Evidence map›Paper›PMID 41163129›Full record

Trial reportEuropean journal of medical research2025

Analysis of common treatment-related adverse events of donafenib and its correlation with efficacy: exploratory analysis of the ZGDH3 study.

Feng Bi, Shukui Qin, Shanzhi Gu, Yuxian Bai, Zhendong Chen, Zishu Wang, Jieer Ying, Yinying Lu, Zhiqiang Meng, Hongming Pan and 27 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of medical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02645981 (Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT02645981 phase2 / phase3completednot on this map

Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma: a Controlled,Multicentre,Randomised, Phase 3 Trial

TypeinterventionalSponsorSuzhou Zelgen Biopharmaceuticals Co.,LtdRan2016 to 2019Enrolled668ConditionsHCCArmsDonafenib, Sorafenib
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

37 authors.

Feng BiDepartment of Medical Oncology, West China Hospital, Sichuan University, Chengdu, China.
Shukui QinNanjing Tianyinshan Hospital of China Pharmaceutical University, Nanjing, China. qinsk@csco.org.cn.
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 Clinical Oncology, The Second Hospital of Anhui Medical University, Hefei, China.
Zishu WangDepartment of Clinical 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 Center of PLA General Hospital, Beijing, China.
Zhiqiang MengMinimally Invasive Therapy Centre, Fudan University Shanghai Cancer Center, Shanghai, China.
Hongming PanDepartment of Clinical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Ping YangDepartment of Clinical Oncology, The Sixth Medical Center of PLA General Hospital, Beijing, China.
Helong ZhangDepartment of Clinical Oncology, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Xi ChenDepartment of Clinical Oncology, The 900, Hospital of PLA Joint Service Support Force, Fuzhou, China.
Aibing XuDepartment of Clinical Oncology, Nantong Tumor Hospital, Nantong, China.
Chengxu CuiDepartment of Clinical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Bo ZhuDepartment of Clinical Oncology, Xinqiao Hospital, Army Medical University, Chongqing, China.
Jian WuDepartment of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Xiaoli XinDepartment of Hepatology, The Sixth People's Hospital of Shenyang, Shenyang, China.
Jufeng WangDepartment of Clinical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
Jinlu ShanDepartment of Clinical Oncology, Daping Hospital, Army Medical University, Chongqing, China.
Junhui ChenIntervention and Cell Therapy Centre, Peking University Shenzhen Hospital, Shenzhen, China.
Zhendong ZhengDepartment of Clinical Oncology, General Hospital of Northern Theater Command, Shenyang, China.
Li XuDepartment of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, China.
Xiaoyu WenDepartment of Hepatobiliary and Pancreatic Disease, The First Hospital of Jilin University, Changchun, China.
Zhenyu YouDepartment of Tumor Intervention Therapy, General Hospital of Northern Theater Command, Shenyang, China.
Zhenggang RenDepartment of Hepatic Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.
Jianming XuLiver Cancer Centre, The Fifth Medical Center of PLA General Hospital, Beijing, China.
Chengyou DuDepartment of Clinical Oncology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Qingxia FanDepartment of Clinical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Longzhen ZhangDepartment of Clinical Oncology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Min TaoDepartment of Clinical Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Da JiangDepartment of Clinical Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Senming WangDepartment of Clinical Oncology, Zhujiang Hospital of Southern Medical University, Guangzhou, China.
Yongping ChenDepartment of Infectious Diseases, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Jifang ShengDepartment of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Xuelong ZhuangDepartment of Interventional Radiology, Cancer Hospital of Shantou University Medical College, Shantou, China.
Jun WuDepartment of Clinical Oncology, The First People's Hospital of Changzhou, Changzhou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsDonafenib, a deuterium-modified sorafenib derivative, has improved survival outcomes in patients with advanced hepatocellular carcinoma (HCC). This study aimed to investigate the treatment-related adverse events and their associations with overall survival (OS) and time to progression (TTP) in patients with advanced HCC treated with donafenib.

methodsIn this retrospective analysis, data from 334 patients with unresectable or metastatic HCC who had a Child-Pugh liver function score ≤ 7 and had not received prior systemic treatment were collected from the ZGDH3 study. Donafenib (0.2 g) was administered orally twice daily until either intolerable toxicity or disease progression occurred. The associations between adverse events (AEs) and OS/TTP were analyzed using the Kaplan-Meier method, and statistical significance was tested using the log-rank test. A stratified Cox proportional hazards model was used to estimate hazard ratios (HR) and 95% confidence intervals (CIs).

resultsUnivariate analysis revealed that the median OS (mOS) was significantly longer in patients who experienced Grade 3 hand-foot skin reaction (HFSR), diarrhea, Grade ≥ 3 thrombocytopenia, hypertension, alopecia, rash, and proteinuria compared to those without these AEs (P < 0.05). Conversely, patients with fatigue and Grade ≥ 3 increased blood bilirubin had significantly shorter mOS than those without these AEs (P < 0.05). HFSR was associated with improved survival outcomes, with the mOS of patients with HFSR being 17.6 months, compared to 7.9 months in those without (HR = 0.498, 95% CI 0.384-0.648, P < 0.0001). The mOS was 14.2 months in patients with Grade ≥ 3 AEs, compared to 10.5 months in those without (HR = 0.687, 95% CI 0.442-0.802, P = 0.0061). There was no significant difference in the overall incidence of AEs between patients aged ≥ 65 and those < 65.

conclusionsThe occurrence of HFSR, diarrhea, thrombocytopenia, hypertension, alopecia, rash, proteinuria, fatigue, and Grade ≥ 3 increased blood bilirubin may be associated with the efficacy of donafenib in the treatment of advanced HCC, though these are exploratory associations and not established predictive markers. The AEs associated with donafenib are generally well tolerated, though further validation is needed. TRIAL REGISTRY: NCT02645981.

Indexed as

Antineoplastic AgentsCarcinoma, HepatocellularDrug-Related Side Effects and Adverse ReactionsLiver NeoplasmsPyridinesAdultAgedFemaleHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeAntineoplastic AgentsPyridinesAdverse EventsDeuteriumDonafenibHepatocellular carcinomaSorafenib

Identifiers

PMID41163129
PMCPMC12573851

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Registered trials

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