NCT05314998

Adjuvant Trial in Patients With Resected PDAC Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature

Not yet recruiting Phase 3 Last updated 10 December 2024

What this trial tests

Phase 3 trial testing Oxaliplatin in Pancreatic Ductal Adenocarcinoma in 394 participants. Not yet recruiting.

Timeline

15 January 2025

Primary endpoint
1 January 2031

1 September 2031

Quick facts

Lead sponsor	John Neoptolemos
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	394
Start date	15 January 2025
Primary completion	1 January 2031
Estimated completion	1 September 2031
Sites	33 locations across Sweden, Germany

Drugs / interventions tested

• Oxaliplatin (Oxaliplatin) — full drug profile →
• Irinotecan (irinotecan) — full drug profile →
• Folinic acid — full drug profile →
• 5-fluorouracil
• Gemcitabine (gemcitabine) — full drug profile →
• Capecitabine (capecitabine) — full drug profile →

Conditions studied

• Pancreatic Ductal Adenocarcinoma — all drugs for Pancreatic Ductal Adenocarcinoma →

Sponsor

John Neoptolemos

Who can join

Adults 18 to 79, any sex, with Pancreatic Ductal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicentre open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria (control arm) or by a transcriptomic treatment specific stratification signature or TSS (test arm).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeted therapy for pancreatic ductal adenocarcinoma: Mechanisms and clinical study.
   Kung HC, Yu J. · · 2023 · cited 28× · PMID 36814688 · DOI 10.1002/mco2.216
2. Clinical and Genomic Features of Classical and Basal Transcriptional Subtypes in Pancreatic Cancer.
   Singh H, Xiu J, Kapner KS, Yuan C, et al · · 2024 · cited 27× · PMID 39283131 · DOI 10.1158/1078-0432.ccr-24-1164
3. Spatial tumor immune heterogeneity facilitates subtype co-existence and therapy response in pancreatic cancer.
   Klein L, Tu M, Krebs N, Urbach L, et al · · 2025 · cited 20× · PMID 39762215 · DOI 10.1038/s41467-024-55330-7
4. Refining the Treatment of Pancreatic Cancer From Big Data to Improved Individual Survival.
   Bailey P, Zhou X, An J, Peccerella T, et al · · 2023 · cited 13× · PMID 37168490 · DOI 10.1093/function/zqad011
5. ESMO 2023 pancreatic cancer guidelines signal stepwise progress.
   Springfeld C, Bailey P, Büchler MW, Neoptolemos JP. · · 2024 · cited 3× · PMID 38617485 · DOI 10.21037/hbsn-24-37
6. Molecular Subtypes of Pancreatic Cancer: A Review of the Literature.
   Wnuk J, Skowron W, Długaszek A, Sadurska J, et al · · 2026 · PMID 42193106 · DOI 10.3390/cimb48050502
7. Current Advances in Preclinical Patient-Derived Cultivation Models for Individualized Drug Response Prediction in Pancreatic Cancer.
   Heckelmann B, Duhn J, Braun R. · · 2026 · PMID 42065069 · DOI 10.32604/or.2026.075028
8. New implications from long-term outcomes of perioperative therapy in resectable pancreatic cancer.
   Springfeld C, Hackert T, Palmer DH, Öhlund D, et al · · 2026 · PMID 41345265 · DOI 10.1038/s41416-025-03295-9