Evidence map›Paper›PMID 34185551›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Donafenib Versus Sorafenib in First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma: A Randomized, Open-Label, Parallel-Controlled Phase II-III Trial.

Shukui Qin, Feng Bi, Shanzhi Gu, Yuxian Bai, Zhendong Chen, Zishu Wang, Jieer Ying, Yinying Lu, Zhiqiang Meng, Hongming Pan and 20 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 267 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
267citing papers in PubMed, 11 pooled it
33.4field-weighted citation impact, top 1% 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.

NCT05171166 phase2 / phase3terminatednot on this map

Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage Hepatocellular Carcinoma Out Up-to-seven: a Multi-center Randomized Controlled Trial.

TypeinterventionalSponsorPeking UniversityRan2021 to 2025Enrolled18ConditionsHepatocellular CarcinomaArmsHAIC, TACE, FOLFOX, cTACE or DEB-TACE, Donafenib
NCT05546619 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Research on Effectiveness and Safety of the Treatment, Hyperthermic Intraperitoneal Chemotherapy Combined With Tislelizumab and Targeted Therapy, That is Used for High-risk Hepatocellular Carcinoma After R0 Resection

TypeinterventionalSponsorSulai LiuRan2022 to 2025Enrolled30ConditionsHepatocellular CarcinomaArmsHIPEC+tislelizumab + targeted therapy
NCT06232759 phase2completednot on this mapstarted 2022, after this paper: background citation

Transarterial Chemoembolization Combined With Tyrosine Kinase Inhibitors and Tislelizumab in Unresectable Hepatocellular Carcinoma

TypeinterventionalSponsorGuangxi Medical UniversityRan2022 to 2024Enrolled56ConditionsHepatocellular CarcinomaArmsTransarterial chemoembolization combined with Tyrosine Kinase Inhibitors and Tislelizumab
3 · Its place in the literature

Who cites it

267 citing papers in PubMed, 11 syntheses or guidelines pooled it, 391 citations in OpenAlex.

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

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

30 authors at 20 institutions in 1 country.

Shukui QinCancer Centre of Bayi Hospital, Nanjing Chinese Medicine University, Nanjing, China.ORCID 0000-0003-2289-1521
Feng BiDepartment of Medical Oncology, West China Hospital, Sichuan University, Chengdu, China.ORCID 0000-0002-0527-5105
Shanzhi GuDepartment of Interventional Radiology, Hunan Cancer Hospital of Central South University, Changsha, China.
Yuxian BaiDepartment of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
Zhendong ChenDepartment of Medical Oncology, The Second Hospital of Anhui Medical University, Hefei, China.
Zishu WangDepartment of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
Jieer YingDepartment of Abdominal Oncology, Zhejiang Cancer Hospital, Hangzhou, China.
Yinying LuLiver Cancer Centre, The Fifth Medical Centre of PLA General Hospital, Beijing, China.
Zhiqiang MengMinimally Invasive Therapy Centre, Fudan University Shanghai Cancer Centre, Shanghai, China.
Hongming PanDepartment of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Ping YangDepartment of Medical Oncology, The Sixth Medical Centre of PLA General Hospital, Beijing, China.
Helong ZhangDepartment of Oncology, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Xi ChenDepartment of Oncology, The 900th Hospital of PLA Joint Service Support Force, Fuzhou, China.ORCID 0000-0001-8691-1232
Aibing XuDepartment of Medical Oncology, Nantong Tumor Hospital, Nantong, China.
Chengxu CuiDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Bo ZhuInstitute of Cancer, Xinqiao Hospital, Army Medical University, Chongqing, China.
Jian WuDepartment of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
Xiaoli XinDepartment of Hepatology, The Sixth People's Hospital of Shenyang, Shenyang, China.
Jufeng WangDepartment of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
Jinlu ShanDepartment of Medical Oncology, Daping Hospital, Army Medical University, Chongqing, China.
Junhui ChenIntervention and Cell Therapy Centre, Peking University Shenzhen Hospital, Shenzhen, China.
Zhendong ZhengDepartment of Medical Oncology, General Hospital of Northern Theater Command, Shenyang, China.
Li XuDepartment of Liver Surgery, Sun Yat-sen University Cancer Centre, Guangzhou, China.ORCID 0000-0003-4405-1048
Xiaoyu WenDepartment of Hepatobiliary and Pancreatic Disease, The First Hospital of Jilin University, Changchun, China.ORCID 0000-0003-2109-1557
Zhenyu YouDepartment of Tumor Intervention Therapy, Heping Branch, General Hospital of Northern Theater Command, Shenyang, China.
Zhenggang RenDepartment of Hepatic Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
Xiufeng LiuCancer Centre of Bayi Hospital, Nanjing Chinese Medicine University, Nanjing, China.
Meng QiuDepartment of Medical Oncology, West China Hospital, Sichuan University, Chengdu, China.
Liqing WuSuzhou Zelgen Biopharmaceuticals Co, Ltd, Suzhou, China.
Feng ChenSchool of Public Health, Nanjing Medical University, Nanjing, China.
Sichuan University · CNArmy Medical University · CNChinese PLA General Hospital · CNGeneral Hospital of Shenyang Military Region · CN82th Hospital of Pla · CNAir Force Medical University · CNAnhui Medical University · CNCentral South University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFirst Affiliated Hospital of Bengbu Medical College · CNFudan University · CNFudan University Shanghai Cancer Center · CNHarbin Medical University · CNJilin University · CNNanjing Medical University · CNNantong Tumor Hospital · CNPeking University Shenzhen Hospital · CNSir Run Run Shaw Hospital · CNSun Yat-sen University · CNThe Sixth People's Hospital of Shenyang · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDonafenib, a novel multikinase inhibitor and a deuterated sorafenib derivative, has shown efficacy in phase Ia and Ib hepatocellular carcinoma (HCC) studies. This study compared the efficacy and safety of donafenib versus sorafenib as first-line therapy for advanced HCC. PATIENTS AND

methodsThis open-label, randomized, parallel-controlled, multicenter phase II-III trial enrolled patients with unresectable or metastatic HCC, a Child-Pugh score ≤ 7, and no prior systemic therapy from 37 sites across China. Patients were randomly assigned (1:1) to receive oral donafenib (0.2 g) or sorafenib (0.4 g) twice daily until intolerable toxicity or disease progression. The primary end point was overall survival (OS), tested for noninferiority and superiority. Efficacy was primarily assessed in the full analysis set (FAS), and safety was assessed in all treated patients.

resultsBetween March 21, 2016, and April 16, 2018, 668 patients (intention-to-treat) were randomly assigned to donafenib and sorafenib treatment arms; the FAS included 328 and 331 patients, respectively. Median OS was significantly longer with donafenib than sorafenib treatment (FAS; 12.1

conclusionDonafenib showed superiority over sorafenib in improving OS and has favorable safety and tolerability in Chinese patients with advanced HCC, showing promise as a potential first-line monotherapy for these patients.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularFemaleHumansLiver NeoplasmsMaleMiddle AgedNeoplasm MetastasisPyridinesSorafenibdonafenibPyridinesSorafenib

Identifiers

PMID34185551
PMCPMC8445562
OpenAlexW3175451049

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.