Evidence map›Paper›PMID 33630475›Full record

Trial reportAnnals of surgery2022

A Phase 3 Randomized Clinical Trial of Chemotherapy With or Without Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy in Subjects With Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer.

Daniel Brock Hewitt, Nicholas Nissen, Hassan Hatoum, Benjamin Musher, John Seng, Andrew L Coveler, Raed Al-Rajabi, Charles J Yeo, Benjamin Leiby, Joshua Banks and 11 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Annals of surgery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 67 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 5% 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.

NCT01836432 phase3terminatednot on this map

A Phase III Study of Chemotherapy With or Without Algenpantucel-L (HyperAcute®-Pancreas) Immunotherapy in Subjects With Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer

TypeinterventionalSponsorNewLink Genetics CorporationRan2013 to 2017Enrolled302ConditionsPancreatic Cancer, Pancreatic Carcinoma Non-resectable, Locally Advanced Malignant NeoplasmArmsFOLFIRINOX, Algenpantucel-L Immunotherapy, 5-FU Chemoradiation, Gemcitabine, Capecitabine
NCT06050317 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Sintilimab Plus Chemotherapy and Radiotherapy for Patients With Inoperable Pancreatic Cancer: a Single-arm, Exploratory, Phase II Trial

TypeinterventionalSponsorShandong Cancer Hospital and InstituteRan2023 to 2026Enrolled25ConditionsPancreas CancerArmsSintilimab Plus mFFN or NALIRIFOX and Radiation
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 1 synthesis or guideline pooled it, 86 citations in OpenAlex.

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7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 13 institutions in 1 country.

Daniel Brock HewittThomas Jefferson University Hospital and The Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, Pennsylvania.
Nicholas NissenCedars Sinai Medical Center, Los Angeles, California.
Hassan HatoumUniversity of Oklahoma, Oklahoma City, Oklahoma.
Benjamin MusherBaylor College of Medicine, Houston, Texas.
John SengVirginia Piper Cancer Institute, Minneapolis, Minnesota.
Andrew L CovelerUniversity of Washington-Seattle Cancer Care, Seattle, Washington.
Raed Al-RajabiUniversity of Kansas Cancer Center, Westwood, Kansas.
Charles J YeoThomas Jefferson University Hospital and The Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, Pennsylvania.
Benjamin LeibyThomas Jefferson University Hospital and The Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, Pennsylvania.
Joshua BanksThomas Jefferson University Hospital and The Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, Pennsylvania.
Lodovico BalducciH. Lee Moffitt Cancer Center, Tampa, Florida.
Gina VaccaroOregon Health and Science University, Portland, Oregon.
Noelle LoConteUniversity of Wisconsin, Madison, Wisconsin.
Thomas J GeorgeUniversity of Florida, Gainesville, Florida.
Warren BrennerBoca Raton Hospital, Boca Raton, Florida.
Emad ElquzaUniversity of California at Irvine, Irvine, California.
Nicholas VahanianNewLink Genetics Corporation, Ames, Iowa.
Gabriela RossiNewLink Genetics Corporation, Ames, Iowa.
Eugene KennedyNewLink Genetics Corporation, Ames, Iowa.
Charles LinkNewLink Genetics Corporation, Ames, Iowa.
Harish LavuThomas Jefferson University Hospital and The Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, Pennsylvania.
Thomas Jefferson University Hospital · USNewLink Genetics (United States) · USBaylor College of Medicine · USBoca Raton Regional Hospital · USCedars-Sinai Medical Center · USMoffitt Cancer Center · USOklahoma City University · USOregon Health & Science University · USThe University of Kansas Cancer Center · USUniversity of California, Irvine · USUniversity of Florida · USUniversity of Washington · USUniversity of Wisconsin–Madison · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo compare the efficacy and safety of algenpantucel-L [HyperAcute-Pancreas algenpantucel-L (HAPa); IND# 12311] immunotherapy combined with standard of care (SOC) chemotherapy and chemoradiation to SOC chemotherapy and chemoradiation therapy alone in patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC). SUMMARY BACKGROUND DATA: To date, immunotherapy has not been shown to benefit patients with borderline resectable or locally advanced unresectable PDAC. HAPa is a cancer vaccine consisting of allogeneic pancreatic cancer cells engineered to express the murine α(1,3)GT gene.

methodsA multicenter, phase 3, open label, randomized (1:1) trial of patients with borderline resectable or locally advanced unresectable PDAC. Patients received neoadjuvant SOC chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) followed by chemoradiation (standard group) or the same standard neoadjuvant regimen combined with HAPa immunotherapy (experimental group). The primary outcome was overall survival.

resultsBetween May 2013 and December 2015, 303 patients were randomized from 32 sites. Median (interquartile range) overall survival was 14.9 (12.2-17.8) months in the standard group (N = 158) and 14.3 (12.6-16.3) months in the experimental group (N = 145) [hazard ratio (HR) 1.02, 95% confidence intervals 0.66-1.58; P = 0.98]. Median progression-free survival was 13.4 months in the standard group and 12.4 months in the experimental group (HR 1.33, 95% confidence intervals 0.72-1.78; P = 0.59). Grade 3 or higher adverse events occurred in 105 of 140 patients (75%) in the standard group and in 115 of 142 patients (81%) in the experimental group (P > 0.05).

conclusionsAlgenpantucel-L immunotherapy did not improve survival in patients with borderline resectable or locally advanced unresectable PDAC receiving SOC neoadjuvant chemotherapy and chemoradiation.

trial registrationClinicalTrials.gov Identifier: NCT01836432.

Indexed as

ImmunotherapyNeoadjuvant TherapyAgedAntineoplastic Combined Chemotherapy ProtocolsCancer VaccinesDeoxycytidineFemaleFluorouracilGemcitabineHumansIrinotecanLeucovorinMaleMiddle AgedOxaliplatinPaclitaxelAlgenpantucel-LCancer VaccinesDeoxycytidineFluorouracilfolfirinoxGemcitabineIrinotecanLeucovorinOxaliplatinPaclitaxel

Identifiers

PMID33630475
OpenAlexW3117348128

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.