Evidence map›Paper›PMID 37752117›Full record

Trial reportSignal transduction and targeted therapy2023

Combined FOLFOX4 with all-trans retinoic acid versus FOLFOX4 with placebo in treatment of advanced hepatocellular carcinoma with extrahepatic metastasis: a randomized, double-blind comparative study.

Juxian Sun, Feifei Mao, Chang Liu, Fan Zhang, Dafeng Jiang, Weixing Guo, Lei Huo, Liping Zhou, Wan Yee Lau, Jie Shi and 1 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Signal transduction and targeted therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
4.0field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 26 citations in OpenAlex.

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  19. Epigallocatechin Gallate Derivative YRecent patents on anti-cancer drug discovery · 2025
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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

11 authors at 4 institutions in 2 countries.

Juxian Sun *Department of Hepatic Surgery VI, Third Affiliated Hospital of Naval Medical University, Shanghai, China.
Feifei Mao *Tongji University Cancer Center, Shanghai Tenth People's Hospital, School of Medicine, Tongji University, Shanghai, China.
Chang Liu *Department of Hepatic Surgery VI, Third Affiliated Hospital of Naval Medical University, Shanghai, China.
Fan ZhangDepartment of General Surgery, Fujian Cancer Hospital, Fujian Medical University, Fuzhou, China.
Dafeng JiangDepartment of Oncology, Zhejiang Sian International Hospital, Jiaxing, China.
Weixing GuoDepartment of Hepatic Surgery VI, Third Affiliated Hospital of Naval Medical University, Shanghai, China.
Lei HuoDepartment of Radiology, Third Affiliated Hospital of Naval Medical University, Shanghai, China.
Liping ZhouDepartment of Hepatic Surgery VI, Third Affiliated Hospital of Naval Medical University, Shanghai, China.
Wan Yee LauDepartment of Hepatic Surgery VI, Third Affiliated Hospital of Naval Medical University, Shanghai, China.
Jie ShiDepartment of Hepatic Surgery VI, Third Affiliated Hospital of Naval Medical University, Shanghai, China. docshijie@aliyun.com.
Shuqun ChengDepartment of Hepatic Surgery VI, Third Affiliated Hospital of Naval Medical University, Shanghai, China. chengshuqun@aliyun.com.
Tongji University · CNChinese University of Hong Kong · HKFujian Medical University · CNShanghai Medical College of Fudan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The majority of hepatocellular carcinoma (HCC) cases are diagnosed at an advanced stage. Currently, there are only a few therapeutic methods available for patients with advanced HCC and extrahepatic metastasis (EHM). Systemic chemotherapy, such as FOLFOX4 (infusions of fluorouracil, leucovorin, and oxaliplatin), has been reported for treating advanced HCC with EHM, but its effectiveness is very poor. In this randomized, double-blind, placebo-controlled study, we aimed to assess the efficacy and safety of FOLFOX4 with all-trans-retinoic acid (ATRA) as a palliative treatment for HCC patients with EHM, compared to FOLFOX4 with a placebo. The primary endpoint was overall survival (OS), and subsequently, an exploratory model was developed based on bioinformatics to predict the efficacy of FOLFOX4-ATRA treatment. A total of 108 patients were randomly assigned in a 1:1 ratio to receive either FOLFOX4-ATRA or FOLFOX4-placebo. The intention-to-treat (ITT) population showed a median OS of 16.2 months for the FOLFOX4-ATRA group, compared with 10.7 months for the FOLFOX4-placebo group (HR 0.56, 95% CI 0.33-0.93; p = 0.025). The median progression-free survival (PFS) was 7.1 months for the FOLFOX4-ATRA group and 4.2 months for the FOLFOX4-placebo group (HR 0.62, 95% CI 0.41-0.94; p = 0.024). A panel of proteins with unique upregulation during complete response (CR) (SOD3, TTR, SSC5D, GP5, IGKV1D-33) and partial response (PR) (TGFB1, GSS, IGHV5-10-1) effectively predicted CR and PR in patients treated with FOLFOX4-ATRA, as compared to FOLFOX4-placebo. The results suggest that FOLFOX4-ATRA is a safe and effective treatment for patients with advanced HCC and EHM in eastern China.

Indexed as

Carcinoma, HepatocellularLiver NeoplasmsFluorouracilHumansTreatment OutcomeTretinoinFluorouracilTretinoin

Identifiers

PMID37752117
PMCPMC10522582
OpenAlexW4387036383

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.