Evidence map›Paper›PMID 34794396›Full record

ArticleBMC cancer2021

Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC).

Florian Gebauer, Alexander Ioannis Damanakis, Felix Popp, Alexander Quaas, Fabian Kütting, Katrin Lutz, Swantje Held, Burkhard Deuß, Tobias Göser, Dirk Waldschmidt and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04617457 (Open-label, Single Arm Phase II Trial Investigating the Efficacy, Safety and Quality of Life of Neoadjuvant Chemotherapy With Liposomal Irinotecan Combined With Oxaliplatin and 5-Fluorouracil/Folinic Acid Followed by Curative Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04617457 phase2unknown statusnot on this map

Open-label, Single Arm Phase II Trial Investigating the Efficacy, Safety and Quality of Life of Neoadjuvant Chemotherapy With Liposomal Irinotecan Combined With Oxaliplatin and 5-Fluorouracil/Folinic Acid Followed by Curative Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas

TypeinterventionalSponsorUniversity of CologneRan2021 to 2025Enrolled150ConditionsPancreatic Cancer, Metastasis, Surgery, Oligometastatic DiseaseArmsnal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
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  4. [Oligometastasis in the gastrointestinal tract].Chirurgie (Heidelberg, Germany) · 2026
    Article
  5. Oligometastatic disease in pancreatic cancer: is there a role for curative-intent surgery? A narrative review.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
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  15. Article
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  18. Neoadjuvant therapy for pancreatic cancer.Nature reviews. Clinical oncology · 2023
    Review
  19. [Surgical treatment of pancreatic cancer-What is new?]Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2022
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Florian Gebauer *Department of General, Visceral, Tumor and Transplantation Surgery, University of Cologne, Kerpener Strasse 62, 50937, Cologne, Germany. florian.gebauer@uk-koeln.de.ORCID http://orcid.org/0000-0001-5312-4814
Alexander Ioannis Damanakis *Department of General, Visceral, Tumor and Transplantation Surgery, University of Cologne, Kerpener Strasse 62, 50937, Cologne, Germany.
Felix PoppDepartment of General, Visceral, Tumor and Transplantation Surgery, University of Cologne, Kerpener Strasse 62, 50937, Cologne, Germany.
Alexander QuaasInstitute of Pathology, University of Cologne, Cologne, Germany.
Fabian KüttingDepartment of Gastroenterology, University of Cologne, Cologne, Germany.
Katrin LutzClinAssess GmbH, Leverkusen, Germany.
Swantje HeldClinAssess GmbH, Leverkusen, Germany.
Burkhard DeußClinAssess GmbH, Leverkusen, Germany.
Tobias GöserDepartment of Gastroenterology, University of Cologne, Cologne, Germany.
Dirk Waldschmidt *Department of Gastroenterology, University of Cologne, Cologne, Germany.
Christiane Bruns *Department of General, Visceral, Tumor and Transplantation Surgery, University of Cologne, Kerpener Strasse 62, 50937, Cologne, Germany.
University of Cologne · DEClinAssess (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAccording to current guidelines, treatment of patients with hepatic oligometastasis in pancreatic cancer is not reflected and systemic chemotherapy is recommended in those patients. Retrospective data suggest beneficial outcomes in patients with hepatic oligometastasis, though prospective data from clinical trials addressing this particular patient group is not available.

methodsIn this single arm, phase-2 trial, survival data from patients receiving neoadjuvant chemotherapy followed by R0/R1 resection will be compared to historic data from patients with oligometastatic adenocarcinoma of the pancreas. The clinical trial will focus on a well-defined patient collective with metastatic load limited to the liver as target organ with a maximum of five metastases. The combination of liposomal irinotecan (nal-IRI), oxaliplatin (OX) and 5-fluouracil (5-FU)/folinic acid (FA) (nal-IRI + OX+ 5-FU/FA, NAPOX) was chosen as neoadjuvant chemotherapy; the choice was based on an ongoing clinical study in which NAPOX appeared manageable, with promising anti-tumor activity in first-line treatment of patients with metastatic pancreatic adenocarcinoma. In total 150 patients will be enrolled for this trial with an aim of 55 patients receiving a complete macroscopic synchronous tumor and metastatic resection. DISCUSSION: This is the first clinical study to prospectively evaluate the value of multimodality therapy concepts in oligometastatic pancreatic cancer. TRIAL REGISTRATION NUMBERS: EudraCT 2019-002734-37 ; NCT04617457 .

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsLiver NeoplasmsNeoadjuvant TherapyPancreatic NeoplasmsQuality of LifeAdultChemotherapy, AdjuvantClinical Trials, Phase II as TopicFemaleFluorouracilGermanyHumansIrinotecanLeucovorinLiposomesFluorouracilIrinotecanLeucovorinLiposomesOxaliplatinChemotherapyClinical trialsLiver metastasisPancreatic cancerPancreatic surgery

Identifiers

PMID34794396
PMCPMC8600696
OpenAlexW3211832946

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.