by study conditions).

Locations(1)

Ordensklinikum Linz Barmherzige Schwestern

Linz, Upper Austria, Austria

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NCT06391892

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