Pancreatic Locally Advanced Irresectable Cancer Ablation

The aim of the PELICAN trial is to investigate the survival benefit of RFA plus standard palliative chemotherapy as compared to palliative chemotherapy alone in patients with LAPC after 2 months of induction chemotherapy.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
2. Locally irresectable tumor
3. Primary tumor
4. Stable disease or partial response after 2 months of induction chemotherapy (according to RECIST)
5. Fit for chemotherapy as assessed by the medical oncologist, plus:

   * Absolute neutrophil count: 1.5 × 109/L
   * Platelet count: 100 × 109/L
   * Renal function: creatinine clearance\> 50 ml/min
   * Transaminases ≤ 3 x ULN
6. Fit for surgery assessed by the treating surgeon and anesthesiologist
7. RFA technical feasible
8. Written informed consent
9. Age ≥ 18 years
10. Expert panel approval for randomisation

Exclusion Criteria:

1. WHO performance status ≥ 3
2. Distant metastases on abdominal or thoracic CT scan\*
3. Previous surgical, local ablative or radiotherapy for pancreatic cancer or chemotherapy which is inconsistent with the prescribed induction schedule according to protocol\*\*
4. Stenosis of \> 50% of the hepatic artery AND stenosis of \>50% of the portal vein/ superior mesenteric vein
5. Second primary malignancy, except adequately treated non-melanoma skin cancer, in situ carcinoma of the cervix uteri or other malignancies treated at least 5 years previously without signs of recurrence.
6. Pregnancy

   * Positive regional lymph nodes metastases are not a reason for exclusion. Lymph nodes are considered as regional, according to the consensus statement by the International Study Group of Pancreatic Surgery (ISGPS). Suspicious lymph nodes only on radiologic basis are not considered as metastasis. Only when suspicion is high due to large infiltration, pathological examination by FNA can be considered.

     * Surgical exploration is not a contra-indication for inclusion

• DERIVEDSeelen LWF, Brada LJH, Walma MS, Rombouts SJE, Braat MN, Bollen TL, Borel Rinkes IH, Bruijnen RCG, Busch OR, Cirkel GA, Daamen LA, Daams F, van Dam RM, van Delden OM, Derksen WJM, Festen S, Groothuis K, Hagendoorn J, de Hingh IHJT, D'Hondt M, Liem MSL, van Lienden KP, Los M, de Meijer VE, Mekenkamp LJM, Nijkamp MW, Nio CY, Pando E, Patijn GA, Polee MB, Te Riele WW, Roeyen G, Stommel MWJ, de Vos-Geelen J, de Vries JJ, Wessels FJ, Wilmink JW, van de Ven PM, Besselink MG, van Santvoort HC, Molenaar IQ; Dutch Pancreatic Cancer Group. Radiofrequency Ablation and Chemotherapy vs Chemotherapy Only in Locally Advanced Pancreatic Cancer: The PELICAN Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e263861. doi: 10.1001/jamanetworkopen.2026.3861. PMID 41915391
• DERIVEDWalma MS, Rombouts SJ, Brada LJH, Borel Rinkes IH, Bosscha K, Bruijnen RC, Busch OR, Creemers GJ, Daams F, van Dam RM, van Delden OM, Festen S, Ghorbani P, de Groot DJ, de Groot JWB, Haj Mohammad N, van Hillegersberg R, de Hingh IH, D'Hondt M, Kerver ED, van Leeuwen MS, Liem MS, van Lienden KP, Los M, de Meijer VE, Meijerink MR, Mekenkamp LJ, Nio CY, Oulad Abdennabi I, Pando E, Patijn GA, Polee MB, Pruijt JF, Roeyen G, Ropela JA, Stommel MWJ, de Vos-Geelen J, de Vries JJ, van der Waal EM, Wessels FJ, Wilmink JW, van Santvoort HC, Besselink MG, Molenaar IQ; Dutch Pancreatic Cancer Group. Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial. Trials. 2021 Apr 29;22(1):313. doi: 10.1186/s13063-021-05248-y. PMID 33926539