Evidence map›Paper›PMID 39441483›Full record

ArticleOncology and therapy2024

Stereotactic Radiotherapy Plus Nivolumab in Patients with Locally Advanced Pancreatic Cancer: Results from Phase 1/2 Clinical CA209-9KH Trial.

Milan Vošmik, Stanislav John, Josef Dvořák, Beatrice Mohelníková-Duchoňová, Bohuslav Melichar, Radka Lohynská, Aleš Ryška, Aml Mustafa Banni, Johana Krempová, Igor Sirák

Registry-linked trialAbstract read
In one paragraph

Article in Oncology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04098432 (Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients with Locally Advanced Unresectable Pancreatic Adenocarcinoma), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT04098432 phase1 / phase2completednot on this map

Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients with Locally Advanced Unresectable Pancreatic Adenocarcinoma

TypeinterventionalSponsorUniversity Hospital Hradec KraloveRan2018 to 2022Enrolled15ConditionsLocally Advanced Unresectable Pancreatic AdenocarcinomaArmsNivolumab, Stereotactic radiotherapy
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Review
  6. Review
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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

10 authors.

Milan VošmikDepartment of Oncology and Radiotherapy, University Hospital Hradec Králové, Sokolská 581, 50005, Hradec Králové, Czech Republic. milan.vosmik@fnhk.cz.ORCID http://orcid.org/0000-0001-6497-7505
Stanislav JohnDepartment of Oncology and Radiotherapy, University Hospital Hradec Králové, Sokolská 581, 50005, Hradec Králové, Czech Republic.
Josef DvořákDepartment of Oncology, Thomayer University Hospital, Prague, Czech Republic.
Beatrice Mohelníková-DuchoňováDepartment of Oncology, University Hospital Olomouc, Olomouc, Czech Republic.
Bohuslav MelicharDepartment of Oncology, University Hospital Olomouc, Olomouc, Czech Republic.
Radka LohynskáDepartment of Oncology, Thomayer University Hospital, Prague, Czech Republic.
Aleš RyškaFaculty of Medicine in Hradec Králové, Charles University, Prague, Czech Republic.
Aml Mustafa BanniDepartment of Oncology and Radiotherapy, University Hospital Hradec Králové, Sokolská 581, 50005, Hradec Králové, Czech Republic.
Johana KrempováDepartment of Oncology and Radiotherapy, University Hospital Hradec Králové, Sokolská 581, 50005, Hradec Králové, Czech Republic.
Igor SirákDepartment of Oncology and Radiotherapy, University Hospital Hradec Králové, Sokolská 581, 50005, Hradec Králové, Czech Republic.

Funding

Ministerstvo Zdravotnictví Ceské Republiky 00179906Ministerstvo Zdravotnictví Ceské Republiky UHHK
6 · The paper itself

Abstract

introductionThe dismal prognosis of pancreatic ductal adenocarcinoma (PDAC) highlights the urgent need for novel therapeutic strategies. Immune checkpoint inhibitors (ICIs) seem to be ineffective in most PDAC studies. Therefore, we conducted an open-label, multicenter phase 1/2 study (CA209-9KH) to evaluate the safety of stereotactic radiotherapy (SRT) and sequential ICI therapy in PDAC, as well as to validate the efficacy of this regimen as a potential activator of antitumor immunity.

methodsPatients aged ≥ 18 years with unresectable non-metastatic PDAC following four FOLFIRINOX induction cycles were included. Treatment comprised SRT (4 × 8 Gy) and sequential nivolumab administration until disease progression or unacceptable toxicity. The primary endpoints were safety and toxicity assessment. Secondary endpoints included progression-free survival (PFS), overall survival (OS), biomarker evaluation, and quality of life (QoL) analysis.

resultsTwenty-two patients were screened, with 15 enrolled. Eleven (median) nivolumab cycles were administered. SRT demonstrated low and clinically nonsignificant toxicity, whereas nivolumab toxicity aligned with prior safety profiles, without grade 4-5 events observed. Three patients discontinued therapy owing to toxicity. Median PFS and OS were 8.1 and 13.0 months, respectively, with 12-month PFS and OS rates of 0% and 66.7%, respectively, and a 24-month OS rate of 8.9%. Biomarker levels correlated with clinical or radiological disease control. Patient-reported QoL remained acceptable, deteriorating with disease progression.

conclusionSRT and nivolumab therapy exhibited manageable toxicity profiles consistent with previous findings; however, long-term treatment responses were not achieved with this regimen in locally advanced PDAC. Another strategy to trigger antitumor immunity in PDAC needs to be sought.

trial registrationEudraCT: 2017-003404-52; ClinicalTrials.gov: NCT04098432.

Indexed as

NivolumabPancreatic ductal adenocarcinomaStereotactic radiotherapy

Identifiers

PMID39441483
PMCPMC11574225

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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.