Evidence map›Paper›PMID 39095759›Full record

Trial reportBMC cancer2024

Digital subtraction angiography-guided pancreatic arterial infusion of GEMOX chemotherapy in advanced pancreatic adenocarcinoma: a phase II, open-label, randomized controlled trial comparing with intravenous chemotherapy.

Changjing Huang, Chien-Shan Cheng, Yehua Shen, Hao Chen, Junhua Lin, Yongqiang Hua, Lanyun Feng, Caijun Wu, Peng Wang, Zhen Chen and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02635971 (A Randomized Controlled Phase II Study on Intra-arterial Versus Intravenous Chemotherapy Infusion With Gemcitabine and Oxaliplatin for Locally Advanced Pancreatic Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

NCT02635971 phase2unknown statusnot on this map

A Randomized Controlled Phase II Study on Intra-arterial Versus Intravenous Chemotherapy Infusion With Gemcitabine and Oxaliplatin for Locally Advanced Pancreatic Cancer

TypeinterventionalSponsorFudan UniversityRan2015 to 2022Enrolled168ConditionsCarcinoma, PancreaticArmsTranscatheter arterial infusion, Intravenous chemotherapy, Gemcitabine, Oxaliplatin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. 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.

Changjing Huang *Minimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Chien-Shan Cheng *Minimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Yehua ShenMinimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, 200032, China. yehuash25@163.com.
Hao ChenMinimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Junhua LinMinimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Yongqiang HuaMinimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Lanyun FengMinimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Caijun WuMinimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Peng WangMinimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Zhen ChenMinimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Zhiqiang MengMinimally Invasive Therapy Center, Fudan University Shanghai Cancer Center, Shanghai, 200032, China. mengshca@fudan.edu.cn.

Funding

Clinical research funding of Fudan University Shanghai Cancer Center Grant No. YJLC201504National Natural Science Foundation of China Grant No. 82074204
6 · The paper itself

Abstract

backgroundAdvanced pancreatic adenocarcinoma lacks effective treatment options, and systemic gemcitabine-based chemotherapy offers only marginal survival benefits at the cost of significant toxicities and adverse events. New therapeutic options with better drug availability are warranted. This study aims to evaluate the safety and efficacy of digital subtraction angiography (DSA)-guided pancreatic arterial infusion (PAI) versus intravenous chemotherapy (IVC) using the gemcitabine and oxaliplatin (GEMOX) regimen in unresectable locally advanced or metastatic pancreatic cancer (PC) patients. MATERIALS AND

methodsThis study prospectively enrolled 51 eligible treatment-naive patients with unresectable PC to receive GEMOX treatment via PAI or IVC (1:1 ratio randomization) from December 2015 to December 2019. Cycles were repeated monthly, and each process consisted of two treatments administered bi-weekly. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), 1-year survival, 6-month survival, tumor-site subgroup survival, and incidences of adverse events were compared.

resultsThe median OS of the PAI and IVC groups were 9.93 months and 10.07 months, respectively (p = 0.3049). The median PFS of the PAI and IVC groups were 5.07 months and 4.23 months (p = 0.1088). No significant differences were found in the ORR (11.54% vs. 4%, p = 0.6312), DCR (53.85% vs. 44%, p = 0.482), and 1-year OS rate (44% vs. 20.92%, p = 0.27) in PAI and IVC groups. The 6-month OS rate was significantly higher in the PAI group (100%) than in the IVC group (83.67%) (p = 0.0173). The median OS of patients in PAI group with pancreatic head and neck tumors were significantly higher than those of body and tail tumors (12.867 months vs. 9 months, p = 0.0214). The incidences of hematologic disorders, liver function disorders, and digestive disorders in the IVC group were higher than in the PAI group (p < 0.05).

conclusionGEMOX PAI therapy presented a higher 6-month OS rate and fewer adverse events than IVC in advanced pancreatic adenocarcinoma patients. Those with pancreatic head and neck tumors may yield a superior treatment outcome from PAI treatment. TRIAL REGISTRATION NUMBER: NCT02635971. DATE OF REGISTRATION: 21/12/2015.

Indexed as

AdenocarcinomaAngiography, Digital SubtractionAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidinePancreatic NeoplasmsAdultAgedFemaleGemcitabineHumansInfusions, Intra-ArterialInfusions, IntravenousMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinDeoxycytidineGemcitabineOrganoplatinum CompoundsOxaliplatinGEMOXIntravenous chemotherapyPancreatic arterial infusionPancreatic head and neck tumorsUnresectable pancreatic cancer

Identifiers

PMID39095759
PMCPMC11295591

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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.