Evidence map›Paper›PMID 31036040›Full record

ArticleTrials2019

All-trans-retinoic acid (ATRA) plus oxaliplatin plus 5-fluorouracil/leucovorin (FOLFOX) versus FOLFOX alone as palliative chemotherapy in patients with advanced hepatocellular carcinoma and extrahepatic metastasis: study protocol for a randomized controlled trial.

Jie Shi, Juxian Sun, Chang Liu, Zongtao Chai, Nanya Wang, Hui Zhang, Shuqun Cheng

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

7 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. TheFrontiers in oncology · 2022
    Article
  4. Article
  5. Review
  6. Article
  7. [Analysis of clinical efficacy, safety and prognosis of anlotinib hydrochloride in the treatment of advanced primary liver cancer].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2020
    Article
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

7 authors at 3 institutions in 1 country.

Jie ShiDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Changhai Rd No.225, Shanghai, 200438, China.
Juxian SunDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Changhai Rd No.225, Shanghai, 200438, China.
Chang LiuDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Changhai Rd No.225, Shanghai, 200438, China.
Zongtao ChaiDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Changhai Rd No.225, Shanghai, 200438, China.
Nanya WangDepartment of Cancer Center, First Hospital of Jilin University, Xinmin Rd No71, Changchun, 130021, Jilin Province, China.
Hui ZhangDepartment of Surgery of Hepato-Biliary & Pancreatic Tumor, Fujian Provincial Cancer Hospital, Fuma Rd No.420, Fuzhou, 350011, Fujian Province, China.
Shuqun ChengDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Changhai Rd No.225, Shanghai, 200438, China. chengshuqun@aliyun.com.ORCID http://orcid.org/0000-0001-6760-7470
Second Military Medical University · CNFujian Provincial Cancer Hospital · CNJilin University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAmong patients with hepatocellular carcinoma (HCC), 85% of patients have an advanced disease stage at diagnosis and curative therapies cannot be performed. Prognosis has been quite poor as until recently there was no proven effective chemotherapy. Our group found that all-trans-retinoic acid (ATRA) could improve the efficacy of platinum in HCC in vivo and in vitro, thus we wish to validate the efficiency of ATRA in clinical practice.

methodsThis is a double-blinded, 1:1 randomized, controlled, multicenter clinical trial. Three hundred and sixty-eight patients with HCC and extrahepatic metastases will receive palliative chemotherapy at the Eastern Hepatobiliary Surgery Hospital, First Hospital of Jilin University and Fujian Provincial Cancer Hospital. Subjects will be randomly assigned to one of the two arms, either ATRA + oxaliplatin + 5-fluorouracil/leucovorin (FOLFOX4) or FOLFOX4 alone. ATRA 20 mg will be given orally three times/day for 3 days prior to the initiation of FOLFOX4. ATRA will be discontinued at the end of FOLFOX4. DISCUSSION: Overall survival rate is the primary endpoint. Secondary endpoints are time to progression according to the modified response evaluation criteria in solid tumors (mRECIST) criteria, acute and chronic adverse events, and quality of life.

trial registrationChinese Clinical Trial Registry, ChiCTR-IIR-17012916 . Registered on 9 October 2017.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularChinaDisease ProgressionDouble-Blind MethodFemaleFluorouracilHumansLeucovorinLiver NeoplasmsMaleMulticenter Studies as TopicOrganoplatinum CompoundsPalliative CareProgression-Free SurvivalRandomized Controlled Trials as TopicFluorouracilLeucovorinOrganoplatinum CompoundsTretinoinATRAExtrahepatic metastasisFOLFOX4Palliative chemotherapy

Identifiers

PMID31036040
PMCPMC6489221
OpenAlexW2947951060

What OpenQuestion holds

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Registered trials

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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.