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. 2025 Feb 6;25(1):208.
doi: 10.1186/s12885-025-13573-7.

Study protocol of the METAPANC trial - intensified treatment in patients with local operable but oligometastatic pancreatic cancer - multimodal surgical treatment versus chemotherapy alone: a randomized controlled trial

Michael Ghadimi  1   2 , Uwe Pelzer  3 , Marc G Besselink  4 , Jens Siveke  5 , Ralph Telgmann  6 , Rickmer Braren  7 , Hanneke Wilmink  8 , Marie Crede  9 , Alexander Koenig  10 , Ute Koenig  10 , Sven Thorsten Liffers  5 , Kai Antweiler  11 , Bas Uijterwijk  4 , Hanna Seppanen  12 , Arno Nordin  12 , Pauli Puolakkainen  13 , Olav F Dajani  14 , Knut Jørgen Labori  15 , Mia Johansson  16 , Svein Olav Bratlie  17 , Tim Friede  11 , Peter Jo  9
Affiliations

Study protocol of the METAPANC trial - intensified treatment in patients with local operable but oligometastatic pancreatic cancer - multimodal surgical treatment versus chemotherapy alone: a randomized controlled trial

Michael Ghadimi et al. BMC Cancer. .

Abstract

Background: Based on current guidelines, surgical treatment of hepatic oligometastases in patients with pancreatic ductal adenocarcinoma (PDAC) is not primarily recommended. Systematic chemotherapy is the therapy of choice for these patients. The relevance of subsequent surgical resection after chemotherapy remains unclear. This multicentre, randomized, controlled phase III trial is planned to evaluate whether resection of the primary tumor and liver metastases can improve overall survival in patients with PDAC with hepatic oligometastases in a multimodal treatment setting.

Methods: After an induction therapy with eight cyles of mFOLFIRINOX and a response assessment after four and eight cycles, patients will be randomized to either Arm 1 (perioperative mFOFIRINOX plus resection of the primary tumor with resection or ablation of all hepatic metastases) or Arm 2 (continuation of 4 cycles of the standard-of-care mFOLFIRINOX chemotherapy). This clinical trial will focus on a well-defined patient group with metastatic disease limited to the liver as the target organ, with a maximum of three metastases.

Discussion: METAPANC is the first international, randomized, controlled, open-label, multicentre, phase III clinical trial for curative intended surgical therapy of oligometastatic pancreatic cancer in Europe and America. The multimodal surgical treatment of patients with oligometastatic pancreatic cancer could significantly extend the overall survival of this patient group. A possible recommendation of this multimodal treatment regimen outside of clinical trials requires data from randomized controlled trials first. To identify patient subgroups that might benefit from multimodal surgical therapy, additional information on tumor genetics could supplement valid parameters.

Trial registration: EU Clinical Trials No. 2023-503558-10-00.

Keywords: Chemotherapy; Clinical trials; Liver metastasis; Multimodal treatment; Oligometastasis; Oligometastatic pancreatic cancer; Pancreatic ductal carcinoma (PDAC); Pancreatic surgery.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: METAPANC is a phase III clinical trial implemented and reported in accordance with the CTR (EU) 536/2014, ICH-GCP, with applicable member states regulations, and with the ethical principles laid down in the Declaration of Helsinki. It was submitted, evaluated, and approved via CTIS with Germany as the reporting member state. A statement of ethical approval and consent was issued by the State Office for Health and Social Affairs (LAGESO) Berlin, Germany. The ethic committee of the federal state of Berlin approved the study. METAPANC is registered under its EU Clinical Trial Number 2023-503558-10-00 in the EU Clinical Trial Register. Consent for publication: Not applicable Competing interests: TF declares personal fees for statistical consultancies (including data monitoring committees) from Actimed, Apellis, Aslan, AstraZeneca, Bayer, BiosenseWebster, BMS, Cardior, CSL Behring, Daiichi Sankyo, Enanta, Fresenius Kabi, Galapagos, IQVIA, Immunic, KyowaKirin, LivaNova, Minoryx, Novartis, PINK! gegen Brustkrebs, PPD, RECARDIO, Recordati, Relaxera, Roche, Servier, Viatris, Vifor, VICO Therapeutics; all outside the submitted work.All other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the entire study including the optional percutaneous interventional ablation of metastases in Arm 1. In these cases the liver ablation of selected metastatic lesion(s) can be planned 1–3 weeks after the last mFOLFIRINOX cycle, but within six weeks between the last cycle of chemotherapy and surgery. Alternatively, the ablation can be conducted intraoperatively
Fig. 2
Fig. 2
Flow chart of the METAPANC trial
See this image and copyright information in PMC

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